OBJECTIVE: To summarize the safety data arising from clinical trials of anakinra, a human recombinant form of interleukin-1 receptor antagonist (IL-1Ra) developed for the treatment of rheumatoid arthritis (RA).
DATA SOURCES: Primary articles and abstracts identified through the National Library of Medicine’s PubMed database (1982-2001) and secondary sources.
STUDY SELECTION AND DATA EXTRACTION: All the articles and abstracts identified from the data sources were evaluated and all information deemed relevant was included in this review.
DATA SYNTHESIS: Overall, anakinra was shown in 4 trials to be efficacious as monotherapy or combination therapy, compared with placebo, for the treatment of active RA. The magnitude of clinical improvement tended to increase with increasing doses of anakinra. In monotherapy trials, the primary adverse event was injection-site reactions, which usually were mild and transient. In combination therapy (anakinra plus methotrexate), the frequency and severity of adverse events were similar to those seen in the monotherapy trials.
CONCLUSIONS: The use of anakinra in patients with RA inhibits disease activity with a favorable tolerability profile.