ACR Highlights 2019

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importance of cytokine signalling
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ACR 2019
Conference Highlights
Find us at Stand 2423
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Steering Committee
Professor Iain B. McInnes
University of Glasgow,
UK
CHAIR
Professor Johannes W.J. Bijlsma
University Medical Centre, Utrecht,
The Netherlands
Professor Leonard Calabrese
Cleveland Clinic,
USA
Professor Anca Catrina
Karolinska Institutet,
Sweden
Professor Maurizio Cutolo
University of Genova,
Italy
Professor Cem Gabay
University Hospitals of Geneva,
Switzerland
Professor Juan J. Gómez-Reino
University Hospital,
Santiago de Compostela, Spain
Professor Ahmet Gül
Istanbul University,
Turkey
Professor Pierre Miossec
Hôpital Edouard Herriot, Lyon,
France
Professor Peter Nash
University of Queensland,
Brisbane, Australia
Professor John J. O’Shea
NIAMS, Maryland,
USA
Professor Christopher Ritchlin
University of Rochester Medical
Center, USA
Professor Georg Schett
University of Erlangen-Nuremberg,
Erlangen, Germany
Professor Leonie Taams
Kings College London,
UK
Professor Tsutomu Takeuchi
Keio University, Tokyo,
Japan
Professor Kevin Winthrop
Oregon Health and Science
University, USA
SPONSORSHIP AND UNRESTRICTED
EDUCATIONAL GRANTS FROM

Chairman’s Welcome
Dear CSF Member,
Welcome to this year’s selection of ACR abstracts on cytokine signalling agents and my ‘Chairman’s picks’.
As in previous years, there continues to be an intense focus on the Janus kinase (JAK) inhibitors, with late stage trial
results from filgotinib, peficitinib and newly approved upadacitinib – as well as a host of real-world and trial data for the
more established baricitinib and tofacitinib.
The largest number of trial abstracts concern upadacitinib. Key among them are the 48-week data from SELECT
MONOTHERAPY [513], SELECT EARLY [928] and 60-week data from SELECT BEYOND [518], and SELECT NEXT
[538]. There is an interesting study analysing the clinical and functional outcomes of switching between upadacitinib
and adalimumab following initial non-response [2907] and another looking into structural joint damage inhibition with
upadacitinib monotherapy and combination use [547].
For filgotinib, Combe et al and Westhovens et al are presenting data from the FINCH trials [506; 927], whilst Takeuchi
et al are presenting data on the inhibition of joint destruction with peficitinib in combination with methotrexate [507].
There is new clinical data for both tofacitinib and baricitinib – with a phase 3 study assessing disease trajectories in
baricitinib patients [1350], and a look at MTX-withdrawal in patients taking the extended-release formulation of tofacitinib
[1412]. Real-world studies examine the utility of these two drugs in clinical practice, exploring the impact of time since
first diagnosis on tofacitinib [1484] and an updated baricitinib safety profile with patients exposed for up to 7 years [847].
At this year’s congress there is a focus on safety and patient reported outcomes, with pain relief in patients investigated
for both baricitinib [1407] and tofacitinib [1502]. MACE and VTEs are also in the spotlight with meta-analyses across JAK
inhibitors [2358] and data for upadacitinib [846] being presented.
We will also see Phase 2 data from Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib [929]. It will be important to
see how these agents progress over the coming years, and to find out what hope they can offer to patients who fail on
current therapies.
Within the following pages, we share our selection of the congress highlights, including my ‘Chairman’s picks’.
As always, thank you for your continued support, and we hope you enjoy your time in Atlanta at ACR 2019!
Kind regards,
Professor Iain McInnes

