Serono's Raptiva performs well in Ph III psoriasis study

Swiss biotechnology group Serono says the data from a clinical study of Raptiva (efalizumab), the firm's psoriasis treatment, shows that the drug confers clinically-significant benefits in patients with moderate-to-severe refractory forms of the condition.

The findings, which were published in the June edition of the British Journal of Dermatology, were derived from the Clinical Experience Acquired with Raptiva (CLEAR) study which examined the drug's efficacy in the treatment of patients with plaque psoriasis. Subjects, who were included in the trial if they had experienced at least two failed therapeutic regimen, were randomized to receive either 1mg/kg of the drug, or placebo, once a week for three months. The primary efficacy endpoint was defined as the proportion of patients achieving a 75% improvement in psoriasis area and severity index score (PASI), after week 12.

The results demonstrated that Raptiva brought about a PASI-75 score in 29.5% of refractory patients, in comparison with 2.1% in the placebo group. In the overall study population, 31.4% of those treated with the compound showed PASI-75 improvement, versus 4.2% in the placebo cohort. The firm added that the drug's safety and tolerability profile was consistent with that seen in previous US Phase III trials, with the incidence of adverse skin events comparable between the treated and placebo groups (2.5% and 2.3%, respectively).