Gastroenterology Today Winter 2022

Volume 32 No. 4 

Winter 2022 

18 Week Support: 

Using patient comfort scores 

to improve endoscopy services

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CONTENTS 

CONTENTS 

4 EDITORS COMMENT 

10 FEATURE Comparison the effects and side effects 

of Covid-19 vaccination in patients with 

infl ammatory bowel disease (IBD): a systematic 

scoping review 

25 FEATURE Transient alterations in plasma sodium 

concentrations with NER1006 bowel preparation: 

an analysis of three phase III, randomized clinical 

trials 

29 COMPANY NEWS 

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Dr Andrew Poullis 

c/o Media Publishing Company 

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The views and opinions expressed in 

this issue are not necessarily those of 

the Publisher, the Editors or Media 

Publishing Company. 

Next Issue Spring 2023 

COVER STORY 

In this edition, Dr Matthew Banks, Clinical Lead 18 Week Support 

Gastroenterology, reports on increasing patient numbers being treated post- 

Covid and explores the opportunities for Quality Improvement in endoscopy 

services by auditing patient comfort scores and using those to drive 

measurable improvements in patient experience. 

Subscription Information – Winter 2022 

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GASTROENTEROLOGY TODAY - WINTER 2022 

3

EDITORS COMMENT 

EDITORS COMMENT 


“Waiting 

lists from the 

pandemic 

and ongoing 

Covid related 

admissions 

have hampered 

recovery 

efforts with 

all metrics of 

acute medical 

care, cancer 

diagnostics and 

treatment and 

management 

of chronic 

diseases 

all showing 

similar 

worrying 

trends.” 

Long Winter Ahead 

The health service is looking at a difficult few months ahead. With a nursing strike about 

to start, junior doctors about to be balloted about strike action and an on-going crisis with 

regards consultant terms and conditions leading to a senior doctor exodus from the NHS 

there are even more pressures than usual. 

Waiting lists from the pandemic and ongoing Covid related admissions have hampered 

recovery efforts with all metrics of acute medical care, cancer diagnostics and treatment 

and management of chronic diseases all showing similar worrying trends. 

Steve Barclay the present secretary of state for health and social care (in post at time 

of writing this) is the 5th MP to hold this post in 5 years - not a good sign for a large 

institution in need of stability and vision needing strong consistent leadership. Unfortunately 

the 5 key priorities identified in his first speech do not include anything on helping the 

present beleaguered workforce. Steve Barclay may well be keeping an eye on how Matt 

Hancock fares in his winter sun break - a reported £400,000 fee may temp future ex-health 

secretaries to look at this in their retirement plan. 

With so many problems on our doorstep the wider impact of healthcare on broader concerns 

such as global environmental issues barely get a seat at the table. As gastroenterologists it 

only takes a quick look at the waste generated by every endoscopy list to start to get a feel 

for the size of the problem. Unfortunately the solution will not be cheap (potato starch biodegradable 

medical aprons are around 40% more expensive than conventional plastic ones). 

In a resource poor environment this sort of change will always be low priority. 

A persistent focus on short term “fi xes” means we can expect all winters to be a permanent 

crisis and healthcare engagement with wider global issues to be limited/absent. 

A Poullis 

4

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VSL/22/005. Date of Preparation: October 2022. 

1. Cancello R, et al. Nutrients 2019, 11, 3011. 

2. Vecchione A, et al. Front Med. 2018;5(59). doi: 10.3389/fmed.2018.00059. 

3. Singh G, et al. 2021 Clinical Nutrition ESPEN 47 (2022) 70-77.

ADVERTORIAL FEATURE 

WORKING TOWARDS QUALITY 

STANDARDISATION FOR FAECAL 

IMMUNOCHEMICAL TESTING 

Alpha Laboratories recently held a FIT user group meeting that 

was attended by some of the leading laboratories who utilise 

the HM-JACKarc technology for their faecal immunochemical 

testing service. Key speakers discussed their challenges and 

contributions towards standardisation and quality in FIT testing. 

So far, work has been completed to establish the current status of four 

automated FIT systems (5): HM-JACKarc (Minaris Medical Co. Ltd, 

Japan): OC-Sensor PLEDIA (Eiken Chemical Co. Ltd, Japan); SENTiFIT 

270 (Sentinel Diagnostics, Italy), NS-Prime (Alfresa Pharma, Japan); 

data show that all analysers met manufacturers’ claims. 


6 

FIT Quality Assurance 

Carolyn Piggott, FIBMS, Research Scientist, Bowel Cancer Screening 

Programme (BCSP), Southern Hub, Guildford 

Carolyn Piggott presented on the factors that contribute towards the 

pre-analytical and laboratory challenges faced in FIT testing. The major 

contributors are the differences in faecal samples, inconsistent sampling 

by participants and haemoglobin (Hb) stability in faeces. In addition 

to sample variability, there is no FIT assay standardisation. Different 

reagents are used between each manufacturer and there is no primary 

reference materials of methodologies. The lack of standardisation or 

harmonisation of FIT means that variations are observed in f-Hb results 

generated on different systems. 

Carolyn mentioned a range of approaches to tackle these challenges. 

One development is that manufacturers have developed new buffers 

focused on improved sample stability. Also projects are being 

undertaken at BCSP Guildford, which include evaluation of the available 

EQA (1), third party internal QC (2) and the effect of Hb-variants (3). In 

addition, they are working in conjunction with the IFCC FIT Working 

group, established in 2017, to formally address the challenges 

(representatives from other manufacturers, clinical scientists, and 

representatives from EQA companies) according to the references 

below(4): 

Terms of Reference 

• To attempt to standardise analysis of haemoglobin in faecal samples 

by immunochemistry (FIT) 

• To identify all sources of pre-analytical variation and standardise if 

possible 

• To establish external quality assurance and third-party internal quality 

control programmes 

• To determine impact of assay interference of Hb variants and other 

factors 

Additionally, EQA programmes investigated types and imprecision of 

EQAS available worldwide. 13 manufacturers of EQA were identified 

and 11 agreed to take part, to either provide: faecal-like material 

loaded by participants (UK NEQAS and HECTEF, Japan), faecal-like 

material loaded by EQA provider (WEQAS and CEQAL, Canada), or 

aqueous material loaded directly onto the analysers in cups (CRB, 

Italy, ESFEQA, Germany, Labquality, Finland, SEKK, Czech Republic, 

SEQC, Spain, SKML, Netherlands). Results showed that faecal-like 

matrices have larger coefficient of variant (CVs), and liquid materials 

have smaller CVs. 

Carolyn also reported on the evaluation of QC material from each FIT 

manufacturer, measured on the other three analysers, and the CVs 

were overall


Current Status and Future Plans for the UK 

NEQAS for Faecal Haemoglobin 

Finlay MacKenzie, Director of Birmingham Quality, an NHS Department 

within University Hospitals Birmingham 

Finlay defined External Quality Assessment as a retrospective 

assessment of quality – 

‘EQA is an independent assessment of quality and is an essential 

component of an accredited laboratory’s governance system and 

assesses the performance of in-vitro diagnostic examination procedures.’ 

Part of the role of EQA is to assess the stability of diagnostic tests over time, 

this includes the Alpha Laboratories’ HM-JACKarc system, in comparison 

to other faecal haemoglobin (f-Hb) detection systems that are available. 

EQA aims to send representative patient samples to a network of national 

laboratories. Finlay shared his observations on the variations associated 

with differing f-Hb cut-offs between the National Screening Hubs and how 

critical it is to ensure homogeneity of a specimen for true representation. He 

shared his concerns about the large differences in numerical data between 

FIT testing methodologies, although this is not limited to f-Hb testing, as it 

also affects most other clinical chemistry tests, so it is a wider problem. 

Furthermore, the stability of samples may affect the uniformity of 

assessments as he expanded on the fact that biological samples may 

not respond in the same way all the time due to: 

• Tolerance limits 

• Manufacturing systems 

• Presence of antibodies 

Lastly, adapting to the clamour for ‘sanitisation’ by both patients and 

laboratories is also a challenge. Having a pre-filled cartridge assumes 

that the sample was taken correctly, and you have to take on trust that it 

was an accurate representative sample of the whole, real, stool. 

Overall, EQA aims to evaluate the entirety of the process and not just the 

relatively simple, well controlled parts, like the analysis itself. That said, 

all EQA providers aim to send easy-to-use materials to laboratories, 

in order to provide a sample type that is representative of what the 

laboratory routinely receives. 

Find out more about support for your FIT service at 

www.faecal-immunochemical-test.co.uk 

References 

1. O’Driscoll S, Piggott C, Bruce H, Benton SC. An evaluation of ten 

external quality assurance scheme (EQAS) materials for the faecal 

immunochemical test (FIT) for haemoglobin. Clinical chemistry and 

laboratory medicine. 2020;59(2):307-13. 

2. Piggott C, Shugaa Z, Benton SC. Independent internal quality 

control (IQC) for faecal immunochemical tests (FIT) for haemoglobin: 

use of FIT manufacturers’ IQC for other FIT systems. Clinical 

chemistry and laboratory medicine. 2020. 

3. Carroll MR, John C, Mantio D, Djedovic NK, Benton SC. An 

assessment of the effect of haemoglobin variants on detection by faecal 

immunochemical tests. Annals of clinical biochemistry. 2018;55(6):706-9. 

4. Benton SC, Symonds E, Djedovic N, Jones S, Deprez L, Kocna 

P, et al. Faecal immunochemical tests for haemoglobin: Analytical 

challenges and potential solutions. Clinica chimica acta; international 

journal of clinical chemistry. 2021;517:60-5. 

5. Piggott C, Carroll MRR, John C, O’Driscoll S, Benton SC. Analytical 

evaluation of four faecal immunochemistry tests for haemoglobin. 

Clinical chemistry and laboratory medicine. 2020;59(1):173- 

6. Benton SC, Piggott C, Zahoor Z, O’Driscoll S, Fraser CG, D’Souza 

N, et al. A comparison of the faecal haemoglobin concentrations 

and diagnostic accuracy in patients suspected with colorectal 

cancer and serious bowel disease as reported on four different 

faecal immunochemical test systems. Clinical chemistry and 

laboratory medicine. 2022;60(8):1278-86. 


7

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A COST-EFFECTIVE SOLUTION 

FOR IMMEDIATE IDENTIFICATION 

OF GASTRIC CANCER RISK 

Improving gastric cancer survival rates requires timely 

detection to enable proactive therapeutic interventions. 

Currently, late diagnosis means that only 21 % of UK 

patients identified as having gastric cancer survive longer 

than five years, but this figure could increase to 65 % with 

earlier medical care. 1 However, standard gastrointestinal 

diagnostic methods – like endoscopies and biopsies – place 

a considerable burden on the healthcare system, highlighting 

a need for an efficient investigative pathway for digestive 

complaints. 

The challenge of diagnosing gastric cancer 

Gastric carcinogenesis is a lengthy multi-step process, called the 

‘Correa’s Cascade’, 2,3 that begins with chronic H. pylori infection 

and progresses through multiple stages of infl ammation, wasting 

of healthy mucosa, and propagation of abnormal gastric cells. 

There is a small window of opportunity within this disease cycle for 

prompt detection and action to prevent the cascade from advancing. 

