Safety of adalimumab in inflammatory bowel disease: Insights from a clinical cohort

Abstract

Real-world data on the safety of adalimumab are essential for ongoing pharmacovigilance, while long-term evidence remains limited. This study aimed to evaluate adverse events (AEs) and their temporal patterns in a cohort of patients with inflammatory bowel disease (IBD). A retrospective observational study included 217 adult patients with IBD treated with adalimumab at University Medical Center "Zvezdara" in Belgrade, Republic of Serbia. AEs were identified from medical records and coded using MedDRA terminology. Incidence rates were calculated per 100 patient-years (PY) of exposure. Time-to-event (TTE) analysis was performed to evaluate the occurrence of the first AE. The total adalimumab exposure was 591.29 PY, with 630 AEs (106.55/100 PY) recorded. The most frequently reported AEs belonged to the MedDRA system organ classes of infections and infestations, investigations, general disorders and administration-site conditions, and skin and subcutaneous tissue disorders. The most commonly reported individual AEs were COVID-19, nasopharyngitis, respiratory tract infection, pyrexia, and elevated liver enzymes. Adalimumab was discontinued due to AEs in 17 patients, most commonly infections, injection-site and dermatological reactions, lupus-like syndrome, and neurological events, consistent with its known safety profile. No deaths were recorded. TTE analysis showed that the Weibull distribution provided the best fit for the occurrence of the first AE, with an estimated median time of 12.7 months (95% confidence interval, CI: 10.6-15.2). Adalimumab safety profile in this real-world IBD cohort was consistent with the available data. First AEs occurred throughout treatment exposure, highlighting the need for ongoing safety monitoring during long-term treatment.