Patients demonstrated improved disease response in 2 clinical trials.
Orencia (abatacept) used alone or in combination with methotrexate has been approved by the European Commission (EC) for the treatment of active psoriatic arthritis in adult patients for whom the response to previous disease-modifying antirheumatic drug therapy, including methotrexate (MTX), has been inadequate and additional systemic therapy for psoriatic skin lesions is not required, Bristol-Myers Squibb Company announced.
The approval allows for expanded marketing of Orencia as a treatment for psoriatic arthritis in all 28 Member States of the EU.
This is the second new indication for Orencia in less than a year. Last September, the EC approved Orencia, in combination with MTX, for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with MTX.
Psoriatic arthritis is the third autoimmune condition for which Orencia has been approved in Europe, joining rheumatoid arthritis and juvenile idiopathic arthritis.
“This EC approval builds on the well-established profile of Orencia in rheumatoid arthritis and exemplifies our commitment to ongoing clinical research of Orencia as a potential treatment for autoimmune conditions where treatment options are limited or where patients have not been helped enough by other medications,” said Brian J. Gavin, PhD, Vice President, Orencia Development Lead, at Bristol-Myers Squibb.
“Despite the current availability of medications, there are many people with active psoriatic arthritis who are in need of a new treatment option,” he added. “The approval of Orencia now provides a novel immunotherapy approach that may help these patients.”
The approval was based on results from 2 randomized, double-blind, placebo-controlled studies (PSA-I and PSA-II) in which a higher proportion of patients achieved an American College of Rheumatology 20 response, the primary end point, after treatment with Orencia 10 mg/kg intravenous or 125 mg subcutaneous injection compared with placebo at Week 24: 47.5% vs 19.0% and 39.4% vs 22.3%, respectively. In both studies, responses were seen regardless of prior tumor necrosis factor inhibitor treatment.
Both intravenous and subcutaneous injection formulations of Orencia are now approved to treat adult patients with active psoriatic arthritis.