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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>2018</strong><br />

Conference <strong>Highlights</strong><br />

Find us at Booth C35<br />

Developed under<br />

the auspices of the<br />

University of Glasgow<br />

Register for all this FREE content at<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,<br />

Utrecht, The Netherlands<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 Georg Schett<br />

University of Erlangen-Nuremberg,<br />

Erlangen, Germany<br />

Professor Tsutomu Takeuchi<br />

Keio University, Tokyo, Japan<br />

DEVELOPMENT PARTNERS<br />

Professor Kevin Winthrop<br />

Oregon Health and Science<br />

University, USA


Chairman’s Welcome<br />

Dear CSF Member,<br />

Following the continued success of the Cytokine Signalling Forum, it is my pleasure to welcome you to our selection of<br />

the <strong>ACR</strong> <strong>2018</strong> abstracts. The selection includes my ‘Chairman’s Picks,’ abstracts that I feel have the most significant<br />

impact on cytokine signalling science.<br />

This year it is exciting to see more data supporting the use of JAK inhibitors in rheumatoid arthritis, with new Phase 3<br />

data released for two unapproved JAK inhibitors. Two Phase 3 peficitinib abstracts are presented with results from two<br />

different patient populations: DMARD inadequate responders [#887] and methotrexate inadequate responders [#888].<br />

In addition, upadacitinib Phase 3 data continues to be presented following the abstracts at EULAR earlier this year. Smolen<br />

presents data on upadacitinib monotherapy in methotrexate inadequate responders [#889], followed by an investigation by<br />

van Vollenhoven of upadacitinib monotherapy in methotrexate-naïve patients [#891]. The upadacitinib Phase 3 data also<br />

includes an upadacitinib comparison study in methotrexate inadequate responders presented by Fleischmann [#890].<br />

Updates on the long-term safety profile of baricitinib are presented in a 6-year integrated safety analysis presented by<br />

Genovese [#962], with a focus on cardiovascular safety discussed by Weinblatt [#2815].<br />

Similar data is presented on tofacitinib within a longer-term safety analysis study containing data up to 9.5 years [#963].<br />

Cardiovascular disease risk associated with tofacitinib was evaluated in comparison to csDMARD in patients with RA<br />

[#2817], and herpes zoster risk is analysed in an abstract by Curtis using data over a 5-year period [#885]. Tofacitinib<br />

clinical effectiveness is also evaluated in an observational cohort by Cohen [#580].<br />

We also have long-term safety data on filgotinib in patients with RA, using data up to 132 weeks [#2551]. Outside<br />

RA, filgotinib is showing positive Phase 2 data in psoriatic arthritis and in csDMARD inadequate responders<br />

presented by Mease [#1821].<br />

In this booklet, you will find our selection of the abstract highlights from <strong>ACR</strong> <strong>2018</strong> with my ‘Chairman’s Picks’ highlighted.<br />

As always, thank you for your continued support of the Cytokine Signalling Forum and we hope you enjoy your time at<br />

<strong>ACR</strong> in Chicago this year!<br />

Don’t forget to visit us at the Cytokine Signalling Forum stand at <strong>ACR</strong>.<br />

