Low rate of adverse events with adalimumab in long term

The rate of adverse events in patients using adalimumab remains low over time, with infections indicated as the most common adverse event, according to a study.

Investigators with Charité University Hospital, Berlin, analyzed the long-term safety of the anti-tumor necrosis factor (TNF) agent adalimumab in 23,458 patients from 71 global clinical trials for rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, psoriasis and Crohn’s disease. Researchers calculated events per 100 patient-years using events reported after the first dose through 70 days after the last dose, according to the study abstract.

The most frequently reported adverse events across all indications were infections, and were most common among patients with rheumatoid arthritis and Crohn’s disease. Nonmelanoma skin cancer incidence was raised in patients with rheumatoid arthritis, psoriasis and Crohn’s disease. The death rates were lower than or equivalent to those expected in the general population, study authors noted.

“Analysis of adverse events of interest through nearly 12 years of adalimumab exposure in clinical trials across indications demonstrated individual differences in rates by disease populations, no new safety signals and a safety profile consistent with known information about the anti-TNF class,” authors concluded.

The findings were published in the April issue of Annals of the Rheumatic Diseases.