A review of data based on ten years of experience using efalizumab (Raptiva®) to treat chronic plaque psoriasis confirms that that the drug has a favorable long-term safety profile.
The chronic plaque form of psoriasis accounts for about 75 percent of psoriasis cases.
The new findings, reported at the 5th European Association of Dermatology and Venereology (EADV) Spring Symposium, are based on a safety analysis in patients with chronic, moderate-to-severe plaque psoriasis who were exposed to efalizumab before and after the medication was approved for the treatment of moderate to severe, chronic plaque psoriasis.
. “Psoriasis is a chronic, T-cell mediated skin disorder that often requires long-term systemic treatment, and patients tend to have multiple co-morbidities which are aggravated by the use of conventional systemic therapies,” Kim Papp, MD, Director of Probity Medical Research Inc. in Waterloo, Canada, observed. “Thus, there is a need for anti-psoriasis treatments that are well tolerated and associated with good long-term safety profiles.”
Overall, the analysis included data from more than 40,000 patients who received efalizumab, with a cumulative clinical experience that corresponds to more than 28,000 patient-years of exposure. The ten- year experience with efalizumab included 3.5 years of post-market data obtained from spontaneous reports, published literature, regulatory authorities, epidemiological databases, clinical trials, and observational studies.
“We found that the data from continuous post-marketing surveillance confirm the favorable safety profile of efalizumab that was demonstrated in clinical trials,” Dr. Papp said. “Specifically, there was no increase in the reporting rate for infections (including tuberculosis) or malignancies, no reports of seizures or cases of multiple sclerosis, and no apparent increase in the risk of cardiovascular disorders.”
“We believe out findings strengthen earlier evidence demonstrating a role for efalizumab as a suitable treatment for many patients with moderate-to-severe chronic plaque psoriasis,” Dr. Papp said.
Efalizumab is a T-cell targeted, recombinant, humanized, monoclonal IgG1 antibody that inhibits key T-cell mediated steps in the pathogenesis of psoriasis.
The study was supported by Merck Serono International S. A. in Geneva, Switzerland.
Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.
jillstein03(at)gmail.com