A phase 4 clinical trial was undertaken using a randomized, double-blind, placebo-controlled design to investigate the efficacy and safety of efalizumab for the treatment of hand and foot plaque psoriasis. After 12 weeks of once-weekly injections, significantly more patients in the efalizumab group achieved the primary efficacy endpoint compared with controls, 46.2 percent vs. 17.9 percent.
St. Louis - Results of a phase 4, multicenter, randomized, placebo-controlled, double-blind study support the use of efalizumab (Raptiva, Genentech) as a safe and well-tolerated treatment for hand and foot plaque psoriasis, says Craig Leonardi, M.D., associate clinical professor of dermatology, St. Louis University, St. Louis.
The study enrolled 80 patients who were randomized 2:1 to subcutaneous treatment with efalizumab (0.7 mg/kg x 1, then 1.0 mg/kg x 11) or placebo once a week for 12 weeks.
Eligible patients were required to have a disease severity rating of at least moderate [3 in the five- point (0-4) Physician's Global Assessment (PGA)].
Efalizumab was also significantly superior to placebo in the secondary efficacy analysis that used the more stringent outcome measure of proportion of patients achieving PGA ratings of clear or almost clear. That endpoint was reached by 32.7 percent of efalizumab patients and 7.1 percent of controls (p = 0.013).
"These results validate anecdotal user experience and published case reports where efalizumab was found effective in treating hand and foot plaque psoriasis," Dr. Leonardi says.
FROM PHOTOS TO STUDY
Dr. Leonardi tells Dermatology Times that the phase 4 study was developed as the result of a recommendation made by efalizumab users to Genentech.
"At a meeting bringing together key users of efalizumab, it was interesting that most of the attendees brought with them pictures of cases showing impressive responses of hand and foot disease. We encouraged Genentech to formally study the efficacy of efalizumab in this indication and advised that it would be best done in the context of a double-blind, randomized, placebo-controlled trial," Dr. Leonardi says.
Other patient eligibility criteria for the study required that patients had moderate-to-severe hand and/or foot disease for at least six months, be considered a candidate for systemic therapy but naïve to efalizumab, and weigh no more than 125 kg. Three-fourths of the patients enrolled had a moderate PGA rating and approximately 55 percent had received systemic therapy or phototherapy previously, including three placebo patients (11 percent) and 10 efalizumab patients (19 percent) who had been treated with another biologic agent.
Ninety-four percent of the efalizumab patients and only 75 percent of patients in the placebo group completed the study. Adverse events were common in both treatment groups, but the incidence was similar among the placebo- and efalizumab-treated patients, and the majority of the events were mild in severity. There were two severe psoriasis-related adverse events - an erythrodermic flare of psoriasis in a placebo patient and a palmoplantar-pustular flare in an efalizumab patient.