Evidence map›Paper›PMID 40451616›Full record

Trial reportLupus science & medicine2025

Deucravacitinib, an oral, selective, allosteric, tyrosine kinase 2 inhibitor, in patients with active SLE: efficacy on patient-reported outcomes in a phase II randomised trial.

Marta Mosca, Laurent Arnaud, Anca Askanase, Coburn Hobar, Brandon Becker, Shalabh Singhal, Subhashis Banerjee, Samantha Pomponi, Jiyoon Choi, Vibeke Strand

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lupus science & medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03252587 (A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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.

NCT03252587 phase2completednot on this map

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus

TypeinterventionalSponsorBristol-Myers SquibbRan2017 to 2021Enrolled363ConditionsSystemic Lupus ErythematosusArmsBMS-986165, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. 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

10 authors.

Marta MoscaUniversity of Pisa, Pisa, Italy.
Laurent ArnaudDepartment of Rheumatology, Hôpitaux universitaires de Strasbourg, Strasbourg, France.ORCID 0000-0002-8077-8394
Anca AskanaseColumbia University Irving Medical Center, New York City, New York, USA.ORCID 0000-0003-4597-5023
Coburn HobarBristol Myers Squibb Co, Princeton, New Jersey, USA.
Brandon BeckerBristol Myers Squibb Co, Princeton, New Jersey, USA.
Shalabh SinghalBristol Myers Squibb Co, Princeton, New Jersey, USA.
Subhashis BanerjeeBristol Myers Squibb Co, Princeton, New Jersey, USA.
Samantha PomponiBristol Myers Squibb Co, Princeton, New Jersey, USA.
Jiyoon ChoiBristol Myers Squibb Co, Princeton, New Jersey, USA Jiyoon.Choi@bms.com.ORCID 0009-0008-0948-5717
Vibeke StrandStanford University School of Medicine, Stanford, California, USA.ORCID 0000-0003-4978-4072

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIn PAISLEY, a 48-week, phase II, randomised controlled trial that assessed deucravacitinib in patients with active SLE, all primary and secondary endpoints were met with the deucravacitinib 3 mg two times per day dose. Changes in patient-reported outcomes, collected as exploratory endpoints, were evaluated in this study.

methodsPatients with SLE (n=363) were randomised to placebo (n=90) or deucravacitinib 3 mg two times per day (n=91), 6 mg two times per day (n=93) or 12 mg once daily (n=89). Patients assessed pain levels on a Numeric Rating Scale and completed the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a and 36-Item Short Form Health Survey (SF-36) at scheduled intervals. These outcomes were stratified by Systemic Lupus Erythematosus Responder Index 4 (SRI-4) and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response. Missing data were imputed using control-based pattern imputation.

resultsAt week 48, greater mean improvement in pain and fatigue scores from day 1 were reported across all deucravacitinib dose groups compared with placebo. Regardless of treatment group, SRI-4 and BICLA responders reported greater improvements in pain and fatigue than non-responders at week 48. Additionally, deucravacitinib-treated patients generally saw greater SRI-4 and BICLA response rates than placebo-treated patients. Pain decreased by 1.3 points vs 2.2-2.3 points and fatigue scores decreased by 3.4 points vs 5.9-7.3 points in the placebo versus deucravacitinib dose groups, respectively. Mean SF-36 physical scores were 41.5 vs ≥44.6 and mean SF-36 mental scores were 45.2 vs ≥46.3 with placebo versus deucravacitinib dose groups, respectively. A greater proportion of patients receiving deucravacitinib also reported clinically meaningful improvements in SF-36 scores compared with placebo.

conclusionPatients with SLE experienced greater improvements in pain, fatigue and health-related quality-of-life scores at week 48 with deucravacitinib versus placebo treatment. TRIAL REGISTRATION NUMBER: NCT03252587.

Indexed as

Lupus Erythematosus, SystemicProtein Kinase InhibitorsAdministration, OralAdultDouble-Blind MethodFatigueFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresTreatment OutcomeProtein Kinase InhibitorsClinical TrialLupus Erythematosus, SystemicPatient Reported Outcome MeasuresQuality of LIfe

Identifiers

PMID40451616
PMCPMC12142172

What Socratic 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 Socratic graph.