The effects of golimumab on radiographic progression in rheumatoid arthritis: Results of randomized controlled studies of golimumab before methotrexate therapy and golimumab after methotrexate therapy

Authors

  • Paul Emery,

    Corresponding author
    1. University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK
    • Academic Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK
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    • Dr. Emery has received consulting fees, speaking fees, and/or honoraria from MSD, Pfizer, Roche, Bristol-Myers Squibb, and Abbott (less than $10,000 each).

  • Roy Fleischmann,

    1. University of Texas Southwest Medical Center at Dallas
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    • Dr. Fleischmann has received consulting fees, speaking fees, and/or honoraria from Centocor (less than $10,000).

  • Désirée van der Heijde,

    1. Leiden University Medical Center, Leiden, The Netherlands
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    • Dr. van der Heijde has received consulting fees, speaking fees, and/or honoraria from Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Chugai, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough/Merck, UCB, and Wyeth (less than $10,000 each).

  • Edward C. Keystone,

    1. University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada
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    • Dr. Keystone has received consulting fees, speaking fees, and/or honoraria from Abbott, Amgen, Bristol-Myers Squibb, Centocor, F. Hoffmann-La Roche, Genentech, Schering-Plough/Merck, UCB, and Pfizer (less than $10,000 each) and has received research funding from Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, F. Hoffmann-La Roche, Novartis, Schering-Plough/Merck, UCB, and Wyeth.

  • Mark C. Genovese,

    1. Stanford University, Palo Alto, California
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    • Dr. Genovese has received grant support from, and served as a consultant to, Johnson & Johnson.

  • Philip G. Conaghan,

    1. University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK
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    • Dr. Conaghan has received consulting fees, speaking fees, and/or honoraria from AstraZeneca, Roche, Novartis, MSD, and Bristol-Myers Squibb (less than $10,000 each).

  • Elizabeth C. Hsia,

    1. Centocor Research and Development, Inc., Malvern, Pennsylvania, and University of Pennsylvania School of Medicine, Philadelphia
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    • Drs. Hsia, Xu, Beutler, and Rahman own stock or stock options in Johnson & Johnson.

  • Weichun Xu,

    1. Centocor Research and Development, Inc., Malvern, Pennsylvania
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    • Drs. Hsia, Xu, Beutler, and Rahman own stock or stock options in Johnson & Johnson.

  • Anna Baratelle,

    1. Baratelle and Associates, LLC, Springfield, Pennsylvania
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  • Anna Beutler,

    1. Centocor Research and Development, Inc., Malvern, Pennsylvania
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    • Drs. Hsia, Xu, Beutler, and Rahman own stock or stock options in Johnson & Johnson.

  • Mahboob U. Rahman

    1. Pfizer, Collegeville, Pennsylvania
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    • Drs. Hsia, Xu, Beutler, and Rahman own stock or stock options in Johnson & Johnson.

Errata

This article is corrected by:

  1. Errata: Erratum: The effects of golimumab on radiographic progression in rheumatoid arthritis: Results of randomized controlled studies of golimumab before methotrexate therapy and golimumab after methotrexate therapy Volume 64, Issue 4, 1045, Article first published online: 27 March 2012

Abstract

Objective

To evaluate the effects of golimumab on radiographic progression in patients with rheumatoid arthritis (RA).

Methods

Methotrexate (MTX)–naive patients (in the Golimumab Before Employing Methotrexate as the First-Line Option in the Treatment of Rheumatoid Arthritis of Early Onset [GO-BEFORE] study; n = 637) and patients with active RA despite MTX therapy (in the Golimumab in Active Rheumatoid Arthritis Despite Methotrexate Therapy [GO-FORWARD] study; n = 444) were randomly assigned to receive placebo plus MTX (group 1), golimumab 100 mg plus placebo (group 2), golimumab 50 mg plus MTX (group 3), or golimumab 100 mg plus MTX (group 4). Golimumab or placebo was administered subcutaneously every 4 weeks. Radiographs of the hands and feet were taken at baseline, week 28, and week 52 in the GO-BEFORE study and at baseline, week 24 (week 16 for patients who entered early escape), and week 52 in the GO-FORWARD study. Radiographs were scored by 2 independent readers in each study using the van der Heijde modification of the Sharp score.

Results

In the GO-BEFORE study, the mean ± SD changes in the modified Sharp score from baseline to week 52 (control period) were 1.4 ± 4.6 in group 1, 1.3 ± 6.2 in group 2 (P = 0.266), 0.7 ± 5.2 in group 3 (P = 0.015), and 0.1 ± 1.8 in group 4 (P = 0.025). In the GO-FORWARD study, changes from baseline to week 24 (control period) were 0.6 ± 2.4 in group 1, 0.3 ± 1.6 in group 2 (P = 0.361), 0.6 ± 2.7 in group 3 (P = 0.953), and 0.2 ± 1.3 in group 4 (P = 0.293).

Conclusion

Golimumab in combination with MTX inhibited radiographic progression significantly better than did MTX alone in the GO-BEFORE study. Radiographic progression in the GO-FORWARD study was minimal in all treatment arms, precluding an adequate assessment of the effect of golimumab on radiographic progression in this study.

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