Gastroenterology Today Summer 2021

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FEATURE DIAGNOSIS AND MANAGEMENT OF COELIAC DISEASE IN SPECIALIST PAEDIATRIC GASTROENTEROLOGY CENTRES IN THE UK By Alice Andrews, Coeliac UK Coeliac disease (CD) is a systemic autoimmune condition, characterised by enteropathy of the small intestine, triggered by dietary gluten in genetically susceptible individuals. CD is estimated to affect 1% of the UK population however, only around 30% of those with the condition have been diagnosed [1]. The clinical presentation of CD varies from intestinal and extraintestinal symptoms to asymptomatic presentations, making diagnosis challenging for healthcare professionals. Recent research published in the Journal of Pediatric Gastroenterology and Nutrition has demonstrated excellent uptake of no-biopsy diagnosis guidelines, but sheds light on variations in follow up care amongst 29 specialist paediatric gastroenterology centres in the UK [2]. Diagnosis via the no biopsy pathway In 2012, European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) revised guidelines to allow some children with CD to be diagnosed without having a duodenal biopsy. Within these guidelines, a no biopsy pathway was suitable for symptomatic children who: • have IgA based anti-tissue transglutaminase antibodies (TGA-IgA) >ten times the upper limit of normal • positive anti-endomysial antibodies (EMA-IgA) • Positive HLA-DQ2/DQ8 haplotype. These guidelines have since been updated in 2020 with two notable changes. Diagnosis can now be made without the need for HLA-DQ2/ DQ8 testing and secondly, a no biopsy approach can also be offered to asymptomatic children [3]. NICE guidelines recommend that the need for a DEXA scan should be considered on an individual basis at annual review [5]. A minority (4/29) of centres reported that they performed routine DEXA scan post diagnosis and some centres only offered a scan if there was a risk of fractures or reported low vitamin D levels. Most children do not need to have a DEXA scan as early diagnosis and adherence to the GFD has been shown to improve bone density. Most centres (28/29) routinely measured vitamin D status but practice around supplementation varied. Most centres based their approach on vitamin D levels, but in some centres vitamin D supplements are offered to all CD patients regardless of their vitamin D status. Since 2015, NICE guidelines have recommended that patients can introduce gluten free (GF) oats to the diet at any stage [5]. GF oats add variety to the gluten free diet and are also a good source of soluble fibre but a small minority of people with CD are sensitive to GF oats. Less than a third of centres recommended that children included GF oats from diagnosis and the majority of centres waited until normalisation of TGA-IgA before introducing GF oats to the diet [2]. New developments in paediatric coeliac disease management As there is limited research to inform the best management strategies, current guidance is based on expert consensus opinion. There is a need for more research in this area and an opportunity to undertake prospective research to assess different follow up strategies. An infographic summarising this publication is available at http://links. lww.com/MPG/C303. GASTROENTEROLOGY TODAY - SUMMER 2021 The survey carried out in 2019 concluded that in the UK, there was excellent uptake of the ESPGHAN 2012 diagnostic guidelines, with 76% centres (n=22) adopting the no biopsy pathway by 2013. Diagnosis should only be made by a paediatric gastroenterologist or consultant paediatrician with a special interest in CD however, at some UK centres the diagnosis is made by a general paediatrician [4] or an expert dietitian. Follow up care The research also investigated follow up care and found discrepancies across the UK [2]. Adopting a gluten free diet (GFD) is challenging for children and their families as they face several difficulties, from the increased cost of gluten free staple foods to school meals and socialising with friends, which can all affect their quality of life and adherence to the diet. For this reason, regular follow ups are important for providing support and help maintaining adherence to the GFD. References [1] West, J. et al. (2019) “Changes in Testing for and Incidence of Celiac Disease in the United Kingdom,” Epidemiology. Ovid Technologies (Wolters Kluwer Health), 30(4) e23–e24. doi: 10.1097/ede.0000000000001006. [2] Paul, S. P. et al. (2021) “Celiac disease management in the United Kingdom specialist pediatric gastroenterology centers – a service survey” Journal of Pediatric Gastroenterology and Nutrition. 