ACR Highlights 2019
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Enhancing knowledge of the clinical<br />
importance of cytokine signalling<br />
The Cytokine Signalling Forum<br />
www.cytokinesignalling.com<br />
<strong>ACR</strong> <strong>2019</strong><br />
Conference <strong>Highlights</strong><br />
Find us at Stand 2423<br />
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University of Glasgow<br />
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Steering Committee<br />
Professor Iain B. McInnes<br />
University of Glasgow,<br />
UK<br />
CHAIR<br />
Professor Johannes W.J. Bijlsma<br />
University Medical Centre, Utrecht,<br />
The Netherlands<br />
Professor Leonard Calabrese<br />
Cleveland Clinic,<br />
USA<br />
Professor Anca Catrina<br />
Karolinska Institutet,<br />
Sweden<br />
Professor Maurizio Cutolo<br />
University of Genova,<br />
Italy<br />
Professor Cem Gabay<br />
University Hospitals of Geneva,<br />
Switzerland<br />
Professor Juan J. Gómez-Reino<br />
University Hospital,<br />
Santiago de Compostela, Spain<br />
Professor Ahmet Gül<br />
Istanbul University,<br />
Turkey<br />
Professor Pierre Miossec<br />
Hôpital Edouard Herriot, Lyon,<br />
France<br />
Professor Peter Nash<br />
University of Queensland,<br />
Brisbane, Australia<br />
Professor John J. O’Shea<br />
NIAMS, Maryland,<br />
USA<br />
Professor Christopher Ritchlin<br />
University of Rochester Medical<br />
Center, USA<br />
Professor Georg Schett<br />
University of Erlangen-Nuremberg,<br />
Erlangen, Germany<br />
Professor Leonie Taams<br />
Kings College London,<br />
UK<br />
Professor Tsutomu Takeuchi<br />
Keio University, Tokyo,<br />
Japan<br />
Professor Kevin Winthrop<br />
Oregon Health and Science<br />
University, USA<br />
SPONSORSHIP AND UNRESTRICTED<br />
EDUCATIONAL GRANTS FROM
Chairman’s Welcome<br />
Dear CSF Member,<br />
Welcome to this year’s selection of <strong>ACR</strong> abstracts on cytokine signalling agents and my ‘Chairman’s picks’.<br />
As in previous years, there continues to be an intense focus on the Janus kinase (JAK) inhibitors, with late stage trial<br />
results from filgotinib, peficitinib and newly approved upadacitinib – as well as a host of real-world and trial data for the<br />
more established baricitinib and tofacitinib.<br />
The largest number of trial abstracts concern upadacitinib. Key among them are the 48-week data from SELECT<br />
MONOTHERAPY [513], SELECT EARLY [928] and 60-week data from SELECT BEYOND [518], and SELECT NEXT<br />
[538]. There is an interesting study analysing the clinical and functional outcomes of switching between upadacitinib<br />
and adalimumab following initial non-response [2907] and another looking into structural joint damage inhibition with<br />
upadacitinib monotherapy and combination use [547].<br />
For filgotinib, Combe et al and Westhovens et al are presenting data from the FINCH trials [506; 927], whilst Takeuchi<br />
et al are presenting data on the inhibition of joint destruction with peficitinib in combination with methotrexate [507].<br />
There is new clinical data for both tofacitinib and baricitinib – with a phase 3 study assessing disease trajectories in<br />
baricitinib patients [1350], and a look at MTX-withdrawal in patients taking the extended-release formulation of tofacitinib<br />
[1412]. Real-world studies examine the utility of these two drugs in clinical practice, exploring the impact of time since<br />
first diagnosis on tofacitinib [1484] and an updated baricitinib safety profile with patients exposed for up to 7 years [847].<br />
At this year’s congress there is a focus on safety and patient reported outcomes, with pain relief in patients investigated<br />
