To review and update the pharmacology, pharmacokinetics, safety, precautions, efficacy, and use of abatacept for rheumatoid arthritis (RA).
Studies and abstracts were identified through MEDLINE, International Pharmaceutical Abstracts, Cochrane databases, and Science Citation Index (1990-April 2007). Key search terms included abatacept, CTLA4-Ig, and BMS 1888667. Information available only in abstract form was retrieved from national and international rheumatology associations. Additional data were obtained from the manufacturer.
All available animal and human studies describing the pharmacology of abatacept and human studies describing the pharmacokinetics, pharmacodynamics, efficacy, safety, adverse events, and precautions of abatacept were included.
Abatacept significantly improves the signs and symptoms of moderate-to-severe RA in patients who experienced an inadequate response to methotrexate or antitumor necrosis factor-alpha inhibitors. By month 12, approximately 50% of patients achieved remission (defined as a disease activity score <2.6) that was maintained until at least 24 months of therapy. The most common adverse events include headache, upper respiratory tract infections, nausea, and nasopharyngitis. Rare but serious adverse events include serious infections and malignancy.
Abatacept has documented efficacy and safety in patients with inadequate responses to methotrexate and antitumor necrosis factor agents in both short- and long-term studies. Additional clinical trial and postmarketing evidence is necessary to understand the long-term safety, efficacy, economics, and role of abatacept in clinical practice.