"Efalizumab (Raptiva) Appears Safe for Up to 3 years of Psoriasis Therapy: Presented at AAD"
By Bruce Sylvester
SAN FRANCISCO, CA -- March 9, 2006 -- Efalizumab (Raptiva) appears to be safe for up to 3 years of continuous weekly therapy for chronic moderate to severe plaque psoriasis, researchers reported here at the 64[th Annual Meeting of the American Academy of Dermatology.
"The point of this study is to look at safety," said Alice Gottlieb, MD, Director, University of Medicine and Dentistry of New Jersey -- Robert Wood Johnson Medical School Clinical Research Center, New Brunswick, New Jersey, United States, in a poster discussion session on March 6th.
"We saw flu-like symptoms in the first 12 weeks of treatment that are typical of this therapy, and they tend to diminish over time," she noted.
"There does not seem to be a signal of increased internal malignancy, increased arthritis events, increased adverse events related to psoriasis or increased cardiac events over the 60 weeks in the retrospective look at the data," she reported.
Efalizumab is a T-cell inhibitor approved by the FDA for the treatment of moderate to severe psoriasis.
Many traditional systemic psoriasis agents are useful only for short-term therapy because of concerns about organ toxicity and teratogenicity. To evaluate the safety profile of efalizumab over extended therapy periods, Dr. Gottlieb and colleagues looked retrospectively the results from two studies that addressed the safety of efalizumab, one at 15 months and the other at 3 years.
Patient populations were similar in both studies. For the combined population of the studies, the mean duration of psoriasis was 18.1 years, with a range of 0-68 years. The mean Psoriasis Area and Severity Index (PASI) at enrollment was 19.2 with a range of 9.6 to 63.6. The mean percent Body Surface Area Affected (BSA) was 28.7% with a range of 10% to 90%.
The most frequently observed adverse events included acute-type adverse events, specifically, headache, fever, chills, nausea and myalgia occurring within 48 hours of efalizumab injection.
"No new common adverse events appeared during the extended therapy periods," the authors reported.
Serious adverse events occurred in 2.3% to 3.3% of the patients during each 12-week exposure. With the exception that serious adverse events related to skin occurred at a rate of 1.1% during 37-48 weeks of exposure, the incidence of each serious event was not greater than 1%.
The incidence of selected adverse events (arthritis, infection, malignancy, psoriasis) within any 12-week treatment period was similar to that seen in shorter individual clinical trials.
This is the largest compilation of psoriasis patients studied out to 60 weeks for any biologic therapy, according to the researchers.
"This combined analysis of more than 1000 patients further demonstrates that extended exposure to efalizumab for up to 15 months appears to be well tolerated by patients with moderate to severe chronic plaque psoriasis."
The study was supported by Genentech, Inc.
[Presentation title: Safety and Tolerability of Extended Efalizumab Therapy in Patients With Chronic Moderate to Severe Plaque Psoriasis. Abstract P44]
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