Bristol-Myers Squibb Company (BMS) announced that on 20 January 2010, the European Commission approved Orencia (abatacept) in combination with methotrexate for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (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.
Disease-modifying treatment options for children with pJIA have been extremely limited to date. Orencia in combination with methotrexate (MTX), offers another treatment option for children six years of age and older with pJIA, filling an unmet need. Orencia has not been studied in children under six years old. Orencia is designed to act early in the immune cascade by selectively modulating T-cells to reduce downstream inflammatory responses.
The approval of Orencia in pJIA is based on findings from the double-blind, randomised controlled study AWAKEN (Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment) which 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.
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.
JIA is the most common form of arthritis affecting children and an important cause of short-term and long-term disability in children. Studies in developed countries have reported that JIA may affect between 16–150 in every 100,000 children and the disease usually begins before the age of 16.6 Like adult rheumatoid arthritis (RA), JIA is an autoimmune disease, where the body’s immune system mistakenly attacks healthy joint tissues causing chronic pain, stiffness and swelling of the joints, which if not treated early may ultimately lead to joint damage and deformities.T-cells are thought to play a major part in the development of JIA.
Orencia is a selective co-stimulation modulator of T-cell activation. Orencia is designed to prevent full T-cell activation and inhibit the release of chemicals leading to joint inflammation and destruction as observed in RA11 and pJIA.
Orencia is the first biologic discovered and developed in Bristol-Myers Squibb research centres and was first approved for adult RA in May 2007 by the European Commission.
Orencia in combination with MTX is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs including at least one TNF inhibitor. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with Orencia and MTX.
Orencia, in combination with MTX, is also indicated for the treatment of moderate to severe active pJIA in paediatric patients six years of age and older who have had an insufficient response or who are intolerant to other DMARDS, including at least one TNF inhibitor. Orencia has not been studied in children under six years old.
The safety profile of Orencia has been studied through more than 10,000 patient-years of exposure and has demonstrated a consistent safety profile to seven years.
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