UMMS Affiliation
Department of Medicine, Division of Rheumatology
Publication Date
1-22-2015
Document Type
Article Postprint
Disciplines
Musculoskeletal Diseases | Rheumatology | Skin and Connective Tissue Diseases
Abstract
Introduction: The aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor- inverted question mark (TNF)-inhibitor(s).
Methods:Patients enrolled into this multicenter, randomized, double-blind, placebo-controlled study of active RA ( inverted question mark4 tender, inverted question mark4 swollen joints) received placebo (Group 1) or golimumab 50 mg (Group 2) or 100 mg (Group 3) injections every 4 weeks. Patients in Groups 1 and 2 with inadequate response at week 16 escaped to golimumab 50 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. During the long-term-extension (LTE), golimumab 50 mg could be increased to 100 mg, and 100 mg could be decreased to 50 mg. Data through 5 years are reported for all patients (safety) and patients using methotrexate (efficacy, intention-to-treat (ITT) analysis with last-observation-carried-forward for missing data and non-responder imputation for unsatisfactory efficacy discontinuations).
Results: In total, 459 of 461 randomized patients received the study agent, 304 of whom were methotrexate-treated and included in efficacy analyses. Through week 256, the proportions of methotrexate-treated patients achieving American-College-of-Rheumatology (ACR) responses were 37.6% to 47.0% for ACR20, 21.4% to 35.0% for ACR50, and 7.8% to 17.0% for ACR70 response across randomized groups. Golimumab safety through week 268 was generally consistent with that at week 24 and week 160 and other anti-TNF agents.
Conclusions:In some patients with active RA discontinuing previous TNF-antagonist therapy, golimumab safety and efficacy, assessed conservatively with ITT analyses, was confirmed through 5 years.
Trial registrationClinicaltrials.gov NCT00299546. Registered 03 March 2006.
DOI of Published Version
10.1186/s13075-015-0516-6
Source
Smolen JS, Kay J, Doyle M, Landewé R, Matteson EL, Gaylis N, Wollenhaupt J, Murphy FT, Xu S, Zhou Y, Hsia EC. Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study. Arthritis Res Ther. 2015 Jan 22;17(1):14. doi: 10.1186/s13075-015-0516-6. PubMed PMID: 25627338; PubMed Central PMCID: PMC4382834. Link to article on publisher's site
Journal/Book/Conference Title
Arthritis research and therapy
Related Resources
PubMed ID
25627338
Repository Citation
Smolen, Josef S.; Kay, Jonathan; Doyle, Mittie; Landewe, Robert; Matteson, Eric L.; Gaylis, Norman; Wollenhaupt, Jurgen; Murphy, Frederick T.; Xu, Stephen; Zhou, Yiying; and Hsia, Elizabeth C., "Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor inverted question mark inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study" (2015). Rheumatology Publications and Presentations. 110.
https://escholarship.umassmed.edu/rheumatology_pubs/110
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
Included in
Musculoskeletal Diseases Commons, Rheumatology Commons, Skin and Connective Tissue Diseases Commons
Comments
This is the authors' final, peer-reviewed version of the article as prepared for publication in Arthritis Research and Therapy.