Objectives: Clinical trials of tumour necrosis factor antagonists have raised questions about the potential risk of certain serious adverse events (SAEs). To assess the safety of adalimumab in rheumatoid arthritis (RA) over time and across five other immune-mediated inflammatory diseases and to compare adalimumab malignancy and mortality rates with data on the general population.
Methods: This analysis included 19 041 patients exposed to adalimumab in 36 global clinical trials in RA, psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), psoriasis (Ps), and juvenile idiopathic arthritis (JIA) through April 15, 2007. Events per 100-patient-years were calculated using serious adverse events reported after the first dose through 70 days after the last dose. Standardised incidence rates were calculated for malignancies using national and state specific databases. Standardised mortality rates (SMRs) were calculated for each disease using data from the World Health Organization.
Results: Cumulative rates of SAEs of interest in RA have remained stable over time. Rates of SAEs of interest for PsA, AS, CD, Ps, and JIA were similar to or lower than rates for RA. Overall malignancy rates for adalimumab treated patients were as expected for the general population. SMRs across all six diseases indicated that no more deaths occurred with adalimumab than expected in the general population.
Conclusions: Based on 10 years of clinical trial experience across six diseases, this safety report and the established efficacy of adalimumab in these diseases provide the foundation for a better understanding of its benefit-risk profile.