Key Presentations
Sunday, November 10, 2019
POSTER SESSION: 9:00AM – 11:00AM
RA – Etiology & Pathogenesis Poster I
45 bDMARD-experienced Filgotinib-treated Patient
Samples Exhibit a Partial Reversion to the Peripheral
Molecular Profile of a Demographically Matched
Healthy Population
46 Key Inflammatory Biomarkers at Baseline Are
Associated with Filgotinib Response at Week 12
in Rheumatoid Arthritis Patients with Inadequate
Response or Intolerance to Biologic DMARDs
59 Evaluation of Potential Mechanisms Underlying the
Safety Observations of Filgotinib in Clinical Studies
in RA
Health Services Research Poster I – ACR/ARP
252 Treatment Sequences, Effectiveness, and Costs of
Tumor Necrosis Factor Inhibitor Cycling Compared
with Swapping to a Novel Disease-modifying
Antirheumatic Drug in Rheumatoid Arthritis Patients
RA – Treatments Poster I: Novel Treatments
504 A Subgroup Analysis of the Efficacy of Filgotinib in
Demographic and Clinical Subgroups of Patients
with Refractory Rheumatoid Arthritis
506 Efficacy and Safety of Filgotinib for Patients with
Rheumatoid Arthritis with Inadequate Response to
Methotrexate: FINCH1 Primary Outcome Results
507 Inhibition of Joint Destruction in Patients with
Rheumatoid Arthritis Treated with Peficitinib in
Combination with Methotrexate: A Randomised,
Double-Blind, Placebo-Controlled Trial in Japan
508 Longer Term Safety and Efficacy of Peficitinib in
Patients with Rheumatoid Arthritis After 22.7 Months
Mean Treatment Exposure: Interim Data from a
Long-Term, Open-label Extension Study in Japan,
Korea and Taiwan
509 Safety Profile of Upadacitinib in Rheumatoid
Arthritis: Integrated Analysis from the SELECT
Phase 3 Clinical Program
510 Treatment with Upadacitinib Is Associated with
Improvements in Reverse Cholesterol Transport in
Patients with Rheumatoid Arthritis: Correlation with
Changes in Inflammation and HDL Levels
511 A Comparative Analysis of Upadacitinib
Monotherapy and Upadacitinib Combination
Therapy for the Treatment of Rheumatoid Arthritis
from Two Phase 3 Trials
512 Efficacy and Safety of Upadacitinib Monotherapy in
MTX-naïve Patients with Early Active RA Receiving
Treatment Within 3 Months of Diagnosis: A Post Hoc
Analysis of the SELECT-EARLY
513 Upadacitinib as Monotherapy in Patients with
Rheumatoid Arthritis: Results at 48 Weeks
515 Clinical Responses in Patients with Inadequate
Response to bDMARDs upon Treatment
with Upadacitinib
516 Impact of Baseline Demographics and Disease
Activity on Outcomes in Patients with Rheumatoid
Arthritis Receiving Upadacitinib
517 A Subgroup Analysis of Clinical Efficacy Response
and Quality of Life Outcomes from Phase 3 Study of
Filgotinib in Patients with Inadequate Response to
Biologic DMARDs
518 Upadacitinib in Patients with Rheumatoid Arthritis
and Inadequate Response or Intolerance to
Biological DMARDs: Results at 60 Weeks
522 Treatment with Upadacitinib Results in the
Normalization of Key Pathobiologic Pathways in
Patients with Rheumatoid Arthritis
523 The Impact of Upadacitinib versus Methotrexate or
Adalimumab on Individual and Composite Disease
Measures in Patients with Rheumatoid Arthritis
524 A Comparison of Upadacitinib Plus Methotrexate
and Upadacitinib Plus Other CsDMARDs in Patients
with Rheumatoid Arthritis: An Analysis of Two
Phase 3 Studies
527 Safety and Effectiveness of Upadacitinib or
Adalimumab in Patients with Rheumatoid Arthritis:
Results at 48-Weeks
529 Characterization of Remission in Patients with
Rheumatoid Arthritis Treated with Upadacitinib
or Comparators
Chairman’s picks

