RHODES, GREECE — Adalimumab does not appear to increase the risk of serious infection in patients with rheumatoid arthritis, Dr. J. Kent reported at the 15th Congress of the European Academy of Dermatology and Venereology.
There was concern that rheumatoid arthritis (RA) patients, who are more prone to infection than are their healthy peers, would develop more infections while on anti-tumor necrosis factor (anti-TNF) agents like adalimumab (Humira) because of the role these agents play in host defense, Dr. Kent explained in a poster at the meeting.
However, in a study of more than 2,500 patients who participated in North American and European trials of adalimumab—which is also approved for the treatment of psoriatic arthritis and ankylosing spondylitis—there was no increased incidence of serious infections in RA patients, compared with the reported incidence of such infections in RA patients naive to anti-TNF therapy.
A total of 378 serious infections—most commonly pneumonia (70 patients), septic arthritis (37 patients), urinary tract infection (34 patients), and cellulitis (30 patients)—occurred in 305 patients (4.3 infections per 100 patient-years). The rates were similar to those reported in RA patients prior to availability of anti-TNF agents (3.1–9.6 infections per 100 patient-years), according to Dr. Kent of Abbott Laboratories (the maker of Humira).
The rate of serious infections also was not affected by diabetes status; a total of 23 serious infections occurred in the 146 patients with RA who had diabetes (4.9 infections per 100 patient-years), compared with 355 of 2,358 patients without diabetes (4.3 infections per 100 patient-years). Of note is a finding that 73% of patients with serious infections were using steroids at the time of the infection.