BMS’ Orencia shows comparable efficacy to Abbott’s Humira in patients with moderate to severe rheumatoid arthritis

Bristol-Myers Squibb (BMS) announced the results of AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis (RA) Subjects With Background Methotrexate), a head-to-head clinical trial of 646 patients comparing the subcutaneous (SC) formulation of Orencia (abatacept) vs Humira (adalimumab), each on a background of methotrexate (MTX), in biologic naïve patients with moderate to severe RA.

AMPLE met its primary endpoint (as measured by non-inferiority) and demonstrated that Orencia plus MTX achieved comparable rates of efficacy for the American College of Rheumatology criteria of 20 per cent (ACR20) response at one year of 64.8 per cent vs 63.4 per cent Humira plus MTX.

ACR50, 70 and major clinical response (ACR70 for six consecutive months), considered to be more stringent measures of efficacy, as well as DAS-28-CRP, were also assessed at one year and found to be generally comparable for the two arms. Kinetics of response and inhibition of radiographic progression were generally comparable for the two groups over a 12-month period. Injection-site reactions (a key secondary endpoint) were statistically significantly fewer in the Orencia plus MTX group.

Discontinuations due to adverse events were 3.5 per cent for Orencia plus MTX compared to 6.1 per cent for Humira plus MTX while discontinuations due to serious adverse events were 1.3 per cent for Orencia plus MTX compared to three per cent for Humira plus MTX. Autoimmune events (mild to moderate in severity) reported in the Orencia SC plus MTX group was 3.1 per cent and 1.2 per cent in the Humira plus MTX group. Other safety outcomes were similar at 12 months. The results of AMPLE were presented at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.

“Results from AMPLE provide important information comparing the efficacy of Orencia SC to Humira, including kinetics of response. The results demonstrate comparability between two agents for the primary endpoint of ACR20 and provides relevant data on ACR50 and 70,” said Michael Schiff, University of Colorado, and principal AMPLE study investigator.

“AMPLE is the first head-to-head study between two biologics which incorporates radiographic progression endpoints and provides important data on erosions and joint space narrowing in patients using Orencia SC and Humira, both on a background of methotrexate,” said Désirée van der Heijde,  Professor of Rheumatology, Leiden University Medical Center.

EP News Bureau — Mumbai