Aventis announced that the European Commission approved a new indication for Arava (leflunomide) used in the treatment of adult patients with active psoriatic arthritis (PsA).

Results of clinical studies (pivotal study: TOPAS) demonstrate Arava alone provides decisive advantages in the treatment of PsA. "The product is highly effective in moderating joint and skin symptoms and therefore significantly improves patients' quality of life," explains Gilles Brisson, head of Aventis Europe, "Moreover the product is well tolerated, easy to use, due to its oral administration route, and cost-effective. These characteristics, make Arava a major treatment option for patients with PsA," he asserted.

Psoriatic arthritis is a potentially disabling inflammatory disease that affects up to 30 per cent of patients with psoriasis, a skin condition found in about 1-3 per cent of the population. PsA is most probably under diagnosed; therefore the true prevalence may be higher. PsA is associated with significant disability, reducing quality of life and increased mortality. Approved and effective treatment options for patients with PsA are limited. Classic agents used to treat joint symptoms often do little to improve skin lesions and vice versa.

PsA and psoriasis are accompanied by a significant disease burden, affecting both health-related and emotional aspects of a patient's life. Accordingly, improving quality of life is a critical goal for therapeutic agents used to treat PsA. Arava demonstrated significant improvements compared to placebo both in functional status and in skin-related quality of life. The Dermatological Life Quality Index in Arava patients lead to an improvement of skin related quality of life of 24 per cent as compared to the index for psoriatic patients in general.

Arava is indicated for the treatment of adult patients with active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD), a debilitating disease that leads to inflammation in the lining of the joints.