Evidence map›Paper›PMID 35577477›Full record

Trial reportRMD open2022

Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies.

Ara H Dikranian, Miguel A Gonzalez-Gay, Frank Wellborne, José María Álvaro-Gracia, Liza Takiya, Lori Stockert, Jerome Paulissen, Harry Shi, Svitlana Tatulych, Jeffrey R Curtis

6 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2022. 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 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing 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.

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
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
3 · Its place in the literature

Who cites it

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

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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.

Ara H DikranianCabrillo Center for Rheumatic Disease, San Diego, California, USA.ORCID 0000-0002-2010-3272
Miguel A Gonzalez-GaySection of Rheumatology, Hospital Universitario Marques de Valdecilla, Santander, Spain.ORCID 0000-0002-7924-7406
Frank WellborneRheumatic Innovative Therapies, Houston Institute for Clinical Research, Houston, Texas, USA.
José María Álvaro-GraciaRheumatology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Liza TakiyaInflammation and Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA.
Lori StockertInflammation and Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA.
Jerome PaulissenInflammation and Immunology, Pfizer Inc, New York, New York, USA.
Harry ShiInflammation and Immunology, Pfizer Inc, New York, New York, USA.
Svitlana TatulychInflammation and Immunology, Pfizer Inc, Groton, Connecticut, USA.
Jeffrey R CurtisDivision of Clinical Immunology and Rheumatology, The University of Alabama at Birmingham, Birmingham, Alabama, USA jcurtis@uab.edu.ORCID 0000-0002-8907-8976

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTofacitinib is an oral Janus kinase for the treatment of rheumatoid arthritis (RA). This post hoc analysis assessed whether baseline body mass index (BMI) impacts tofacitinib efficacy in patients with RA.

methodsPooled data from six phase 3 studies in patients receiving tofacitinib 5 mg (N=1589) or 10 mg (N=1611) twice daily or placebo (advancing to active treatment at months 3 or 6; N=680), ±conventional synthetic disease-modifying antirheumatic drugs, were stratified by baseline BMI (<25, 25 to <30, ≥30 kg/m

resultsOf 3880 patients included, 1690 (43.6%), 1173 (30.2%) and 1017 (26.2%) had baseline BMI <25, 25 to <30 and ≥30 kg/m

conclusionsBaseline BMI did not consistently affect tofacitinib response suggesting that tofacitinib is an effective oral treatment option for adults with moderate to severe RA regardless of baseline BMI, including patients with BMI ≥30 kg/m TRIAL REGISTRATION NUMBERS: NCT00814307, NCT01039688; NCT00960440; NCT00847613; NCT00856544; NCT00853385.

Indexed as

Arthritis, RheumatoidPyrrolesAdultBody Mass IndexHumansPiperidinesPyrimidinesPiperidinesPyrimidinesPyrrolestofacitinibantirheumatic agentsarthritis, rheumatoidtherapeutics

Identifiers

PMID35577477
PMCPMC9114845

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.