for both baricitinib [1407] and tofacitinib [1502]. MACE and VTEs are also in the spotlight with meta-analyses across JAK<br />
inhibitors [2358] and data for upadacitinib [846] being presented.<br />
We will also see Phase 2 data from Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib [929]. It will be important to<br />
see how these agents progress over the coming years, and to find out what hope they can offer to patients who fail on<br />
current therapies.<br />
Within the following pages, we share our selection of the congress highlights, including my ‘Chairman’s picks’.<br />
As always, thank you for your continued support, and we hope you enjoy your time in Atlanta at <strong>ACR</strong> <strong>2019</strong>!<br />
Kind regards,<br />
Professor Iain McInnes
Key Presentations<br />
Sunday, November 10, <strong>2019</strong><br />
POSTER SESSION: 9:00AM – 11:00AM<br />
RA – Etiology & Pathogenesis Poster I<br />
45 bDMARD-experienced Filgotinib-treated Patient<br />
Samples Exhibit a Partial Reversion to the Peripheral<br />
Molecular Profile of a Demographically Matched<br />
Healthy Population<br />
46 Key Inflammatory Biomarkers at Baseline Are<br />
Associated with Filgotinib Response at Week 12<br />
in Rheumatoid Arthritis Patients with Inadequate<br />
Response or Intolerance to Biologic DMARDs<br />
59 Evaluation of Potential Mechanisms Underlying the<br />
Safety Observations of Filgotinib in Clinical Studies<br />
in RA<br />
Health Services Research Poster I – <strong>ACR</strong>/ARP<br />
252 Treatment Sequences, Effectiveness, and Costs of<br />
Tumor Necrosis Factor Inhibitor Cycling Compared<br />
with Swapping to a Novel Disease-modifying<br />
Antirheumatic Drug in Rheumatoid Arthritis Patients<br />
RA – Treatments Poster I: Novel Treatments<br />
504 A Subgroup Analysis of the Efficacy of Filgotinib in<br />
Demographic and Clinical Subgroups of Patients<br />
with Refractory Rheumatoid Arthritis<br />
506 Efficacy and Safety of Filgotinib for Patients with<br />
Rheumatoid Arthritis with Inadequate Response to<br />
Methotrexate: FINCH1 Primary Outcome Results<br />
507 Inhibition of Joint Destruction in Patients with<br />
Rheumatoid Arthritis Treated with Peficitinib in<br />
Combination with Methotrexate: A Randomised,<br />
Double-Blind, Placebo-Controlled Trial in Japan<br />
508 Longer Term Safety and Efficacy of Peficitinib in<br />
Patients with Rheumatoid Arthritis After 22.7 Months<br />
Mean Treatment Exposure: Interim Data from a<br />
Long-Term, Open-label Extension Study in Japan,<br />
Korea and Taiwan<br />
509 Safety Profile of Upadacitinib in Rheumatoid<br />
Arthritis: Integrated Analysis from the SELECT<br />
Phase 3 Clinical Program<br />
510 Treatment with Upadacitinib Is Associated with<br />
Improvements in Reverse Cholesterol Transport in<br />
Patients with Rheumatoid Arthritis: Correlation with<br />
Changes in Inflammation and HDL Levels<br />
511 A Comparative Analysis of Upadacitinib<br />
Monotherapy and Upadacitinib Combination<br />
Therapy for the Treatment of Rheumatoid Arthritis<br />
from Two Phase 3 Trials<br />
512 Efficacy and Safety of Upadacitinib Monotherapy in<br />
MTX-naïve Patients with Early Active RA Receiving<br />
Treatment Within 3 Months of Diagnosis: A Post Hoc<br />
Analysis of the SELECT-EARLY<br />
513 Upadacitinib as Monotherapy in Patients with<br />
Rheumatoid Arthritis: Results at 48 Weeks<br />
515 Clinical Responses in Patients with Inadequate<br />
Response to bDMARDs upon Treatment<br />
with Upadacitinib<br />
516 Impact of Baseline Demographics and Disease<br />
Activity on Outcomes in Patients with Rheumatoid<br />
Arthritis Receiving Upadacitinib<br />
