Evidence map›Paper›PMID 29045212›Full record

Trial reportThe New England journal of medicine2017

Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis.

Philip Mease, Stephen Hall, Oliver FitzGerald, Désirée van der Heijde, Joseph F Merola, Francisco Avila-Zapata, Dorota Cieślak, Daniela Graham, Cunshan Wang, Sujatha Menon and 2 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 276 papers, 26 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
276citing papers in PubMed, 26 pooled it
46.2field-weighted citation impact, top 1% 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.

NCT01877668 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorPfizerRan2014 to 2015Enrolled422ConditionsPsoriatic ArthritisArmsTofacitinib 5 mg BID, Tofacitinib 10 mg BID, Adalimumab, Placebo
NCT03736161 phase3completednot on this map

Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis

TypeinterventionalSponsorGlobe Pharmaceuticals LimitedRan2017 to 2019Enrolled61ConditionsPsoriatic ArthritisArmsGroup A- Tofacitinib, Group B- Methotrexate
3 · Its place in the literature

Who cites it

276 citing papers in PubMed, 26 syntheses or guidelines pooled it, 553 citations in OpenAlex.

  1. Large-scale meta-analysis of infection risk with JAK-STAT inhibitors in 29,000 patients.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
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  3. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
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  4. La Tunisie medicale · 2025
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  17. Brazilian Society of Rheumatology 2020 guidelines for psoriatic arthritis.Advances in rheumatology (London, England) · 2021
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216 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 6 countries.

Philip MeaseFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Stephen HallFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Oliver FitzGeraldFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Désirée van der HeijdeFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Joseph F MerolaFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Francisco Avila-ZapataFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Dorota CieślakFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Daniela GrahamFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Cunshan WangFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Sujatha MenonFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Thijs HendrikxFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Keith S KanikFrom the Swedish Medical Center and University of Washington, Seattle (P.M.); Cabrini Health and Monash University, Melbourne, VIC, Australia (S.H.); the Department of Rheumatology, St. Vincent's University Hospital and Conway Institute of Biomolecular and Biomedical Research, University College, Dublin (O.F.); Leiden University Medical Center, Leiden, the Netherlands (D.H.); Brigham and Women's Hospital, Harvard Medical School, Boston (J.F.M.); Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán Sociedad Civil Privada, Merida, Mexico (F.A.-Z.); the Department of Rheumatology and Clinical Immunology, Medical University of Poznan, Poznan, Poland (D.C.); Pfizer, Groton, CT (D.G., C.W., S.M., K.S.K.); and Pfizer, Collegeville, PA (T.H.).
Pfizer (United States) · USCabrini Hospital · AUHarvard University · USLeiden University Medical Center · NLPoznan University of Medical Sciences · PLSecretaría de Investigación, Innovación y Educación Superior · MXUniversity College Dublin · IEUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTofacitinib is an oral Janus kinase inhibitor that is under investigation for the treatment of psoriatic arthritis. We evaluated tofacitinib in patients with active psoriatic arthritis who previously had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs).

methodsIn this 12-month, double-blind, active-controlled and placebo-controlled, phase 3 trial, we randomly assigned patients in a 2:2:2:1:1 ratio to receive one of the following regimens: tofacitinib at a 5-mg dose taken orally twice daily (107 patients), tofacitinib at a 10-mg dose taken orally twice daily (104), adalimumab at a 40-mg dose administered subcutaneously once every 2 weeks (106), placebo with a blinded switch to the 5-mg tofacitinib dose at 3 months (52), or placebo with a blinded switch to the 10-mg tofacitinib dose at 3 months (53). Placebo groups were pooled for analyses up to month 3. Primary end points were the proportion of patients who had an American College of Rheumatology 20 (ACR20) response (≥20% improvement from baseline in the number of tender and swollen joints and at least three of five other important domains) at month 3 and the change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score (scores range from 0 to 3, with higher scores indicating greater disability) at month 3.

resultsACR20 response rates at month 3 were 50% in the 5-mg tofacitinib group and 61% in the 10-mg tofacitinib group, as compared with 33% in the placebo group (P=0.01 for the comparison of the 5-mg dose with placebo; P<0.001 for the comparison of the 10-mg dose with placebo); the rate was 52% in the adalimumab group. The mean change in the HAQ-DI score was -0.35 in the 5-mg tofacitinib group and -0.40 in the 10-mg tofacitinib group, as compared with -0.18 in the placebo group (P=0.006 for the comparison of the 5-mg dose with placebo; P<0.001 for the comparison of the 10-mg dose with placebo); the score change was -0.38 in the adalimumab group. The rate of adverse events through month 12 was 66% in the 5-mg tofacitinib group, 71% in the 10-mg tofacitinib group, 72% in the adalimumab group, 69% in the placebo group that switched to the 5-mg tofacitinib dose, and 64% in the placebo group that switched to the 10-mg tofacitinib dose. There were four cases of cancer, three serious infections, and four cases of herpes zoster in patients who received tofacitinib during the trial.

conclusionsThe efficacy of tofacitinib was superior to that of placebo at month 3 in patients with psoriatic arthritis who had previously had an inadequate response to conventional synthetic DMARDs. Adverse events were more frequent with tofacitinib than with placebo. (Funded by Pfizer; OPAL Broaden ClinicalTrials.gov number, NCT01877668 .).

Indexed as

AdalimumabAdministration, OralAdultAntirheumatic AgentsArthritis, PsoriaticDisability EvaluationDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleHumansJanus KinasesMaleMiddle AgedPiperidinesProtein Kinase InhibitorsAdalimumabAntirheumatic AgentsJanus KinasesPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinib

Identifiers

PMID29045212
OpenAlexW2766846920

What OpenQuestion holds

Textmetadata
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.