Evidence map›Paper›PMID 30414064›Full record

ArticleRheumatology and therapy2018

Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies.

Peter Nash, Laura C Coates, Roy Fleischmann, Kim A Papp, Juan Jesus Gomez-Reino, Keith S Kanik, Cunshan Wang, Joseph Wu, Sujatha Menon, Thijs Hendrikx and 1 more

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

Article in Rheumatology and therapy, 2018. 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 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
5.1field-weighted citation impact, top 4% 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
NCT01882439 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) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor

TypeinterventionalSponsorPfizerRan2013 to 2016Enrolled395ConditionsPsoriatic ArthritisArmsTofacitinib, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. La Tunisie medicale · 2025
    Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. JAK/STAT inhibition reprograms T cell activation and metabolism in inflammatory arthritis patients.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026
    Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. JAK Inhibitors in Psoriatic Disease.Clinical, cosmetic and investigational dermatology · 2023
    Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. 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

11 authors at 6 institutions in 5 countries.

Peter NashDepartment of Medicine, University of Queensland, St Lucia, Brisbane, Australia. drpnash@tpg.com.au.
Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Roy FleischmannMetroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.
Kim A PappProbity Medical Research and K Papp Clinical Research Inc, Waterloo, ON, Canada.
Juan Jesus Gomez-ReinoFundación Ramón Domínguez, Hospital Clinico Universitario, Santiago de Compostela, Spain.
Keith S KanikPfizer Inc, Groton, CT, USA.
Cunshan WangPfizer Inc, Groton, CT, USA.
Joseph WuPfizer Inc, Groton, CT, USA.
Sujatha MenonPfizer Inc, Groton, CT, USA.
Thijs HendrikxPfizer Inc, Collegeville, PA, USA.
William C PortsPfizer Inc, Groton, CT, USA.
Pfizer (United States) · USFundación Ramón Domínguez · ESMetroplex Clinical Research Center · USProbity Medical Research · CAUniversity of Oxford · GBUniversity of Queensland · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). This post hoc analysis assessed the efficacy of tofacitinib using pooled data from two phase 3 studies of patients with active PsA.

methodsData were pooled from OPAL Broaden (NCT01877668) and OPAL Beyond (NCT01882439). Patients had active PsA and either an inadequate response (IR) to ≥ 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) and were tumor necrosis factor inhibitor (TNFi)-naïve (OPAL Broaden), or had IR to ≥ 1 TNFi (OPAL Beyond). Pooled data included tofacitinib 5 or 10 mg twice daily (BID; to month 6) and placebo (to month 3; patients then switched to tofacitinib 5 or 10 mg BID). Patients also received one background csDMARD. Endpoints included American College of Rheumatology (ACR)20 response and change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at month 3 (primary endpoints), ACR50/70 response, HAQ-DI response (decrease from baseline ≥ 0.35) and improvements in painful and swollen joint counts, psoriasis, enthesitis and dactylitis to month 6.

resultsA total of 710 patients were included (tofacitinib 5 mg BID: 238; tofacitinib 10 mg BID: 236; placebo: 236). Primary endpoints showed significant improvements at month 3 in patients receiving tofacitinib 5 or 10 mg BID vs. placebo. Significant improvements in HAQ-DI response, painful and swollen joints, psoriasis, enthesitis and dactylitis vs. placebo were observed for both tofacitinib doses at month 3. Efficacy was maintained to month 6 (final pooled time point).

conclusionsIn a pooled analysis of csDMARD-IR/TNFi-naïve and TNFi-IR patients, tofacitinib was superior to placebo at month 3 across four PsA domains: peripheral arthritis, psoriasis, enthesitis and dactylitis.

trial registrationOPAL Broaden (NCT01877668); OPAL Beyond (NCT01882439).

fundingPfizer Inc.

Indexed as

Janus kinase inhibitorPsoriatic arthritisSpondyloarthritisTofacitinibTreatment

Identifiers

PMID30414064
PMCPMC6251851
OpenAlexW2899718933

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.