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Original article
Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden—a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs
  1. Vibeke Strand1,
  2. Kurt de Vlam2,
  3. Jose A Covarrubias-Cobos3,
  4. Philip J Mease4,
  5. Dafna D Gladman5,
  6. Daniela Graham6,
  7. Cunshan Wang6,
  8. Joseph C Cappelleri6,
  9. Thijs Hendrikx7 and
  10. Ming-Ann Hsu6
  1. 1 Division of Immunology/Rheumatology, Stanford University, Palo Alto, California, USA
  2. 2 Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium
  3. 3 Unidad Reumatologica Las Americas S.C.P., Mérida, Yucatán, Mexico
  4. 4 Swedish Medical Center and University of Washington, Seattle, Washington, USA
  5. 5 University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada
  6. 6 Pfizer Inc, Groton, Connecticut, USA
  7. 7 Pfizer Inc, Collegeville, Pennsylvania, USA
  1. Correspondence to Dr Vibeke Strand; vstrand{at}stanford.edu

Abstract

Objectives Tofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). We evaluated patient-reported outcomes (PROs) in patients with PsA refractory to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and tumour necrosis factor inhibitor-naïve in a 12-month, phase III randomised controlled trial (OPAL Broaden [NCT01877668]).

Methods Patients (N=422) received tofacitinib 5 mg or 10 mg twice daily, adalimumab 40 mg subcutaneously every 2 weeks or placebo advancing to tofacitinib 5 mg or 10 mg twice daily at month 3. Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences (MCID); and scores ≥normative values in: Patient Global Assessment of disease activity (PtGA), Pain, Patient Global Joint and Skin Assessment (PGJS), Short Form-36 Health Survey version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), EuroQol 5-Dimensions-3-level questionnaire (EQ-5D-3L) and Ankylosing Spondylitis Quality of Life (ASQoL) were determined. Nominal p values were cited without multiple comparison adjustments.

Results At month 3, PtGA, Pain, PGJS, FACIT-Fatigue, EQ-5D-3L, ASQoL and SF-36v2 Physical Component Summary (PCS), physical functioning (PF), bodily pain (BP) and vitality domain scores exceeded placebo with both tofacitinib doses (p≤0.05); SF-36v2 social functioning with 5 mg twice daily (p≤0.05). Percentages reporting improvements ≥MCID in PtGA, Pain, PGJS, FACIT-Fatigue, ASQoL and SF-36v2 PCS, PF, BP and general health scores exceeded placebo with both tofacitinib doses (p≤0.05) and were similar with adalimumab.

Conclusion csDMARD-IR patients with active PsA reported statistically and clinically meaningful improvements in PROs with tofacitinib compared with placebo at Month 3.

  • DMARDs (synthetic)
  • outcomes research
  • patient perspective
  • psoriatic arthritis
  • treatment

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors All authors were involved in the analysis and interpretation of data and critically revising the manuscript for important intellectual content. All authors agree to be accountable for all aspects of the work and read and approved the final manuscript to be published.

  • Funding This study was funded by Pfizer Inc.

  • Competing interests VS has received consulting fees from AbbVie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Genentech/Roche, GSK, Janssen, Lilly, Merck, Novartis, Pfizer Inc, Regeneron, Samsung, Sandoz, Sanofi and UCB. KdV is a consultant and advisory board member for Pfizer Inc. JAC-C is an investigator for Pfizer Inc. PJM has received research grants from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer Inc, Sun and UCB; has acted as a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Janssen, Lilly, Merck, Novartis, Pfizer Inc, Sun, UCB and Zynerba; and has participated in speakers’ bureaus for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer Inc and UCB. DDG has received research grants from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer Inc and UCB and has acted as a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer Inc and UCB. M-AH, DG, CW and JCC are shareholders and employees of Pfizer Inc. TH is a shareholder, and was an employee, of Pfizer Inc during the time of this analysis.

  • Patient consent Not required.

  • Ethics approval This trial was conducted in accordance with the Good Clinical Practice guidelines of the International Conference on Harmonisation and with the principles of the Declaration of Helsinki. The trial protocol and all documentation were approved by the institutional review board or independent ethics committee at each investigational site.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Upon request, and subject to certain criteria, conditions and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual deidentified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the USA and/or EU, or (2) in programmes that have been terminated (ie, development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The deidentified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.

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