517 A Subgroup Analysis of Clinical Efficacy Response<br />
and Quality of Life Outcomes from Phase 3 Study of<br />
Filgotinib in Patients with Inadequate Response to<br />
Biologic DMARDs<br />
518 Upadacitinib in Patients with Rheumatoid Arthritis<br />
and Inadequate Response or Intolerance to<br />
Biological DMARDs: Results at 60 Weeks<br />
522 Treatment with Upadacitinib Results in the<br />
Normalization of Key Pathobiologic Pathways in<br />
Patients with Rheumatoid Arthritis<br />
523 The Impact of Upadacitinib versus Methotrexate or<br />
Adalimumab on Individual and Composite Disease<br />
Measures in Patients with Rheumatoid Arthritis<br />
524 A Comparison of Upadacitinib Plus Methotrexate<br />
and Upadacitinib Plus Other CsDMARDs in Patients<br />
with Rheumatoid Arthritis: An Analysis of Two<br />
Phase 3 Studies<br />
527 Safety and Effectiveness of Upadacitinib or<br />
Adalimumab in Patients with Rheumatoid Arthritis:<br />
Results at 48-Weeks<br />
529 Characterization of Remission in Patients with<br />
Rheumatoid Arthritis Treated with Upadacitinib<br />
or Comparators<br />
Chairman’s picks
538 Long-Term Safety and Efficacy of Upadacitinib<br />
in Patients with Rheumatoid Arthritis and an<br />
Inadequate Response to csDMARDs: Results at<br />
60-Weeks<br />
545 Molecular Analysis of the Mode of Action of<br />
Upadacitinib in Rheumatoid Arthritis Patients:<br />
Whole Blood RNA Expression Data from the<br />
SELECT-NEXT Study<br />
547 Inhibition of Structural Joint Damage with<br />
Upadacitinib as Monotherapy or in Combination with<br />
Methotrexate in Patients with Rheumatoid Arthritis<br />
550 Rheumatoid Arthritis Treatment with Filgotinib:<br />
Week 156 Safety and Efficacy Data from a<br />
Phase 2b Open-label Extension Study<br />
551 Upadacitinib Treatment and the Routine Assessment<br />
of Patient Index Data 3 (RAPID3) Among Patients<br />
with Rheumatoid Arthritis<br />
ABSTRACT SESSION: 2:30PM – 4:00PM<br />
3S080: RA – Treatments I: Safety and Outcomes<br />
846 MACE and VTE Across Multiple Upadacitinib Studies<br />
in Rheumatoid Arthritis: Integrated Analysis from the<br />
SELECT Phase 3 Clinical Program<br />
847 Safety Profile of Baricitinib for the Treatment of<br />
Rheumatoid Arthritis up to 7 Years: An Updated<br />
Integrated Safety Analysis<br />
ABSTRACT SESSION: 4:30PM – 6:00PM<br />
3S109: RA – Treatments II: Novel Treatments for RA<br />
927 Efficacy and Safety of Filgotinib for Patients with<br />
Rheumatoid Arthritis Naïve to Methotrexate Therapy:<br />
FINCH3 Primary Outcome Results<br />
928 Monotherapy with Upadacitinib in MTX-naïve<br />
Patients with Rheumatoid Arthritis: Results at<br />
48-Weeks<br />
929 Efficacy and Safety of Fenebrutinib, a BTK Inhibitor,<br />
Compared to Placebo in Rheumatoid Arthritis<br />
Patients with Active Disease Despite TNF Inhibitor<br />
Treatment: Randomised, Double Blind, Phase 2 Study<br />
Monday, November 11, <strong>2019</strong><br />
POSTER SESSION: 9:00AM – 11:00AM<br />
RA – Animal Models Poster<br />
992 Identification of CJ-15314, a Novel Highly Selective<br />
JAK1 Inhibitor, for the Treatment of Rheumatoid Arthritis<br />
RA – Diagnosis, Manifestations, & Outcomes<br />
Poster II: Treatments, Outcomes, & Measures<br />
1329 Pooled Safety Analyses from Phase 3 Studies of<br />
Filgotinib in Patients with Rheumatoid Arthritis<br />
1338 Joint-specific Responses to Tofacitinib and<br />
Methotrexate in Rheumatoid Arthritis: A Post Hoc<br />
Analysis of Data from ORAL Start<br />
1348 Impact of Tofacitinib on the Individual Components<br />
of the <strong>ACR</strong> Composite Score in Patients with<br />
Rheumatoid Arthritis: A Post Hoc Analysis of Phase<br />
