Evidence map›Paper›PMID 37925660›Full record

ArticleRheumatology and therapy2024

Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials.

Gustavo Citera, Rakesh Jain, Fedra Irazoque, Hugo Madariaga, David Gruben, Lisy Wang, Lori Stockert, Karina Santana, Abbas Ebrahim, Dario Ponce de Leon

6 registry-linked trialsOpen access · goldAbstract 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 6 registered trials, which are 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
0.7field-weighted citation impact, top 35% 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.

NCT00814307 phase3completednot on this map

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2009 to 2010Enrolled611ConditionsArthritis, RheumatoidArmsCP-690,550, Placebo
NCT00847613 phase3completednot on this map

Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

TypeinterventionalSponsorPfizerRan2009 to 2012Enrolled800ConditionsArthritis, RheumatoidArmsCP-690,550, Placebo
NCT00853385 phase3completednot on this map

Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled717ConditionsRheumatoid ArthritisArmsCP 690,550, CP-690,550, Placebo, Biologic TNFi
NCT00856544 phase3completednot on this map

Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled795ConditionsArthritis, RheumatoidArmsCP-690,550, Placebo
NCT00960440 phase3completednot on this map

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled399ConditionsArthritis, RheumatoidArmsCP-690,550, Placebo
NCT02187055 phase4completednot on this map

A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2014 to 2016Enrolled1,152ConditionsRhematoid ArthritisArmsTofacitinib with methotrexate, Tofacitinib without methotrexate, Adalimumab with methotrexate
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. 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

10 authors at 5 institutions in 4 countries.

Gustavo CiteraInstituto de Rehabilitación Psicofísica, Buenos Aires, Argentina.
Rakesh JainTexas Tech University School of Medicine, Permian Basin, Midland, TX, USA.
Fedra IrazoqueHospital Angeles Mocel, San Miguel, Mexico.
Hugo MadariagaClínica del Sur, Arequipa, Peru.
David GrubenPfizer Inc, Groton, CT, USA.
Lisy WangPfizer Inc, Groton, CT, USA.
Lori StockertPfizer Inc, Collegeville, PA, USA.
Karina SantanaPfizer Inc, Ciudad de Mexico, Mexico.
Abbas EbrahimPfizer Inc, Collegeville, PA, USA.
Dario Ponce de LeonPfizer Inc, Las Orquídeas 585, San Isidro, 15046, Lima, Peru. dario.poncedeleon@pfizer.com.ORCID http://orcid.org/0000-0003-2250-6849
Pfizer (United States) · USHospital Angeles Pedregal · MXInstituto Nacional de Rehabilitación Psicofísica · ARThe University of Texas of the Permian Basin · USUniversidad Científica del Sur · PE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of our work is to assess the prevalence of probable major depressive disorder and/or probable generalized anxiety disorder (pMDD/pGAD) in patients with moderate to severe rheumatoid arthritis (RA), and to evaluate the efficacy of tofacitinib on RA symptoms stratified by baseline pMDD/pGAD status.

methodsData were pooled from five phase 3 randomized controlled trials (RCTs) and one phase 3b/4 RCT, assessing tofacitinib 5 or 10 mg twice daily (BID), adalimumab (two RCTs), or placebo. pMDD/pGAD was defined as Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) score ≤ 38. Efficacy outcomes over 12 months included least squares mean change from baseline in SF-36 MCS score and Health Assessment Questionnaire-Disability Index, proportions of patients with pMDD/pGAD in those with baseline pMDD/pGAD, and American College of Rheumatology 20/50/70 response, and Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission (< 2.6) rates.

resultsA total of 4404 patients with non-missing baseline values were included. Baseline pMDD/pGAD was reported by 44.5%, 39.8%, 45.4%, and 39.1% of patients receiving tofacitinib 5 mg BID, tofacitinib 10 mg BID, adalimumab, and placebo, respectively. SF-36 MCS improvements were greater for tofacitinib versus adalimumab/placebo through month 6, with numerical improvements for tofacitinib versus adalimumab sustained through month 12, when the proportions of patients with baseline pMDD/pGAD who continued to have pMDD/pGAD were reduced. RA efficacy outcomes were generally similar in patients with/without baseline pMDD/pGAD.

conclusionsThe percentage of patients with pMDD/pGAD reduced from baseline over 1 year of treatment with tofacitinib or adalimumab. Effective treatment of underlying RA may lead to improvements in depression and anxiety, based on the SF-36 MCS. Specially designed studies using gold-standard diagnostic tools would be warranted to investigate this further. Video Abstract available for this article.

trial registrationNCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT02187055. Video Abstract (MP4 204475 KB).

Indexed as

AnxietyJAK inhibitorRheumatoid arthritisTofacitinib

Identifiers

PMID37925660
PMCPMC10796892
OpenAlexW4388379576

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.