To: Alper H.YUKSEL who wrote (27791 ) 2/3/1999 2:35:00 PM From: Henry Niman Respond to of 32384
The data for Panretin (Alitretinoin) gel for KS was also presented at the current AIDS conference: Topical Alitretinoin Gel as Treatment for Cutaneous Lesions of Patients with AIDS-Related Kaposi's Sarcoma: Results of Two Multicenter, Double-Blind, Vehicle-Controlled Trials. M. CONANT*. Univ. of California, San Francisco. The efficacy, tolerability and safety of 9-cis-retinoic acid (alitretinoin, LGD1057, Panretin R gel) 0.1% gel in the treatment of cutaneous lesions associated with AIDS-related KS were evaluated in two multicenter, double-blind, randomized, vehicle-controlled studies involving 402 patients. Patients' response rates were assessed according to the AIDS Clinical Trials Group criteria as applied to topical therapy. Response rates were significantly higher with alitretinoin gel, when applied to target lesions 2-4 times daily for up to 12+ weeks, compared to vehicle gel (35.1% vs. 17.9%, p = 0.002 in the North American trial; 41.7% vs. 6.5%, p = 0.00027 in the International trial). The overall response rate with alitretinoin gel increased to 48.9% on continued treatment in a subsequent open-label phase of the North American study. The efficacy of alitretinoin gel was also superior to that of vehicle gel in both trials after adjusting for baseline CD4+ lymphocyte count (p <> 0.001). Alitretinoin gel was generally well tolerated. The superior efficacy of alitretinoin gel over vehicle gel was achieved regardless of the extent of concurrent therapy with multiple antiretroviral agents. Response rates for patients on alitretinoin vs. vehicle gel and receiving concurrent combinations containing at least one protease inhibitor were 36.7% vs. 20.9%, p = 0.01, and 50.0% vs. 7.5%, p = 0.0001, for each respective trial.