Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2012 Oct;71(10):1671-9.
doi: 10.1136/annrheumdis-2011-200956. Epub 2012 Mar 29.

Golimumab in patients with active rheumatoid arthritis who have previous experience with tumour necrosis factor inhibitors: results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160

Josef S Smolen  1 , Jonathan Kay, Robert B M Landewé, Eric L Matteson, Norman Gaylis, Jurgen Wollenhaupt, Frederick T Murphy, Yiying Zhou, Elizabeth C Hsia, Mittie K Doyle
Affiliations
Clinical Trial

Golimumab in patients with active rheumatoid arthritis who have previous experience with tumour necrosis factor inhibitors: results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160

Josef S Smolen et al. Ann Rheum Dis. 2012 Oct.

Abstract

Objective: The aim of this study was to assess long-term golimumab therapy in patients with rheumatoid arthritis (RA) who discontinued previous tumour necrosis factor alpha (TNFα) inhibitor(s) for any reason.

Methods: Results through week 24 of this multicentre, randomised, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) were previously reported. Patients received placebo (Group 1), 50 mg golimumab (Group 2) or 100 mg golimumab (Group 3) subcutaneous injections every 4 weeks. Patients from Groups 1 and 2 with <20% improvement in tender/swollen joints at week 16 early escaped to golimumab 50 mg and 100 mg, respectively. At week 24, Group 1 patients crossed over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status and Group 3 maintained dosing. Data through week 160 are reported.

Results: 459 of the 461 randomised patients were treated; 236/459 (51%) continued treatment through week 160. From week 24 to week 100, ACR20 (≥20% improvement in American College of Rheumatology criteria) response and ≥0.25 unit HAQ (Health Assessment Questionnaire) improvement were sustained in 70-73% and 75-81% of responding patients, respectively. Overall at week 160, 63%, 67% and 57% of patients achieved ACR20 response and 59%, 65% and 64% had HAQ improvement ≥0.25 unit in Groups 1, 2 and 3, respectively. Adjusted for follow-up duration, adverse event incidences (95% CI) per 100 patient-years among patients treated with golimumab 50 mg and 100 mg were 4.70 (2.63 to 7.75) and 8.07 (6.02 to 10.58) for serious infection, 0.95 (0.20 to 2.77) and 2.04 (1.09 to 3.49) for malignancy and 0.00 (0.00 to 0.94) and 0.62 (0.17 to 1.59) for death, respectively.

Conclusion: In patients with active RA who discontinued previous TNF-antagonist treatment, golimumab 50 and 100 mg injections every 4 weeks yielded sustained improvements in signs/symptoms and physical function in ∼57-67% of patients who continued treatment. Golimumab safety was consistent with other anti-TNF agents, although definitive conclusions regarding long-term safety require further monitoring.

PubMed Disclaimer

Conflict of interest statement

Competing interests: JS Smolen has received research grant support from Abbott, BMS, MSD, Pfizer, Roche and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Glaxo, Janssen, MSD, Novo-Nordisk, Pfizer, Roche, Sanofi-Aventis and UCB. J Kay has received research funding paid to the University of Massachusetts Medical School from Bristol Myers Squibb Co., F. Hoffmann-La Roche Ltd. and Sanofi-Aventis and consulting income from Bristol Myers Squibb Co., Crescendo BioScience Inc., Eisai Co. Ltd., Janssen, Johnson & Johnson, Mallinckrodt Inc., NovoNordisk Inc., Pfizer Inc. and UCB S.A. R Landewé has received research grant support from Abbott, Pfizer, Roche and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Glaxo, Janssen, MSD, Pfizer, Roche and UCB. EL Matteson has received research grant support and consultation honoraria from Janssen. N Gaylis has received research grant support and consultation and/or speaking honoraria from Janssen/Johnson & Johnson and serves as Medical Director Rheumatology Division—Cardinal Health. J Wollenhaupt has received consultation and/or speaking honoraria from Abbott, Amgen, BMS, Chugai, MSD, Medac, Pfizer, Roche, Sanofi-Aventis and UCB. FT Murphy has received speaking honoraria from Abbott Immunology and Janssen. Y Zhou, EC Hsia and MK Doyle are employees of Janssen Research and Development.

Figures

Figure 1
Figure 1
Patient disposition through week 160.
See this image and copyright information in PMC

References

    1. Smolen JS, Kay J, Doyle MK, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet 2009;374:210–21 - PubMed
    1. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315–24 - PubMed
    1. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727–35 - PubMed
    1. Prevoo ML, van't Hof MA, Kuper HH, et al. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44–8 - PubMed
    1. Aletaha D, Landewe R, Karonitsch T, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Ann Rheum Dis 2008;67:1360–4 - PubMed

Publication types

MeSH terms