Evidence map›Paper›PMID 37919780›Full record

ArticleArthritis research & therapy2023

Efficacy and safety of tofacitinib in patients with rheumatoid arthritis by previous treatment: post hoc analysis of phase II/III trials.

John Tesser, Ahmet Gül, Ewa Olech, Kurt Oelke, Tatjana Lukic, Kenneth Kwok, Abbas Ebrahim

13 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Arthritis research & therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 13 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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.

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
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
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
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

7 authors at 4 institutions in 2 countries.

John TesserArizona Arthritis & Rheumatology Research, Arizona Arthritis & Rheumatology Associates, Glendale, AZ, USA.ORCID 0000-0002-2706-7171
Ahmet GülDepartment of Internal Medicine, Division of Rheumatology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.ORCID 0000-0001-8219-3720
Ewa OlechUNLV School of Medicine, Las Vegas, NV, USA.ORCID 0000-0001-7386-0894
Kurt OelkeRheumatic Disease Center, Glendale, WI, USA.
Tatjana LukicInflammation & Immunology, Pfizer Inc, New York, NY, USA.
Kenneth KwokInflammation & Immunology, Pfizer Inc, New York, NY, USA.ORCID 0000-0002-7475-3369
Abbas EbrahimInflammation & Immunology, Pfizer Inc, 500 Arcola Road, Collegeville, PA, 19426, USA. Abbas.Ebrahim@pfizer.com.ORCID 0000-0002-8100-9677
Pfizer (United States) · USArthritis and Rheumatism Associates · USIstanbul University · TRUniversity of Nevada, Las Vegas · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study sought to evaluate the efficacy and safety of tofacitinib in patients with rheumatoid arthritis with distinct treatment histories.

methodsPooled phase II/III trial data from patients who received tofacitinib 5 or 10 mg twice daily or placebo, as monotherapy or with conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs), were analyzed post hoc. Separate evaluations were conducted for populations with a prior inadequate response (IR) to: 1) non-methotrexate (MTX) csDMARDs only (non-MTX csDMARD-IR; n = 537); 2) MTX (MTX-IR; n = 3113); and 3) biologic (b)DMARDs (bDMARD-IR; n = 782). Efficacy outcomes included rates of response (American College of Rheumatology 20/50/70% response criteria) and remission (Disease Activity Score in 28 joints derived from 4 measures, erythrocyte sedimentation rate [DAS28-4(ESR)] < 2.6) at month 3, and changes from baseline in DAS28-4(ESR) and Health Assessment Questionnaire-Disability Index scores. Safety was assessed up to month 24.

resultsAt month 3, efficacy was generally improved with tofacitinib (both doses) vs placebo in each population. Generally, efficacy outcomes with tofacitinib were numerically more favorable in non-MTX csDMARD-IR vs MTX-IR or bDMARD-IR patients. Over 24 months, crude incidence rates for adverse events (AEs), serious AEs, and discontinuations due to AEs were generally numerically lower in non-MTX csDMARD-IR and MTX-IR vs bDMARD-IR populations; rates for AEs of special interest were generally similar across populations.

conclusionsTofacitinib provided clinical benefit across patients with rheumatoid arthritis with a range of prior treatment experience but may have greater efficacy and an improved benefit/risk profile in those with fewer prior treatments.

trial registrationNCT00147498/NCT00413660/NCT00550446/NCT00603512/NCT00687193/NCT00976599/NCT01359150/NCT00847613/NCT00814307/NCT00853385/NCT00960440/NCT01039688/NCT00856544.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDrug Therapy, CombinationHumansPiperidinesPyrimidinesTreatment OutcomeAntirheumatic AgentsPiperidinesPyrimidinestofacitinibAntirheumatic agentsArthritisMethotrexate

Identifiers

PMID37919780
PMCPMC10621211
OpenAlexW4388228050

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

and 7 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.