538 Long-Term Safety and Efficacy of Upadacitinib
in Patients with Rheumatoid Arthritis and an
Inadequate Response to csDMARDs: Results at
60-Weeks
545 Molecular Analysis of the Mode of Action of
Upadacitinib in Rheumatoid Arthritis Patients:
Whole Blood RNA Expression Data from the
SELECT-NEXT Study
547 Inhibition of Structural Joint Damage with
Upadacitinib as Monotherapy or in Combination with
Methotrexate in Patients with Rheumatoid Arthritis
550 Rheumatoid Arthritis Treatment with Filgotinib:
Week 156 Safety and Efficacy Data from a
Phase 2b Open-label Extension Study
551 Upadacitinib Treatment and the Routine Assessment
of Patient Index Data 3 (RAPID3) Among Patients
with Rheumatoid Arthritis
ABSTRACT SESSION: 2:30PM – 4:00PM
3S080: RA – Treatments I: Safety and Outcomes
846 MACE and VTE Across Multiple Upadacitinib Studies
in Rheumatoid Arthritis: Integrated Analysis from the
SELECT Phase 3 Clinical Program
847 Safety Profile of Baricitinib for the Treatment of
Rheumatoid Arthritis up to 7 Years: An Updated
Integrated Safety Analysis
ABSTRACT SESSION: 4:30PM – 6:00PM
3S109: RA – Treatments II: Novel Treatments for RA
927 Efficacy and Safety of Filgotinib for Patients with
Rheumatoid Arthritis Naïve to Methotrexate Therapy:
FINCH3 Primary Outcome Results
928 Monotherapy with Upadacitinib in MTX-naïve
Patients with Rheumatoid Arthritis: Results at
48-Weeks
929 Efficacy and Safety of Fenebrutinib, a BTK Inhibitor,
Compared to Placebo in Rheumatoid Arthritis
Patients with Active Disease Despite TNF Inhibitor
Treatment: Randomised, Double Blind, Phase 2 Study
Monday, November 11, 2019
POSTER SESSION: 9:00AM – 11:00AM
RA – Animal Models Poster
992 Identification of CJ-15314, a Novel Highly Selective
JAK1 Inhibitor, for the Treatment of Rheumatoid Arthritis
RA – Diagnosis, Manifestations, & Outcomes
Poster II: Treatments, Outcomes, & Measures
1329 Pooled Safety Analyses from Phase 3 Studies of
Filgotinib in Patients with Rheumatoid Arthritis
1338 Joint-specific Responses to Tofacitinib and
Methotrexate in Rheumatoid Arthritis: A Post Hoc
Analysis of Data from ORAL Start
1348 Impact of Tofacitinib on the Individual Components
of the ACR Composite Score in Patients with
Rheumatoid Arthritis: A Post Hoc Analysis of Phase
3 Trials
1350 Patient Disease Trajectories in Baricitinib 2 Mg
Treated Patients with Rheumatoid Arthritis and
Inadequate Response to Biologic DMARDs
1352 Effects of Upadacitinib on Patient-reported
Outcomes After 24-Weeks in Patients with
Active Rheumatoid Arthritis and an Inadequate
Response to Conventional Synthetic or Biologic
Disease-modifying Antirheumatic Drugs:
Results from SELECT-NEXT and SELECT-BEYOND
Phase 3 Studies
1375 Patient-reported Outcomes of Upadacitinib versus
Adalimumab Use in Patients with Moderately
to Severely Active Rheumatoid Arthritis and an
Inadequate Response to Methotrexate: 26-Week
Analysis of a Phase 3 Study
1376 Impact of 24- or 26-Week Upadacitinib
Monotherapy on Patient-reported Outcomes
in Patients with Moderately to Severely Active
Rheumatoid Arthritis and No Prior Use of or an
Inadequate Response to Methotrexate: Results from
Two Phase 3 Trials
Chairman’s picks

RA – Treatments Poster II: Established Treatments
1377 MTX Withdrawal in Patients with RA Who Achieve
Low Disease Activity with Tofacitinib Modified-release
11 Mg Once Daily + MTX: An Assessment of the
Impact on the Short Form-36 Patient-reported Outcome
1400 Real Life Retention of Tofacitinib in Patients with
Rheumatoid Arthritis
1407 Baricitinib Provides Better Pain Relief Across All
Disease Activity Levels Compared with Placebo and
Adalimumab in Rheumatoid Arthritis
1412 Efficacy and Safety of Tofacitinib Modified-release
11 Mg Once Daily + MTX in RA Patients with an
Inadequate Response to MTX: Open-label Phase
Results from a Global Phase 3b/4 MTX
Withdrawal Study
1413 Efficacy of Tofacitinib Monotherapy, Tofacitinib with
Methotrexate and Adalimumab with Methotrexate
in Patients with Early (≤ 2 Years) versus Established
(> 2 Years) Rheumatoid Arthritis: A Post Hoc
Analysis of Data from ORAL Strategy
1415 Effect of Tofacitinib on the Qualitative Profile of High
Density Lipoproteins Molecules in Patients with
Rheumatoid Arthritis
1420 Heterogeneity in the Pattern of Use of JAK-inhibitors
Between Countries Participating in an International
Collaboration of Registers of Rheumatoid Arthritis
Patients (the JAK-pot Study)
1426 Impact of TNF Inhibitor Cycling with Adalimumab
and Etanercept versus Switching to Tofacitinib
1428 Time to Discontinuation of Tofacitinib in Rheumatoid
Arthritis Patients with and Without Methotrexate:
Results from a Rheumatoid Arthritis Cohort
1439 Effect of Baricitinib on Functional Impairment in
RA Patients with Moderate Disease Activity and an
Inadequate Response to Conventional DMARDs
1444 Tofacitinib in Patients with Rheumatoid Arthritis and
Indicative of Depression And/or Anxiety: A Post Hoc
Analysis of Phase 3 and Phase 3b/4 Clinical Trials
1445 Pre-Biologic Use of Janus Kinase Inhibitors for the
Treatment of Rheumatoid Arthritis in the
United States
Spondyloarthritis Including Psoriatic Arthritis
– Clinical Poster II: Treatment of Axial
Spondyloarthritis & Psoriatic Arthritis
1484 The Impact of Time Since First Diagnosis on the
Efficacy and Safety of Tofacitinib in Patients with
Active Psoriatic Arthritis
1492 Exposure-Response Analyses for Upadacitinib
Efficacy and Safety in Ankylosing Spondylitis –
Analyses of the SELECT-AXIS I Study
1502 The Effect of Tofacitinib on Residual Pain in Patients
with Psoriatic Arthritis
1513 Impact of Baseline Body Mass Index on the Efficacy
and Safety of Tofacitinib in Patients with
Psoriatic Arthritis
1534 Long-term Safety of Filgotinib in Patients with
Psoriatic Arthritis, Week 52 Safety Data from a
Phase 2 Open-label Extension Study
ABSTRACT SESSION: 4:30PM – 6:00PM
4M115: Pain Mechanisms – Basic and
Clinical Science
1880 Baricitinib 4 Mg and 2 Mg Once Daily Reduced
Pain in Both Patients Who Were Opioid Users and
Non-users in Active Rheumatoid Arthritis: A Post
Hoc Analysis of Phase 3 Trials
4M117: RA – Treatments III: Cardiovascular
Disease and Readmissions
1894 Risk of Venous Thromboembolism in Rheumatoid
Arthritis Patients Initiating Biologic and Non-biologic
DMARDs, a Population-based Study
4M118: Reproductive Issues in
Rheumatic Disorders
1901 Serious Infections in Offspring Exposed in Utero to
Non-TNFi Biologics and Tofacitinib
Chairman’s picks

