Real-World Safety and Effectiveness of Golimumab in Rheumatic Diseases: Post-Marketing Surveillance in Korea

Abstract

Introduction Golimumab is a human monoclonal antibody that inhibits tumor necrosis factor-α (TNF-α). Inhibition of TNF-α by golimumab inhibits the inflammatory response, thereby modulating the immune response in immune-mediated inflammatory diseases. Although the efficacy of golimumab has been demonstrated in randomized controlled trials (RCTs), various patient populations, such as those at high risk of infection, including those with latent tuberculosis and various comorbidities, or on co-administered medications, were excluded from the RCTs. Therefore, safety cannot be sufficiently evaluated by RCTs in the patient group with heterogenous characteristics. The aim of this study was to assess the safety and effectiveness of golimumab in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondyloarthritis (AS) in a real-world setting in Korea. Methods We conducted an open-label, prospective, non-interventional study as post-marketing surveillance. Safety was evaluated by collecting and recording adverse events, and effectiveness was evaluated by assessing disease activity using DAS28-CRP, DAS28-ESR, ACR20, and ASAS20 outcome measures. Multiple logistic regression was performed to identify factors associated with the incidence of adverse events, and changes in disease activity scores from baseline were analyzed using the Wilcoxon signed-rank test. Results A total 673 patients were enrolled, of whom 621 were included in the safety analysis. During the study, 97 adverse drug reactions (ADRs) were reported in 62 patients (10.0%). The most frequently reported ADRs were related to infection, including nasopharyngitis (0.8%), upper respiratory tract infection (0.6%), and herpes zoster (0.5%). The mean (± standard deviation) changes from baseline in global disease activity at weeks 12 and 24 were − 3.37 ± 2.529 and − 3.68 ± 2.404, respectively, with statistical significance. In those patients with RA, 72.5 and 47.0% of individuals had a good response based on DAS28-CRP and DAS28-ESR outcomes at week 24. At week 24, 71.4% of patients with PsA had an ACR20 response and 72.9% of patients with AS had an ASAS20 response. Conclusion In the real-world setting, golimumab was safe and effective in Korean patients with RA, PsA, and AS. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-021-00352-6.

Infections in the era of immunobiologicals

“… 48 The safety of golimumab was verified in a recent large series in which infections were the most common adverse effect; however, no fungal infections were observed. 49 …”

Safety of Anti-TNFs in Patients with Immune-Mediated Disease

“…For example, patients with CD treated with infliximab had an active TB rate of 0.01 event per 100 PY; 28 patients with RA treated with anti-TNFs had a rate of approximately 0.1 per 100 PY; 34 and patients with RA, PsA, or AS treated with golimumab did not experience any reactivation of TB. 35 Moreover, the risk of TB may differ between anti-TNF drugs. In an analysis of the British Society for Rheumatology Biologics Register (BSRBR) of patients with RA (n=10,712), treatment with monoclonal antibodies infliximab or adalimumab was associated with an increased risk of TB compared with treatment with the soluble TNF receptor, etanercept, with infection rates of 0.14, 0.14, and 0.04 events per 100 PY, respectively.…”