However, the diverse presentation of gastrointestinal disorders makes 

early-stage stomach cancer diffi cult to identify. Many patients with 

serious pathological changes to their stomach lining have few or no 

symptoms, so those most at risk of progression to gastric cancer are 

not easily identifi able. 4 Conversely, individuals who present with nonspecifi 

c stomach complaints – ranging from mild discomfort to nausea 

and vomiting – are often sent straight for endoscopy unnecessarily. 

Drawbacks of gastroscopies 

The key to cost-effective diagnosis 

GastroPanel ® , a simple blood test produced by BIOHIT HealthCare, 

measures a combination of these biomarkers – pepsinogen I, 

pepsinogen II, gastrin-17 and H. pylori IgG – in order to establish gastric 

cancer risk and highlight individuals who would benefi t from further 

examination. Initial analysis of gastrointestinal status with GastroPanel 

could reduce reliance on precious NHS gastroscopy resources by up 

to 90 %, enabling early detection and proactive treatment to reduce 

waiting times and improve care pathways for more vulnerable patients. 

And, at a cost of just £30 per test, employing GastroPanel in primary 

and secondary care settings has the potential to cut annual procedural 

costs to only £14.4 million, saving the NHS an incredible £69 million 

each year. 

To find out more about BIOHIT HealthCare’s GastroPanel®, visit: 

https://biohithealthcare.co.uk/biohit-product/gastropanelpepsinogen-i-pepsinogen-ii-h-pylori-igg-and-gastrin-17-elisas/ 

References 

1. Cancer Research UK, https://www.cancerresearchuk.org/healthprofessional/cancer-statistics/statistics-by-cancer-type/stomachcancer/survival#heading-Three. 

Accessed 25 th October 2022. 

2. Correa P, Haenszel W, Cuello C, et al. A model for gastric cancer 

epidemiology. Lancet. 1975;2(7924):58-60. doi: 10.1016/s0140- 

6736(75)90498-5. PMID: 49653. 

3. Correa P. A human model of gastric carcinogenesis. Cancer Res. 

1988;48(13):3554-60. PMID: 3288329. 

Endoscopy is the standard technique for identifying atrophic gastritis 

and related gastric cancer lesions. However, use of gastroscopy as 

a fi rst-line diagnostic tool places a signifi cant burden on the NHS, 

as this method is resource heavy, labour intensive and tends to be 

poorly accepted by patients due to its invasive nature. In addition, 

at a cost of £436 per procedure, 5 conservative calculations show 

that gastroscopies could be responsible for over £84 million of the 

NHS annual spend, based on the estimate that 3,000 diagnostic 

oesophagogastroduodenoscopies (OGDs) are performed per 250,000 

people each year. 6 With this in mind, researchers have identifi ed 

several serological biomarkers that can effectively characterise 

key aspects of gastric mucosal health before any more substantial 

investigation is required, directing treatment when milder conditions 

are indicated and identifying at-risk patients for whom endoscopy may 

be necessary. 

4. Chapelle, N., Petryszyn, P., Blin, J., et al. A panel of stomachspecifi 

c biomarkers (GastroPanel ® ) for the diagnosis of atrophic 

gastritis: A prospective, Multicenter Study in a low gastric cancer 

incidence area. Helicobacter. 2020;25(5):e12727. doi: 10.1111/ 

hel.12727. 

5. NHS England. 2022/23 National Tariff Payment System: Annex A - 

National tariff workbook. https://www.england.nhs.uk/wp-content/ 

uploads/2020/11/22-23NT_Annex-A-National-tariff-workbook_ 

Apr22.xlsx. Accessed 10 th November 2022. 

6. Beg S, Ragunath K, Wyman A, et al. Quality standards in upper 

gastrointestinal endoscopy: a position statement of the British 

Society of Gastroenterology (BSG) and Association of Upper 

Gastrointestinal Surgeons of Great Britain and Ireland (AUGIS). Gut. 

2017;66(11):1886-1899. doi: 10.1136/gutjnl-2017-314109. 


9

FEATURE 

COMPARISON THE EFFECTS AND SIDE EFFECTS 

OF COVID-19 VACCINATION IN PATIENTS WITH 

INFLAMMATORY BOWEL DISEASE (IBD): 

A SYSTEMATIC SCOPING REVIEW 

Elham Tabesh 1 , Maryam Soheilipour 1 , Mohammad Rezaeisadrabadi 1 , Elahe Zare-Farashbandi 2 and Razieh Sadat 

Mousavi-Roknabadi 3,4* 

BMC Gastroenterology volume 22, Article number: 393 (2022) https://doi.org/10.1186/s12876-022-02460-1 

Abstract 

Introduction 


Covid-19 is a pandemic disease that is more severe and mortal in 

people with immunodeficiency, such as those with inflammatory bowel 

disease (IBD). On the other hand, no definitive treatment has been 

identified for it and the best way to control it is wide spread vaccination. 

The aim of this study was to evaluate the benefits and side effects of 

different vaccines in patients with IBD. Three Electronic databases 

[Medline (accessed from PubMed), Scopus, Science Direct, and 

Cochrane] were searched systematically without time limit, using MESH 

terms and the related keywords in English language. We focused on the 

research studies on the effect and side effects of Covid-19 vaccination 

in patients with IBD. Articles were excluded if they were not relevant, or 

were performed on other patients excerpt patients with IBD. Considering 

the titles and abstracts, unrelated studies were excluded. The full texts 

of the remained studies were evaluated by authors, independently. Then, 

the studies’ findings were assessed and reported. Finally, after reading 

the full text of the remained articles, 15 ones included in data extraction. 

All included studied were research study, and most of them (12/15) had 

prospective design. Totally, 8/15 studies were performed in singlecenter 

settings. In 8/15 studies, patients with IBD were compared with 

a control group. The results were summarized the in two categories: (1) 

the effect of vaccination, and (2) side effects. The effect of vaccination 

were assessed in 13/15 studies. Side effects of Covid-19 vaccination 

in patients with IBD were reported in 7/15 studies. Patients with IBD 

can be advised that vaccination may have limited minor side effects, 

but it can protect them from the serious complications of Covid-19 and 

its resulting mortality with a high success rate. They should be also 

mentioned in booster doses. 

Highlights 

Studies showed that the risk of developing Covid-19 is more worrying 

in people with immunocompromised conditions, such as inflammatory 

bowel disease (IBD). On the other hand, no definitive treatment has been 

identified for it and the best way to control it is wide spread vaccination. 

The results of this systematic scoping review revealed that patients with 

IBD can be advised that vaccination may have limited minor side effects, 

but it can protect these patients from the serious complications of 

Covid-19. Also, they should be also mentioned in booster doses. 

Keywords: Side effects, Covid-19 vaccines, Immunity, Inflammatory 

bowel disease 

Covid-19 is a contagious disease which causes numerous deaths 

throughout the world and known as a pandemic disease without definite 

treatment. Based on current World Health Organization’s statistics, the 

number of affected population is more than 505 million; and more than 6 

million died from the disease [1-3]. Despite scientists’ efforts and global 

vaccination against the disease, new strains of the virus are emerging 

and spreading like: alpha, beta, gamma, delta, and Omicron, which 

challenge the treatment [4]. 

In spite of its virulence pattern, the disease transfer extremely rapid and 

causes complications such as respiratory distress, cardiac condition 

and liver failure [2, 5-7]. Furthermore, the risk of developing this disease 

is more worrying in people with immunocompromised conditions. 

Such as other communicable infections, it causes concern among 

gastroenterologists for patients who are affected by inflammatory bowel 

disease (IBD) [8]. This concern is arising due to statistics that showed 

more than 6.8 million people worldwide have IBD and this prevalence is 

increasing [9]. 

Immunosuppressive therapeutic regimens are the most common 

treatment for IBD which make the patient more prone to infection. 

Severe pulmonary disease like previously diagnosed pattern including 

pneumonia and acute respiratory distress syndrome (ARDS) with 

various imaging findings is the most mortal complication which was 

characterized by the activation of the inflammatory cascade and an 

increase in inflammatory factors such as C-reactive protein (CRP) and 

interleukin [10-12]. Hence, there is a possibility that patients with IBD 

are more vulnerable to affect with Covid-19 due to immunosuppressive 

drugs that they have consumed as IBD therapy [8]. 

According to the growing number of IBD patients, widespread and rapid 

change of Covid-19 variants, and current challenges on effectiveness 

of Covid-19 on patients with IBD [13, 14], this study aims to conduct 

a systematic review on the effectiveness of Covid-19 vaccine and its 

complications in IBD patients. 

Materials and methods 

The current systematic scoping review was performed based on the 

recommendations of the Preferred Reporting Items for Systematic 

10 

* Correspondence: mousavi_razieh@sums.ac.ir 

3 

Emergency Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran 

© The Author(s) 2022.

FEATURE 

Included Eligibility Screening 

Identification 

Included Eligibility Screening 

Identification 

Records identified through database 

searching 

(n=164) 

Recordsafter duplicates removed 

(n=147) 

Full-text articles assessed for 

Recordsafter eligibility duplicates removed 

(n=147) (n=20) 

Studies included in 

qualitative Records screened synthesis 

(n=147) (n=15) 

Additional records identified through 

other sources 

(n=48) 

Records identified through database 

Additional records identified 

Records screened 

Records through excluded through 

searching 

other sources 

(n=147) 

reading titles and abstracts 

(n=164) 

(n=48) 

(n=127) 

Fig. 1 Preferred reporting items for systematic reviews and meta-analyses (PRISMA) flow diagram of the study 

Full-text articles excluded, 

with reasons 

(n=5) 

Records excluded through 

reading titles and abstracts 

(n=127) 

Full-text articles assessed for 

Full-text articles excluded, 

Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA- eligibility literature in English. To ensure literature with saturation, reasons the reference lists 

ScR) Table statement 1 Search [15]. strategy used in the present study 

(n=20) of the included studies or relevant reviews (n=5) identified through the search 

were scanned. All the following searches were conducted by two 

PubMed 

Data sources 

authors [RSM, MR]. 

(((ulcerative colitis) OR (Crohn’s disease)) OR ("Inflammatory bowel disease")) AND (Covid-19 vaccine)Scopus: 

As was TITLE(covid shown OR in Fig. corona 1, a OR multi-step sars cov 2) search AND TITLE-ABS-KEY(methanol strategy was OR alcohol) 

implemented. Scopus The electronic literature searches were conducted Studies included Study in eligibility criteria 

to identify ( TITLE-ABS-KEY all relevant ( "ulcerative studies on colitis") Medline OR TITLE-ABS-KEY (accessed from ( "Crohn’s PubMed), qualitative disease") OR synthesis TITLE-ABS-KEY We focused on ( "Inflammatory the research bowel studies disease") on the AND effect TITLE-ABS-KEY and side effects ( of 

"Covid-19 vaccine")) 

Scopus, Science Direct, and Cochrane without time limit, using (n=15) Covid-19 vaccination in patients with IBD. Articles were excluded if they 

Science Direct 

MESH terms and the related keywords (Table 1). Google Scholar and were not relevant, or were performed on other patients excerpt patients 

"Ulcerative colitis" "Crohn’s disease" "Covid-19 vaccine" "Inflammatory bowel disease" 

researchgate.net Fig. 1 Preferred were reporting also reviewed items for manually systematic to reviews explore and the meta-analyses grey (PRISMA) with IBD, flow through diagram reading of the the study titles and the abstracts [MR, RSM, ET]. 

