Evidence map›Paper›PMID 34498056›Full record

Trial reportRheumatology (Oxford, England)2022

Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study.

Victoria P Werth, Roy Fleischmann, Michael Robern, Zahi Touma, Iyabode Tiamiyu, Oksana Gurtovaya, Alena Pechonkina, Afsaneh Mozaffarian, Bryan Downie, Franziska Matzkies and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03134222 (A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
8.3field-weighted citation impact, top 2% of its field
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.

NCT03134222 phase2completednot on this map

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

TypeinterventionalSponsorGilead SciencesRan2017 to 2019Enrolled47ConditionsCutaneous Lupus ErythematosusArmsLanraplenib, Filgotinib, Lanraplenib placebo, Filgotinib placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Pooled it
  2. Infection risk with JAK inhibitors in dermatoses: a meta-analysis.International journal of dermatology · 2025
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  7. What's New in Cutaneous Lupus Erythematosus: Guidelines, Biologics, and Beyond.The Journal of clinical and aesthetic dermatology · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 2 countries.

Victoria P WerthDepartment of Dermatology, Perelman School of Medicine, University of Pennsylvania, Corporal Michael J. Crescenz VAMC, Philadelphia, PA.ORCID 0000-0003-3030-5369
Roy FleischmannDepartment of Internal Medicine, Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Michael RobernDermatology Ottawa Research Center, Ottawa.
Zahi ToumaDivision of Rheumatology, Department of Medicine, Toronto Western Hospital; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0001-5177-2076
Iyabode TiamiyuGilead Sciences, Inc., Foster City.
Oksana GurtovayaGilead Sciences, Inc., Foster City.
Alena PechonkinaGilead Sciences, Inc., Foster City.
Afsaneh MozaffarianGilead Sciences, Inc., Foster City.
Bryan DownieGilead Sciences, Inc., Foster City.
Franziska MatzkiesGilead Sciences, Inc., Foster City.
Daniel WallaceRheumatology, Cedars-Sinai/David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Gilead Sciences (United States) · USCedars-Sinai Medical Center · USMetroplex Clinical Research Center · USPhiladelphia VA Medical Center · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo explore the safety and efficacy of filgotinib (FIL), a Janus kinase 1 inhibitor, and lanraplenib (LANRA), a spleen kinase inhibitor, in cutaneous lupus erythematosus (CLE).

methodsThis was a phase 2, randomized, double-blind, placebo-controlled, exploratory, proof-of-concept study of LANRA (30 mg), FIL (200 mg) or placebo (PBO) once daily for 12 weeks in patients with active CLE. At week 12, PBO patients were rerandomized 1:1 to receive LANRA or FIL for up to 36 additional weeks.

resultsOf 47 randomized patients, 45 were treated (PBO, n = 9; LANRA, n = 19; FIL, n = 17). The primary endpoint [change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at week 12] was not met. The least squares mean CLASI-A score change from baseline was -5.5 (s.e. 2.56) with PBO, -4.5 (1.91) with LANRA and -8.7 (1.85) with FIL. Numerical differences between FIL and PBO were greater in select subgroups. A ≥5-point improvement in the CLASI-A score at week 12 was achieved by 50.0%, 56.3% and 68.8% in the PBO, LANRA and FIL arms, respectively. A numerically greater proportion of patients in the FIL arm (50%) also achieved ≥50% improvement in the CLASI-A score at week 12 (37.5% PBO, 31.3% LANRA). Most adverse events (AEs) were mild or moderate in severity. Two serious AEs were reported with LANRA and one with FIL.

conclusionThe primary endpoint was not met. Select subgroups displayed a numerically greater treatment response to FIL relative to PBO. LANRA and FIL were generally well tolerated.

trial registrationClinicalTrials.gov identifier NCT03134222.

Indexed as

Janus Kinase InhibitorsLupus Erythematosus, CutaneousDouble-Blind MethodHumansProtein Kinase InhibitorsPyridinesSeverity of Illness IndexTreatment OutcomeTriazolesGLPG0634Janus Kinase InhibitorsProtein Kinase InhibitorsPyridinesTriazolesclinical trials and methodscytokines and inflammatory mediatorsinflammationskinsystemic lupus erythematosus and autoimmunity

Identifiers

PMID34498056
PMCPMC9157055
OpenAlexW3197001173

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.