Anakinra treatment of patients with rheumatoid arthritis.
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).


METHODS
Primary articles and abstracts identified through the National Library of Medicine's PubMed database (1982-2001) and secondary sources.


METHODS
All the articles and abstracts identified from the data sources were evaluated and all information deemed relevant was included in this review.


RESULTS
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 com bination 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.
Calabrese
Leonard H
LH
Department of Rheumatic & Immunologic Diseases, Cleveland, OH, USA. calabri@cesmtp.ccf.org
D018501:Antirheumatic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000209:etiology; D004359:Drug Therapy, Combination; D006207:Half-Life; D006801:Humans; D053590:Interleukin 1 Receptor Antagonist Protein; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D017472:Receptors, Interleukin-1 / Q000037:antagonists & inhibitors*; D012795:Sialoglycoproteins / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*
D018501:Antirheumatic Agents; C507763:IL1RN protein, human; D053590:Interleukin 1 Receptor Antagonist Protein; D017472:Receptors, Interleukin-1; D012795:Sialoglycoproteins; D008727:Methotrexate