Kind regards,<br />

Professor Iain McInnes


Key Presentations<br />

Sunday, 21 October <strong>2018</strong><br />

<strong>ACR</strong> POSTER SESSION A: 9 :00 – 11:00 AM<br />

Rheumatoid Arthritis – Animal Models Poster<br />

37 Discovery of DWP213388, a Potent ITK and<br />

BTK Dual Target Inhibitor with Excellent Efficacy,<br />

as a Treatment for Autoimmune Diseases<br />

Epidemiology and Public Health Poster I:<br />

Rheumatoid Arthritis<br />

224 Risk of Venous Thrombotic Events in<br />

Rheumatoid Arthritis Patients Initiating<br />

Tofacitinib or Adalimumab<br />

Rheumatoid Arthritis – Diagnosis,<br />

Manifestations, and Outcomes Poster I:<br />

Comorbidities<br />

525 Low Interstitial Lung Disease Event Rate in<br />

Patients with Rheumatoid Arthritis: Pooled<br />

Post Hoc Analysis of Data from the Tofacitinib<br />

Clinical Development Program<br />

Rheumatoid Arthritis – Treatment Poster I:<br />

Strategy and Epidemiology<br />

546 Baricitinib: Early vs. Delayed Start in Patients<br />

with Rheumatoid Arthritis<br />

557 The Impact of Comedication with Conventional<br />

Synthetic DMARDs on Drug Retention and<br />

Clinical Effectiveness of Tofacitinib, Anti–Tumor<br />

Necrosis Factor Therapy and Biologics with<br />

an Alternative Mode of Action in Patients with<br />

Rheumatoid Arthritis. A Cohort Study<br />

574 Longitudinal Efficacy Analysis of Patients with<br />

Active Rheumatoid Arthritis and Inadequate<br />

Response to Conventional Synthetic DMARDs:<br />

Response Following Rescue from Baricitinib 2<br />

mg to 4 mg Once-Daily<br />

580 Clinical Effectiveness of Tofacitinib 11 mg<br />

Once Daily (QD) versus Tofacitinib 5 mg Twice<br />

Daily (BID) in the Corrona US RA Registry<br />

581 Comparative Analysis of Outcomes among<br />

Patients with Rheumatoid Arthritis Initiating<br />

Tofacitinib in Combination with Oral MTX who<br />

Discontinue, Interrupt, or Persist with MTX<br />

582 Baseline Power Doppler and Multi-Biomarker<br />

Disease Activity Score Predict 12-Week<br />

Disease Activity Response to Tofacitinib<br />

586 Effectiveness, Tolerability, and Safety<br />

of Tofacitinib in Rheumatoid Arthritis: A<br />

Retrospective Analysis of Real-World DATA<br />

from the St. Gallen and Aarau RA-Cohort<br />

596 Combination of Intra-articular Steroid Injection<br />

and Tofacitinib More Effective than Tofacitinib in<br />

Rapid Radiographic Progression Patients with<br />

Rheumatoid Arthritis<br />

599 Comparative Effectiveness in Pain and<br />

HAQ-DI Improvement for Baricitinib versus<br />

Adalimumab, Tocilizumab, and Tofacitinib<br />

Monotherapies in csDMARD-naïve<br />

Rheumatoid Arthritis Patients: A Matchingadjusted<br />

Indirect Comparison (MAIC)<br />

607 Clinical and Functional Response to Tofacitinib<br />

and Adalimumab in Patients with Rheumatoid<br />

Arthritis: Probability Plot Analysis of Results<br />

from the ORAL Strategy Trial<br />

629 Real-world Use of Tofacitinib Compared with<br />

Tumor Necrosis Factor Inhibitors in a Cohort of<br />

211 Patients with Rheumatoid Arthritis: Data<br />

from a Drug-based Registry Study in Taiwan<br />

Chairman’s picks


Spondyloarthritis including Psoriatic<br />

Arthritis – Clinical Poster I: Imaging, Clinical<br />

Studies, and Treatment<br />

685 Changes in Key Laboratory Values with<br />

Tofacitinib 5 mg BID Treatment in Patients with<br />

Psoriatic Arthritis and Rheumatoid Arthritis<br />

<strong>ACR</strong> CONCURRENT ABSTRACT SESSION:<br />

2:30 – 4:00PM<br />

3S086 <strong>ACR</strong> Abstract: RA–DX, Manifestations,<br />

& Outcomes I: Other Co-Morbidities<br />

885 Herpes Zoster in Tofacitinib Users with and without<br />

Concomitant Methotrexate and Glucocorticoids<br />

