Micellar paclitaxel improves severe psoriasis in a prospective phase II pilot study

Abstract

Background Taxanes (eg, paclitaxel) are chemotherapeutic agents that have antiproliferative, antiangiogenic, and antiinflammatory properties. Objective We sought to explore the safety and efficacy of paclitaxel in individuals with severe psoriasis. Methods An open-label, prospective, phase II pilot study was conducted at the National Institutes of Health Clinical Center, a federal government medical research facility, in Bethesda, Maryland. Twelve patients with severe psoriasis, as defined by a baseline Psoriasis Area and Severity Index (PASI) score of ≥ 20), were studied. Initially, patients received 6 intravenous infusions of micellar paclitaxel, 75 mg/m 2, at 4-week intervals (stage I). Later patients received 9 intravenous infusions of micellar paclitaxel at 2-week intervals (37.5 mg/m 2 for 3 doses followed by 50 mg/m 2 for six additional doses) (stage II). The primary end point was the percent change in the PASI from week 0 to week 24 in stage I and from week 0 to week 20 in stage II. Results In stage I, all 5 patients improved (mean = 59.7% decrease in PASI, median = 59.6%, range: 40.3%-79.2%). Four of the 7 patients completed stage II and all of these patients improved (mean = 45.9% decrease in PASI, median = 45.0%, range: 14.6%-79.1%). Micellar paclitaxel was well tolerated by most patients. Conclusions Micellar paclitaxel demonstrates therapeutic activity in patients with severe psoriasis.