Cochrane 

"ulcerative colitis" "Covid-19 vaccine" 

"Crohn’s disease" "Covid-19 vaccine" 

"Inflammatory bowel disease" "Covid-19 vaccine" 

Table 1 Search strategy used in the present study 

PubMed 

(((ulcerative colitis) OR (Crohn’s disease)) OR ("Inflammatory bowel disease")) AND (Covid-19 vaccine)Scopus: 

TITLE(covid OR corona OR sars cov 2) AND TITLE-ABS-KEY(methanol OR alcohol) 

Scopus 

( TITLE-ABS-KEY ( "ulcerative colitis") OR TITLE-ABS-KEY ( "Crohn’s disease") OR TITLE-ABS-KEY ( "Inflammatory bowel disease") AND TITLE-ABS-KEY ( 

"Covid-19 vaccine")) 

Science Direct 

"Ulcerative colitis" "Crohn’s disease" "Covid-19 vaccine" "Inflammatory bowel disease" 

Cochrane 

"ulcerative colitis" "Covid-19 vaccine" 

"Crohn’s disease" "Covid-19 vaccine" 

"Inflammatory bowel disease" "Covid-19 vaccine" 


11

FEATURE 

Participants, and interventions 

The target population were all patients with IBD. 

(5/15) [17-20, 27], following by Fatigue/malaise (4/15) [17, 18, 20, 27] 

and Myalgia (4/15) [17, 18, 20, 27]. 

Study appraisal and synthesis methods 

Full texts of the studies were evaluated by three authors [MR, ET, RSM]; 

they decided whether these met the inclusion criteria, independently. 

They resolved any disagreement through discussions, and finally the 

articles were selected based on consensus. Neither of the authors were 

blind to the journal titles or to the study authors or institutions. Then, the 

level of evidence of each study was determined [16]. The following data 

were extracted from the included studies and recorded in a Microsoft 

Excel sheet, 2016: study authors, country, title, methods, sample size, 

and main findings [MS, EZ, RSM, ET, MR]. 

Ethical issues 

Ethical issues (including plagiarism, informed consent, misconduct, data 

fabrication and/or falsification, double publication and/or submission, 

redundancy, etc.) have been completely observed by the authors. 

Discussion 

In this systematic scoping review, fifteen studies were assessed, which 

that the obtained results were summarized in two areas. Here, we will 

discuss the findings. 

The effect of vaccination 

Caldera et al. revealed that all control group and 97% of patients with 

IBD developed antibodies. Antibody concentrations were lower in 

patients with IBD. Those who received Moderna had higher antibody 

concentrations compared with those who received the Pfizer vaccine 

series. Also, patients on immunemodifying therapy had lower antibody 

concentrations compared with those who were on no treatment, 

aminosalicylates, or vedolizumab [14]. 


Results 

In total, 212 (69 articles in Medline, 60 articles in Scopus, 33 article 

from Science Direct, 2 articles from Cochrane, and 48 articles from 

other resources) were achieved at the first step search. After initial 

assessment, 65 duplications were found. After the identification and 

the screening, 147 articles were selected as potential studies. After 

reading the full text of these articles, 15 articles formed the final sample 

and considered for the final data extraction [10, 14, 17-29]. Interrater 

agreement following the first round of screening between the 

investigators was 85% (Cohen’s k =0.67). Within the second round 

of screening, inter-rater agreement rose to 100%. Table 2 shows the 

summary of these studies. 

Thirteen (13/14) studies were peer-reviewed [10, 14, 17-24, 26-29] 

and 1/14 of them was in-review article [25]. All included studied were 

research study, and 12/15 had prospective design [10, 14, 17, 19-24, 

26-29] and 4/15 were based on registries [10, 17, 21, 24]. Totally, 8/15 

studies were performed in single-center settings [14, 18, 20, 22, 25, 

27-29]. In 8/15 studies, patients with IBD were compared with a control 

group [10, 14, 18, 19, 21, 25, 27, 28]. 

The studied patients were vaccinated with one of mRNA SARS-CoV-2 

such as. 

Pfizer (mRNA), Moderna (mRNA), Janseen & AstraZeneca (vector), 

and AstraZeneca (vector). One study mentioned the most prevalent 

causes of vaccination refusal in patients with IBD, such as fear of side 

effects, lack of confidence in the vaccine development process, and little 

information about vaccination [20]. We summarized the results in two 

categories: (1) the effect of vaccination, and (2) side effects. 

The effect of vaccination were assessed in 13/15 studies [10, 14, 18, 

19, 21-24, 26-29]. Measuring antibodies was performed in 10/15 

studies [14, 18, 19, 22-24, 26-29]. Side effects of Covid-19 vaccination 

in patients with IBD were reported in 7/15 studies [17-21, 27, 28]. The 

mentioned side effects in evaluated articles are presented in Table 3. 

Localized injection-site were the most common side effect in the studies 

Also, Cerna et al. stated that the post vaccine seropositivity rate among 

IBD patients and controls was 97.8% vs 100%. Median anti-Covid-19 

IgG levels were lower among IBD recipients of AstraZeneca compared 

with 2 other vaccines and control AstraZeneca recipients. These were 

no correlation between serum trough levels and anti-Covid-19 IgG 

concentrations for any of the biological drugs used. The TNF-α inhibitors 

with concomitant immunosuppressive treatmen,t but no other treatment 

modalities were associated with a lower postvaccination antibody 

response. The laboratory activity of IBD evaluated by C-reactive 

protein and fecal calprotectin levels. However, there were no significant 

differences before the vaccination and 8 weeks after its completion [28]. 

Classen et al. reported that all patients with IBD (100%) developed an 

immune response after full vaccination. Also, there was no significant 

difference in antibody levels between the 3 different vaccines received 

upon first vaccination. The kind of IBD disease and medication had 

no significant effect on the level of antibody titers. Also, they found 

that compared to the healthy group, reduced antibody response was 

detected. There was no vaccination failure in the IBD group after 2 

doses vaccinations. In patients with IBD, antibody titers were positively 

associated with days between last vaccination and blood sample taken, 

whereas in the control group, antibody titers negatively correlated 

with the days after dose 1. Moreover, the days between two doses of 

vaccination had no impact on antibody response in both groups [18]. 

Similarly, Levin et al. showed a 95% overall response rate after Covid-19 

vaccination. Also, none of the patients with positive results for spike 

domain antibodies had elevations of nucleocapsid antibodies, suggesting 

a true vaccine response rather than prior undiagnosed infection. In 

patients with elevated spike domain antibodies (a true vaccine response 

rather than prior undiagnosed infection), 89% had the highest measurable 

levels, at > 250.00 U/mL, with assay reference ranges of 0.79 U/mL 

indicating negative and 0.80 U/mL (positive results) [29]. 

Lev-Tzion et al. indicated that overall 0.3% developed Covid-19 

after vaccination. Infection rates were slightly higher in the 

unvaccinated IBD patients compare to non IBD patients. 

Also, patients on tumor necrosis factor (TNF) inhibitors and/or 

corticosteroids did not have a higher incidence of infection. 

12

FEATURE 

Table 2 An overview of studies included in this systematic scoping review and their main findings 

Authors (year) Title Aim Sample size Method Treatment drugs Vaccine type Effects Side effects Conclusion Level of 

evidence 

Botwin et al. [17] Adverse Events 

After SARS-CoV-2 

mRNA Vaccination 

Among Patients With 

Inflammatory Bowel 

Disease 

To evaluate postmRNA 

vaccination 

adverse events in 

vaccinated adults 

with IBD patients. 

246 (67% CD, 33% 

indeterminate or UC) 

Prospective 

web-based 

survey in a 

longitudinal 

vaccine 

registry 

Sulfasalazine/ 

mesalamine, 

budesonide, oral/ 

parenteral Steroids, 

Mercaptopurine 

Azathioprine monotherapy, 

Methotrexate 

monotherapy, 

anti- Tumor necrosis 

factor (TNF) without 

Mercaptopurine/ 

Azathioprine/ 

methotrexate, anti- 

TNF + Mercaptopurine/ 

Azathioprine/ 

Methotrexate, antiintegrin, 

IL12/23 

inhibitor Janus 

kinase (JAK) inhibitor, 

Mesalamine 

Pfizer, Moderna 

Similar to general population 

More common among younger patients 

More common in patients with prior 

Covid-19 

Less common in patients receiving 

biologic therapy Age was associated 

with side effects after dose 1 (OR=0.97, 

P=0.015), suggesting reduced AE risk 

with each year of advancing age 

Significant side effects associations 

after dose 2 included age (OR=0.97, 

P=0.018) and biologic status (OR=0.32, 

P=0.049), suggesting a reduced side 

effects risk among biologic recipients, 

independent of age 

Injection-site 

symptoms, 

Fatigue/ 

malaise, 

Headache/ 

dizziness/ 

lightheadedness, 

fever/ 

chills, Muscle/ 

bone/joint/ 

nerve symptoms, 

Gastrointestinal 

symptoms 

(including 

nausea, vomiting, 

diarrhea), 

Sleep 

changes, 

Swollen 

lymph node, 

Skin/nail or 

face changes, 

Eye/ear/ 

mouth/throat 

changes, 

cough, chest/ 

breathing 

symptoms, 

memory/ 

mood 

changes 

IBD and other 

immune-mediated 

inflammatory diseases 

on immunosuppressive 

and biologic 

therapies can be reassured 

that the adverse 

events risk is likely not 

increased, and may 

be reduced, while on 

biologics. 

III 

Caldera et al. [14] Humoral Immunogenicity 

of mRNA 

Covid-19 Vaccines 



Disease and Healthy 

Controls 

To evaluate humoral 

immunogenicity of 

mRNA coronavirus 

disease 2019 (Covid- 

19) vaccines among 

patients with IBD 

and healthy controls. 

182 (122 in IBD 

group, 60 in control 

group) 

Prospective 

study 

Mesalamine monotherapy, 

Vedolizumab monotherapy, 

Thiopurine, 

Anti-TNF therapy, 

Anti-TNF combination, 

Ustekinumab 

monotherapy 

or combination, 

Tofacitinib, 

Corticosteroid 

therapy 

Moderna, 

Pfizer 

All control group and 97% of patients 

with IBD developed antibodies 

Antibody concentrations were lower in 


Those who received Moderna had 

higher antibody concentrations compared 

with those who received the Pfizer 

vaccine series 

Patients on immunemodifying therapy 

had lower antibody concentrations 

compared with those who were on 

no treatment, aminosalicylates, or 

vedolizumab 

Not reported Almost all patients 

with IBD in our study 

mounted an antibody 

response. 

II 


13

FEATURE 


Table 2 (continued) 


evidence 

Cerna et al. [28] Anti-SARS-CoV-2 

Vaccination and 

Antibody Response 

in Patients With 


Disease on Immunemodifying 

Therapy: 

Prospective Single- 

Tertiary Study 

To evaluate the rate 

and magnitude of 

seroconversion, 

assess the effect of 

different immunemodifying 

treatment 

modalities on the 

magnitude of 

anti-SARS-CoV-2 IgG 

antibody levels, and 

analyze the impact 

of anti-SARS-CoV-2 

vaccination on 

the inflammatory 

biomarkers of IBD. 

