Evidence map›Paper›PMID 38958913›Full record

ArticleRheumatology and therapy2024

Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials.

Grace C Wright, Eduardo Mysler, Kenneth Kwok, Mary Jane Cadatal, Rebecca Germino, Arne Yndestad, Cassandra D Kinch, Alexis Ogdie

15 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 15 registered trials, which are not on this map. Cited by 2 papers.

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

NCT00147498 phase2completednot on this map

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2005 to 2006Enrolled264ConditionsRheumatoid ArthritisArmsCP-690,550, Placebo
NCT00413660 phase2completednot on this map

A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone

TypeinterventionalSponsorPfizerRan2007 to 2008Enrolled509ConditionsArthritis, RheumatoidArmsCP-690,550, placebo
NCT00550446 phase2completednot on this map

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2007 to 2009Enrolled386ConditionsArthritis, RheumatoidArmsAdalimumab, CP-690-550, CP-690,550, Placebo
NCT00603512 phase2completednot on this map

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone

TypeinterventionalSponsorPfizerRan2008 to 2008Enrolled140ConditionsArthritis, RheumatoidArmsPlacebo, CP-690,550
NCT00687193 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD

TypeinterventionalSponsorPfizerRan2009 to 2010Enrolled318ConditionsArthritis, RheumatoidArmsPlacebo, CP-690,550
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
NCT00976599 phase2completednot on this map

An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled29ConditionsRheumatoid ArthritisArmsCP-690,550 + methotrexate, Placebo + Methotrexate
NCT01039688 phase3completednot on this map

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled956ConditionsArthritis, RheumatoidArmsCP-690,550, Disease-modifying antirheumatic drug
NCT01164579 phase2completednot on this map

An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled109ConditionsRheumatoid ArthritisArmsTasocitinib plus Methotrexate, Tofacitinib plus placebo methotrexate, Placebo tofacitinib plus Methotrexate
NCT01359150 phase2completednot on this map

A Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background Methotrexate

TypeinterventionalSponsorPfizerRan2011 to 2012Enrolled223ConditionsRheumatoid ArthritisArmsCP-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

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Grace C WrightGrace C. Wright MD PC and Association of Women in Rheumatology, New York, NY, USA.ORCID http://orcid.org/0000-0002-6043-7277
Eduardo MyslerDivision of Rheumatology, Organización Médica de Investigación, Buenos Aires, Argentina.ORCID http://orcid.org/0000-0002-8993-0313
Kenneth KwokInflammation and Immunology, Pfizer Inc, New York, NY, USA.
Mary Jane CadatalInflammation and Immunology, Pfizer Inc, Manila, Philippines.
Rebecca GerminoInflammation and Immunology, Pfizer Inc, New York, NY, USA.
Arne YndestadInflammation and Immunology, Pfizer Inc, Oslo, Norway.
Cassandra D KinchInflammation and Immunology, Pfizer Canada ULC, Kirkland, QC, Canada. kinch.cassandra.d@gmail.com.ORCID http://orcid.org/0000-0002-2712-1668
Alexis OgdieDepartment of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRacial disparities in disease activity, clinical outcomes, and treatment survival persist despite advancements in rheumatoid arthritis (RA) therapies and clinical management. In this post hoc analysis of pooled data from the tofacitinib global clinical program, we evaluated the impact of race on the efficacy and safety of tofacitinib in patients with RA.

methodsData were pooled from 15 phase 2-3b/4 studies of patients with RA treated with tofacitinib 5 or 10 mg twice daily, adalimumab, or placebo. Outcomes were stratified by self-reported patient race (White/Black/Asian/Other). Efficacy outcomes to month 12 included: American College of Rheumatology (ACR)20/50/70 responses, Clinical Disease Activity Index (CDAI)/Disease Activity Score in 28 joints, erythrocyte sedimentation rate [DAS28-4(ESR)] low disease activity (LDA) rates, least squares (LS) mean change from baseline (∆) in CDAI, DAS28-4 (ESR), Health Assessment Questionnaire-Disability Index (HAQ-DI), and Pain [Visual Analog Scale (VAS)]. Odds ratios (ORs; 95% CI) versus placebo, and placebo-adjusted ∆LS means were calculated for active treatments using logistic regression model and mixed-effect model of repeated measurements, respectively. Safety outcomes were assessed throughout.

resultsA total of 6355 patients were included (White, 4145; Black, 213; Asian, 1348; Other, 649). For tofacitinib-treated patients, ORs for ACR20/50/70 responses and CDAI/DAS28-4(ESR) LDA rates through month 3 were generally numerically higher for White/Asian/Other versus Black patients. Across active treatments, trends toward higher placebo-adjusted improvements from baseline in CDAI, DAS28-4 (ESR), HAQ-DI, and Pain (VAS) were observed in Asian/Other versus White/Black patients. Numerically higher placebo responses in Black versus White/Asian/Other patients were generally observed across outcomes through month 12. Safety outcomes were mostly similar across treatment/racial groups.

conclusionsIn patients with RA, tofacitinib was efficacious across racial groups with similar safety outcomes; observed racial differences potentially reflect patient demographics or regional practice disparities. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov identifiers: NCT00147498; NCT00413660; NCT00550446; NCT00603512; NCT00687193; NCT01164579; NCT00976599; NCT01359150; NCT00960440; NCT00847613; NCT00814307; NCT00856544; NCT00853385; NCT01039688; NCT02187055.

Indexed as

Disease-modifying antirheumatic drugsOutcomesRheumatoid arthritis

Identifiers

PMID38958913
PMCPMC11422414

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 9 more above

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.