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Enhancing knowledge of the clinical
importance of cytokine signalling
The Cytokine Signalling Forum
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ACR 2021
Congress Preview
Rheumatoid Arthritis
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Chairman’s Introduction
Dear CSF Member,
Welcome to the 2021 selection of ACR abstracts on cytokine signalling, and my ‘Chairman’s Picks’. Year-on-year our
knowledge regarding cytokine biology and targeted agents continues to grow – a fact reflected in the volume of data being
released – and so this year again the selections here focus on RA, with other indications addressed in a separate review.
Of those agents already approved in one market or another, we see new long-term and post-marketing data. For
baricitinib, Taylor et al share the latest integrated safety analysis – now up to 9.3 years [1688]. There are also new data
on pain and fatigue from RA-BEAM and -BEACON [1235 and 1236], and Strand et al present post hoc analyses of
patient-reported outcomes and quality of life [0741]. Fujii et al bring us safety data in 3,445 Japanese patients treated with
baricitinib in clinical practice [1676].
ORAL Surveillance data are released for tofacitinib – part of an FDA-mandated safety trial comparing tofacitinib to
TNFi [0831]. These are matched with a multi-database population-based study which aimed to look at the FDA safety
concerns in real-world settings [1675]. Racial disparities in clinical outcomes have been described, so a timely post hoc
analysis of Phase 2, 3, and 3b/4 trials brings us a poster on the impact of race on the efficacy and safety of tofacitinib in RA
[1680]. Turning to real-world populations, Krüger et al share effectiveness, safety, quality of life and patient satisfaction data
from ESCALATE-RA – a non-interventional, prospective study in Germany [0560]. Canadian registry data further enhance
the real-world picture, with tofacitinib discontinuation rates pooled from OBRI and RHUMADATA [0827 and 1217], and
primary results from CANTORAL [1674]. Further OBRI data look at physician- and patient-reported effectiveness with
tofacitinib compared to TNFi [1233]. Contextualisation of real-world and trial data is provided by Pope et al, with a look at
patient characteristics, efficacy, and treatment patterns of tofacitinib monotherapy in various cohorts [0814].
Upadacitinib clinical data continue to come through, with 3-year results from SELECT-COMPARE presented by
Fleischmann et al [0828] and Nash et al [0837]. Long-term safety is presented for RA patients in SELECT-EARLY [1692],
and in a pooled analysis totalling 8,562 patient-years of exposure across indications [1691]. A post hoc analysis evaluates
the consistency in time to achieving meaningful clinical response in four Phase 3 trials [0832]. Another post hoc analysis
of Phase 3 SELECT data evaluates the impact of upadacitinib on RAPID3 [1234]. Real-world data are also available, with
a poster from the UPwArds study sharing clinical practice results from Germany [0833]. Finally, predictors of response
to upadacitinib are explored by Kavanaugh et al [1237], and sustainability of response in bDMARD-refractory patients is
covered in an analysis by van Vollenhoven at al [1694].
We have picked out just one poster for filgotinib: clinical outcomes in a long-term extension trial in bDMARD inadequate
responders, presented by Buch et al on Tuesday [1696].
For new agents coming through, there are in vitro data for deucravacitinib – a novel TYK2 inhibitor [0509]. Finally, general
safety questions for the JAKi are examined in posters on VTE [1245] and herpes zoster [1545]. With the arrival of so many
different JAKi, it is important to understand the practicalities of cycling or switching – a question examined by the JAK-pot
study [1442].
We hope our selection of highlights is useful. As always, thank you for your support, and we hope you enjoy the ACR
Convergence meeting.
Kind regards,
Prof. Iain McInnes
Chairman’s picks
Key Presentations
Saturday 6 th November 2021
08:30 – 10:30 POSTER SESSION A
RA – Etiology & Pathogenesis Poster
0029
JAK1 Regulates Autophagy and Reinforces the Inflammatory and Autoimmune
Potentials in Rheumatoid Arthritis Synovial Fibroblasts
12:00 – 12:30 INDUSTRY SESSION
AbbVie
Why does Remission in RA Matter?
