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

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.

Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients

“…No new safety signals were observed over the course of the 7-year treatment period, with AE ERs comparable to other long-term anti-TNF studies [21–24]. AEs were consistent with other long-term evaluations of CZP in combination with MTX given as a 200 mg dose every 2 weeks (Q2W) [25–27].…”

Persistence with golimumab in immune-mediated rheumatic diseases: a systematic review of real-world evidence in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis

“…In RA, three OLE studies13,44,45 presented data on per sistence to golimumab after 256 weeks (approximately five years). In biologic-naive patients, GO-BEFORE enrolled methotrexate-naive patients;45 and GO-FORWARD enrolled patients with inadequate response to methotrexate 13.…”

Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

“…In addition to overall AE and SAE, the incidence of AE of special interest (serious infections including opportunistic infections and TB, deaths, malignancies, and demyelination) per 100 pt-yrs was determined. Patient retention was substantial, with about 60% of patients with RA, 69% with PsA, and 72% with AS completing 5 years of followup, reflecting the sustained efficacy observed through up to 5 years of GOL treatment 10,14,17,21,24 . This retention, which compares favorably with 5-and 10-year drug survival rates for ETN 29 and ADA 30 , respectively, allowed for the analysis of 2228 patients with a mean of 203 weeks of GOL safety followup.…”

“…No further ethical approval was required to conduct the additional data analyses reported herein. Patient entrance criteria and study designs for each trial have been reported [8][9][10][11][12][13][14][15][16][17]18,19,20,21,22,23,24 and are summarized in Table 1. Additionally, further details of each trial are available at clinicaltrials.gov (GO-BEFORE: NCT00264537, GO-FORWARD: NCT00264550, GO-AFTER: NCT00299546, GO-REVEAL: NCT00265096, GO-RAISE: NCT00265083).…”

“…Our current study was a pooled analysis of previously collected safety data from 5 large multicenter trials [8][9][10][11][12][13][14][15][16][17]18,19,20,21,22,23,24 , each of which was conducted according to the Declaration of Helsinki and the International Committee on Harmonisation Good Clinical Practices. Each of the phase 3 study protocols was approved by central or individual site institutional review boards/ethics committees, and all patients provided written informed consent prior to any study-related procedures.…”