770 (602 in IBD 

group, 168: control 

group) 

Prospective 

study 

Infliximab, 

Adalimumab, 

Vedolizumab, 

Ustekinumab, Tofacitinib, 

Thiopurines 

monotherapy, 

5-ASA monotherapy 

Pfizer, Moderna, 

AstraZeneca 

The post vaccine seropositivity rate 

among IBD patients and controls was 

97.8% vs 100% 

Median anti-Covid-19 IgG levels were 

lower among IBD recipients of AstraZeneca 

compared with 2 other vaccines and 

control AstraZeneca recipients 

No correlation was found between 

serum trough levels and anti-Covid-19 

IgG concentrations for any of the biological 

drugs used 

The TNF-α inhibitors with concomitant 

immunosuppressive treatment but 

no other treatment modalities were 

associated with a lower postvaccination 

antibody response 

The laboratory activity of IBD evaluated 

by C-reactive protein and fecal calprotectin 

levels, and no significant differences 

were found before the vaccination 

and 8 weeks after its completion 

Not reported It is necessary to 

particular attention 

to the anti-Covid-19 

vaccination of IBD 

patients treated with 

TNF-α inhibitors with 

concomitant immunomodulators 

IBD patients can 

continue their highefficacy 

immunemodifying 

therapy 

even during the 

anti-SARS-CoV-2 vaccination 

In limited access areas, 


should be encouraged 

to receive any readily 

available vaccine 

mRNA vaccines are 

preferred for patients 

with IBD. 

II 

Classen et al. [18] Anti-SARS-CoV-2 

Vaccination and 

Antibody Response 



Disease on Immunemodifying 

Therapy: 

Prospective Single- 

Tertiary Study 

To investigate 

antibody response 

to SARS-CoV-2 vaccination 

in patients 

with IBD receiving 

immunomodulators 

or biologics 

compared to healthy 

controls. 

144 (72 in IBD group: 

55.6% CD and 44.4% 

UC, and 72 in control 

group) 

Retrospective 

observational 

design 

Steroids, Mesalazine, 

Azathioprine, 

Methothrexate, 

Calcineurin inhibitor, 

TNF blocker, Integrin 

inhibitor, JAK inhibitor, 

Ustekinumab 

Pfizer, Moderna, 

AstraZeneca 

All patients with IBD developed an 

immune response after full vaccination 

There was no significant difference in 

antibody levels between the 3 different 

vaccines received upon first vaccination 

Compared to the healthy group, 

reduced antibody response could be 

detected 

There was no vaccination failure in the 

IBD group after 2 vaccinations 

There was a trend to a reduced immune 

response in elderly patients 

Muscle pain, 

Fever, Joint 

pain, Local 

redness, Pain 

injection side, 

Fatigue, Nausea/vomiting, 

Diarrhea 

A 100% antibody 

response to vaccination 

against Covid-19 

in patients with IBD 

and immunomodulatory 

therapies after 2 

vaccinations. Antibody 

response was high in 

IBD patients even after 

the first vaccination 

– however, antibody 

levels were lower in 

IBD patients compared 

to controls. Overall, 

vaccination was well 

tolerated and no 

further or new adverse 

events were detected 

in IBD patients 

compared to healthy 

controls. 

III 

14

FEATURE 



evidence 

Edelman-Klapper 

et al. [19] 

Lower Serologic 

Response to 

Covid-19 mRNA 

Vaccine in 

Patients With 

Inflammatory 

Bowel Diseases 

Treated With 

Anti-TNFalpha 

To assess serologic 

responses 

to BNT162b2 in 


stratified according 

to therapy, 

compared with 

healthy controls. 

258 (185 in IBD 

group, 73 in 

control group) 

Patients with 

IBD were divided 

to 2 separate 

groups: anti-TNFa 

group (67) and 

non-anti-TNFa 

group (118) 

Prospective 

controlled 

study 

Infliximab, Adalimumab, 

Vedolizumab, 

Ustekinumab, 

5-ASA, 

Corticosteroids, 

Immunomodulatorsc, 

JAK 

inhibitor 

Pfizer Covid- anti-S IgG antibodies in all 

control group were seropositive, 

whereas about 7% of patients 

with IBD, regardless of treatment, 

remained seronegative after dose 

1, and it was positive in all patients 

after dose 2 

Anti-TNFa treatment was associated 

with significantly lower antibody 

levels 

Neutralizing and inhibitory functions 

were both lower in anti-TNFa treated 

Anti-TNFa drug levels and vaccine 

responses did not affect anti-spike 

levels 

IBD activity was unaffected by vaccination 

Only anti-TNFa treatment and older 

age maintained a significant distinct 

association with lower IgG anti-S 

response 

Local 

pain, 

Headache 

All patients 

mounted serologic 

response to 2 

doses of vaccination. 

Its magnitude 

was significantly 

lower in patients 

treated with anti- 

TNFa, regardless 

of administration 

timing and drug 

levels. Vaccine was 

safe. As vaccine 

serologic response 

longevity in this 

group may be 

limited, vaccine 

booster dose 

should be considered. 

II 

Garrido et al. [20] "Safety of Covid-19 

vaccination in 

inflammatory bowel 

disease patients on 

biologic therapy" 

To assess adverse 

events of Covid-19 

vaccination among 

IBD patients. 

239 (76.7% CD and 

23.3% UC) 

Cohort/ reallife 

survey: 

telephone 

questionnaire 

TNF inhibitors, 

Ustekinumab, 

Vedolizumab 

Pfizer, 

Moderna, 

Janssen and 

AstraZeneca 

Not reported Pain /redness/ 

Swelling 

State of 

sleep/fatigue 

Headache 

Myalgia 

Fever 

Joint pain 

Nausea/vomiting 

Diarrhea 

Abdominal 

pain 

IBD exacerbation 

A high acceptance 

rate and a good safety 

profile of Covid-19 

vaccination in IBD 

patients treated with 

biologics 

Adverse effects were 

common but overall 

mild and transitory. 

IV 


15

FEATURE 




evidence 

Hadi et al. [21] Covid-19 Vaccination 

Is Safe and Effective 



Disease: Analysis of 

a Large Multi-institutional 

Research 

Network in the 

United States 

To assess safety and 

efficacy of Covid-19 

vaccination in 

patients with IBD in 

comparison 

with the general 

population without 

IBD. 

864,575, 

(5562 patients 

with prior diagnosis 

of IBD: 2933 UC, 

2629 CD) 

Retrospective 

study 

Biologics/thiopurines 


Similar in adverse events of special interest 

and a new diagnosis of Covid-19 in 

two groups 

Similar in the 30-day hospitalization after 

the Covid-19 vaccination, after matching 

Similar in steroid prescription at the 

1 month follow-up in vaccinated and 

unvaccinated patients with IBD in 

unmatched and matched analysis 

Similar in 30-day adverse events of 

special interest after the vaccination 

between patients with IBD with and 

without biologic or immunomodulator 

use, and also between patients with CD 

and UC 

Similar in steroid use after vaccination 

was found between patients with and 

without biologic or immunomodulator 

use, or both, and between patients with 

CD and UC 

Special 

adverse 

events of 

interest 

include: acute 

myocardial 

infarction, 

anaphylaxis, 

facial 

nerve palsy, 

coagulopathy, 

deep vein 

thrombosis, 

pulmonary 

embolism, 

Guillain-Barré 

syndrome, 

transverse 

myelitis, 

immune 

thrombocytopenia, 

disseminated 

intravascular 

coagulation, 

myocarditis, 

pericarditis, 

hemorrhagic 

stroke, 

nonhemorrhagic 

stroke, 

appendicitis, 

narcolepsy, 

and encephalomyelitis 

Incidence 

of Covid-19 in patients 

with IBD after vaccination 

is 

very low, including 

patients on immunosuppressive 

agents, 

and is similar to population 

without IBD. 

III 

16

FEATURE 



evidence 

Kappelman et al. [22]Humoral Immune 

Response to 

Messenger RNA 

Covid-19 Vaccines 



Disease 

Kennedy et al. [23] Infliximab is associated 

with attenuated 

immunogenicity 

to BNT162b2 and 

ChAdOx1 nCoV-19 

SARS-CoV-2 vaccines 


To assess serologic 

response after completion 

of the 2-part 

mRNA vaccination 

series in a geographically 

diverse 

US IBD population. 

To investigated 

whether patients 

with inflammatory 

bowel 

disease treated with 

infliximab have 

attenuated serological 

responses to a 

single 

dose of a Covid-19 

vaccine. 

317 Prospective 

study 

1293 (Infliximab 

:865, 

Vedolizumab-treated 

patients: 428) 

Prospective 

study 

5ASA, Sulfasalazine, 

Budesonide, Vedolizumab 

monotherapy 

Ustekinumab 

monotherapy, 

Mercaptopurine, 

Azathioprine, 

Methotrexate,Anti- 

TNF 

monotherapy,Anti- 

TNF combination 

therapy 

Infliximab, Vedolizumab 


Pfizer, Astra- 

Zeneca 

Antibody response was decreased in IBD 

patients receiving systemic corticosteroids 

The proportion of detectible antibodies 

was 85% among steroid users versus 

95% among non-steroid users 

Antibody response was generally similar 

across age group, vaccine type, and use 

of other classes of IBD medications 

The concentration of anti-Covid-19 antibody 

were lower in patients treated with 

infliximab than vedolizumab, following 

vaccination 

Multivariable models showed that 

antibody concentrations were lower in 

patients on infliximab compared with 

vedolizumab 

Age ≥ 60 years, immunomodulator 

use, Crohn’s disease and smoking 

were associated with lower anti-body 

concentration 

Non-white ethnicity was associated with 

higher Covid-19 antibody concentrations 

Seroconversion rates after a single dose 

of either vaccine were higher in patients 

with prior Covid-19 infection and after 

two doses of Pfizer vaccine 

Not reported Two doses of mRNA 

Covid-19 vaccine 

in a geographically 

diverse cohort of over 

300 patients with IBD, 

most had detectable 

antibody responses 

after the second dose 

Most patients mount 

detectable humoral 

immune response to 

mRNA vaccinations 

and support current 

recommendations 

to vaccinate patients 

regardless of immunosuppressive 

treatment. 

Not reported Infliximab is associated 

with attenuated 

immunogenicity to a 

single dose of Covid- 

19 vaccines. Vaccination 

after Covid-19 

infection, or a second 

dose of vaccine led 

to seroconversion in 

most patients. Delayed 

second dosing should 

be avoided in patients 

treated with infliximab. 

IV 

IV 

Lev-Tzion et al. [10] Covid-19 Vaccine Is 

Effective in Inflammatory 

Bowel Disease 

Patients and Is 

Not Associated With 

Disease Exacerbation 

To explore the 

effectiveness of 

Covid-19 vaccination 

in IBD and to assess 

its effect on disease 

outcomes. 


study 

Mesalamine, 

Corticosteroid, 

Immunomodulator, 

Anti-TNF, 

Vedolizumab, 

Ustekinumab, 

Tofacitinib 

Pfizer Overall, 0.3% developed Covid-19 after 

vaccination (OR=1) 

Infection rates were slightly higher in the 

unvaccinated IBD patients 

Patients on tumor necrosis factor (TNF) 

inhibitors and/or corticosteroids did not 

have a higher incidence of infection 

No difference in disease outcome was 

seen during the first 40 days after the 

second vaccination, however time to 

flare was shorter in vaccinated compared 

with unvaccinated IBD patients 

The risk of 

exacerbation 

was 

29% in the 

vaccinated 

patients 

compared 

with 26% in 

unvaccinated 

patients, but 

it was similar 

statistically 

Covid-19 vaccine effectiveness 

in IBD patients 

is comparable with that 

in non-IBD controls 

and is not influenced 

by treatment with 

TNF inhibitors or 

corticosteroids. The 

IBD exacerbation rate 

did not differ between 

vaccinated and unvaccinated 

patients. 

