Efficacy and safety of golimumab in patients with ankylosing spondylitis: Results of a randomized, double-blind, placebo-controlled, phase III trial

Authors

  • Robert D. Inman,

    Corresponding author
    1. University of Toronto, Toronto, Ontario, Canada
    • University of Toronto, Toronto Western Hospital, 399 Bathurst Street, Toronto, Ontario M5T 2S8, Canada
    Search for more papers by this author
    • Dr. Inman has received consulting fees, speaking fees, and/or honoraria from Schering-Plough, Centocor, Amgen, and Abbott (less than $10,000 each).

  • John C. Davis Jr.,

    1. University of California, San Francisco
    Search for more papers by this author
  • Désirée Van Der Heijde,

    1. Leiden University Medical Center, Leiden, The Netherlands
    Search for more papers by this author
    • Dr. van der Heijde has received consulting fees, speaking fees, and/or honoraria from Abbott, Amgen, Centocor, UCB, Wyeth, Roche, Schering-Plough, Novartis, and Chugai (less than $10,000 each).

  • Laura Diekman,

    1. University of Texas–Houston
    Search for more papers by this author
  • Joachim Sieper,

    1. Charité Hospital, Berlin, Germany
    Search for more papers by this author
    • Dr. Sieper has received consulting fees, speaking fees, and/or honoraria from Schering-Plough, Abbott, and Wyeth (less than $10,000 each).

  • Sung Il Kim,

    1. Pusan National University Hospital, Pusan, South Korea
    Search for more papers by this author
  • Michael Mack,

    1. Centocor Research and Development, Malvern, Pennsylvania
    Search for more papers by this author
    • Drs. Mack, Han, Visvanathan, Xu, Beutler, and Hsu own stock and/or stock options in Johnson & Johnson, of which Centocor is a subsidiary.

  • John Han,

    1. Centocor Research and Development, Malvern, Pennsylvania
    Search for more papers by this author
    • Drs. Mack, Han, Visvanathan, Xu, Beutler, and Hsu own stock and/or stock options in Johnson & Johnson, of which Centocor is a subsidiary.

  • Sudha Visvanathan,

    1. Centocor Research and Development, Malvern, Pennsylvania
    Search for more papers by this author
    • Drs. Mack, Han, Visvanathan, Xu, Beutler, and Hsu own stock and/or stock options in Johnson & Johnson, of which Centocor is a subsidiary.

  • Zhenhua Xu,

    1. Centocor Research and Development, Malvern, Pennsylvania
    Search for more papers by this author
    • Drs. Mack, Han, Visvanathan, Xu, Beutler, and Hsu own stock and/or stock options in Johnson & Johnson, of which Centocor is a subsidiary.

  • Benjamin Hsu,

    1. Centocor Research and Development, Malvern, Pennsylvania
    Search for more papers by this author
    • Drs. Mack, Han, Visvanathan, Xu, Beutler, and Hsu own stock and/or stock options in Johnson & Johnson, of which Centocor is a subsidiary.

  • Anna Beutler,

    1. Centocor Research and Development, Malvern, Pennsylvania
    Search for more papers by this author
    • Drs. Mack, Han, Visvanathan, Xu, Beutler, and Hsu own stock and/or stock options in Johnson & Johnson, of which Centocor is a subsidiary.

  • Jürgen Braun

    1. Rheumazentrum Ruhrgebiet, Herne, Germany
    Search for more papers by this author
    • Dr. Braun has received consulting fees, speaking fees, and/or honoraria from Centocor, Schering-Plough, Wyeth, Amgen, Abbott, Pfizer, and Bristol-Myers Squibb (less than $10,000 each).


  • ClinicalTrials.gov identifier: NCT00265083.

Abstract

Objective

To evaluate the efficacy and safety of golimumab in patients with ankylosing spondylitis (AS) in the GO-RAISE study.

Methods

Patients with active AS, a Bath AS Disease Activity Index (BASDAI) score ≥4, and a back pain score of ≥4 were randomly assigned in a 1.8:1.8:1 ratio to receive subcutaneous injections of golimumab (50 mg or 100 mg) or placebo every 4 weeks. The primary end point was the proportion of patients with at least 20% improvement in the ASsessment in AS (ASAS20) criteria at week 14.

Results

At randomization, 138, 140, and 78 patients were assigned to the 50-mg, 100-mg, and placebo groups, respectively. After 14 weeks, 59.4%, 60.0%, and 21.8% of patients, respectively, were ASAS20 responders (P < 0.001). A 40% improvement in the ASAS criteria at week 24 occurred in 43.5%, 54.3%, and 15.4% of patients, respectively. Patients receiving golimumab also showed significant improvement in the physical and mental component summary scores of the Short Form 36 Health Survey, the Jenkins Sleep Evaluation Questionnaire score, the BASDAI score, and the Bath AS Functional Index score, but not the Bath AS Metrology Index score. Through week 24, 85.6% of golimumab-treated patients and 76.6% of patients in the placebo group had ≥1 adverse event, and 5.4% and 6.5% of patients, respectively, had ≥1 serious adverse event. Eight golimumab-treated patients and 1 placebo-treated patient had markedly abnormal liver enzyme values (≥100% increase from baseline and a value >150 IU/liter), which were transient.

Conclusion

Golimumab was effective and well tolerated in a large cohort of patients with AS during a 24-week study period.

Ancillary