Adalimumab was generally well tolerated during the 24-week trial. Common side effects “were similar to those seen in clinical trials involving patients with RA or were thought to be related to underlying disease,” according to the authors.
Serious adverse events were experienced by 12 patients, including 7 in the placebo group and 5 in the adalimumab group. In the latter, events included nasal septum disorder, toe arthrodesis, aggravation of convulsions, viral meningitis (attributed to West Nile virus) and renal calculus; most of these were considered unrelated to the study medication.
The authors stress that longer-term follow-up from the open-label extension study is needed to confirm these results. The study was supported by Abbott Laboratories.
Dr. Mease has received consulting fees or honoraria of less than $10,000/year from Abbott.