作者: J. Michael Ryan , Michael Grundman
关键词: Dosing 、 Medicine 、 Vasculitis 、 Active immunotherapy 、 Biopsy 、 Review article 、 Internal medicine 、 Adverse effect 、 Clinical trial 、 Disease
摘要: We would like to clarify and update information in the review article by Wilcock Colton recently published JAD [1]. In their discussion of clinical trials, authors stated that trials investigating ACC-001 (an active immunotherapy under development Wyeth Elan) had failed. The with have not failed are currently ongoing. were suspended April 2008 while report a single serious adverse event skin lesions was investigated. attributed vasculitis; however, serologic tests biopsy subsequently performed did confirm diagnosis. case reported U.S. Food Drug Administration (FDA), decision made place Phase II on hold. After available safety data, FDA lifted hold May 2008. Elan reinitiated dosing those patients who previously been enrolled studies resumed recruitment these (http://www. alzforum.org/new/detail.asp?id=1859).