Evidence map›Paper›PMID 36369798›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2023

Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial.

Eric Morand, Marilyn Pike, Joan T Merrill, Ronald van Vollenhoven, Victoria P Werth, Coburn Hobar, Nikolay Delev, Vaishali Shah, Brian Sharkey, Thomas Wegman and 3 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 129 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
129citing papers in PubMed, 7 pooled it
35.4field-weighted citation impact, top 1% 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.

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

129 citing papers in PubMed, 7 syntheses or guidelines pooled it, 227 citations in OpenAlex.

  1. Pooled it
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  12. Review
  13. Updates on the Evaluation of Lupus Arthritis.Rheumatology and therapy · 2026
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  15. Article
  16. Observational
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69 more citing papers are in PubMed but not listed here.

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

13 authors at 6 institutions in 3 countries.

Eric MorandMonash University and Department of Rheumatology, Monash Health, Victoria, Australia.ORCID 0000-0002-9507-3338
Marilyn PikeMedPharm Consulting, Inc., Raleigh, North Carolina.
Joan T MerrillOklahoma Medical Research Foundation, Oklahoma City.ORCID 0000-0002-4514-2382
Ronald van VollenhovenAmsterdam University Medical Centers, Amsterdam, the Netherlands.
Victoria P WerthUniversity of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia.ORCID 0000-0003-3030-5369
Coburn HobarBristol Myers Squibb, Princeton, New Jersey.
Nikolay DelevBristol Myers Squibb, Princeton, New Jersey.
Vaishali ShahBristol Myers Squibb, Princeton, New Jersey.
Brian SharkeyBristol Myers Squibb, Princeton, New Jersey.
Thomas WegmanBristol Myers Squibb, Princeton, New Jersey.
Ian CatlettBristol Myers Squibb, Princeton, New Jersey.
Subhashis BanerjeeBristol Myers Squibb, Princeton, New Jersey.
Shalabh SinghalBristol Myers Squibb, Princeton, New Jersey.
Bristol-Myers Squibb (United States) · USAmsterdam University Medical Centers · NLGad Consulting Services (United States) · USMonash Health · AUOklahoma Medical Research Foundation · USPhiladelphia VA Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of deucravacitinib, an oral, selective, allosteric inhibitor of TYK2, in a phase II trial in adult patients with active systemic lupus erythematosus (SLE).

methodsAdults with active SLE were enrolled from 162 sites in 17 countries. Patients (n = 363) were randomized 1:1:1:1 to receive deucravacitinib 3 mg twice daily, 6 mg twice daily, 12 mg once daily, or placebo. The primary end point was SLE Responder Index 4 (SRI-4) response at week 32. Secondary outcomes assessed at week 48 included SRI-4, British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response, Cutaneous Lupus Erythematosus Disease Area and Severity Index 50 (CLASI-50), Lupus Low Disease Activity State (LLDAS), and improvements in active (swollen plus tender), swollen, and tender joint counts.

resultsAt week 32, the percentage of patients achieving SRI-4 response was 34% with placebo compared to 58% with deucravacitinib 3 mg twice daily (odds ratio [OR] 2.8 [95% confidence interval (95% CI) 1.5, 5.1]; P < 0.001 versus placebo), 50% with 6 mg twice daily (OR 1.9 [95% CI 1.0, 3.4]; P = 0.02 versus placebo), and 45% with 12 mg once daily (OR 1.6 [95% CI 0.8, 2.9]; nominal P = 0.08 versus placebo). Response rates were higher with deucravacitinib treatment for BICLA, CLASI-50, LLDAS, and joint counts compared to placebo. Rates of adverse events were similar across groups, except higher rates of infections and cutaneous events, including rash and acne, with deucravacitinib treatment. Rates of serious adverse events were comparable, with no deaths, opportunistic infections, tuberculosis infections, major adverse cardiovascular events, or thrombotic events reported.

conclusionDeucravacitinib treatment elicited higher response rates for SRI-4 and other end points compared with placebo, with an acceptable safety profile, in adult patients with active SLE.

Indexed as

Antibodies, Monoclonal, HumanizedLupus Erythematosus, SystemicAdultDouble-Blind MethodHeterocyclic CompoundsHumansSeverity of Illness IndexTreatment OutcomeTYK2 KinaseAntibodies, Monoclonal, HumanizeddeucravacitinibHeterocyclic CompoundsTYK2 Kinase

Identifiers

PMID36369798
PMCPMC10100399
OpenAlexW4308834504

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.