Posted by Michael Wonder on 26 Jul 2017
Bristol-Myers Squibb’s Orencia (abatacept) receives second European Commission approval in less than a year – new approval for treatment of active psoriatic arthritis
26 July 2017 - Patients demonstrated improved disease response in two clinical trials that included both TNF-naïve and challenging to treat TNF-exposed patients with active musculoskeletal involvement.
Bristol-Myers Squibb announced today that the European Commission has approved Orencia alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients for whom the response to previous disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.
The approval was based on results from two randomised, double-blind, placebo-controlled studies (Studies PSA-I and PSA-II) in which a higher proportion of patients achieved an ACR 20 response, the primary endpoint, after treatment with Orencia 10 mg/kg intravenous or 125 mg subcutaneous injection compared to placebo at Week 24: 47.5% versus 19.0% and 39.4% versus 22.3% (p< 0.05), respectively. Responses were seen regardless of prior tumour necrosis factor inhibitor treatment in both studies.
