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Abstract Number: 0986

BIIB059, a Humanized Monoclonal Antibody Targeting Blood Dendritic Cell Antigen 2 on Plasmacytoid Dendritic Cells, Shows Dose-Related Efficacy in a Phase 2 Study in Participants with Active Cutaneous Lupus Erythematosus

Victoria Werth1, Richard Furie2, Juanita Romero-Díaz3, Sandra Navarra4, Kenneth Kalunian5, Ronald van Vollenhoven6, Filippa Nyberg7, Benjamin Kaffenberger8, Saira Sheikh9, Goran Radunovic10, Xiaobi Huang11, Hua Carroll12, Francois Gaudreault12, Adam Meyers11, Catherine Barbey13, Cristina Musselli11 and Nathalie Franchimont11, 1University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, 2Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, 3Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, 4University of Santo Tomas, Manila, Philippines, 5University of California San Diego, La Jolla, CA, 6Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, 7Karolinska University Hospital, Stockholm, Sweden, 8Ohio State University, Columbus, OH, 9Division of Rheumatology, Allergy and Immunology, University of North Carolina, Chapel Hill, NC, 10Institute of Rheumatology, University of Belgrade, Belgrade, Serbia, 11Biogen, Cambridge, MA, 12Biogen, Cambridge, 13Biogen, Baar, Switzerland

Meeting: ACR Convergence 2020

Keywords: Biologicals, Cutaneous, interferon, Randomized Trial, Systemic lupus erythematosus (SLE)

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Session Information

Date: Saturday, November 7, 2020

Session Title: SLE – Treatment (0985–0989)

Session Type: Abstract Session

Session Time: 3:00PM-3:50PM

Background/Purpose: No approved targeted therapies have been developed for cutaneous lupus erythematosus (CLE), a disfiguring autoimmune disease that severely impairs quality of life.1 BIIB059 is a humanized monoclonal antibody that binds blood dendritic cell antigen 2 (BDCA2), a receptor uniquely expressed on plasmacytoid dendritic cells, leading to BDCA2 internalization and subsequent inhibition of inflammatory mediator production, most notably type I IFNs.2 LILAC (NCT02847598) was a 2-part, phase 2 study investigating the efficacy and safety of BIIB059. Part A enrolled SLE participants. Part B, presented here, is the largest interventional study to date in CLE participants.

Methods: To be eligible for enrollment, adults with histologically confirmed CLE must have had active CLE defined as a Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score ≥8 despite prior use of or documented intolerance to topical CS and/or antimalarials and ≥1 lesion diagnostic of subacute CLE (CLASI-A erythema score ≥2) and/or chronic CLE (CLASI-A erythema score ≥2 and CLASI-Damage scarring score ≥1); all with or without systemic manifestations. Concomitant CLE/SLE therapy was allowed if doses were initiated ≥12 weeks and kept stable ≥4 weeks prior to randomization and throughout the treatment period; systemic CS doses could not exceed 15 mg/day of prednisone (or equivalent). BIIB059 (50, 150, 450 mg) or placebo was subcutaneously administered once every 4 weeks, with an additional dose at week 2, for 12 weeks. The primary endpoint was a multiple comparison procedure–modeling test of dose response in % change in CLASI-A score from baseline to week 16. Secondary endpoints included proportion of participants with a 50% improvement in CLASI-A score (CLASI-50 response rate) and ≥7-point reduction in CLASI-A score from baseline over time. Safety was assessed throughout the study.

Results: Of 33, 26, 25, and 48 participants dosed in the placebo and BIIB059 50, 150, and 450 mg groups, respectively, 93.9%, 88.5%, 96.0%, and 87.5% completed treatment. The study met its primary endpoint, demonstrating a dose response (p=0.0005) and statistically significant differences in least squares mean % changes (SE) in CLASI-A score between the placebo vs. BIIB059-treated participants (Table 1). Meaningful clinical improvements in secondary skin-related efficacy endpoints were observed in the BIIB059 groups. AEs and serious AEs (SAEs) for the placebo and pooled BIIB059 groups occurred in 66.7% vs. 71.7% and 9.1% vs. 7.1%, respectively (Table 2). Three (3.0%) BIIB059 participants and no placebo participants had AEs of hypersensitivity. Herpes zoster meningitis was observed in 1 participant (BIIB059 50 mg) after study completion.

Conclusion: BIIB059 significantly reduced disease activity in CLE with an acceptable safety profile. Further development of BIIB059 for the treatment of CLE is warranted.

  1. Ogunsanya. Br J Dermatol. 2017;176:52; 2. Pellerin. EMBO Mol Med. 2015;7:464


Disclosure: V. Werth, Biogen, 2, 5; R. Furie, AstraZeneca/MedImmune, 2, 5; J. Romero-Díaz, Biogen, 5; S. Navarra, Eli Lilly, 5, 8, Astra-Zeneca, 5, 8, Astellas, 8, Janssen, 5, 8, Novartis, 8, Pfizer, 8, Biogen, 2, 5; K. Kalunian, Roche, 5, Biogen, 5, Janssen, 5, AstraZeneca, 5, Lupus Research Alliance, 2, Pfizer, 2, Sanford Consortium, 2, Eli Lilly, 5, Genetech, 5, Gilead, 5, ILTOO, 5, Nektar, 5, Viela, 5, Equillium, 5, Bristol-Meyers Squibb, 5; R. van Vollenhoven, AbbVie, 2, 5, Bristol-Meyers Squibb, 2, 5, GlaxoSmithKline, 2, 5, Lilly, 2, 5, Pfizer, 2, 5, UCB, 2, 5, 8, AstraZeneca, 5, 8, Biotest, 2, 5, Celgene, 5, Janssen, 5, 8, Roche, 5, Biogen, 5, Galapagos, 5, 8, Gilead, 5, Servier, 5; F. Nyberg, Biogen, 5; B. Kaffenberger, Amgen, 2, Biogen, 2, Eli Lilly, 2, InflaRx, 2, Onquality Pharmaceuticals, 2; S. Sheikh, Pfizer, 2, GSK, 5; G. Radunovic, None; X. Huang, Biogen, 1, 3; H. Carroll, Biogen, 1, 3; F. Gaudreault, Biogen, 1, 3; A. Meyers, Biogen, 1, 3; C. Barbey, Biogen, 1, 3; C. Musselli, Biogen, 1, 3; N. Franchimont, Biogen, 1, 3.

To cite this abstract in AMA style:

Werth V, Furie R, Romero-Díaz J, Navarra S, Kalunian K, van Vollenhoven R, Nyberg F, Kaffenberger B, Sheikh S, Radunovic G, Huang X, Carroll H, Gaudreault F, Meyers A, Barbey C, Musselli C, Franchimont N. BIIB059, a Humanized Monoclonal Antibody Targeting Blood Dendritic Cell Antigen 2 on Plasmacytoid Dendritic Cells, Shows Dose-Related Efficacy in a Phase 2 Study in Participants with Active Cutaneous Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/biib059-a-humanized-monoclonal-antibody-targeting-blood-dendritic-cell-antigen-2-on-plasmacytoid-dendritic-cells-shows-dose-related-efficacy-in-a-phase-2-study-in-participants-with-active-cutaneous/. Accessed February 27, 2021.
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