2021 Mar 17. doi: 10.1097/ MPG.0000000000003126. [3] Husby, S. et al. (2019) European Society Paediatric Gastroenterology, Hepatology and Nutrition Guidelines for Diagnosing Coeliac Disease 2020. Journal of Pediatric Gastroenterology and Nutrition. 70(1):141-156. doi: 10.1097/ MPG.0000000000002497. [4] Paul S. P. et al. (2019) “HLA-DQ2/DQ8 typing for non-biopsy diagnosis of coeliac disease: is it necessary?” Arch Dis Child. 104:1119-20. doi: 10.1136/ archdischild-2019-317297. [5] National Institute for Health and Care Excellence (2015). Coeliac disease: recognition, assessment and management. NICE guidelines 20. NICE, London. Available at https://www.nice.org.uk/guidance/ng20. [Accessed 27.04.2021] 12
Optimising maintenance therapy for ulcerative colitis: Real choices When mesalazine doesn’t seem to be working, stepping up to immunosuppressants isn’t the only option Together we know more. Together we do more. FEATURE Real solution Salofalk Granules are easy to take, they have a pleasant vanilla flavour, and they’re a proven way to help patients get the most from their mesalazine 1-3 Optimising therapy with once-daily Salofalk Granules in patients who were inadequately maintained on previous mesalazine resulted in: 2 69% 45% 50% fewer days off work fewer GP visits due to UC fewer steroid courses used Mesalazine, the Dr Falk way Prescribing Information (refer to full SPC before prescribing): Salofalk gastro-resistant prolonged-release granules Presentation: Stick-formed or round, greyish white gastro-resistant prolonged-release granules in sachets containing 500mg, 1000mg, 1.5g or 3g mesalazine per sachet. Indications: Treatment of acute episodes and the maintenance of remission of ulcerative colitis. Dosage: Adults: Once daily 1 sachet of 3g granules, 1 or 2 sachets of 1.5g granules or 3 sachets of 1000mg or 500mg granules (equivalent to 1.5 – 3.0g mesalazine daily) preferably taken in the morning, according to individual clinical requirement. May be taken in three divided doses (1 sachet of 500mg granules three times daily or 1 sachet of 1000mg granules three times daily) if more convenient. Maintenance: 0.5g mesalazine three times daily (morning, midday and evening) corresponding to a total dose of 1.5g mesalazine per day. For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to three daily doses, give 3.0g mesalazine as a single daily dose, preferably in the morning. Children: There is only limited documentation for an effect in children (age 6-18 years). Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50mg/ kg/day once daily preferably in the morning or in divided doses. Maximum dose: 75mg/kg/day. The total dose should not exceed the maximum adult dose. Maintenance treatment: To be determined individually, starting with 15-30mg/kg/day in divided doses. The total dose should not exceed the recommended adult dose. It is generally recommended that half the adult dose may be given to children up to a body weight of 40kg; and the normal adult dose to those above 40kg. Method of administration: Taken on the tongue and swallowed, without chewing, with plenty of liquid. Contraindications: Hypersensitivity to salicylates or any of the excipients. Severe impairment of renal or hepatic function. Warnings/ Precautions: Blood tests and urinary status (dip sticks) should be determined prior to and during treatment. Caution is recommended in patients with impaired hepatic function. Should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment. Cases of nephrolithiasis reported; ensure good hydration. Patients with pulmonary disease, in particular asthma, should be carefully monitored. Patients with a history of adverse drug reactions to preparations containing sulphasalazine should be kept under close medical surveillance. If acute intolerance reactions e.g., abdominal cramps, acute abdominal pain, fever, severe headache and rash, occur, stop treatment immediately. Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported. Discontinue treatment at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity. Salofalk granules contain aspartame, a source of phenylalanine that may be harmful for patients with phenylketonuria. Salofalk granules contain sucrose: 0.02mg, 0.04mg, 0.06mg and 0.12mg (500mg/1g/1.5g and 3g granules respectively). Interactions: Specific interaction studies have not been performed. Lactulose or similar preparations that lower stool pH: possible reduction of mesalazine release from granules due to decreased pH caused by bacterial metabolism of lactulose. With concomitant treatment with azathioprine, 6-mercaptopurine or thioguanine consider a possible increase in their myelosuppressive effects. There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin. Use in pregnancy and lactation: There are no adequate data. Do not use during pregnancy unless the potential benefit outweighs the possible risks. Limited experience in the lactation period. Use during breast-feeding only if the potential benefit outweighs the possible risks; if the infant develops diarrhoea, breast-feeding should be discontinued. Undesirable effects: Headache, dizziness, peri- and myocarditis, abdominal pain, diarrhoea, dyspepsia, flatulence, nausea, vomiting, aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia, peripheral neuropathy, allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis), acute pancreatitis, impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency, nephrolithiasis, photosensitivity especially with pre-existing skin conditions, alopecia, Stevens- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), myalgia, arthralgia, hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis, changes in hepatic function parameters, hepatitis, cholestatic hepatitis and oligospermia (reversible), asthenia, fatigue, changes in pancreatic enzymes, eosinophil count increased. Legal category: POM. Basic cost: Salofalk 500mg granules, pack size 100 sachets - £28.74; 31.47€. Salofalk 1000mg granules, pack size 50 sachets – £28.74; 32.87€. Salofalk 1.5g Granules, pack size 60 sachets - £48.85; 51.29€. Salofalk 3g Granules pack size 60 sachets - £97.70; 104.06€ (UK- NHS price; IE - PtW). Product licence number: Salofalk 500mg granules – PL08637/0007; PA573/3/1. Salofalk 1000mg granules – PL08637/0008; PA573/3/2. Salofalk 1.5g granules PL08637/0016; PA573/3/7. Salofalk 3g granules PL08637/0025; PA573/3/6. Product licence holder: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. Date of preparation: November 2020 Further information is available on request. GASTROENTEROLOGY TODAY - SUMMER 2021 Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ (UK residents) or in Ireland at https://www.hpra.ie/homepage/ about-us/report-an-issue/human-adverse-reaction-form. Adverse events should also be reported to Dr Falk Pharma UK Ltd at PV@drfalkpharma.co.uk. References: 1. Salofalk Granules. Summary of Product Characteristics. 2. Aldulaimi D et al. Poster DRF16/057 presented at the BSG Annual Meeting, June 2016, Liverpool UK. 3. Keil R et al. Scand J Gastroenterol 2018; 21: 1-7. UC: ulcerative colitis 13 Date of preparation: January 2021 DrF 20/226
Page 1 and 2: Volume 31 No. 2 Summer 2021 Gastroe
Page 3 and 4: CONTENTS CONTENTS Gastroenterology
Page 5 and 6: WITH YOUR HELP We’ve made Gastroe
Page 7 and 8: FEATURE simple, easy to use, hygien
Page 9 and 10: FEATURE How can you reduce the risk
Page 11: IDENTIFYING ATROPHIC GASTRITIS WITH
Page 15 and 16: FEATURE Study design and study popu
Page 17 and 18: FEATURE The criterion “registrati
Page 19 and 20: FEATURE GASTROENTEROLOGY TODAY - SU
Page 21 and 22: CASE REPORT of toxicity. Clinical m
Page 23 and 24: CASE REPORT Table 1 Summary of pati
Page 25 and 26: CASE REPORT The mechanism of inflix
Page 27 and 28: NEWS were assessed for how they had
Page 29 and 30: NEWS addition, we host a dedicated
Page 31 and 32: COMPANY NEWS POINT-OF-CARE CALPROTE

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