Evidence map›Paper›PMID 40488251›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2025

Pharmacodynamic Effects of Litifilimab in Lupus in a Randomized, Placebo-Controlled Phase 2 Study: Rapid and Sustained Reductions in Type I Interferon-Associated Gene Expression and Cytokines.

Richard Furie, Victoria P Werth, Eric Milliman, Kyle Ferber, Roland Brown, Jad Zoghbi, Nathalie Franchimont, Youmna Lahoud, Catherine Barbey

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Litifilimab efficacy on skin outcomes in cutaneous lupus erythematosus in the Phase 2 LILAC study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
  2. Review
  3. Review
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.

Richard FurieNorthwell Health, Great Neck, New York.ORCID https://orcid.org/0000-0001-6712-1585
Victoria P WerthUniversity of Pennsylvania and Corporal Michael J. Crescenz VA Medical Center, Philadelphia.
Eric MillimanBiogen, Cambridge, Massachusetts.
Kyle FerberBiogen, Cambridge, Massachusetts.
Roland BrownBiogen, Cambridge, Massachusetts.
Jad ZoghbiBiogen, Cambridge, Massachusetts.
Nathalie FranchimontBiogen, Cambridge, Massachusetts.
Youmna LahoudBiogen, Cambridge, Massachusetts.
Catherine BarbeyBiogen, Baar, Switzerland.

Funding

Biogen
6 · The paper itself

Abstract

objectiveThe pharmacodynamic effects of litifilimab on type I interferon (IFN) response and correlations with clinical outcomes were investigated in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).

methodsParticipants from part A (SLE) or part B (CLE with or without SLE) of the randomized phase 2 LILAC trial who received litifilimab (at 50 mg, 150 mg, or 450 mg) or a placebo were included. IFN gene signature (IFNGS) scores were assessed from whole-blood samples using a 22-gene panel in 120 and 131 participants (parts A and B, respectively). IFNα and other IFN-regulated cytokine concentrations were measured in serum in 112 and 131 participants (parts A and B, respectively).

resultsMost participants were IFNGS-high at baseline (79-91%), and no baseline IFNGS-low participant results were reported. In IFNGS-high participants, litifilimab induced rapid, significant (nominal P < 0.05), and sustained reductions in IFNGS scores and IFNα concentrations versus a placebo for litifilimab at 450 mg in part A and for litifilimab at 150 mg and 450 mg in part B. In part A, IFNα reductions with litifilimab were correlated with clinical response measures. In part B, dose-response relationships for IFNGS score and IFNα concentration were observed, similar to those for disease activity measured with the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score.

conclusionAdministration of litifilimab resulted in reductions in both IFNGS scores and IFNα concentrations, pharmacodynamic effects that correlated with clinical responses. These findings support the mechanism of action of litifilimab and its continued evaluation in larger studies of patients with SLE or CLE.

Indexed as

Antibodies, Monoclonal, HumanizedCytokinesInterferon Type ILupus Erythematosus, CutaneousLupus Erythematosus, SystemicAdultDose-Response Relationship, DrugDouble-Blind MethodFemaleGene ExpressionHumansInterferon-alphaMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedCytokinesInterferon-alphaInterferon Type I

Identifiers

PMID40488251
PMCPMC12750138

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.