III 


17

FEATURE 




evidence 

Levine et al. [29] COVID-19 Vaccination 

and Inflammatory 

Bowel Disease: 

Desired Antibody 

Responses, Future 

Directions, and a 

Note of Caution 

Pozdnyakova et al. 

[24] 

Decreased Antibody 

Responses to Ad26. 

COV2.S Relative to 

SARS-CoV-2 mRNA 

Vaccines in Patients 

With Inflammatory 

Bowel Disease 

To assess Covid-19 

nucleocapsid and 

spike domain antibodies 

using a commercially 

available ELISA assay 

among consecutively 

tested postvaccination 

patients with 

IBD on biologic or 

immunomodulator 

therapy. 

To assess for differences 

in serologic 

responses among 


who received Ad26. 

CoV2.S relative to 

those receiving 

mRNA-1273 or 

BNT162b2. 

19 patients Prospective 

study 


study 

Biologic therapies: 

Infliximab, 

Adalimumab, 

Golimumab, Ustekinumab, 

Vedolizumab, 

Tofacitinib, 

Methotrexate 

Immune-modifying 

therapies 

(IMTs), as defined by 

receipt of advanced 

therapies (biologics 

or JAK inhibitors), 

Immunomodulators, 

and/or systemic 

Corticosteroids 


Moderna, 

Pfizer, 

Johnson & 

Johnson 

A 95% overall response rate were 

observed 

In patients with elevated spike domain 

antibodies (a true vaccine response 

rather than prior undiagnosed infection), 

89% (17/19) had the highest measurable 

levels, at > 250.00 U/mL, with assay 

reference ranges of 0.79 U/mL indicating 

negative and 0.80 U/mL (positive results) 

Two weeks after vaccination, positive 

antibody levels were detected in more 

than 90% of IBD patients 

At week 2, only vaccine type was associated 

with antibody levels, with both 

Moderna and Pfizer having significantly 

higher levels than Jahnson & Jahnson 

At week 8, vaccine type remained 

independently associated with antibody 

levels 

Lower titers were independently 

associated with both a longer duration 

between completion of vaccine regimen 

and blood sampling and IMT receiving 

Not reported Time and vaccine 

availability will lead to 

the same approach 

with regard to 

Covid-19 

patients. 

Not reported Positive levels of IgG(S) 

were achieved in 

virtually all IBD vaccine 

recipients regardless 

of vaccine type and 

IMT use. 

IV 

IV 

Rodriguez-Martino 

et al. [25] 

Early immunologic 

response to mRNA 

COVID-19 vaccine 

in patients receiving 

biologics and/or 

immunomodulators 

To evaluate humoral 

and cellular response 

to Covid-19 vaccines 


using biologic and/ 

or immunomodulatory 

therapies. 

19 (CD, 2 UC) Prospective 

study 

Biologicmonotherapy, 

Azathioprine 

Pfizer Total IgG antibodies increased 21.13 

times after dose 1 and 90 times after 

dose 2 

VTN% increased 11.92 times after dose 1 

and 53.79 times after dose 2 

Total IgG antibodies and VTN% were 

lower in IBD patients after dose 2 

IgG antibodies increased after dose 2, 

but remained lower than controls 

VTN% were similar to controls after 

dose 2 

CD4 and CD8 mean levels had an 

upward trend after vaccinationn 

Not reported Neutralizing capacity 

response to the vaccine 

in subjects was 

similar to a healthy 

cohort in spite of 

lower increases in total 

IgG antibodies. The 

CD4 and CD8 results 

observed may support 

the capacity to mount 

an effective cellular 

response in patients 

on biologics. 

IV 

18

FEATURE 



evidence 

Shehab et al. [26] Serological Response 



Vaccines in Patients 

with Inflammatory 

Bowel Disease on 

Biologic Therapies 

Wong et al. [27] Serologic Response 

to Messenger RNA 

Coronavirus Disease 

2019 Vaccines in 


Disease Patients 

Receiving Biologic 

Therapies 

To measure the 

serological response 



vaccines in patients 

with IBD receiving 

different biologic 

therapies. 

To evaluated 

serologic responses 

to Covid-19 vaccination 

with Pfizer and 

Moderna in patients 

with IBD. 

126 (71 CD, 29 UC) Prospective 

study 

91 (48 in IBD group: 

23 CD, 25 UC, 43 in 

control group) 

Prospective 

study 

Adalimumab, 

Infliximab, 

Vedolizumab, 

Ustekinumab 

Infliximab 

monotherapy, Adalimumab 

monotherapy, 

Vedolizumab 

monotherapy, 

Vedolizumab plus 

immunomodulator, 

Ustekinumab, 

Tofacitinib, Biologic, 

anya, Corticosteroids, 

oralb, Immunomodulatorb, 

Mesalamineb 

Pfizer, Astra- 

Zeneca 

Moderna, 

Pfizer 

In patients being treated with infliximab 

and adalimumab, the proportion of 

patients who achieved positive anti- 

Covid-19 IgG antibody levels after receiving 

two doses of the vaccine were 74.5% 

and 81.2% 

In patients receiving ustekinumab and 

vedolizumab, the proportion of patients 

who achieved positive anti-Covid-19 IgG 

antibody levels after receiving two doses 

of the vaccine were 100% and 92.8% 

In patients receiving infliximab and 

adalimumab, the proportion of patients 

who had positive anti-Covid-19 neutralizing 

antibody levels after two-dose 

vaccination were 67.7% and 87.5% 

The proportion of patients who had 

positive anti-Covid-19 neutralizing 

antibody levels were 92.3% and 92.8% 

in patients receiving ustekinumab and 

vedolizumab 

Side effect was not different in vaccinated 

IBD patients compared vaccinated 

non-IBD 

Anti-TNF were associated with lower 

anti-RBD total immunoglobulin 

Vedolizumab was associated with lower 

anti-RBD total immunoglobulin, anti- 

RBD IgG, and anti-S IgG than in control 

group 

Not reported The majority of 

patients with IBD who 

were on infliximab, 

adalimumab, and 

vedolizumab seroconverted 

after two 

doses of Covid-19 vaccination. 

All patients 

on ustekinumab 

seroconverted after 

two doses of Covid-19 

vaccine. The vaccines 

are likely to be effective 

after two doses in 

patients with IBD on 

biologics. 

Local arm 

pain/swelling/rash, 

Myalgia, 

Arthralgia, 

Fatigue, 

Headache, 

Fever/subjective 

fever, 

Chills, Gastrointestinal 

symptoms, 

Other rash 

Results support the 

consensus recommendation 

for IBD 

patients to receive 

Covid-19 vaccines 

when available. 

IV 

IV 


19

FEATURE 

Table 3 The reported side effects after Covid-19 vaccination in 


Side effects 

Localized injection-site [17–20, 27] (5/15) 

Fatigue/malaise [17, 18, 20, 27] (4/15) 

Myalgia [17, 18, 20, 27] (4/15) 

Gastrointestinal symptoms (including nausea, vomiting, diarrhea, 

abdominal pain) [17, 18, 27] (3/15) 

Headache/dizziness/lightheadedness [17, 19, 27] (3/15) 

Joint pain [18, 20, 27] (3/15) 

Fever/chills [17, 27] (2/15) 

IBD exacerbation [20] (2/15) 

Skin/nail or face changes [17, 27] (2/15) 

Sleep changes [17] (1/15) 

Memory/mood changes [17] (1/15) 

Swollen lymph node [17] (1/15) 

Cough, chest/breathing symptoms [17] (1/15) 

Eye/ear/mouth/throat changes [17] (1/15) 

In a study by Pozdnyakova et al., it was revealed that two weeks after 

vaccination, positive antibody levels were detected in more than 90% 

of IBD patients. Tthe multivariable analysis showed that at week 2, only 

vaccine type was associated with antibody levels, with both Moderna 

and Pfizer having significantly higher levels than Jahnson & Jahnson. 

Also, at week 8, vaccine type remained independently associated with 

antibody levels. On the other hand, lower titers were independently 

associated with both a longer duration between completion of vaccine 

regimen and blood sampling and IMT receiving. They concluded 

that positive levels of IgG(S) were achieved in virtually all IBD vaccine 

recipients regardless of vaccine type and IMT use [24]. 

Furthermore, total IgG antibodies increased 21.13 times after dose 1 

and 90 times after dose 2 in Rodriguez-Martino et al.’s study. VTN% 

increased 11.92 times after dose 1 and 53.79 times after dose 2. Total 

IgG antibodies and VTN% were lower in IBD patients after dose 2. In 

their study, IgG antibodies increased after dose 2, but remained lower 

than control group. However, VTN% were similar to controls after dose 

2. CD4 and CD8 mean levels had an upward trend after vaccination 

[25]. 


No difference in disease outcome was observed during the first 40 

days after the second vaccination, however time to flare was shorter in 

vaccinated compared with unvaccinated IBD patients [10]. 

In another study, Edelman-Klapper et al. found that Covid-19 anti-S IgG 

antibodies in all control group were seropositive, whereas about 7% of 

patients with IBD, regardless of treatment, remained seronegative after 

dose 1, and it was positive in all patients after dose 2. It means that 

neither IBD itself nor anti-TNFa treatment eliminate the ability to mount 

serologic response to vaccination. However, anti-TNFa treatment was 

associated with significantly lower antibody levels compared with nonanti-TNFa 

treated patients, and control group. Also, neutralizing and 

inhibitory functions were both lower in anti-TNFa treated compared with 

non-anti-TNFa treated patients, and control group. Moreover, Anti-TNFa 

drug levels and vaccine responses did not affect anti-spike levels. But, 

IBD activity was unaffected by vaccination. The results of multivariate 

linear regression model showed that only anti-TNFa treatment and older 

age maintained a significant distinct association with lower IgG anti-S 

response [19]. 

Kappelman et al. found antibody response was decreased in IBD patients 

receiving systemic corticosteroids. In these patients, the proportion of 

detectible antibodies was 85% versus 95% among non-steroid users. 

However, antibody response was generally similar across age group, 

vaccine type, and use of other classes of IBD medications [22]. 

Moreover, Kennedy et al. showed that the concentration of anti- 

Covid-19 antibody following vaccination were lower in patients treated 

with infliximab than vedolizumab. Multivariable models indicated that 

antibody concentrations were lower in patients treated with infliximab 

compared with vedolizumab. Age≥60 years, immunomodulator use, 

Crohn’s disease and smoking were related with lower, while non-white 

ethnicity was related with higher Covid-19 antibody concentrations. 

Moreover, seroconversion rates after a single dose of either vaccine 

were higher in patients with prior Covid-19 infection and after two doses 

of Pfizer vaccine [23]. 

In Shehab et al.’s study, in patients being treated with infliximab and 

adalimumab, the proportion of patients who achieved positive anti- 

Covid-19 IgG antibody levels after receiving two doses of the vaccine 

were 74.5% and 81.2%. Also, it was found that in patients receiving 

ustekinumab and vedolizumab, the proportion of patients who achieved 

positive anti-Covid-19 IgG antibody levels after receiving two doses of 

the vaccine were 100% and 92.8%. In patients receiving infliximab and 

adalimumab, the proportion of patients who had positive anti-Covid-19 

neutralizing antibody levels after two-dose vaccination were 67.7% 

and 87.5%. The proportion of patients who had positive anti-Covid-19 

neutralizing antibody levels were 92.3% and 92.8% in patients receiving 

ustekinumab and vedolizumab [26]. 