Grace Wright
12:30 – 13:30 INDUSTRY SESSION
AbbVie
The Benefit-Risk Balance: A Deep Dive into Efficacy and Safety of a JAK Inhibitor
Robert Chambers, Philip J. Mease, and Alvin F. Wells
16:00 – 17:00 SCIENTIFIC SESSION
Not Another Pill! Integrative Pain Management Approaches
Janet L. Poole and Ricardo Ferreira
17:30 – 19:00 INDUSTRY SESSION
Pfizer
Review of the Clinical Development Program for an Approved JAK Inhibitor in
Patients with Moderate to Severe Rheumatoid Arthritis
Janet Pope and Grace Wright
Chairman’s picks
Sunday 7 th November 2021
08:30 – 10:30 POSTER SESSION B
Cytokines & Cell Trafficking Poster
0509
Selective Inhibition of Tyrosine Kinase 2 with Deucravacitinib Compared with
Janus Kinase 1/2/3 Inhibitors
Epidemiology & Public Health Poster II: Inflammatory Arthritis – RA, SpA, & Gout
0560
Effectiveness, Safety, Quality of Life and Patient Satisfaction with Tofacitinib Treatment
in Adult Patients with Rheumatoid Arthritis Under Routine Clinical Care: Second
Interim Analysis of a German Non-Interventional, Prospective, Multi-Center Study
Patient Outcomes, Preferences, & Attitudes Poster II: Measurements
0741
Assessing the Relationship of Patient Global Assessment of Disease Activity and
Health Related Quality of Life by SF-36 with Other Patient-Reported Outcomes in
Rheumatoid Arthritis: Post Hoc Analyses of Data from Phase 3 Trials of Baricitinib
RA – Diagnosis, Manifestations, & Outcomes Poster II: Miscellaneous Aspects of RA
0812
Are Biologic and Targeted Synthetic Disease Modifying Anti-Rheumatic Drugs
Associated with Work Participation Improvement in Early Rheumatoid Arthritis?
A Systematic Review and Meta-analysis
RA – Treatments Poster I: Comparative Effectiveness, Biosimilars, Withdrawal, & the Real World
0814
0824
0827
0828
0831
0832
0833
0837
Patient Characteristics, Efficacy, and Treatment Patterns of Tofacitinib
Monotherapy in Patients with RA: Contextualization of Randomized Controlled
Trial Results with Real-world Data
Physicians’ Reasons for Prescribing Janus Kinase Inhibitors (JAKi) in Patients
with Rheumatoid Arthritis, and Associated Alignment Between Physicians and
Patients in a Real-world Clinical Setting
Discontinuation Rate of Tofacitinib as Monotherapy Is Similar Compared to
Combination Therapy with Methotrexate in Rheumatoid Arthritis Patients: Pooled
Data from Two Rheumatoid Arthritis Registries in Canada
Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in Patients with
Rheumatoid Arthritis: Results at 3 Years from the SELECT-COMPARE Study
Safety and Efficacy of Tofacitinib vs TNF Inhibitors in RA Patients Aged 50 Years
or Older with One or More Cardiovascular Risks: Results from a Phase 3b/4
Randomized Safety Trial
Consistency in Time to Response with Upadacitinib as Monotherapy or
Combination Therapy and Across Patient Populations with Rheumatoid Arthritis
Effectiveness of Upadacitinib in Patients with Rheumatoid Arthritis in German
Real-World Practice: Interim Results from a Post-Marketing Observational Study
Sustainability of Response Between Upadacitinib and Adalimumab in Patients with
Rheumatoid Arthritis: Results Through 3 Years from the SELECT-COMPARE Trial
RA – Treatments Poster I: Comparative Effectiveness, Biosimilars, Withdrawal, & the Real World
0841 Persistence on JAK Inhibitors in Daily Practice: Evaluation of the Rhadar-registry
Chairman’s picks
Monday 8 th November 2021
14:00 – 14:15 ABSTRACT SESSION
Abstracts: RA – Treatments II: New Findings in Established Therapies
Effectiveness of Cycling JAKi Compared to Switching to bDMARD in Patients Who
1442 Failed a First JAKi in an International Collaboration of Registries of Rheumatoid
Arthritis Patients (the JAK-pot Study)
08:30 – 10:30 POSTER SESSION C
RA – Diagnosis, Manifestations, & Outcomes Poster III: Prediction, Biomarkers, & Treatment Response
1213 Persisting Pain in Rheumatoid Arthritis – an Essential yet Underrated Challenge
1217
