Patient-Reported Outcomes and the Association With Clinical Response in Patients With Active Psoriatic Arthritis Treated With Golimumab: Findings Through 2 Years of a Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Authors

  • Arthur Kavanaugh,

    Corresponding author
    • University of California, San Diego, La Jolla
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    • Dr. Kavanaugh has received clinical research support from Abbott, Amgen, Janssen, and UCB.

  • Iain B. McInnes,

    1. University of Glas-gow, Glasgow, UK
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    • Dr. McInnes has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) and/or clinical research support from Abbott, Janssen, Merck/Schering-Plough, Roche, and Wyeth.

  • Gerald G. Krueger,

    1. University of Utah Health Sciences Center, Salt Lake City
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    • Dr. Krueger has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from and/or has served as a member of the advisory board for Abbott, Amgen, ApoPharma, Astellas, Boehringer Ingleheim, Bristol-Myers Squibb, Centocor, Idera, Isis, Genentech, Janssen, Lilly, L'Oreal, MEDACorp, Medicis, Merck/Schering-Plough, Novartis, National Psoriasis Foundation, Pfizer, Vascular Biologics Limited, and UCB.

  • Dafna Gladman,

    1. Toronto Western Hospital, Toronto, Ontario, Canada
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    • Dr. Gladman has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) and/or clinical research support from AbbVie, Abbott, Amgen, Bristol-Myers Squibb, Janssen, Novartis, Pfizer, and UCB.

  • Anna Beutler,

    1. Janssen Research & Development, LLC, Spring House, Pennsylvania
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    • Drs. Beutler, Gathany, Mack, Tandon, and Han own stock or stock options in Janssen.

  • Tim Gathany,

    1. Janssen Global Services, LLC, Malvern, Pennsylvania
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    • Drs. Beutler, Gathany, Mack, Tandon, and Han own stock or stock options in Janssen.

  • Michael Mack,

    1. Janssen Research & Development, LLC, Spring House, Pennsylvania
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    • Drs. Beutler, Gathany, Mack, Tandon, and Han own stock or stock options in Janssen.

  • Neeta Tandon,

    1. Janssen Pharmaceuticals, Titusville, New Jersey
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    • Drs. Beutler, Gathany, Mack, Tandon, and Han own stock or stock options in Janssen.

  • Chenglong Han,

    1. Janssen Global Services, LLC, Malvern, Pennsylvania
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    • Drs. Beutler, Gathany, Mack, Tandon, and Han own stock or stock options in Janssen.

  • Philip Mease

    1. Swedish Medical Center and University of Washington, Seattle
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    • Dr. Mease has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) and/or clinical research support from Abbott, Biogen Idec, Celgene, Crescendo, Lilly, Merck, and Novartis and (more than $10,000 each) from AbbVie, Amgen, Bristol-Myers Squibb, Genentech, Janssen, Pfizer, and UCB.


  • ClinicalTrials.gov identifier: NCT00265096.

University of California, San Diego, 9500 Gilman Drive, Room A-112, La Jolla, CA 92093-0943. E-mail: akavanaugh@ucsd.edu

Abstract

Objective

To evaluate the effect of golimumab on physical function, health-related quality of life (HRQOL), and productivity in psoriatic arthritis (PsA).

Methods

GO-REVEAL was a multicenter, randomized, placebo-controlled study. Adult patients with active PsA (n = 405) received golimumab (50 or 100 mg) or placebo every 4 weeks, with early escape at week 16 (placebo → 50 mg, 50 → 100 mg) or placebo crossover to golimumab 50 mg at week 24. Patient-reported outcomes included physical function (Health Assessment Questionnaire [HAQ] disability index [DI] score), HRQOL (36-item Short Form health survey [SF-36] mental component summary [MCS] and physical component summary [PCS] scores), and productivity (home/school/work). Clinical response was assessed using the 28-joint Disease Activity Score using the C-reactive protein level (DAS28-CRP) and the Psoriasis Area and Severity Index (PASI) score for arthritis and skin symptoms, respectively.

Results

At week 24, golimumab-treated patients had significant mean improvements in HAQ DI (0.36), SF-36 (PCS 7.83, MCS 3.84), and productivity (2.24) scores compared with placebo (−0.01, 0.67, −0.60, and 0.08, respectively; P < 0.001 for all). Also, greater proportions of golimumab- than placebo-treated patients had clinically meaningful improvements in HAQ DI (≥0.30) and SF-36 PCS and MCS (≥5) scores at week 24 (P < 0.05). Also at week 24, improvements in DAS28-CRP scores were significantly but moderately correlated with improvements in HAQ DI, SF-36 PCS, and productivity scores. Correlations between these patient-reported outcomes and improvements in PASI, enthesitis, and dactylitis scores were very weak. Improvements in HAQ DI, SF-36, and productivity scores were similar among all groups by week 52 and week 104 when including placebo → golimumab crossover patients.

Conclusion

Golimumab-treated patients had significant improvements in physical function, HRQOL, and productivity through week 24; these improvements correlated with clinical improvement in signs and symptoms of peripheral arthritis and were sustained through 2 years.

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