It was reported in Wong et al.’s study that all IBD patients with 2 doses 

of vaccination, had positive anti-RBD tests, of whom 84.6% achieved 

index levels. Also, it was found that anti-TNF were related to lower 

anti-RBD total immunoglobulin. Moreover, Vedolizumab was associated 

with lower anti-RBD total immunoglobulin, anti-RBD IgG, and anti-S IgG 

than in control group. The results of multiple linear regression analyses 

showed no association between timing of infusion and antibody 

response [27]. 

Side effects 

Totally, seven studies mentioned the side effects of Covid-19 

vaccinations in patients with IBD [17-21, 27, 28]. 

In the study by Edelman-Klapper et al., it was reported that immediate 

and short-term side effects s were detected using phone call and 

accepted questionnaires, respectively. However, no severe adverse 

events were reported. Side effects were more after dose 2 compared 

with dose 1. The most common side effects were local pain (< 70%) and 

headache (about 30%). Infection rate (about 2%) and side effects were 

similar in all groups [19]. 

In another study by Botwin et al., the most common severe symptom 

after dose 1 was fatigue/malaise (3%); other severe symptoms were 

reported by 2% or fewer subjects. The most common severe symptoms 

20

FEATURE 

after dose 2 included fatigue/malaise (10%), fever/chills (8%), and 

headache (8%). Most symptoms resolved in less than 2 days except for 

injection site reactions, which mostly resolved within 7 day. Also, it was 

reported that 39% of patients suffered from side effects after dose 1, 

and 62% after dose 2. The frequency of side effects was similar to the 

general population. Also, they found that the frequency of side effects 

was less common in individuals receiving biologic therapy, and it more 

in those with prior Covid-19. However, they found that side effects 

were more common among younger patients, and the massive majority 

of adverse effects were non-severe. Severe side effects (defined as 

preventing daily activity) were observed in few patients and 3 patients 

were hospitalized after dose 1 [17]. 

Also, Garrido et al. stated that the frequency of side effects was 56.8% 

after dose 1 and 74.1% after dose 2. Also, it be lower than general 

population during the first week after vaccination. No serious side effects 

were reported and all side effects were mild and transitory, and lasted 

only a few days without any necessity of patients’ hospitalization. The 

percentage of side effects was higher among patients younger than 50 

years. However, side effects were reported to be similar in patients with 

different sex, vaccine type, biological drug or disease type. They finally 

concluded a high acceptance rate and a good safety profile of Covid-19 

vaccination in IBD patients treated with biologics, and diverse effects 

were common but overall mild and transitory [20]. 

It was found in Classen et al.’s study that in the IBD group, 58.3% 

patients had significantly more side effects after dose 1 compared to 

the control group. But, after dose 2, the side effects were higher in 

the control group, significantly. The observed side effects after dose 1 

were muscle pain, pain at the injection site, and fatigue, which were 

not significantly higher in IBD patients than in the control group. Similar 

complaints occurred after dose 2 (with pain at the injection site, fatigue, 

muscle pain, and fever being the most frequent complaints) [18]. 

Hadi et al. reported that special adverse events of interest developed 

in 2.03% patients with IBD, and in 0.81% patients without IBD. There 

was no significant difference in adverse events of special interest and 

a new diagnosis of Covid-19 in two groups. Also, it was similar in the 

30-day hospitalization after the Covid-19 vaccination, after matching. 

No difference was found in steroid prescription at the 1 month follow-up 

in vaccinated and unvaccinated patients with IBD in unmatched and 

matched analysis. No difference in 30-day adverse events of special 

interest after the vaccination between patients with IBD with and without 

biologic or immunomodulator use, and also between patients with CD 

and UC were found. No difference in steroid use after vaccination was 

found between patients with and without biologic or immunomodulator 

use, or both, and between patients with CD and UC [21]. 

Finally, the results of Wong et al.’s study showed that Covid-19 

vaccination’s side effect was not different in vaccinated IBD patients 

compared vaccinated non-IBD healthcare workers [27]. 

It is worthy to mention that IBD exacerbation was reported in the Garrido 

et al. and Lev-Tzion et al.’s studies [10, 20]. IBD exacerbation was 

defined as treatment escalation, commencement of corticosteroids or 

enema, or hospitalization. Lev-Tzion et al. found that 44% of vaccinated 

and 34% of unvaccinated patients experienced an exacerbation or 

treatment escalation, and this difference was statistically significant. 

However, the overall risk of exacerbation was 29% in vaccinated 

patients and 26% in unvaccinated patients, which was statistically 

similar [10]. 

Costantino et al. reported a value results on Covid-19 vaccine 

willingness and hesitancy in Italian IBD patients, as well as the most 

common reasons. It was mentioned that lack of data on long-term 

safety can reduce vaccine acceptance. They found that 20% of IBD 

patients were hesitant or would currently refuse vaccination [30]. 

The main characteristics of the current systematic scoping review 

on IBD patients and Covid-19 vaccination was the simultaneous 

comparison of the complications and benefits of various vaccination. 

The main limitation of this study was that lack of any clinical trial study, 

specially randomized controlled trial. 

It was concluded that regardless of the vaccine type, IBD patients that 

receiving immunosuppressive drugs need more careful monitoring of 

the effects of the vaccine, including screening for antibodies against 

the Covid-19 virus, as well as more booster doses. On the other hand, 

the concern that exists among patients with IBD about the side effects 

of the vaccine was investigated in various studies and it was revealed 

that the vaccine does not lead to worsening of the disease and the 

side effects are almost the same like other healthy people. According 

to existing studies, vaccination has not led to flare of IBD, too. 

As a final conclusion, patients with IBD can be advised that vaccination 

may have limited minor side effects, but it can protect them from the 

serious complications of Covid-19 disease and its resulting mortality 

with a high success rate. 

Acknowledgements 

The authors would like to thank all the healthcare providers who are 

fighting the Covid-19 around the world. 

Author contributions 

ET and MS completed study concept and design. ET, MS, MR, EZ, 

and RSM completed acquisition of data. ET, MS, MR, EZ, RSM 

finished drafting the manuscript. All authors read and approved the 

final manuscript. 

Funding 

NA. 

Availability of data and materials 

Data sharing is not applicable to this article. 

Declarations 

Ethics approval and consent to participate 

NA. 

Competing interests 

The authors declare no competing interests. 

Author details 

1 

Isfahan Gastroenterology and Hepatology Research Center, Isfahan 

University of Medical Sciences, Isfahan, Iran. 2 Clinical Informationist 


21

FEATURE 

Research Group, Health Information Research Center, Isfahan University 

of Medical Sciences, Isfahan, Iran. 3 Emergency Medicine Research 

Center, Shiraz University of Medical Sciences, Shiraz, Iran. 4 Health 

System Research, Vice-Chancellor of Treatment, Shiraz University of 

Medical Sciences, 5th Floor, Administration Building of Shiraz University 

of Medical Sciences, Zand St., 71348-14336, Shiraz, Iran. 

Received: 30 June 2022 Accepted: 2 August 2022 

Published online: 20 August 2022 

16. Melnyk BM, Fineout-Overholt E. Evidence-based practice in nursing & healthcare: a 

guide to best practice. Lippincott Williams & Wilkins; 2011. 

17. Botwin GJ, Li D, Figueiredo J, Cheng S, Braun J, McGovern DPB, et al. Adverse 

events after SARS-CoV-2 mRNA vaccination among patients with inflammatory 

bowel disease. Am J Gastroenterol. 2021;116(8):1746–51. 

18. Classen JM, Muzalyova A, Nagl S, Fleischmann C, Ebigbo A, Rommele C, et al. 

Antibody response to SARS-CoV-2 vaccination in patients with inflammatory bowel 

disease—results of a single-center cohort study in a tertiary hospital in Germany. 

Dig Dis. 2021. https://doi.org/10.1159/000521343 


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Publisher’s Note 

Springer Nature remains neutral with regard to jurisdictional claims in 

published maps and institutional affiliations. 

22


INNOVATING PRODUCTS THAT 

BALANCE PATIENT SAFETY AND 

ENVIRONMENTAL CONCERNS 

As greater transparency surrounding the environmental footprint of 

hospitals is becoming more of a driving factor for hospital management, 

it is important for medical device manufacturers to recognize the need 

for action to tackle global challenges, such as climate change. 

With preliminary studies suggesting that endoscopy is one of the 

largest polluters , the urgency to offer treatment that best protects 

patients and the planet is imperative. 

This was recently emphasized by ESGE-ESGENA, in their positioning 

paper “Reducing the environmental footprint of gastrointestinal 

endoscopy”, in which they advocate to raise awareness for the 

ecological footprint of GI endoscopy and provide guidance on how to 

reduce its environmental impact. 

PENTAX Medical is taking its own measures to make GI endoscopy 

more sustainable, by incorporating sustainable thinking in every aspect 

of its value chain. Patient safety remains the primary goal against which 

sustainability ambitions need to be weighted. Rainer Burkard, President 

PENTAX Medical EMEA, comments on the company’s sustainability 

journey: “PENTAX Medical helps to improve the quality of people’s lives 

and contributes to a brighter future for coming generations, by improving 

health and minimising the impact on our planet.” 

Energy-efficient drying and storage for 

reusable scopes 

Drying and storing reprocessed endoscopes can be a time consuming 

and energy-intensive procedure due to their complex design. 

Regular solutions require long drying cycles, as well as continuous 

medical air and heat supply for storage, which involves non-stop 

electricity consumption. 

The PlasmaTYPHOON+ and PlasmaBAG system is a unique solution 

for fast drying and active storage of endoscopes, allowing to significantly 

reduce energy and overall electricity consumption while improving 

efficiency, yielding a small footprint for endoscope drying and storage. 

The PENTAX Medical PlasmaBAG ECO 

The system accelerate endoscope reprocessing by substantially 

reducing drying times from hours to just 1 to 3 minutes, while 

maintaining the disinfected state of endoscopes for up to 31 days. 

Additionally, the storage provided with the PlasmaBAG, ensures 

reusable scopes available whenever and wherever needed; offering 

physicians a sustainable alternative to single-use endoscopes. 

Ensuring patient safety, without compromising on 

environmental responsibility 

The proliferation of waste and the lack of responsible disposal, pose 

a great threat to natural resources. The healthcare industry alone 

produces around two million tons of waste every year – from which the 

majority is of low risk and could easily be recycled . 

For that reason, PENTAX Medical is developing solutions that have less 

environmental impact to achieve more. Central to this is investigating 

the use of sustainable materials for products – such as, the PlasmaBAG 

ECO. The new endoscope storage bag, is made with 80% recycled 

polyethylene and holds the German eco label ‘Blue Angel’. It is one 

example of PENTAX Medical’s continuous journey to sustainability. 

PENTAX Medical also supports the Togo reforestation project to 

compensate for the carbon emissions in the production of the 

PlasmaBAG endoscope storage bags, making them carbon neutral. 

The production of medical products is regulated by stringent quality 

assurance processes and safety regulations to ensure patient safety, 

meaning carbon emissions cannot always be completely avoided. For 

this reason, it is important that manufacturers seek ways to compensate 

their emissions. 

