Evidence map›Paper›PMID 37819505›Full record

ArticleRheumatology and therapy2023

Efficacy of Guselkumab on Axial-Related Symptoms Through up to 2 Years in Adults with Active Psoriatic Arthritis in the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Study.

Philip J Mease, Dafna D Gladman, Denis Poddubnyy, Soumya D Chakravarty, May Shawi, Alexa P Kollmeier, Xie L Xu, Stephen Xu, Atul Deodhar, Xenofon Baraliakos

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03158285 (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), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.5field-weighted citation impact, top 7% 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.

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
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 14 citations in OpenAlex.

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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 at 6 institutions in 3 countries.

Philip J MeaseDepartment of Rheumatology, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Rheumatology Research, 601 Broadway, Ste 600, Seattle, WA, 98122, USA. pmease@philipmease.com.ORCID http://orcid.org/0000-0002-6620-0457
Dafna D GladmanCentre for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital, Toronto, ON, Canada.ORCID http://orcid.org/0000-0002-9074-0592
Denis PoddubnyyCharité-Universitatsmedizin Berlin, Berlin, Germany.
Soumya D ChakravartyJanssen Scientific Affairs, LLC, Horsham, PA, USA.ORCID http://orcid.org/0000-0001-7957-838X
May ShawiJanssen Research & Development, LLC, Titusville, NJ, USA.ORCID http://orcid.org/0000-0001-6005-3938
Alexa P KollmeierJanssen Research & Development, LLC, San Diego, CA, USA.
Xie L XuJanssen Research & Development, LLC, San Diego, CA, USA.
Stephen XuJanssen Research & Development, LLC, Spring House, PA, USA.
Atul DeodharOregon Health & Science University, Portland, OR, USA.ORCID http://orcid.org/0000-0002-4195-8616
Xenofon BaraliakosRheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany.ORCID http://orcid.org/0000-0002-9475-9362
Janssen (United States) · USCharité - Universitätsmedizin Berlin · DEOregon Health & Science University · USRheumazentrum Ruhrgebiet · DESwedish Medical Center · USToronto Western Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGuselkumab previously showed greater improvements versus placebo in axial symptoms in patients with psoriatic arthritis (PsA) (assessed by Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] and Ankylosing Spondylitis Disease Activity Score [ASDAS]), in post hoc analyses of the phase 3, placebo-controlled, randomized DISCOVER-1 and DISCOVER-2 studies. We now evaluate durability of response in axial-related outcomes through 2 years of DISCOVER-2.

methodsDISCOVER-2 biologic-naive adults with active PsA (≥ 5 tender/ ≥ 5 swollen joints, C-reactive protein ≥ 0.6 mg/dl) were randomized to guselkumab 100 mg every 4 weeks (Q4W) or at week 0, week 4, then Q8W, or placebo → guselkumab Q4W at week 24. Among patients with imaging-confirmed sacroiliitis (investigator-identified), axial symptoms were assessed through 2 years utilizing BASDAI, BASDAI Question #2 (spinal pain), modified BASDAI (mBASDAI; excludes Question #3 [peripheral joint pain]), and ASDAS. Mean changes in scores and proportions of patients achieving ≥ 50% improvement in BASDAI (BASDAI 50) and ASDAS responses, including major improvement (decrease ≥ 2.0), were determined through week 100. Treatment failure rules (through week 24) and nonresponder imputation of missing data (post-week 24) were utilized. Mean BASDAI component scores were assessed through week 100 (observed data). Exploratory analyses evaluated efficacy by sex and HLA-B*27 status.

resultsAmong 246 patients with PsA and imaging-confirmed sacroiliitis, guselkumab-treated patients had greater mean improvements in BASDAI, mBASDAI, spinal pain, and ASDAS scores, lower mean BASDAI component scores, and greater response rates in achieving BASDAI 50 and ASDAS major improvement vs. placebo at week 24. Differences from placebo were observed for guselkumab-treated patients in selected endpoints regardless of sex or HLA-B*27 status. At week 100, mean improvements were ~ 3 points for all BASDAI scores and 1.6-1.7 for ASDAS; 49-54% achieved BASDAI 50 and 39% achieved ASDAS major improvement at week 100.

conclusionsGuselkumab treatment provided durable and meaningful improvements in axial symptoms and disease activity in substantial proportions of patients with active PsA and imaging-confirmed sacroiliitis.

trial registrationClinicaltrials.gov NCT03158285.

Indexed as

AxialBiologicsGuselkumabPsoriatic arthritis

Identifiers

PMID37819505
PMCPMC10654317
OpenAlexW4387529687

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.