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

Abstract

ObjectiveThe 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.MethodsResults 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.Results459 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.ConclusionIn 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.

Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients

“…Although direct comparisons with other anti-TNFs are limited by differences in study design and lack of head-to-head studies, the observed incidences of SAEs and fatalities in the RAPID 2 OLE were comparable to long-term studies of other anti-TNFs [19][20][21]. Similarly, the IR of serious infections reported in this study (4.1/ 100 PYs) is consistent with IRs reported from OLE studies of other anti-TNFs (ranging from 2.8/100 PYs to 6.4/100 PYs) [19,[22][23][24] and also with a recent pooled safety analysis of clinical CZP trials in RA (3.65/ 100 PYs) [25].…”

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

“…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.…”

“…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).…”

Behçet Disease-associated Uveitis Successfully Treated with Golimumab

“…8 GLM is a recent development in TNF antagonism and has been recently approved for the treatment of a variety of rheumatic inflammatory conditions, [3][4][5] with an acceptable safety profile, and remains the only TNF antagonist that has shown efficacy in patients refractory to other anti-TNF agents. 9 Due to GLM molecular structure, a fully human monoclonal antibody, GLM has a lower probability of developing neutralizing antibodies compared to other anti-TNF such as IFX, a chimeric monoclonal antibody, decreasing the risk of an allergic infusion reaction and any loss of efficacy. Although fully human, resistance to golimumab may potentially develop as well.…”

“…To our knowledge, only two reports have been published related to GLM treatment in patients with ocular inflammation, one in idiopathic retinal vasculitis 9 and the other one in uveitis associated with juvenile idiopathic arthritis. 10 Although the follow-up after switch to golimumab was only 6 months, this case adds to the spectrum of uveitic conditions responsive to GLM.…”