“Medical device manufacturers must aim to innovate solutions that 

address social, economic and environmental sustainability concerns. 

All the while also achieving their primary goal: to maximise patient 

treatment, physicians’ comfort, maximise workflow and minimise the risk 

of infection”, concludes Rainer Burkard. 

Scan the QR code 

to discover more related products by 

PENTAX Medical, contributing to patient 

safety and sustainability in endoscopy. 

1 Siau K, Hayee B, Gayam S. Endoscopy’s current carbon footprint. Techn Innov 

Gastrointest Endosc 2021; 23: 344–352. doi:10.1016/j. tige.2021.06.005 

2 de Santiago Enrique Rodríguez et al. Reducing the … Endoscopy 2022; 54 | © 2022. 

European Society of Gastrointestinal Endoscopy. All rights reserved.. 

3 Validated for up to 744 storage hours (31 days) according to NF EN 16442 norm. The 

maximum storage time may be subject to local regulations on endoscope storage 

4 Singh, N., Ogunseitan, O. A., & Tang, Y. (2021). Medical waste: Current challenges and 

future opportunities for sustainable management. Critical Reviews in Environmental 

Science and Technology, 1–23. https://doi.org/10.1080/10643389.2021.1885325 


23


ENDOSCOPY INTERVENTIONS: REDUCING WAITING 

TIMES, IMPROVING PATIENT COMFORT 


24 

Endoscopy Interventions: Reducing Waiting Times, Improving 

Patient Comfort 

For the past 8 years, 18 Week Support has been actively helping 

endoscopy units across the country manage their RTT pathways, 

delivering high-quality patient care while reducing waiting times. 

Our specialist insourcing clinician teams have been in particular 

demand during Covid as well as beyond, with high volumes of atrisk 

patients seen quickly in the familiar surroundings of their local 

hospital or in specially designed on-site mobile units. 

With the Covid peak now behind us, our focus these past 12 months 

has been helping an increasing number of Trusts address waiting list 

challenges. From October 2021 to September 2022 inclusive, working 

in close partnership with our NHS Trust partners, our consultants and 

specialist nurses delivered some 28,000 individual shifts that resulted in 

the treatment of more than 65,000 priority gastroscopy and endoscopy 

patients that might not otherwise have been seen quickly. In that period, 

our teams cleared around 500 lists per month, with an average of 10 

patients per list. 

We believe we are making a major and positive contribution to patient 

outcomes and reducing waiting times, particularly for those patients 

designated as at-risk by our Trust partners. At a time when the NHS is 

struggling with workload planning challenges and rapidly rising locum 

and recruitment agency costs, our unique insourcing approach gives 

Trusts a valuable, additional tool to manage patient volumes and priority 

patient pathways. 

Endoscopy Post-Covid: Emphasis on Patient Comfort 

As the NHS now looks to recover from the impact of pandemic, we 

believe now is the right time to refocus on continuous improvement in 

the delivery of endoscopy services. One area that we are exploring 

with our Trust partners is how we might map endoscopy patient 

expectations, experience and attitudes and feed those into decisions 

about service delivery. 

The outcomes usually measured in endoscopy are practitioner/nurse 

centred, yet patients arguably attach as much if not more importance 

to the team’s skill and experience, and how good they are at 

communicating with the patient. JAG of course acknowledges that 

an excellent patient experience, high quality and safe endoscopy are 

the priority for any service, including services delivered by insourcing 

providers such as ourselves. Patient comfort is a key factor in the 

overall patient experience within the Endoscopy setting and an 

element of the Global Rating Scale or GRS. The latter mandates that 

nurses monitor and record patient pain and comfort during and after 

the procedure according to the Modified Gloucester Scale, which 

defines a five-point scoring system, with 5 being most severe. 

Here at 18 Week Support, we have been prospectively monitoring 

patient comfort scores from the perspective of the patient, nurses and 

endoscopist, in addition to the single scores entered into the Electronic 

Reporting System (ERS). 

We firmly believe that patient experience can be further enhanced 

with the implementation of several innovative Quality Improvement 

(QI) projects. There is emerging evidence suggesting that addressing 

patients’ attitudes and expectations might help improve both the patient 

experience and outcomes due to better procedure tolerance and 

adherence to recommended on-going treatment. Indeed, patients’ cite 

comfort, operator skill and communication above all other factors. 

As part of our QI project, we introduced two interventions. The first was 

a tailored set of bullet point reminders for our teams, with a clear focus 

on a well-informed patient, helping them relieve concerns and anxieties 

and establishing a clear analogue of what patients are to expect pre, 

post and peri procedure. The second was a structured team brief and 

debrief, again focusing the team on the core themes such as patient 

requirements, the treatment environment and safety. 

Following these two interventions, we have been able to demonstrate 

a marked improvement to the patient’s perception of comfort during 

their procedure. Pre-interventional comfort score audits demonstrated 

87% of patients were scoring the experience as a 3 and below, 

or minimal discomfort. After the introduction of the QI, we found a 

significant improvement with 96% of patients scoring 3 and below, 

minimal discomfort. This quality improvement programme has 

required buy in from all that are involved in the patients’ experience as 

no single element of the patients’ pathway stands alone. 

Looking forward we will focus on the non-technical skills (NTS) of 

endscopists and undertake an audit using an endoscopy NTS or ENTS 

tool to measure such skills comprising communication and teamwork, 

situation awareness, leadership, and judgement. The outcomes will 

be fed back to the endoscopists for reflection and learning in order to 

address further areas for improvement. 18 Week Support attaches 

considerable importance to continuous improvement and we believe 

this new NTS project will lead to a better patient experience as well as 

support our other QI initiatives. 

If you have an excellent NHS record and want to help clear waiting 

list backlogs, reduce RTT waiting times and provide high-quality 

patient care, get in touch by calling on 0203 869 8790 or email us 

at recruitment.team@18weeksupport.com. 

Alternatively, if you are a procurer of 18 Week Support services, 

please contact busdev@18weeksupport.com. 

Follow us: 18-week-support 18 Week Support @18WeekSupport 

Dr Matthew Banks 

Clinical Lead for Gastroenterology 

18 Week Support 

18 Week Support 

www.18weeksupport.com 

London 6th Floor, 51 Eastcheap, London EC3M 1DRT 

Birmingham Unit 25, Lichfield Business Village, The Friary WS13 6QG

FEATURE 

TRANSIENT ALTERATIONS IN PLASMA SODIUM 

CONCENTRATIONS WITH NER1006 BOWEL 

PREPARATION: AN ANALYSIS OF THREE PHASE 

III, RANDOMIZED CLINICAL TRIALS 

Brooks D. Cash 1* , Christopher Allen 2 and David M. Poppers 3 

BMC Gastroenterology volume 22, Article number: 412 (2022) https://doi.org/10.1186/s12876-022-02484-7 

Abstract 

Background 

Background 

This analysis characterized changes in sodium levels in patients 

receiving the 1 L polyethylene glycol-based preparation NER1006. 

Methods 

Data were pooled from three phase III, randomized clinical trials. 

A post hoc subanalysis included adults who received a 2-day 

split-dose (evening/morning) NER1006 regimen, a 1-day splitdose 

(morning only) regimen, or evening-before regimen and 

had an increase in sodium concentrations from normal to above 

the upper limit of normal (143–148 mmol/L) at ≥ 1 of three posttreatment 

visits. Blood samples were collected at baseline, day of 

colonoscopy (visit 2), 2 ± 1 days post-colonoscopy (visit 3), and 

7 ± 1 days post-colonoscopy (visit 4). 

Results 

A total of 214 of 1028 patients were included. Of the 214 patients, 

sodium concentration increased from a mean baseline value 

of 141.8 mmol/L to a mean of 147.1 mmol/L (median increase 

from baseline of approximately 5 mmol/L). The mean sodium 

concentration was within normal range at visit 3 (142.3 mmol/L) and 

visit 4 (142.4 mmol/L), as was the median sodium concentration. 

Overall, ~ 90% of patients had a normal serum concentration at 

visits 3 and 4. Based on day of colonoscopy test results, there were 

four adverse events involving hypernatremia (0.4% of 1028), which 

were mild and did not require medical intervention; sodium levels 

returned to normal range by visit 3. 

Conclusion 

NER1006 was associated with small, transient increases in sodium 

levels that were not considered clinically significant. 

Trial registration NOCT (ClinicalTrials.gov: NCT02254486 [registered 

October 2, 2014]), MORA (ClinTrials.gov: NCT02273167 [registered 

October 23, 2014]; EudraCT number: 2014-002185-78 [registered 

August 13, 2014]), DAYB (ClinicalTrials.gov: NCT02273141 

[registered October 23, 2014]; EudraCT Number: 2014-002186-30 

[registered August 12, 2014]) 

Keywords 

Colonoscopy, NER1006, Polyethylene glycol, Plenvu, Sodium 

Osmotically balanced bowel preparations (e.g., polyethylene 

glycol [PEG] based) were developed to help maintain electrolyte 

homeostasis during bowel cleansing [1, 2]. The first low-volume 

(1 L) PEG-based bowel preparation, NER1006 (Plenvu/Pleinvue, 

Salix Pharmaceuticals/Norgine Ltd), was approved in a European 

country in 2017 and in the United States in 2018. The efficacy, safety, 

and tolerability of NER1006 have been reported in three phase III, 

randomized clinical trials: MORA (Morning Arm), NOCT (Nocturnal 

Pause Arm), and DAYB (Day Before Arm) [3-5]. In these clinical trials, 

NER1006 overall cleansing efficacy, evaluated by treatment-blinded 

central readers, was at least as effective as (i.e., noninferior) standard 

comparators (2 L PEG plus ascorbate, oral sulfate solution, or 

sodium picosulfate plus magnesium citrate) [3-5]. Additional analyses 

demonstrated that high-quality cleansing was superior with NER1006 

(2-days evening/morning split dosing [N2D] or 1-day morning only 

dosing) versus 2 L PEG plus ascorbate (68.0% or 64.0% vs. 50.7%, 

respectively; P < 0.001 for both comparisons) and was greater 

with NER1006 N2D versus oral sulfate solution (69.9% vs. 63.9%, 

respectively; P = 0.07) [6]. Although NER1006 was found to be safe 

and well tolerated, sodium levels were elevated following treatment 

with NER1006, albeit transiently [3, 4, 7]. The current analysis was 

conducted to further characterize elevations in plasma sodium levels 

in patients receiving NER1006 in the three phase III trials. 

Methods 

The patient population, trial design, and NER1006 dosing regimens 

for the NOCT (ClinicalTrials.gov: NCT02254486), MORA (ClinTrials. 

gov: NCT02273167; EudraCT number: 2014-002185-78), and DAYB 

(ClinicalTrials.gov: NCT02273141; EudraCT Number: 2014-002186-30) 

trials have been previously published [3-5]. Furthermore, CONSORT 

information for the three trials was previously documented in those 

publications and is not repeated herein. Briefly, patients included in the 

three trials were males or females 18 to 85 years of age undergoing 

a screening, surveillance, or diagnostic colonoscopy. NER1006 was 

administered as a 2-day evening/morning split-dosing regimen (NOCT 

and MORA trials), a 1-day (split-dose) morning-only regimen (MORA 

trial), or a day-before split-dosing regimen (DAYB trial). In all trials, blood 

samples were collected at baseline, day of colonoscopy (visit 2), 2±1 

days post-colonoscopy (visit 3), and 7±1 days post-colonoscopy (visit 4). 


