Bristol-Myers Squibb Orencia With Methotrexate Receives EC Approval

The EC approval for Orencia is for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.

Bristol-Myers Squibb said that Orencia approval was based on the results of a two-year open-label study from a trial in methotrexate (MTX)-naive RA patients (Agree), as well as by long-term open-label data from the core RA clinical trial programme in MTX inadequate responders (IR) (Aim, Attest, and a Phase IIb study) and in anti-TNF-IRs (Attain and Arrive).

Reportedly, data from these studies demonstrated that Orencia may provide improved outcomes in short-term efficacy as well as durable and sustained long-term efficacy (up to seven years as demonstrated in the Phase IIb study) when used with MTX earlier in the RA treatment paradigm.

Additionally, the Aim trial showed a sustained reduction in the rate of progression of structural damage up to five years.

In Attest trial, a randomised double-blind study to assess the efficacy and safety of Orencia or infliximab versus placebo in MTX-IR, demonstrated that the efficacy of Orencia and of infliximab vs placebo was similar at six months.

Rene Westhovens of the University of Leuven in Belgium, said: “The expanded indication of Orencia into an earlier line of RA treatment is part of the evolution of RA management that is expected to increasingly allow us to slow the progression of the disease.”

Manuela Le Bars, european medical lead for immunoscience at Bristol-Myers Squibb, said: “There is a growing body of evidence to show that earlier use of Orencia may have benefits for patients, for both short-term and long-term efficacy.

“This new indication means patients can benefit sooner from improvements in function and quality of life provided by Orencia.”