3S087 <strong>ACR</strong> Abstract: RA–Treatments I: JAK<br />

Inhibitors<br />

886 Efficacy and Safety of Switching from<br />

Adalimumab to Baricitinib: Long-term Data<br />

from Phase 3 Extension Study in Patients with<br />

Rheumatoid Arthritis<br />

887 Efficacy and Safety of the Novel Oral Janus<br />

Kinase (JAK) Inhibitor, Peficitinib (ASP015K), in<br />

a Phase 3, Double-blind, Placebo-controlled,<br />

Randomized Study of Patients with RA who had<br />

an Inadequate Response to DMARDs<br />

888 Efficacy and Safety of the Novel Oral Janus<br />

Kinase (JAK) Inhibitor, Peficitinib (ASP015K), in<br />

a Phase 3, Double-blind, Placebo-controlled,<br />

Randomized Study of Patients with RA who had<br />

an Inadequate Response to Methotrexate<br />

889 Upadacitinib As Monotherapy: A Phase 3<br />

Randomized Controlled Double-blind Study in<br />

Patients with Active Rheumatoid Arthritis and<br />

Inadequate Response to Methotrexate<br />

890 A Phase 3, Randomized, Double-blind<br />

Study Comparing Upadacitinib to Placebo<br />

and to Adalimumab, in Patients with Active<br />

Rheumatoid Arthritis with Inadequate<br />

Response to Methotrexate<br />

891 A Phase 3, Randomized, Controlled Trial<br />

Comparing Upadacitinib Monotherapy to MTX<br />

Monotherapy, in MTX-naïve Patients with Active<br />

Rheumatoid Arthritis<br />

<strong>ACR</strong> CONCURRENT ABSTRACT SESSION:<br />

4:30 – 6:00PM<br />

3S107 <strong>ACR</strong> Abstract: RA–Etiology &<br />

Pathogenesis I<br />

930 Joint Location-specific IL-6 and JAK-STAT<br />

Signaling in Rheumatoid Arthritis (RA) Fibroblastlike<br />

Synoviocytes (FLS)<br />

3S108 <strong>ACR</strong> Abstract: RA–Treatments II:<br />

Safety<br />

962 Safety Profile of Baricitinib for the Treatment of<br />

Rheumatoid Arthritis up to 6 Years: An Updated<br />

Integrated Safety Analysis<br />

963 Long-term Safety of Tofacitinib up to 9.5 Years:<br />

A Comprehensive Integrated Analysis of the RA<br />

Clinical Development Program<br />

3S110 <strong>ACR</strong> Abstract: SLE–Clinical I: Clinical<br />

Trials<br />

970 Baricitinib in Patients with Systemic Lupus<br />

Erythematosus: Results from a Phase 2, Randomized,<br />

Double-blind, Placebo-controlled Study<br />

Chairman’s picks


Monday, 22 October <strong>2018</strong><br />

<strong>ACR</strong> POSTER SESSION B: 9 :00 – 11:00 AM<br />

Cytokines and Cell Trafficking Poster<br />

983 A MAPK Activated Kinase 2 Inhibitor Attenuates<br />

Inflammatory and Destructive Arthritis in<br />

Human Ex Vivo Models<br />

Innate Immunity Poster<br />

1018 Tofacitinib Impairs Monocyte-derived Dendritic<br />

Cell Differentiation in Rheumatoid Arthritis and<br />

Psoriatic Arthritis<br />

Measures and Measurement of Healthcare<br />

Quality Poster II<br />

1264 Modeling the Costs and Outcomes Associated<br />

with Treatment Sequences, with and without<br />

Tofacitinib, for Moderately to Severely Active<br />

Psoriatic Arthritis in the US<br />

Patient Outcomes, Preferences, and Attitudes<br />

Poster I: Patient-reported Outcomes<br />

1401 Is There a Specific Effect of JAK-inhibitors on<br />

Pain and Fatigue in Rheumatoid Arthritis?<br />

Rheumatoid Arthritis – Diagnosis,<br />

Manifestations, and Outcomes Poster II:<br />

Diagnosis and Prognosis<br />

1495 Baseline Characteristics of Methotrexate<br />

Inadequate Responder Patients with RA<br />

who achieved Low Disease Activity with<br />

Tofacitinib Monotherapy<br />

Rheumatoid Arthritis – Treatments Poster II:<br />

PROs, Safety and Comorbidity<br />

1515 Malignancy in Japanese Patients with Rheumatoid<br />

Arthritis Treated with Tofacitinib: Interim Analysis<br />

of All-case Post-marketing Surveillance<br />

1516 Infection Events in Japanese Patients with<br />

