Drug induced nervous system disorder associated with Humira in treatment of Ankylosing Spondylitis: a pharmacovigilance study based on FDA adverse event reporting system (FAERS) database

Abstract

Ankylosing spondylitis is a genetically inherited rare autoimmune disease. This systemic, seronegative inflammatory spondyloarthropathy fuse and destroy the sacroiliac joints and spinal vertebrae. There are numerous therapeutic choices for this disease, such as TNF-α inhibitors, DMARDS, NSAIDS, and several more. This study's drug of choice is adalimumab, a completely human monoclonal antibody that is also used to treat ankylosing spondylitis and is marketed under the name HUMIRA. Adalimumab has several severe adverse effects, such as nervous system disorder, despite being effective in treating the symptoms of autoimmune diseases. In this study, post-market surveillance case reports from the FAERS database were used to investigate the connection between treatment with adalimumab and nervous system disorders based on age and gender. In addition, incidents reported by healthcare professionals were listed separately to reduce biases. The results were calculated using reporting odds ratio (ROR) and 95% CI to support or disprove the association.