GENEVA, Switzerland—Serono announced that it has initiated a prospective 7-year cohort, multi-national, multicenter study in more than 7000 adult patients with moderate-to-severe plaque psoriasis who have been treated with RaptivaR (efalizumab). The study will gather additional long-term safety data on the use of Raptiva in clinical practice to further support its benefit-to-risk ratio. The primary objective of the study is to document the incidence of adverse events (AEs) in patients treated with Raptiva. The secondary objective, in addition to documenting the incidence of AEs, is to compare the incidence rates of the primary end points observed in patients treated with Raptiva with incidence rates observed in the most adequate comparison cohort: a cohort of patients who have discontinued Raptiva (internal comparison), and external comparison with psoriasis patients of the General Practice Research Database (GPRD) cohort. The GPRD is a large UK database that encompasses ~3 million people who are enrolled with selected general practitioners, covering more than 30 million patient-years of follow-up.
According to Franck Latrille, senior executive vice president, global product development of Serono, CLEAREST™ is the first large-scale pharmaco-epidemiological study in psoriasis in Europe. The study "…will not only provide physicians with additional clinical evidence of the long-term safety profile of Raptiva in psoriasis in clinical practice, but also help to gather scientific data on the long-term safety profile of other agents used to treat psoriasis. With data of approximately 18,000 patient-years, the study will create the largest database of the natural history of psoriasis, its treatments in clinical practice and thus add considerable scientific knowledge about the disease."
The study will be conducted in European hospital dermatology centers and private dermatology practices. Patients starting the study will receive Raptiva; those discontinuing Raptiva during the study will remain included in the study cohort, regardless of their new treatment. The study will therefore allow for multiple long-term cohort comparisons, including a comparison of the cohort of patients exposed to Raptiva versus nonexposed patients, as well as the Raptiva-treated cohort versus the GPRD cohort. Yearly interim analyses of the 7-year study will include incidence analysis and will be presented at major dermatology meetings.
Globally, more than 30,000 patients have received Raptiva, both during clinical trials and post registration. This represents more than 17,500 patient-years of exposure, creating one of the largest existing databases of patients taking a biologic therapy for psoriasis. Serono has the rights to develop and market Raptiva worldwide outside of the US and Japan. To date, Raptiva is available in more than 50 countries, including many countries in Europe, Latin America, and Asia, as well as Australia.
In the US, where Genentech Inc has development and marketing rights for Raptiva (which was approved by the US Food and Drug Administration [FDA] in October 2003), warning statements have been added to the drug label that state the risk of serious infections, malignancies, thrombocytopenia, and immune-mediated hemolytic anemia. Infrequent cases (0.3%) of immune-mediated thrombocytopenia were observed during clinical trials and reports of severe thrombocytopenia have been received postmarketing; therefore, platelet monitoring is recommended. In 2005, Genentech initiated the RESPONSE observational study to further evaluate the long-term safety data on patients receiving Raptiva in clinical practice and to compare the results with long-term data from patients receiving therapy with other biologic agents. The study period is planned for up to 5 years and will include approximately 5000 patients treated with Raptiva and 2500 comparison patients treated with other biologic therapy.
In related news, the UK National Institute of Health and Clinical Excellence (NICE) has endorsed the use by the state National Health Service (NHS) of EnbrelR (etanercept, Wyeth) and Raptiva to treat adult patients with moderate-to-severe plaque psoriasis, and Enbrel and RemicadeR (infliximab, Schering-Plough) to treat patients with severe, active psoriatic arthritis.
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