Merck Serono, the health care unit of Germany's Merck KGaA, has reported strong data from a three-year prospective efficacy and safety study of Raptiva (efalizumab) in moderate-to-severe chronic plaque psoriasis. Published in the May issue of the British Journal of Dermatology, the data demonstrate the sustained safety and efficacy obtained in the long-term three-year therapy of this chronic autoimmune disease, the firm noted.
In the study, Raptiva had a sustained effect in those patients who responded to the initial 12-week treatment (82%). A 75% improvement in the disease, as measured by the standard Psoriasis Area and Severity Index score, was achieved in 73% of responders (as-treated analysis) after three years of therapy. Raptiva was generally well-tolerated during the treatment period of up to three years.
"No efficacy and safety studies of similar duration for biological psoriasis treatments have ever been published. The long-term use of traditional therapies may be limited by inconvenience, as in the case of phototherapy, or increased toxicities, for example with ciclosporin or methotrexate," said study investigator Craig Leonardi. "Efalizumab demonstrated sustained long-term efficacy and a favorable safety profile in this three-year trial. These features make it appropriate for continuous, long-term treatment of plaque psoriasis," he added.
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