Background/Purpose: Tumor necrosis factor alpha (TNFα) inhibitors have been used to treat rheumatoid arthritis (RA) for >10 years. The outcomes has revolutionized the treatment goal of RA to clinical remission, structural remission and functional remission. Although the efficacy of this drug as a treatment for patients with active RA has been widely demonstrated, some RA patients initially respond to treatment but subsequently their responsiveness decreases. One of the alleged reasons for this phenomenon is immunogenicity associated with the drug itself. Thus, it is useful to switch to a less immunogenic biologic agent to maintain disease activity and minimize adverse events. Golimumab is less immunogenic compared other TNF inhibitors.

The purpose of this study was to evaluate the efficacy and safety of switching from tumor necrosis factor (TNF) inhibitor to subcutaneous golimumab (GLM-SC) in RA patients for maintenance of disease activity or adverse events.

Methods: Thirty-seven patients who had treated with infliximab, etanercept or certolizumab pegol were switched to GLM-SC for maintenance of disease activity or adverse event. The patients were divided into three groups: the LDA group and the LDAq8w group, which included patients with low disease activity or remission who switched to GLM therapy at 50 mg at 4-week and 8-week intervals, respectively; and the MDA group, which included patients with moderate disease activity who switched to GLM therapy at 50 mg at 4-week intervals. Effects of TNF inhibitors to GLM-SC switch were evaluated at week 12, 24 and 52 after switching.

Results: A total of 37 patients were analyzed during the survey period: 16 in the LDA group, 14 in the LDAq8w group, and 7 in the MDA group. The mean DAS28-ESR and -CRP values in the LDA and LDAq8w groups maintained from baseline throughout the 52-week treatment period. The proportions of patients who achieved DAS28-ESR remission (defined as < 2.6) in the LDA group and the LDAq8w group were maintained over time from 75.0% (12/16) and 78.6% (11/14) at baseline to 93.8% (15/16) and 92.3% (13/14) at week 52, respectively. There were no patients in flare to moderate or high disease activity. In the MDA groups, the mean (± SD) DAS28-ESR values improved significantly from 4.2 (± 0.6) at baseline to 3.1 (±0.7) and 2.8 (± 0.8) at 24 and 52 weeks, respectively. There were no patients in flare to high disease activity. Treatment discontinuations due to adverse events were occurred 1 patient in the MDA group, and no serious adverse events occurred during the observation period in the LDA group or the LDAq8w group. Treatment continuation rate at 52 weeks was 100% in the LDA and LDAq8w group and 85.7% in the MDA group.

Conclusion: Clinical efficacy in GLM-SC treated patients were sustained or improved in patients switched from TNF inhibitors without serious safety concerns. The present results indicate that therapeutic efficacy is adequately maintained in the majority of Japanese RA patients who switch from TNF inhibitors to GLM-SC. We also consistently demonstrated the safety of this therapy. These results provide supportive evidence for use of GLM-SC for continued control of RA disease activity.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/outcomes-of-switching-from-tnf-inhibitors-to-subcutaneous-golimumab-in-patients-with-rheumatoid-arthritis-to-control-disease-activity-or-adverse-events/