* Correspondence: brooks.d.cash@uth.tmc.edu 

1 

Division of Gastroenterology, Hepatology, and Nutrition, University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 4.234, Houston, TX 77030, USA 

© The Author(s) 2022. 

25

FEATURE 

Pooled safety population* 

(n=1028) 

NOCT 

(n=262) 

MORA 

(n=531) 

DAYB 

(n=235) 

Not included in post hoc subanalysis 

(n=814) 

Subanalysis population † 

(n=214) 

NOCT 

(n=105) 

MORA 

(n=92) 

DAYB 

(n=17) 

Hypernatremia AE ‡ 

(n=4) 

NOCT 

(n=2) 

MORA 

(n=2) 

Fig. 1 Patient populations. * All patients randomly assigned to treatment for whom patient diary data could not rule out that they received at 

least one dose of NER1006. † Patients included in the safety population who had a normal sodium concentration at baseline and an increase from 

baseline to above the upper limit of normal (ULN) for sodium (143–148 mmol/L). ‡ Reported as an adverse event based on test results on the day of 

colonoscopy; medical intervention was not required, and sodium levels returned to normal range within 2±1 days post-colonoscopy. DAYB Day 

Before Arm MORA Morning Arm NOCT Nocturnal Pause Arm 

DAYB 

(n=0) 

This pooled analysis included all patients in the safety population 

(all patients randomly assigned to treatment for whom patient diary 

data could not rule out that they received at least one dose of 

NER1006) who had a normal sodium concentration at baseline and 

an increase from baseline to above the upper limit of normal (ULN) 

for sodium (143–148 mmol/L) during at least one of the three postbaseline 

visits (visits 2–4). Plasma sodium levels were measured via 

standardized procedures at a local laboratory. Data were analyzed 

using descriptive statistics. 

Results 

level at visit 4 (7 ± 1 days post-colonoscopy; Additional file 1: Table 

S1). For the individual trials, a greater percentage of patients in the 

NOCT trial (98.1%) experienced elevated sodium concentrations at 

visit 2 from baseline compared with patients in the MORA (89.1%) 

and DAYB studies (70.6%; Additional file 1: Table S1). There were 

four reported adverse events (AEs) involving hypernatremia (0.4% 

of 1028) during the three trials, all of which were considered of mild 

intensity (Additional file 1: Table S2). These AEs were considered to 

be treatment-related, were reported as an AE based on test results 

on the day of colonoscopy, and did not require medical intervention; 

sodium levels returned to normal range within 2 ± 1 days postcolonoscopy 

(visit 3). 


Of the 1028 patients in the pooled safety population, 214 (20.8%; 

NOCT, n = 105; MORA, n = 92; DAYB, n = 17) had a normal sodium 

baseline value and an increase above the ULN for sodium during 

at least one of the post-baseline visits and were included in the 

analysis (Fig. 1). Overall, and when grouped by trial, the median 

sodium concentration increased from normal at baseline to above 

ULN at visit 2, the day of colonoscopy (Fig. 2a). The sodium 

concentration in the overall populations increased from a baseline 

mean value of 141.8 mmol/L to 147.1 mmol/L (Additional file 1: 

Table S1). The median change (increase) from baseline in sodium 

levels was approximately 5 mmol/L in the overall population 

(n = 214) and when patients were grouped by trial (Fig. 2b). At visit 

2 (day of colonoscopy), 7.9% of patients in the overall subgroup 

continued to have normal sodium concentrations (Additional file 1: 

Table S1). 

In the overall subgroup, the mean sodium concentration was 

within normal range (142.3 mmol/L) at visit 3 (2 ± 1 days postcolonoscopy) 

and remained within the normal range at visit 4 (142.4 

mmol/L; 7 ± 1 days post-colonoscopy; Additional file 1: Table S1). 

Median sodium concentrations returned to the normal range by 

visit 3 (2 ± 1 days post-colonoscopy) and remained at normal levels 

at visit 4 (7 ± 1 days post-colonoscopy; Fig. 2). Overall, 89.6% of 

patients had a normal serum concentration at visit 3 (2 ± 1 days 

post-colonoscopy) and 89.8% of patients had a normal sodium 

Discussion 

The current pooled analysis of three phase III, randomized 

trials indicated that mean and median sodium electrolyte levels 

were increased in 214 of 1028 (20.8%) patients on the day of 

colonoscopy (visit 2) following the use of the NER1006 bowel 

preparation in a variety of administration regimens [3-5]. However, 

observed increases in sodium concentration were transient, 

returning to normal levels within 1 to 3 days post-colonoscopy. 

The transient increases from baseline in sodium concentrations 

were small (~ 5 mmol/L) and not considered clinically significant. 

It is also important to consider baseline sodium levels in order to 

put these findings into clinical context. In the NOCT trial, more 

than half of the patients had baseline sodium concentrations 

above 142 mmol/L, thus requiring only a small increase in 

sodium concentration to exceed the ULN [8]. However, none of 

the patients in the NOCT trial with increased sodium levels after 

NER1006 administration required treatment directed at these 

modest increases in sodium levels [4]. In all three trials, increased 

sodium concentrations in the overall populations were not 

considered to be clinically meaningful [3,4,5]. 

The minor, transient changes in sodium levels that may occur in 

some patients treated with NER1006 are considered to be related 

26

FEATURE 

a. 

Median sodium concentration (mmol/L) 

155 

150 

145 

140 

135 

NOCT (N = 105) 

MORA (N = 92) 

DAYB (N = 17) 

Overall (N = 214) 

Baseline 

Visit 2 

Visit 3 Visit 4 

b. 

Change from baseline in median 

sodium concentration (mmol/L) 

15 

10 

5 

0 

-5 

NOCT (N = 105) 

MORA (N = 92) 

DAYB (N = 17) 

Overall (N = 214) 

-10 

Visit 2 

Visit 3 Visit 4 

Fig. 2 Box and whisker plots of a median and b change from baseline in median sodium concentrations. Values were determined at baseline, day 

of colonoscopy (visit 2), 2 ± 1 days post-colonoscopy (visit 3), and 7 ± 1 days post-colonoscopy (visit 4). Box shows median, and upper and lower 

quartile values; whisker designates upper and lower values. Circles in graph represent outliers. DAYB Day Before Arm MORA Morning Arm NOCT 

Nocturnal Pause Arm 

to the higher quantity of sodium in the second dose versus the 

first dose of preparation (i.e., 297.6 mmol [3.2 g] vs. 160.9 mmol 

[2 g]) and not related to patient volume status or dehydration 

[8, 9]. Of importance to note, elderly patients may be more 

susceptible to adverse reactions due to electrolyte imbalances 

[9]. Also, patients with renal impairment or who are receiving 

concomitant therapies that affect renal function should be advised 

on the importance of adequate hydration before, during, and after 

administration of NER1006, and testing for electrolytes may be 

considered in this population [9]. Although sodium levels increased 

at ≥ 1 post-baseline visit in 214 patients with normal baseline 

sodium levels across the three trials, AEs involving hypernatremia 

were uncommon (0.4%). 

Conclusion 

Increased sodium concentrations from baseline occurred in a subset of 

adults treated with NER1006 as a bowel preparation for colonoscopy 

and were transient in nature. As with any bowel preparation, strict 

adherence to instructions for use is recommended, and additional 

fluid consumption as prescribed is encouraged to minimize potential 

adverse effects. 

Abbreviations 

AEs: Adverse events; DAYB: Day Before Arm; MORA: Morning Arm; 

N2D: 2-Days evening/morning split dosing; NOCT: Nocturnal Pause 

Arm; PEG: Polyethylene glycol; ULN: Upper limit of normal. 


27

FEATURE 


Supplementary Information 

The online version contains supplementary material available at 

https:// doi.org/ 10. 1186/ s12876- 022- 02484-7. 

Acknowledgements 

Technical editorial and medical writing assistance were provided 

under the direction of the authors by Mary Beth Moncrief, PhD, and 

Sophie Bolick, PhD, Synchrony Medical Communications, LLC, 

West Chester, PA. Funding for this assistance was provided by Salix 

Pharmaceuticals. 

Author contributions 

CA contributed to the post hoc analysis study design. BDC, CA, 

and DMP analyzed and interpreted the data, critically revised the 

manuscript for important intellectual content, and approved the final 

manuscript. All authors read and approved the final manuscript. 

Funding 

Funding for the original trials was provided by Norgine Ltd. Funding 

for the post hoc analyses was provided by Norgine Ltd. and Salix 

Pharmaceuticals, which both had a role in the post hoc analysis 

design and collection and interpretation of data. 

Availability of data and materials 

Qualified researchers interested in obtaining access to trial data 

should submit a detailed research proposal and data access 

request to datasharing@bauschhealth.com. For more information, 

please see https://www.bauschhealth.com/responsibility/ 

access-to-clinical-study-data. 

Declarations 

Ethics approval and consent to participate 

All three previously published trials received Institutional Review 

Board (IRB) approval from a centralized IRB (Quorum Review IRB, 

Seattle, WA [NOCT]) or the IRB of each study center (MORA, DAYB) 

and were conducted in accordance with International Conference 

on Harmonisation Guidelines for Good Clinical Practice and ethical 

principles of the Declaration of Helsinki. All patients provided written 

informed consent for participation. 

Consent for publication 

Not applicable. 

Competing interests 

BDC reports serving as a consultant and speaker for Salix 

Pharmaceuticals. CA is an employee of Salix Pharmaceuticals. DMP 

reports serving as a consultant and educator for Olympus Medical; 

and serving as a consultant for Salix Pharmaceuticals. 

Author details 

1 

Division of Gastroenterology, Hepatology, and Nutrition, University 

of Texas Health Science Center at Houston, 6431 Fannin Street, 

MSB 4.234, Houston, TX 77030, USA. 2 Salix Pharmaceuticals, 

400 Somerset Corporate Blvd., Bridgewater, NJ 08807, USA. 3 

New York University Langone Health, 550 First Ave, New York, NY 

10016, USA. 

Received: 15 November 2021 Accepted: 14 August 2022 

Published online: 05 September 2022 

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a randomized controlled phase 3 trial versus trisulfate. 

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Hylands K, et al. Colon cleansing efficacy and safety with 1 L 

NER1006 versus sodium picosulfate with magnesium citrate: a 

randomized phase 3 trial. Endoscopy. 2019;51(1):73–84. 

6. Repici A, Coron E, Sharma P, Spada C, Di Leo M, Noble CL, 

et al. Improved high-quality colon cleansing with 1L NER1006 

versus 2L polyethylene glycol + ascorbate or oral sulfate 

solution. Dig Liver Dis. 2019;51(12):1671–7. 

7. Rex DK. Hyperosmotic low-volume bowel preparations: is 

NER1006 safe? Gastrointest Endosc. 2019;89(3):656–8. 

8. Repici A, Hassan C, Hoorn EJ, Bisschops R. NER1006 is 

clinically safe. Gastrointest Endosc. 2019;89(4):908–9. 

9. Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium 

sulfate, ascorbic acid, sodium chloride and potassium 

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Pharmaceuticals; 2021. 

Publisher’s Note 

Springer Nature remains neutral with regard to jurisdictional claims 

in published maps and institutional affiliations. 

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