Rheumatoid Arthritis Treated with Tofacitinib:<br />

Interim All-case Post-marketing Surveillance<br />

1518 Baricitinib and Tofacitinib in Real Life – Does<br />

Obesity Impact Response to Janus Kinase<br />

Inhibitor Therapy in Rheumatoid Arthritis?<br />

1519 Patient Characteristics Associated with<br />

Discontinuation of Tofacitinib for the Treatment<br />

of Rheumatoid Arthritis in Open-label, Long-term<br />

Extension Studies up to 9.5 Years<br />

1525 Effect of JAK-inhibitor versus bDMARDs on<br />

Quality of Life in Rheumatoid Arthritis: A Meta<br />

Analysis of Randomized Controlled Trials<br />

1527 Tofacitinib Improves Left Ventricular Mass and<br />

Cardiac Output in Rheumatoid Arthritis Patients<br />

with Chronic Heart Failure<br />

1530 CRP Changes during Bacterial Infections in<br />

Baricitinib-treated Patients with RA<br />

1531 Tofacitinib Show Similar Retention When Used<br />

with and without Methotrexate. Analysis from the<br />

Rhumadata® Clinical Database and Registry<br />

1536 Mean Platelet Volume Changes with Baricitinib<br />

Indicate Reduced New Platelet Production in<br />

Baricitinib-treated Rheumatoid Arthritis Patients<br />

1537 Frequency and Duration of Early Non-serious<br />

Adverse Events in Rheumatoid Arthritis Patients<br />

Treated with Tofacitinib 5 mg Twice Daily as<br />

Monotherapy and Combination Therapy<br />

1542 Real-world Data from a Post-approval<br />

Safety Surveillance Study of Tofacitinib vs<br />

Biologic DMARDs and Conventional Synthetic<br />

DMARDs: Five-year Results from a US-based<br />

Rheumatoid Arthritis Registry


1544 Tofacitinib Safety and Efficacy in the Treatment<br />

of Rheumatoid Arthritis in a Central/Eastern<br />

European Subpopulation<br />

1547 Impact of Obesity on Drug Survival of Tofacitinib<br />

in Patients with Rheumatoid Arthritis: Analysis<br />

from the Turkbio Registry<br />

1554 Cigarette Smoking Does Not Affect Treatment<br />

Response to Tofacitinib in Rheumatoid Arthritis<br />

<strong>ACR</strong> PLENARY SESSION: 11:00 – 12:30 PM<br />

4M042 <strong>ACR</strong> Abstract: Plenary Session II<br />

1821 Filgotinib, an Oral, Selective Janus Kinase<br />

1 Inhibitor, Is Effective in Psoriatic Arthritis<br />

Patients with an Inadequate Response to<br />

Conventional Disease-modifying Anti-rheumatic<br />

Drugs: Results from a Randomized, Placebocontrolled,<br />

Phase 2 Study<br />

<strong>ACR</strong> CONCURRENT ABSTRACT SESSION:<br />

4:30 – 6:00AM<br />

4M108 <strong>ACR</strong> Abstract: SLE–Etiology &<br />

Pathogenesis I<br />

1894 Baricitinib-associated Changes in Type l<br />

Interferon Gene Signature during a 24-Week<br />

Phase-2 Clinical SLE Trial<br />

Tuesday, 23 October <strong>2018</strong><br />

<strong>ACR</strong> POSTER SESSION C: 9 :00 – 11:00 AM<br />

Rheumatoid Arthritis – Diagnosis,<br />

Manifestations, and Outcomes Poster III:<br />

Complications of Therapy, Outcomes,<br />

and Measures<br />

2447 Liver Enzyme Abnormalities after Tofacitinib<br />

Treatment in Patients with Hepatic Steatosis from<br />

the Rheumatoid Arthritis, Psoriatic Arthritis, and<br />

Psoriasis Clinical Programs<br />

2454 Virus Reactivation Rate in Rheumatoid Arthritis<br />

Using Tofacitinib<br />

Rheumatoid Arthritis – Etiology and<br />

Pathogenesis Poster III<br />

2035 Effect of Baricitinib on Joint-related Biomarkers<br />

in Patients with Moderate-to-severe<br />

Rheumatoid Arthritis<br />

Rheumatoid Arthritis – Treatments Poster<br />

III: Biosimilars and New Compounds<br />

2517 The JAK1-selective Inhibitor Filgotinib Reverses<br />

the Disease-associated Transcriptional Profile<br />

Found in the Blood of Patients with Active<br />

Rheumatoid Arthritis<br />

2518 GS-9876, a Novel, Highly Selective, SYK Inhibitor<br />

