Actemra

ACTEMRA versus Methotrexate double-Blind Investigative Trial In mONotherapy

The AMBITION trial evaluated 673 patients who had not been treated with methotrexate (MTX) within 6 months prior to randomisation, and who had not discontinued previous MTX treatment as a result of clinically important toxic effects or lack of response. The majority (67%) of patients were MTX-naïve. Doses of 8 mg/kg of ACTEMRA were given every 4 weeks as monotherapy. The comparator group was weekly MTX (dose titrated from 7.5 mg to a maximum of 20 mg weekly over an 8-week period).

Summary of results

The number of patients in the intention-to-treat population was 570. Compared with controls treated with MTX, patients in the ACTEMRA 8 mg/kg arm had superior American College of Rheumatology (ACR) 20 (70.6% vs. 52.1%), ACR50 (44% vs. 34%) and ACR70 (28% vs. 15%) responses (p<0.0001 for ACR20, p<0.01 for ACR50 and ACR70) and more patients achieved Disease Activity Score (DAS28) remission at 24 weeks (34% vs. 12%). C-reactive protein (CRP) levels fell to within normal limits in patients in the ACTEMRA 8 mg/kg arm and remained low for the duration of the study.

   

ACTEMRA monotherapy is clinically superior to MTX monotherapy. ACTEMRA is safe and well tolerated in patients with rheumatoid arthritis (RA) who have not failed previous MTX or biologic treatment.

Reference:

Jones G, et al. American College of Rheumatology Annual Meeting 2008, 25-28 October, San Francisco, USA. Abstract 1210.