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The 2010 annual meeting of the American Academy of Dermatology was the forum for the first public presentation of data from the Psoriasis Longitudinal Assessment and Registry (PSOLAR), a multicenter, Phase 4 observational study sponsored by Centocor and mandated by the FDA when the regulatory agency granted approval of infliximab (Remicade, Centocor) for the treatment of chronic severe plaque psoriasis.
Miami - The 2010 annual meeting of the American Academy of Dermatology (AAD) was the forum for the first public presentation of data from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). PSOLAR is a multicenter, Phase 4, observational study sponsored by Centocor and mandated by the Food and Drug Administration when the regulatory agency granted approval of infliximab (Remicade, Centocor) for the treatment of chronic severe plaque psoriasis.
PSOLAR is being co-directed by Alan Menter, M.D., and Craig Leonardi, M.D., and currently plans to collect data for up to eight years for 4,000 infliximab-treated patients, 4,000 patients being treated with other biologic and nonbiologic systemic therapies, and 4,000 patients receiving ustekinumab (Stelara, Centocor).
"There are registries in the U.S. for single biologic agents and in Europe for all biologics, but 70 percent of all biologic-treated patients in the world reside in North America. PSOLAR is the most broadly encompassing registry, has been well-funded, features a robust design, and I believe it will be the most important safety registry database for all biologics being used for the treatment of psoriasis over the next 10 years," says Dr. Menter, chairman, Psoriasis Research Unit, Baylor Research Institute, Dallas.
"Going forward, hopefully we will have sufficient numbers of patients maintained on treatment for five to eight years that will allow us to look, from a statistical perspective, at safety outcomes of potential concern, including cardiac events, cancer and infection," Dr. Menter says.
The success of PSOLAR will depend on dermatologists' cooperation. "Data collection is at enrollment and then just every six months thereafter, and so it is not an onerous task," Dr. Menter says.
PSOLAR is collecting data on American and Canadian patients, but the possibility of partnering with European colleagues and enrolling patients from countries in Europe, Latin America and Asia is being investigated.
Disclosures: Dr. Menter receives advisory board, consulting and/or lecture fees from Centocor, Amgen, Wyeth and other companies marketing biologic and systemic therapies for psoriasis, but has no stock ownership or board representation in any company.