The addition of anakinra to treatment with a traditional disease-modifying antirheumatic drug (DMARD) safely improves functional status in patients with active rheumatoid arthritis, according to research conducted in Europe.
In previous trials of the interleukin-1 receptor antagonist, anakinra proved safe and effective in reducing disease activity and radiographic progression in patients with rheumatoid arthritis.
For the current report in the August issue of the Journal of Rheumatology, Dr. Xavier Le Loet, at Rouen University Hospital in France, and colleagues analyzed changes in functional status in the Outcome Measures Generated by Anakinra (OMEGA) trial.
The open-label, single-arm trial included 1207 patients who had been treated with a stable dose of methotrexate, sulfasalazine or hydroxychloroquine for at least 3 months. Upon enrollment, patients started treatment with anakinra (100 mg daily as a subcutaneous injection) while continuing with a single DMARD for up to 36 weeks.
The overall mean percentage improvements were 13% in Health Assessment Questionnaire disability index scores and 25% for 28-joint Disease Activity Score. "Meaningful changes" were observed for dressing, grooming, eating, and the ability to reach and grip, with no significant differences associated with specific DMARDs.
"Further," the authors report, "64.0% of patients received a good or moderate European League Against Rheumatism (EULAR) response score at week 36."
Other than injection site reactions, reported by 62% of patients, the most frequent treatment-related adverse events were erythema (4.2%), pruritus (3.9%), headache (2.6%), and nausea (1.3%).
One patient developed lymphoma and there was one case of pulmonary tuberculosis. According to the authors, "to date, this is the only case of tuberculosis infection reported in clinical trials in rheumatoid arthritis with anakinra."
"Our study results support the use of anakinra as a treatment option," Dr. Le Loet and colleagues maintain, "especially when combinations of traditional DMARD or tumor necrosis factor antagonists are not suitable for a given patient."
J Rheumatol 2008;35:1538-1544.