ACR 2019


Conference summaries

Sjögren’s Syndrome

Ianalumab (VAY736), a Dual Mode of Action Biologic Combining BAFF Receptor Inhibition with B Cell Depletion, for Treatment of Primary Sjögren’s Syndrome: Results of an International Randomized, Placebo Controlled Dose Range Finding Study in 190 Patients

Presented by: Simon Bowman, PhD, FRCP
University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
  • Ianalumab showed a dose response defined as change in ESSDAI from baseline to 24 weeks with a good preliminary safety profile.
  • Responder analysis revealed significantly higher ESSDAI responder rates for the 300 mg ianalumab vs. placebo, although a strong placebo effect was observed.
  • Ianalumab may be a new and promising therapy for pSS.

Primary Sjogren’s syndrome (pSS) is a multi-organ autoimmune disease primarily affecting excretory glands and characterized by B-cell hyperactivity, with no approved systemic treatments available. Ianalumab (VAY736) is an anti-B-cell activating factor (BAFF) receptor fully human IgG1 monoclonal antibody, engineered for direct ADCC-mediated B-cell depletion, thus providing a dual mode of action and targeted approach to treat pSS. A single-dose study suggested potent and sustained B cell depletion by ianalumab, which could provide therapeutic benefits in patients with pSS without major side effects. [1] This phase 2b study aims at establishing a dose-response relationship over a wide range of ianalumab doses, using change from baseline in the EULAR Sjogren’s Syndrome Disease Activity index (ESSDAI) over 24 weeks as the primary endpoint.

  • To investigate the efficacy and safety of ianalumab in pSS at 24 weeks of treatment.
  • 190 patients with pSS were randomized 1:1:1:1 to monthly s.c. administrations of placebo (n =49) or one of three ianalumab doses; 5 mg (n =47), 50 mg (n =47), or 300 mg (n =47).
  • First-dose premedication was 250 mg IV methylprednisolone.
  • To be eligible, patients had to fulfil the American European Consensus Group (AECG) classification criteria for pSS, be anti-Ro/SSA positive, have an ESSDAI ≥6 (on 7/12 domains: glandular, articular, lymphadenopathy, constitutional, cutaneous, hematologic, biologic), and a EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI) ≥5.
  • The primary endpoint was the ESSDAI change from baseline to week 24.
  • Secondary endpoints included ESSPRI, Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F), Physician’s (PhGA) and Patient’s Global Assessments (PGA), SF-36, stimulated salivary flow (sSF) and Schirmer’s testStatistical methods included MCP-Mod to assess the dose-response on change of ESSDAI (12 domains) from BL and responder analysis to calculate the proportion of patients with ≥3 points improvement on ESSDAI as secondary analysis.

Principal Findings/Results

  • The primary endpoint of the study was met with a statistically significant dose-response for ESSDAI (Figure).
  • The largest reduction in ESSDAI was 1.92 points over placebo for ianalumab 300 mg at week 24.
  • Secondary analysis on ESSDAI revealed responder rates of 89.4% vs. 61.2%, for ianalumab 300 mg vs. placebo with a difference of 28.1% (p = 0.0019): no differences were observed for ianalumab 5 mg and 50 mg vs placebo.
  • In line with the results of the ESSDAI, the PhGA change from baseline was significantly different between ianalumab 300 mg and placebo (p = 0.022).
  • The secondary efficacy endpoints ESSPRI and FACIT-F showed no benefits over placebo for improvements in the patient reported symptoms such as dryness, fatigue, and pain.
  • Placebo responses were generally high.
  • Incidence of treatment emergent adverse events were comparable across placebo and ianalumab groups, whereby local injection reactions were most frequent, mostly mild and were more frequent with higher ianalumab doses.



  1. Dörner T, Posch MG, Li Y, et al. Treatment of primary Sjögren's syndrome with ianalumab (VAY736) targeting B cells by BAFF receptor blockade coupled with enhanced, antibody-dependent cellular cytotoxicity. Ann Rheum Dis. 2019 May;78(5):641-7.

Presenter disclosure: The presenter has reported relationships with AbbVie, AstraZeneca, Biogen, Bristol-Myers Squibb, Celgene, Fox, Glaxo Smith and Klein, Janssen, Lilly, Medimmune, MTPharma, Novartis, ONO, Pfizer, Roche, Samsung, Sanofi, T. Dörner, UCB, Xtlbio, R.

Written by: Patrick Moore, PhD

Reviewed by: Alessia Alunno, MD, PhD

Local reviewers: Alessia Alunno, MD, PhD (Italian); Aurélie Najm, MD (French); Yukinori Okada, MD, PhD (Japanese); Fabian Proft, MD (German); Javier Rodríguez-Carrio, MD, PhD (Spanish); Priscilla Wong, MD (Chinese)

Scientific Editor:  Leonard H. Calabrese, DO


A Comparative Analysis of Upadacitinib Monotherapy and Upadacitinib Combination Therapy for the Treatment of Rheumatoid Arthritis from Two Phase 3 Trials

Presented by: Maya H. Buch, MD, PhD - University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom

Rheumatoid Arthritis Treatment with Filgotinib: Week 156 Safety and Efficacy Data from a Phase 2b Open-Label Extension Study

Presented by: Arthur Kavanaugh, MD - University of California, San Diego School of Medicine, La Jolla, CA, USA


A Phase 1b/2a Trial of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus

Presented by: Sarfaraz Hasni, MD - National Institute of Arthritis, Musculoskeletal, and Skin diseases/ National Institutes of Health, Bethesda, MD, USA

A Phase 3 Randomized Controlled Trial of Anifrolumab in Patients with Moderate to Severe Systemic Lupus Erythematosus

Presented by: Richard A. Furie, MD - Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA


The Burden of Comorbidity in Patients with RA, PsA or SPA in a General Practice Registry

Presented by: Diederik De Cock, PhD - KU Leuven, Leuven, Belgium



Ixekizumab Demonstrates Improvement Comparable to Adalimumab Across ACR Components in Biologic-Naïve Patients with Psoriatic Arthritis

Presented by: M. Elaine Husni, MD, MPH - Dept. of Rheumatologic and Immunologic Diseases, Cleveland Clinic, Cleveland, OH, USA

Tildrakizumab Efficacy on Psoriasis in Patients with Psoriatic Arthritis—An Analysis from a Phase 2 Study

Presented by: Alan M. Mendelsohn, MD - Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, USA

Development of a Set of ASAS Quality Standards for Adults with Axial Spondyloarthritis

Presented by: Uta Kiltz, MD - Rheumazentrum Ruhrgebiet/Ruhr University Bochum, Herne, Germany

Ixekizumab in Non-Radiographic Axial Spondyloarthritis: Primary Results from a Phase 3 Trial

Presented by: Atul Deodhar, MD, MRCP - Oregon Health & Science University, Portland, OR, USA


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