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The Anti‐LFA‐1 Trial in Islet Transplantation

In this issue of AJT , Posselt et al. present a pilot trial in islet transplantation using potent immunosuppression with a combination of antithymocyte globulin (ATG) induction followed by maintenance with Efalizumab and sirolimus or mycophenolate (1). The patients remained on a steroid-free, calcineurin inhibitor (CNI)-free regimen until the investigators discontinued Efalizumab because of reported safety concerns. Efalizumab has been authorized in the European Union since September 2004 to treat chronic plaque psoriasis in patients who display intolerance, contraindication or failed response to systemic therapies. Following the report of serious side effects, including three confirmed cases of progressive multifocal leukoencephalopathy (PML) in patients on Efalizumab for more than 3 years, the European Medicines Agency (EMEA) reviewed the safety of Efalizumab and concluded on February 19, 2009 that: (1) Efalizumab’s benefits are modest; (2) Efalizumab is associated with PML and other serious side effects (including Guillain–Barré and Miller– Fisher syndromes, encephalitis and opportunistic infections); and (3) there is not enough evidence to identify a group of patients in which the benefits of Efalizumab outweigh its risks (www.emea.europa.eu. Doc. Ref. EMEA/CHMP/20857/2009). On April 8, 2009, Genentech voluntarily withdrew the drug from the US market.