Discontinuation Rate of Tofacitinib Is Similar When Compared to TNF Inhibitors
in Rheumatoid Arthritis Patients: Pooled Data from Two Rheumatoid Arthritis
Registries in Canada
RA – Treatments Poster II: PROs, Biomarkers, & Systemic Inflammation
1233
1234
1235
1236
1237
Physician and Patient Reported Effectiveness Outcomes Are Similar in Tofacitinib
and TNF Inhibitors in Rheumatoid Arthritis Patients: Data from a Rheumatoid
Arthritis Registry in Canada
Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid
Arthritis Treated with Long-Term Upadacitinib Therapy
Treatment Effect of Baricitinib on Fatigue: Mediation Analysis Results from Two
Phase 3 Trials
Pain in Patients with Rheumatoid Arthritis Who Did or Did Not Achieve Treatment
Response Based on Improvement in Swollen Joints with Baricitinib Clinical Trials
Predictors of Response: Baseline Characteristics and Early Treatment Responses
Associated with Achievement of Remission and Low Disease Activity Among
Upadacitinib-Treated Patients with Rheumatoid
1245
Characteristics of RA Patients Treated with JAK Inhibitors Before versus After VTE
Warnings: Results of a Real-World Multicentric Study
09:30 – 10:30 SCIENTIFIC SESSION
FDA Update on Safety Issues in the Treatment of Rheumatic Disease
Michael Weisman
Chairman’s picks
Tuesday 9 th August 2021
08:30 – 10:30 POSTER SESSION D
Infection-related Rheumatic Disease Poster
1545
Safety of JAK Inhibitor in Patients with Rheumatoid Arthritis Who Developed
Reactivation of Herpes Zoster Virus After Receiving JAK Inhibitor
RA – Treatments Poster III: RA Treatments & Their Safety
1674
1675
1676
1680
1688
1691
1692
1694
1696
1697
1702
1704
1710
Effectiveness and Safety of Tofacitinib in Canadian Patients with RA: Primary
Results from a Multicenter, Observational Study
Risk of Malignancy in Patients Treated with Tofacitinib: Results from the Safety of
Tofacitinib in Routine Care Patients with Rheumatoid Arthritis (STAR-RA) Study
Safety of Baricitinib in Japanese Patients with Rheumatoid Arthritis (RA): The
2020 Interim Report from All-case Post Marketing Surveillance in Clinical Practice
Impact of Race on the Efficacy and Safety of Tofacitinib in Patients with RA: A Post
Hoc Analysis of Phase 2, 3, and 3b/4 Clinical Trials
Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 9.3
Years: An Updated Integrated Safety Analysis
Long-Term Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis,
Psoriatic Arthritis, or Ankylosing Spondylitis
Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid
Arthritis: 3-year Results from the SELECT-EARLY Study
Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid
Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs
Clinical Outcomes up to Week 48 of Ongoing Filgotinib RA Long-term Extension
Trial of Biologic DMARD Inadequate Responders Initially on Filgotinib or Placebo in
a Phase 3 Trial
Clinical Outcomes up to Week 48 of Filgotinib Treatment in an Ongoing Long-term
Extension Trial of RA Patients with Inadequate Response to MTX Initially Treated
with Filgotinib or Adalimumab During the Phase 3 Parent Trial
Efficacy and Safety of Baricitinib in B/tsDMARDs Naive and B/tsDMARDs-IR
Patients with Rheumatoid Arthritis
Tofacitinib in Rheumatoid Arthritis: Is There a Correlation Between a Rapid
Analgesic Effect and a Decrease in Activity After 3 and 6 Months?
Clinical Outcomes of MTX-Naïve RA Patients on Filgotinib Long-term Extension
Trial Initially on FIL or MTX During Phase 3 Parent Trial
Abstracts: RA – Treatments I: Safety & Harms
1939
1941
Risk of Cardiovascular Outcomes in Patients Treated with Tofacitinib: First Results
from the Safety of Tofacitinib in Routine Care Patients with Rheumatoid Arthritis
(STAR-RA) Study
The Risk of Venous Thromboembolic Events in Patients with RA Aged ≥ 50 Years
with ≥ 1 Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized
Safety Study of Tofacitinib vs TNF Inhibitors
Chairman’s picks
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