Tuesday, November 12, 2019
POSTER SESSION: 9:00AM – 11:00AM
RA – Etiology and Pathogenesis Poster II
2012 A Composite IFN-Based Signature Is Associated
with a Filgotinib-Specific Clinical Response in
bDMARD-Experienced Rheumatoid Arthritis Patients
RA – Treatments Poster III: Safety and Outcomes
2358 Short-term Risk of Major Adverse Cardiovascular
Events or Venous Thrombo-embolic Events in
Patients with Rheumatoid Arthritis Initiating a Janus
Kinase Inhibitor: A Meta-analysis of Randomised
Controlled Trials
2372 Post-Approval Comparative Safety Study of
Tofacitinib and Biologic DMARDs: Five Year Results
from a US-based Rheumatoid Arthritis Registry
2375 Safety of Baricitinib Under Clinical Settings in
Patients with Rheumatoid Arthritis, Using Data
from All-Case Post-marketing Surveillance and
Spontaneous Reports
2403 Adverse Events of Special Interest in Patients with
Rheumatoid Arthritis Treated with Peficitinib in Asian
Population: Pooled Safety Findings
2407 The Safety Profile of Upadacitinib in Japanese
Patients with Rheumatoid Arthritis
ABSTRACT SESSION: 4:30PM – 6:00PM
5T109: Epidemiology and Public Health III: RA
2826 Risk of Serious Infections in Tofacitinib versus Other
Biologic Drug Initiators in Patients with Rheumatoid
Arthritis: A Multi-database Cohort Study
Wednesday, November 13, 2019
ABSTRACT SESSION: 9:00AM – 10:30AM
6W011: RA – Diagnosis, Manifestations,
& Outcomes V: Treatment
2874 Comparison of Malignancy and Mortality Rates
Between Tofacitinib and Biologic DMARDs in
Clinical Practice: Five-year Results from a US-Based
Rheumatoid Arthritis Registry
2875 Effects of Filgotinib on Anemia, Thrombocytopenia
and Leukopenia: Results from a Phase 3 Study in
Patients with Active Rheumatoid Arthritis and
Prior Inadequate Response or Intolerance to
Biological DMARDs
ABSTRACT SESSION: 11:00AM – 12:30PM
6W021: RA – Treatments V: Switching
and Tapering RA Medications
2907 Clinical and Functional Outcomes Among
Rheumatoid Arthritis Patients Switching Between
JAK1-selective Inhibitor Upadacitinib and
Adalimumab Following Insufficient Response
2909 Efficacy and Safety of the Selective Interleukin-1
Receptor Associated Kinase 4 Inhibitor,
PF-06650833, in Patients with Active Rheumatoid
Arthritis and Inadequate Response to Methotrexate
Chairman’s picks

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