ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1747

BIIB059 Demonstrates Improvement in Joint Manifestations in Participants with Systemic Lupus Erythematosus in Part a of a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study

Ronald van Vollenhoven1, Richard Furie2, Kenneth Kalunian3, Maria Dall'Era4, Victoria Werth5, Xiaobi Huang6, Hua Carroll6, Cristina Musselli6, Catherine Barbey7 and Nathalie Franchimont6, 1Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 2Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, 3UC San Diego, La Jolla, CA, 4University of California San Francisco, Corte Madera, CA, 5Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 6Biogen, Cambridge, MA, 7Biogen, Baar, Switzerland

Meeting: ACR Convergence 2021

Keywords: ,

Session Information

Date: Tuesday, November 9, 2021

Session Title: SLE – Treatment Poster (1732–1772)

Session Type: Poster Session D

Session Time: 8:30AM-10:30AM

Background/Purpose: Joint involvement, a frequent manifestation of SLE, can be assessed using global lupus disease activity indices (SLEDAI-2K, BILAG-2004) and/or by assessing joint tenderness and swelling (28-joint count).1 This post-hoc analysis evaluated changes in joint manifestations in the LILAC Part A trial of BIIB059 versus placebo (NCT02847598)2 using various definitions.

Methods: The randomized, double-blind, placebo-controlled LILAC Part A study enrolled participants who fulfilled 4 of 11 revised ACR 1997 SLE classification criteria3,4 and who had ≥4 tender and ≥4 swollen joints, active skin disease, and positive lupus antibodies (ANA and/or anti-dsDNA). “Joint-50” response was defined as a 50% reduction from baseline in active joint count at Week 24. Three definitions of total active joint count were used: (1) sum of total tender plus total swollen joints; (2) sum of joints that were tender and/or swollen; (3) sum of joints that were both tender and swollen. Arthritis scored on SLEDAI-2K and BILAG-2004 was also analyzed.

Results: The analysis included 56 and 46 participants treated with BIIB059 450mg and placebo, respectively. At Week 24, a greater proportion of BIIB059-treated participants achieved a Joint-50 response compared to placebo; findings were consistent across the 3 different definitions (Figure 1). The percentage of participants with resolution of arthritis by SLEDAI-2K was greater in BIIB059-treated participants (48.2%) versus placebo (21.7%); similar findings were seen with the BILAG-2004 arthritis (musculoskeletal domain) evaluation. Incidence and severity of adverse events were similar with BIIB059 versus placebo in LILAC Part A.

Conclusion: BIIB059 treatment was associated with improvement in SLE arthritis. More participants achieved a Joint-50 response with BIIB059 versus placebo, regardless of how active joint count was defined.

1. Mahmoud. Curr Opin Rheumatol. 2017;29(5):486-492. 2. Furie. Arthritis Rheum. 2020;72(S10):0935. 3. Hochberg. Arthritis Rheum.1997;40(9):1725. 4.Tan. Arthritis Rheum. 1982;25(11):1271-7.

This study was sponsored by Biogen. Funding for medical writing support was provided by Biogen.

Disclosures: R. van Vollenhoven, Bristol Myers Squibb, 2, 5, Eli Lilly, 5, UCB, 2, 5, 6, Pfizer, 2, 6, 12, Support for educational programs; institutional grants, Roche, 12, Support for educational programs; institutional grants, Janssen, 2, 6, AbbVie, 2, 6, AstraZeneca, 2, Biotest, 2, GlaxoSmithKline, 2, 6, Biogen, 2, Galapagos, 2, 6, Gilead, 2, Sanofi, 2, Servier, 2, Vielabio, 2; R. Furie, GlaxoSmithKline, 2, 5; K. Kalunian, Amgen, 2, AbbVie, 2, AstraZeneca, 2, Biogen, 2, Bristol Myers Squibb, 2, Eli Lilly, 2, Equillium, 2, Genentech/Roche, 2, Gilead, 2, Janssen, 2, Lupus Research, 5, Pfizer, 5, Sanford Consortium, 5, Vielabio, 2, Aurinia, 2, Alliance, 2, Nektar, 2; M. Dall'Era, AstraZeneca, 2, Aurinia, 2, Biogen, 2, Bristol Myers Squibb, 2, GlaxoSmithKline, 2, Pfizer, 2; V. Werth, Celgene, 5, Resolve, 2, Janssen, 2, 5, Eli Lilly, 2, Biogen, 2, 5, Bristol Myers Squibb, 2, Gilead, 2, 5, Amgen, 2, EMD Serono, 2, Viela Bio, 2, 5, Kyowa Kirin, 2, AstraZeneca, 2, AbbVie, 2, GlaxoSmithKline, 2; X. Huang, Biogen, 3, 12, Shareholder; H. Carroll, Biogen, 3, 12, Shareholder; C. Musselli, Biogen, 3, 12, Shareholder; C. Barbey, Biogen, 2, 12, Shareholder; N. Franchimont, Biogen, 3, 12, Shareholder, OMass Therapeutics, 4.

To cite this abstract in AMA style:

van Vollenhoven R, Furie R, Kalunian K, Dall'Era M, Werth V, Huang X, Carroll H, Musselli C, Barbey C, Franchimont N. BIIB059 Demonstrates Improvement in Joint Manifestations in Participants with Systemic Lupus Erythematosus in Part a of a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/biib059-demonstrates-improvement-in-joint-manifestations-in-participants-with-systemic-lupus-erythematosus-in-part-a-of-a-phase-2-randomized-double-blind-placebo-controlled-study/. Accessed July 4, 2022.

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