in Patients with Active Rheumatoid Arthritis:<br />

Safety, Tolerability and Efficacy Results of a<br />

Phase 2 Study<br />

2523 Rapid Response with Upadacitinib Treatment<br />

in Patients with Rheumatoid Arthritis and an<br />

Inadequate Response to csDMARDs or bDMARDs<br />

2524 Effect of Upadacitinib on Pain and Morning<br />

Stiffness in Patients with Rheumatoid Arthritis<br />

and Inadequate Response to Conventional<br />

Synthetic or Biologic Disease-modifying<br />

Anti-rheumatic Drugs<br />

2531 Assessment of Pain Relief with Baricitinib by<br />

Treatment History in Patients with Refractory<br />

Rheumatoid Arthritis<br />

Chairman’s picks


2541 Impact of 12-Weeks of Upadacitinib Treatment<br />

on Individual and Composite Disease Measures<br />

in Patients with Rheumatoid Arthritis and<br />

Inadequate Response to Conventional Synthetic<br />

or Biologic DMARDs<br />

2542 Integrated Exposure-response Analyses for<br />

Upadacitinib Efficacy and Effects on Laboratory<br />

Parameters in Rheumatoid Arthritis – Analyses of<br />

Phase 2b Studies<br />

2546 The Association between Patient Reported<br />

Outcomes and Clinical Measures Among<br />

Rheumatoid Arthritis Patients: Analyses using<br />

Phase 3 Clinical Trials of Upadacitinib<br />

2547 Upadacitinib Monotherapy Improves Patientreported<br />

Outcomes in Patients with Rheumatoid<br />

Arthritis and Inadequate Response to Methotrexate<br />

2551 Rheumatoid Arthritis Treatment with Filgotinib:<br />

Week 132 Safety Data from a Phase 2b Openlabel<br />

Extension Study<br />

Spondyloarthritis including Psoriatic Arthritis<br />

– Clinical Poster III: Treatment<br />

2565 Safety and Efficacy of Tofacitinib, an Oral Janus<br />

Kinase Inhibitor, up to 36 Months in Patients with<br />

Active Psoriatic Arthritis: Data from the Third<br />

Interim Analysis of OPAL Balance, an Open-label,<br />

Long-term Extension Study<br />

2588 Baseline Pain Severity as a Predictor of<br />

Pain Improvement Following Treatment with<br />

Tofacitinib in Psoriatic Arthritis<br />

2594 Median Time to Pain Improvement in Patients<br />

with Psoriatic Arthritis Treated with Tofacitinib<br />

Systemic Lupus Erythematosus – Animal<br />

Models Poster<br />

2097 Monotherapy with Filgotinib, a JAK1-selective<br />

Inhibitor, Reduces Disease Severity and Alters<br />

Immune Cell Subsets in the NZB/W F1 Murine<br />

Model of Lupus<br />

<strong>ACR</strong> CONCURRENT ABSTRACT SESSION:<br />

2:30 – 4:00PM<br />

5T088 <strong>ACR</strong> Abstract: RA–DX, Manifestations,<br />

& Outcomes IV: CV Co-morbidities<br />

2815 Cardiovascular Safety – Update from up<br />

to 6 Years of Treatment with Baricitinib in<br />

Rheumatoid Arthritis Clinical Trials<br />

2817 Cardiovascular Disease Risk with Biologics and<br />

Tofacitinib Compared to Conventional Synthetic<br />

DMARDs in Patients with Rheumatoid Arthritis<br />

<strong>ACR</strong> CONCURRENT ABSTRACT SESSION:<br />

4:30 – 6:00PM<br />

5T106 <strong>ACR</strong> Abstract: Measures of Healthcare<br />

Quality I: QI in RA<br />

2858 Gaps in Patient Safety Performance before<br />

Treatment with Biologic Disease-modifying<br />

Antirheumatic Drugs or Tofacitinib in a Large<br />

Academic Healthcare System<br />

Wednesday, 24 October <strong>2018</strong><br />

<strong>ACR</strong> CONCURRENT ABSTRACT SESSION:<br />

9:00 – 10:30AM<br />

6W009 <strong>ACR</strong> Abstract: RA–Etiology &<br />

Pathogenesis II<br />

2899 Sustained Drug-free Remission in Early RA<br />

Following Methotrexate-based Strategy: Role of<br />

the JAK-STAT Pathway<br />

Chairman’s picks


Notes<br />

Chairman’s picks


Notes<br />

Chairman’s picks


Chairman’s picks


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