Bristol-Myers Squibb has presented two-year data from a head-to-head study which show that its rheumatoid arthritis drug Orencia has comparable safety and efficacy to AbbVie's blockbuster Humira.
Results from AMPLE, the first two-year head-to-head biologics trial, have been presented at the European League Against Rheumatism congress in Madrid. It was comprised of 646 biologic-naïve patients with active RA equally randomised to either 125mg Orencia (abatacept) weekly or 40mg Humira (adalimumab) bi-weekly with a stable dose of methotrexate.
At year one, 64.8% Orencia and 63.4% Humira patients were ACR20 responders (ie a 20% improvement in their condition) and consistent with year one, clinical efficacy measures and inhibition of radiographical progression were comparable between groups at year two. There were similar rates of adverse and serious adverse events (13.8% Orencia vs 16.5% Humira).
Lead author of the study, Michael Schiff of the University of Colorado, noted that to date, "there have been no randomised, controlled studies directly comparing the efficacy and safety of different biological DMARDs using the combination of a biologic medication and methotrexate, the most commonly prescribed treatment approach in moderate to severe RA". He added that "this robust data set demonstrates that subcutaneous abatacept and adalimumab are equally efficacious in clinical, functional and radiographic outcomes. This study is a great leap forward for patients as it shows another treatment is as effective as adalimumab".
Orencia, a first-in-class biologic which reduces co-stimulation of T-cells, in turn reducing activation of other cells in the inflammatory process, had first-quarter sales of $320 million. It is benefiting from the approval of a subcutaneous formulation in 2012, giving patients the opportunity to treat themselves at home.
In Europe, Orencia is approved in combination with MTX for RA patients who have had an inadequate response to a disease-modifying anti-rheumatic drug (DMARD), including MTX, or a tumour necrosis factor (TNF) antagonist, like Humira. Dr Schiff concluded by sating that the data from AMPLE "provide important information on the clinical profile of Orencia plus MTX as a first biologic treatment option for patients with severe to moderate RA".