3 Trials<br />
1350 Patient Disease Trajectories in Baricitinib 2 Mg<br />
Treated Patients with Rheumatoid Arthritis and<br />
Inadequate Response to Biologic DMARDs<br />
1352 Effects of Upadacitinib on Patient-reported<br />
Outcomes After 24-Weeks in Patients with<br />
Active Rheumatoid Arthritis and an Inadequate<br />
Response to Conventional Synthetic or Biologic<br />
Disease-modifying Antirheumatic Drugs:<br />
Results from SELECT-NEXT and SELECT-BEYOND<br />
Phase 3 Studies<br />
1375 Patient-reported Outcomes of Upadacitinib versus<br />
Adalimumab Use in Patients with Moderately<br />
to Severely Active Rheumatoid Arthritis and an<br />
Inadequate Response to Methotrexate: 26-Week<br />
Analysis of a Phase 3 Study<br />
1376 Impact of 24- or 26-Week Upadacitinib<br />
Monotherapy on Patient-reported Outcomes<br />
in Patients with Moderately to Severely Active<br />
Rheumatoid Arthritis and No Prior Use of or an<br />
Inadequate Response to Methotrexate: Results from<br />
Two Phase 3 Trials<br />
Chairman’s picks
RA – Treatments Poster II: Established Treatments<br />
1377 MTX Withdrawal in Patients with RA Who Achieve<br />
Low Disease Activity with Tofacitinib Modified-release<br />
11 Mg Once Daily + MTX: An Assessment of the<br />
Impact on the Short Form-36 Patient-reported Outcome<br />
1400 Real Life Retention of Tofacitinib in Patients with<br />
Rheumatoid Arthritis<br />
1407 Baricitinib Provides Better Pain Relief Across All<br />
Disease Activity Levels Compared with Placebo and<br />
Adalimumab in Rheumatoid Arthritis<br />
1412 Efficacy and Safety of Tofacitinib Modified-release<br />
11 Mg Once Daily + MTX in RA Patients with an<br />
Inadequate Response to MTX: Open-label Phase<br />
Results from a Global Phase 3b/4 MTX<br />
Withdrawal Study<br />
1413 Efficacy of Tofacitinib Monotherapy, Tofacitinib with<br />
Methotrexate and Adalimumab with Methotrexate<br />
in Patients with Early (≤ 2 Years) versus Established<br />
(> 2 Years) Rheumatoid Arthritis: A Post Hoc<br />
Analysis of Data from ORAL Strategy<br />
1415 Effect of Tofacitinib on the Qualitative Profile of High<br />
Density Lipoproteins Molecules in Patients with<br />
Rheumatoid Arthritis<br />
1420 Heterogeneity in the Pattern of Use of JAK-inhibitors<br />
Between Countries Participating in an International<br />
Collaboration of Registers of Rheumatoid Arthritis<br />
Patients (the JAK-pot Study)<br />
1426 Impact of TNF Inhibitor Cycling with Adalimumab<br />
and Etanercept versus Switching to Tofacitinib<br />
1428 Time to Discontinuation of Tofacitinib in Rheumatoid<br />
Arthritis Patients with and Without Methotrexate:<br />
Results from a Rheumatoid Arthritis Cohort<br />
1439 Effect of Baricitinib on Functional Impairment in<br />
RA Patients with Moderate Disease Activity and an<br />
Inadequate Response to Conventional DMARDs<br />
1444 Tofacitinib in Patients with Rheumatoid Arthritis and<br />
Indicative of Depression And/or Anxiety: A Post Hoc<br />
Analysis of Phase 3 and Phase 3b/4 Clinical Trials<br />
1445 Pre-Biologic Use of Janus Kinase Inhibitors for the<br />
Treatment of Rheumatoid Arthritis in the<br />
United States<br />
Spondyloarthritis Including Psoriatic Arthritis<br />
– Clinical Poster II: Treatment of Axial<br />
Spondyloarthritis & Psoriatic Arthritis<br />
1484 The Impact of Time Since First Diagnosis on the<br />
Efficacy and Safety of Tofacitinib in Patients with<br />
Active Psoriatic Arthritis<br />
1492 Exposure-Response Analyses for Upadacitinib<br />
Efficacy and Safety in Ankylosing Spondylitis –<br />
Analyses of the SELECT-AXIS I Study<br />
1502 The Effect of Tofacitinib on Residual Pain in Patients<br />
