The Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of expanded labelling for Schering-Plough Corporation's Remicade (infliximab), in combination with methotrexate, for treatment of active and progressive psoriatic arthritis (PsA) in patients who have responded inadequately to disease modifying anti- rheumatic drugs (DMARDs), a release from Schering-Plough said.
The positive opinion for Remicade as a treatment for PsA is primarily based on data from IMPACT (Infliximab Multinational Psoriatic Arthritis Controlled Trial), a randomized, double-blind, placebo-controlled study involving 104 patients with active PsA who had failed at least one DMARD and were enrolled at nine centres in the United States, Canada and Europe. Results demonstrated the safety and efficacy of Remicade in treating this debilitating disorder, the release added.
In IMPACT, patients given Remicade (5mg/kg) experienced rapid and sustained improvement in their joints, as measured by the ACR 20, 50 and 70 response criteria, measurement tools used to assess disease activity and improvement. Specifically, 34 of the 52 patients (65.4 per cent) met the ACR 20 response criteria -the primary efficacy parameter - at week 16, compared to five of the 52 patients (9.6 per cent) in the placebo group.
Responses were sustained through the end of the study (week 50). Results were confirmed in the ACR 50 and ACR 70 scores among those treated with REMICADE: 24 patients (46.2 percent) met the ACR 50 response at week 16 with 26 patients (53.1 per cent) meeting it at week 50; 15 patients (28.8 per cent) met the ACR 70 response at week 16, with 19 patients (38.8 per cent) meeting it at week 50.
The CHMP recommendation serves as the basis for a European Commission approval. A Commission approval of the application will result in Marketing Authorization with unified labelling that will be valid in all EU-Member states, including the current 15 member states and the 10 new accession countries as well as in Iceland and Norway.
Schering-Plough markets Remicade in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product. Centocor Inc, a wholly owned subsidiary of Johnson & Johnson, has exclusive marketing rights to the product in the United States. Centocor plans to submit a supplemental Biologics Application to the US Food and Drug Administration later this year to request approval for this new use.
Remicade is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha, which has been shown to play a role in RA, CD, AS and psoriasis, and may also be important in a wide range of other immune- mediated inflammatory disorders.
The Arthritis Research Campaign estimates 1 in 50 people have psoriasis. Of these, about 1 in 14 will develop PsA. While PsA can develop at any age, onset usually occurs in middle-age, typically in adults between the ages of 30 and 50. Men and women are affected equally.