Litifilimab reduces skin and joint disease in participants with SLE: additional results from Part A of the phase II LILAC study
7 affiliations
- 1Amsterdam University Medical Centers, Amsterdam, The Netherlands
- 2Department of Rheumatology and Immunology, Semmelweis University, Budapest, Hungary
- 3Northwell Health, Great Neck, New York, USA
- 4University of California San Diego, La Jolla, California, USA
- 5University of Pennsylvania, Perelman School of Medicine and Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA
- 6Biogen, Cambridge, Massachusetts, USA
- 7Biogen, Baar, Switzerland
Abstract
Objective To evaluate the effects of litifilimab on skin- and joint-specific outcomes in adults with SLE using LILAC Part A (phase II) data.Methods Prespecified and exploratory analyses were conducted in modified intent-to-treat population subsets from LILAC Part A (n=64 and n=56 for litifilimab 450 mg and placebo, respectively) with active skin and/or joint disease at baseline. Analyses included Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 and CLASI-70, defined as ≥50%/70% improvement from baseline in CLASI-Activity (CLASI-A) score, at week 24 (baseline CLASI-A score ≥8; n=39 vs n=38); week 24 Joint-50 response (50% reduction in active joint counts; baseline ≥4 tender and ≥4 swollen joints; n=56 vs n=46); resolution of baseline SLE Disease Activity Index-2000 (SLEDAI-2K) skin rash and/or arthritis at week 24 and improvement by ≥1 grade from baseline to week 24 in British Isles Lupus Assessment Group 2004 index (BILAG-2004) mucocutaneous and musculoskeletal domains (baseline Grade A/B).Results Greater proportions of participants achieved CLASI-50 and CLASI-70 responses at weeks 4, 8, 12, 16, 20 and 24 with litifilimab than placebo. Regardless of the active joint count definition, greater proportions of participants treated with litifilimab achieved a Joint-50 response at week 24 than placebo (total tender plus total swollen joints, 78.6% vs 54.4%; total tender and/or swollen joints, 75.0% vs 52.2%; total tender and swollen joints, 83.9% vs 63.0%). At week 24, for litifilimab versus placebo, more participants had resolution of SLEDAI-2K rash (28.6% vs 10.7%), arthritis (48.2% vs 21.7%), rash and arthritis (23.0% vs 9.6%), and improvement of ≥1 grade in the BILAG-2004 mucocutaneous and musculoskeletal domains (50.0% vs 34.1%).Conclusions These findings characterise litifilimab’s effects on skin and joints and complement the LILAC Part A primary efficacy results, supporting the benefit of litifilimab for skin and joint manifestations in SLE.Trial registration number NCT02847598.
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BibTeX
@article{vollenhoven2026litifilimab,
title = {{Litifilimab reduces skin and joint disease in participants with SLE: additional results from Part A of the phase II LILAC study}},
author = {Ronald F van Vollenhoven and Richard A Furie and Kenneth Kalunian and Victoria P Werth and Jessica Kong and Catherine Barbey and Youmna Lahoud},
journal = {Lupus Science and Medicine},
year = {2026},
month = nov,
doi = {10.1136/lupus-2026-002159},
url = {https://doi.org/10.1136/lupus-2026-002159},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Litifilimab reduces skin and joint disease in participants with SLE: additional results from Part A of the phase II LILAC study
AU - Ronald F van Vollenhoven
AU - Richard A Furie
AU - Kenneth Kalunian
AU - Victoria P Werth
AU - Jessica Kong
AU - Catherine Barbey
AU - Youmna Lahoud
PY - 2026
DA - 2026/11/02
JO - Lupus Science and Medicine
DO - 10.1136/lupus-2026-002159
UR - https://doi.org/10.1136/lupus-2026-002159
AB - Objective To evaluate the effects of litifilimab on skin- and joint-specific outcomes in adults with SLE using LILAC Part A (phase II) data.Methods Prespecified and exploratory analyses were conducted in modified intent-to-treat population subsets from LILAC Part A (n=64 and n=56 for litifilimab 450 mg and placebo, respectively) with active skin and/or joint disease at baseline. Analyses included Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 and CLASI-70, defined as ≥50%/70% improvement from baseline in CLASI-Activity (CLASI-A) score, at week 24 (baseline CLASI-A score ≥8; n=39 vs n=38); week 24 Joint-50 response (50% reduction in active joint counts; baseline ≥4 tender and ≥4 swollen joints; n=56 vs n=46); resolution of baseline SLE Disease Activity Index-2000 (SLEDAI-2K) skin rash and/or arthritis at week 24 and improvement by ≥1 grade from baseline to week 24 in British Isles Lupus Assessment Group 2004 index (BILAG-2004) mucocutaneous and musculoskeletal domains (baseline Grade A/B).Results Greater proportions of participants achieved CLASI-50 and CLASI-70 responses at weeks 4, 8, 12, 16, 20 and 24 with litifilimab than placebo. Regardless of the active joint count definition, greater proportions of participants treated with litifilimab achieved a Joint-50 response at week 24 than placebo (total tender plus total swollen joints, 78.6% vs 54.4%; total tender and/or swollen joints, 75.0% vs 52.2%; total tender and swollen joints, 83.9% vs 63.0%). At week 24, for litifilimab versus placebo, more participants had resolution of SLEDAI-2K rash (28.6% vs 10.7%), arthritis (48.2% vs 21.7%), rash and arthritis (23.0% vs 9.6%), and improvement of ≥1 grade in the BILAG-2004 mucocutaneous and musculoskeletal domains (50.0% vs 34.1%).Conclusions These findings characterise litifilimab’s effects on skin and joints and complement the LILAC Part A primary efficacy results, supporting the benefit of litifilimab for skin and joint manifestations in SLE.Trial registration number NCT02847598.
SN - 2053-8790
ER -