with Psoriatic Arthritis<br />
1513 Impact of Baseline Body Mass Index on the Efficacy<br />
and Safety of Tofacitinib in Patients with<br />
Psoriatic Arthritis<br />
1534 Long-term Safety of Filgotinib in Patients with<br />
Psoriatic Arthritis, Week 52 Safety Data from a<br />
Phase 2 Open-label Extension Study<br />
ABSTRACT SESSION: 4:30PM – 6:00PM<br />
4M115: Pain Mechanisms – Basic and<br />
Clinical Science<br />
1880 Baricitinib 4 Mg and 2 Mg Once Daily Reduced<br />
Pain in Both Patients Who Were Opioid Users and<br />
Non-users in Active Rheumatoid Arthritis: A Post<br />
Hoc Analysis of Phase 3 Trials<br />
4M117: RA – Treatments III: Cardiovascular<br />
Disease and Readmissions<br />
1894 Risk of Venous Thromboembolism in Rheumatoid<br />
Arthritis Patients Initiating Biologic and Non-biologic<br />
DMARDs, a Population-based Study<br />
4M118: Reproductive Issues in<br />
Rheumatic Disorders<br />
1901 Serious Infections in Offspring Exposed in Utero to<br />
Non-TNFi Biologics and Tofacitinib<br />
Chairman’s picks
Tuesday, November 12, <strong>2019</strong><br />
POSTER SESSION: 9:00AM – 11:00AM<br />
RA – Etiology and Pathogenesis Poster II<br />
2012 A Composite IFN-Based Signature Is Associated<br />
with a Filgotinib-Specific Clinical Response in<br />
bDMARD-Experienced Rheumatoid Arthritis Patients<br />
RA – Treatments Poster III: Safety and Outcomes<br />
2358 Short-term Risk of Major Adverse Cardiovascular<br />
Events or Venous Thrombo-embolic Events in<br />
Patients with Rheumatoid Arthritis Initiating a Janus<br />
Kinase Inhibitor: A Meta-analysis of Randomised<br />
Controlled Trials<br />
2372 Post-Approval Comparative Safety Study of<br />
Tofacitinib and Biologic DMARDs: Five Year Results<br />
from a US-based Rheumatoid Arthritis Registry<br />
2375 Safety of Baricitinib Under Clinical Settings in<br />
Patients with Rheumatoid Arthritis, Using Data<br />
from All-Case Post-marketing Surveillance and<br />
Spontaneous Reports<br />
2403 Adverse Events of Special Interest in Patients with<br />
Rheumatoid Arthritis Treated with Peficitinib in Asian<br />
Population: Pooled Safety Findings<br />
2407 The Safety Profile of Upadacitinib in Japanese<br />
Patients with Rheumatoid Arthritis<br />
ABSTRACT SESSION: 4:30PM – 6:00PM<br />
5T109: Epidemiology and Public Health III: RA<br />
2826 Risk of Serious Infections in Tofacitinib versus Other<br />
Biologic Drug Initiators in Patients with Rheumatoid<br />
Arthritis: A Multi-database Cohort Study<br />
Wednesday, November 13, <strong>2019</strong><br />
ABSTRACT SESSION: 9:00AM – 10:30AM<br />
6W011: RA – Diagnosis, Manifestations,<br />
& Outcomes V: Treatment<br />
2874 Comparison of Malignancy and Mortality Rates<br />
Between Tofacitinib and Biologic DMARDs in<br />
Clinical Practice: Five-year Results from a US-Based<br />
Rheumatoid Arthritis Registry<br />
2875 Effects of Filgotinib on Anemia, Thrombocytopenia<br />
and Leukopenia: Results from a Phase 3 Study in<br />
Patients with Active Rheumatoid Arthritis and<br />
Prior Inadequate Response or Intolerance to<br />
Biological DMARDs<br />
ABSTRACT SESSION: 11:00AM – 12:30PM<br />
6W021: RA – Treatments V: Switching<br />
and Tapering RA Medications<br />
2907 Clinical and Functional Outcomes Among<br />
Rheumatoid Arthritis Patients Switching Between<br />
JAK1-selective Inhibitor Upadacitinib and<br />
Adalimumab Following Insufficient Response<br />
2909 Efficacy and Safety of the Selective Interleukin-1<br />
Receptor Associated Kinase 4 Inhibitor,<br />
PF-06650833, in Patients with Active Rheumatoid<br />
Arthritis and Inadequate Response to Methotrexate<br />
Chairman’s picks
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