Evidence map›Paper›PMID 39320583›Full record

ArticleRheumatology and therapy2024

Guselkumab in Biologic-Naïve Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials.

Philip Mease, Tatiana Korotaeva, Pavel Shesternya, Muza Kokhan, Anton Rukavitsyn, Dmitry Vasilchenkov, Mohamed Sharaf, Frédéric Lavie, Atul Deodhar

2 registry-linked trialsAbstract read
In one paragraph

Article in Rheumatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03158285 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2020Enrolled741ConditionsArthritis, PsoriaticArmsGuselkumab, Placebo
NCT03162796 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNF Alpha Agents

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2019Enrolled383ConditionsArthritis, PsoriaticArmsGuselkumab, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. 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.

Philip MeaseDepartment of Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health, and University of Washington, 601 Broadway, Ste 600, Seattle, WA, 98122, USA. pmease@philipmease.com.ORCID http://orcid.org/0000-0002-6620-0457
Tatiana KorotaevaResearch Institute of Rheumatology n.a. V A Nasonova, Moscow, Russia.ORCID http://orcid.org/0000-0003-0579-1131
Pavel ShesternyaProfessor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk, Russia.ORCID http://orcid.org/0000-0001-8652-1410
Muza KokhanUral Research Institute of Dermatovenerology and Immunopathology, Yekaterinburg, Russia.ORCID http://orcid.org/0000-0001-6353-6644
Anton RukavitsynJohnson & Johnson LLC, Moscow, Russian Federation.ORCID http://orcid.org/0000-0001-7598-5586
Dmitry VasilchenkovJohnson & Johnson LLC, Moscow, Russian Federation.ORCID http://orcid.org/0000-0002-2809-3929
Mohamed SharafJohnson & Johnson EMEA, Dubai, United Arab Emirates.ORCID http://orcid.org/0009-0003-9847-2996
Frédéric LavieJanssen-Cilag, Issy-Les-Moulineaux, France.ORCID http://orcid.org/0000-0002-5213-257X
Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA.ORCID http://orcid.org/0000-0002-2130-1246

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere are limited data on the use of advanced therapies to treat psoriatic arthritis (PsA) in Russia. Guselkumab, an interleukin (IL)-23p19-subunit inhibitor, demonstrated efficacy in patients with PsA in the phase 3 DISCOVER-1 and -2, and COSMOS trials. This analysis evaluated the efficacy and safety of guselkumab in patients with PsA in Russia.

methodsThis post hoc analysis of DISCOVER-1 and -2 included 1002 biologic-naïve patients with active PsA from Russia (n = 317) and the rest of the world (RoW; n = 685). Patients received guselkumab 100 mg every 4 weeks (Q4W), or at week 0 and 4 then Q8W, or placebo then guselkumab Q4W at week 24 (Russian: n = 119, 88, and 110, respectively; RoW: n = 216, 246, and 223, respectively). Outcomes through week 52 were pooled (DISCOVER-1 and -2); outcomes from week 52 to 100 represent DISCOVER-2 only.

resultsIn patients from Russia, ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria response rates were higher with guselkumab vs. placebo at week 24, increased through week 52, and were consistent across all guselkumab-treated groups at week 100. Similar trends were generally observed for ACR50, ≥ 90% improvement in Psoriasis Area and Severity Index (PASI90), achievement of Disease Activity in Psoriatic Arthritis (DAPSA) low disease activity/remission and minimal disease activity, enthesitis and dactylitis resolution, ≥ 0.35 improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI) score, improvement in patient-reported pain, and measures in patients with axial PsA (including Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], Ankylosing Spondylitis Disease Activity Score [ASDAS], and patient-reported spinal pain). Efficacy responses were similar between patients from Russia and the RoW across all endpoints and timepoints. The safety profile of guselkumab in patients from Russia was consistent with previous findings.

conclusionThis analysis demonstrated that the safety and efficacy profiles of guselkumab across all PsA domains and patient-reported outcomes in patients from Russia were similar to those in patients from the RoW. TRIAL REGISTRATION NUMBERS: NCT03162796 and NCT03158285.

Indexed as

BiologicsGuselkumabPsoriatic arthritis

Identifiers

PMID39320583
PMCPMC11557812

What OpenQuestion holds

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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.