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ACTEMRA

is the only biologic that in monotherapy shows superiority over MTX alone in ACR 20, ACR 50 and ACR 70 responses at 6 months.

Ambition

AMBITION

ACTEMRA versus Methotrexate double-Blind Investigative Trial In mONotherapy

The AMBITION trial evaluated 673 patients who had not been treated with MTX within six 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 four weeks as monotherapy. The comparator group was weekly MTX (dose titrated from 7.5 mg to a maximum of 20 mg weekly over an eight 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 Collage of Rheumatology (ACR) 20 (70.6% vs. 52.1%, in the PP population), ACR50 (44% vs. 34%, ITT) and ACR70 (28% vs. 15%, ITT) responses (p<0.0001 for ACR20, p<0.01 for ACR50 and ACR70) and more patients achieved Disease Activity Score (DAS) 28 remission at 24 weeks (34% vs. 12%). C-reative 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.

Jones G, et al. Ann Rheum Dis 2009; 0:1-9.