Long-term, Real-world Safety of Adalimumab in Rheumatoid Arthritis: Analysis of a Prospective US-Based Registry

OBJECTIVE: To assess long-term safety in a US cohort of rheumatoid arthritis (RA) patients treated with adalimumab in real-world clinical care settings. METHODS: This observational study analyzed the long-term incidence of safety outcomes among RA patients initiating adalimumab using data from the Corrona RA registry. Patients were adults ( \u3e /=18 years) who initiated adalimumab treatment between January 2008 and June 2017, and who had at least 1 follow-up visit. RESULTS: In total, 2798 adalimumab initiators were available for analysis, with a mean age of 54.5 years, 77% female, and mean duration of disease of 8.3 years. Nearly half (48%) were biologic naive, and 9% were using prednisone \u3e /=10 mg at adalimumab initiation. The incidence rates per 100 person-years for serious infections, congestive heart failure requiring hospitalization, malignancy (excluding nonmelanoma skin cancer), and all-cause mortality were 1.86, 0.15, 0.64, and 0.33, respectively. The incidence of serious infections was higher in the first year of therapy (3.44 [95% confidence interval: 2.45-4.84]) than subsequent years, while other measured AEs did not vary substantially by duration of exposure. The median time to adalimumab discontinuation was 11 months, while the median time to first serious infection among those experiencing a serious infection event was 12 months. CONCLUSION: Analysis of long-term data from this prospective real-world registry demonstrated a safety profile consistent with previous studies in patients with RA. This analysis did not identify any new safety signals associated with adalimumab treatment and provides valuable guidance for physicians prescribing adalimumab for extended periods of time