Evidence map›Paper›PMID 41574948›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2026

Litifilimab efficacy on skin outcomes in cutaneous lupus erythematosus in the Phase 2 LILAC study.

Victoria P Werth, Joseph F Merola, Richard Furie, Kenneth Kalunian, Ronald F van Vollenhoven, Juanita Romero-Diaz, Qianyun Li, Weihong Yang, Catherine Barbey

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Victoria P WerthDepartment of Dermatology, University of Pennsylvania and Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania, USA.
Joseph F MerolaDepartment of Dermatology and Department of Medicine, Division of Rheumatology, UT Southwestern Medical Center, Dallas, Texas, USA.
Richard FurieDivision of Rheumatology, Northwell Health, Great Neck, New York, USA.
Kenneth KalunianDivision of Rheumatology, Autoimmunity and Inflammation, University of California, San Diego School of Medicine, La Jolla, California, USA.
Ronald F van VollenhovenDepartment of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Juanita Romero-DiazDepartment of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Qianyun LiAnalytics, Technology and Data Sciences (ATDS) Department Unit, Biogen, Cambridge, Massachusetts, USA.
Weihong YangClinical Development, Multiple Sclerosis and Immunology Department Unit, Biogen, Cambridge, Massachusetts, USA.
Catherine BarbeyFormer Employee of Clinical Development, Multiple Sclerosis and Immunology Department Unit, Biogen, Baar, Switzerland.

Funding

Biogen n/a
6 · The paper itself

Abstract

backgroundCutaneous lupus erythematosus (CLE) has no approved targeted therapies. In Part B of the randomized, double-blind, placebo-controlled, Phase 2 LILAC study, litifilimab demonstrated a dose-response relationship for percentage change in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score from baseline to Week 16.

objectivesThese post hoc analyses of Part B of the LILAC study aimed to assess the efficacy of litifilimab on additional skin-specific outcomes.

methodsAdult participants with baseline CLASI-A score ≥8 and histologically confirmed CLE, with/without systemic manifestations, received litifilimab 50 mg, 150 mg or 450 mg, or placebo subcutaneously every 4 weeks through Week 16. Analyses included CLASI-20/50/70/90 responses (≥20%/50%/70%/90% decrease [improvement] from baseline in CLASI-A score), 7-point improvement from baseline in CLASI-A score, subgroup analyses of percentage change in CLASI-A scores by baseline characteristics and achievement of 'clear' (CLASI-A scores of 0-1) or 'almost clear' (0-3) skin status. Shifts from baseline in skin condition were evaluated by the Physician's Global Assessment (PGA) of CLE and the Physician's Global Impression (PGI) of change in CLE.

resultsGreater proportions of litifilimab-treated participants achieved CLASI-20/50/70/90 responses (3.8%-72.1%) than placebo-treated participants (0%-43.8%) at Week 16, with significant differences observed from Week 4 for CLASI-20/50. From Weeks 4 to 16, more litifilimab-treated participants had ≥7-point CLASI-A score decreases from baseline (13.8%-43.9%) compared with placebo (10.5%-21.1%). At Week 16, compared with placebo, more litifilimab-treated participants achieved 'clear' or 'almost clear' skin status; CLASI-A score improvements for subgroups were numerically higher with litifilimab, more litifilimab-treated participants shifted from 'severe' or 'moderate' to 'almost clear' skin status based on PGA of CLE, and more litifilimab-treated participants were 'much improved' based on PGI results.

conclusionsThese analyses provide additional evidence to support litifilimab efficacy in clearing skin disease activity, as demonstrated in the LILAC study.

Indexed as

Antibodies, Monoclonal, HumanizedLupus Erythematosus, CutaneousAdultDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizedautoimmune diseasescutaneousdendritic cellsdermatologylitifilimablupus erythematosusplasmacytoidsystemic

Identifiers

PMID41574948
PMCPMC13505711

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.