Abstract
IntroductionThe aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor-α (TNF)-inhibitor(s).MethodsPatients enrolled into this multicenter, randomized, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 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).ResultsIn 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.ConclusionsIn 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-015-0516-6) contains supplementary material, which is available to authorized users.
Highlights
The aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor-α (TNF)-inhibitor(s)
At week 160 of the GO-AFTER trial, golimumab 50 mg and 100 mg injections every 4 weeks resulted in persistent improvement in signs and symptoms of RA and physical function among patients who continued therapy throughout this observation period of years [2]
Long-term extension (LTE) phases of clinical trials typically are associated with special concerns in data reporting because of the bias resulting from assessment only of patients who were responding to treatment and who continued study participation [3]
Summary
The aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor-α (TNF)-inhibitor(s). Long-term extension (LTE) phases of clinical trials typically are associated with special concerns in data reporting because of the bias resulting from assessment only of patients who were responding to treatment and who continued study participation [3]. Both patients and providers can benefit from assessing the outcome of patients who respond to treatment as well as the outcome for all patients who started a specific therapy. It is challenging for patients with disease refractory to several prior therapies – including biological agents, as was the case for the GO-AFTER study population [1,2] – to achieve and maintain clinical responses
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