Patient registry data on the efficacy and tolerability of adalimumab biosimilar in ankylosing spondylitis: A retrospective multicenter observational study

Abstract

Abstract: BACKGROUND: Adalimumab, a tumor necrosis factor-α inhibitor, is an approved treatment for ankylosing spondylitis (AS). In Iraq, a biosimilar of adalimumab (ABP 501; Amgevita®) has been licensed for prescription since 2021. However, there have been no previous studies on its efficacy and safety in Iraqi AS patients. Multiple studies have shown that adalimumab biosimilars are effective and well tolerated, with comparable rates of clinical response, adverse events (AEs), and immunogenicity to the reference product. OBJECTIVES: To evaluate the efficacy and safety of Amgevita in Iraqi patients with AS. PATIENTS AND METHODS: A retrospective multi-center observational study involving 72 patients with active AS for whom Amgevita 40 mg was prescribed every 2 weeks The data were collected from Amgevita registry data across multiple centers in Iraq. Patients’ entire data sets were retrieved and examined for disease activity parameters and recorded adverse reactions up to 12 months of Amgevita medication. RESULTS: The cumulative percentage of response in active AS patients treated with Amgevita was 82% after 3 months (the baseline) and 61% after 12 months. The mean change from the baseline in the Bath AS Disease Activity Index was statistically significant (−0.5 [P = 0.033; 95% confidence interval (CI): −0.87 to −0.04] and −1.14 [P = 0.0001; 95% CI: −1.68 to −0.60]) at 3 months and 12 months, respectively. On multivariate Cox regression modeling, disease activity was a predictor of a decreased response to treatment by 49%. There were no new, significant AEs. CONCLUSIONS: Adalimumab biosimilar (ABP501; Amgevita®) is clinically effective and tolerable over 12 months of follow-up in Iraqi patients with AS.