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news.The European Commission (EC) has approved Bristol-Myers Squibb's Orencia (abatacept) in combination with methotrexate (MTX). The approval of Orencia in pJIA is based on findings from the double-blind, randomised controlled study, Awaken.
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The study evaluated the efficacy and safety of Orencia in patients six to 17 years of age with moderate to severe active pJIA, who had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as MTX or tumour necrosis factor (TNF) antagonists.
Orencia, in combination with MTX, is used for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis or pJIA, in paediatric patients six years of age and older who have had an insufficient response to other DMARDS, including at least one TNF inhibitor.
The company said that Orencia has not been studied in children under six years old. It is designed to act early in the immune cascade by selectively modulating T-cells to reduce downstream inflammatory responses.
Awaken studied Orencia in pJIA in three phases: the first (Period A) was an open-label, lead-in period where patients received active treatment with Orencia; the second (Period B) was the double-blind period where patients who had demonstrated an ACR Paediatric (Pedi) 30 response were randomised to either Orencia or placebo treatment; and the third (Period C) was the open-label extension period open to those patients experiencing flare or completing Period B as well as non-responders from Period A.
In Period A, Orencia has demonstrated meaningful ACR Pedi response rates, with 65%, 49% and 28% of patients achieving an ACR Paediatric 30, 50 and 70, respectively. ACR Pedi responses throughout the study (Period A, Period B and Period C), remained consistent for one year and were higher in biologic naive patients compared to those previously receiving biologic therapy
Additionally, in Period B, patients on Orencia experienced fewer disease flares versus placebo. The risk of disease flare among patients continuing on Orencia was less than one-third than that for patients who withdrew from Orencia treatment.
The study results suggested that an improvement in quality of life was shown in a study where treatment with Orencia allowed children to miss fewer school days and parents to get back to usual activities.