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Journal of the American Academy of Dermatology
Volume 62, n° 6
pages 968-978 (juin 2010)
Doi : 10.1016/j.jaad.2009.07.032
accepted : 18 July 2009
The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis

Janet L. Roberts, MD a, , Jean-Paul Ortonne, MD b, Jerry K.L. Tan, MD c, Eileen Jaracz, PharmD d, Ellen Frankel, MD e

Alefacept Clinical Study Group

a Northwest Dermatology and Research Center, Portland, Oregon 
b Service de Dermatologie, Hôpital L’Archet II, Nice, France 
c Windsor Clinical Research Inc, Windsor, Ontario, Canada 
d Astellas Pharma US Inc, Deerfield, Illinois 
e Clinical Partners, LLC, Johnston, Rhode Island 

Correspondence to: Janet L. Roberts, MD, Northwest Dermatology and Research Center, 2330 NW Flanders St, Suite 201, Portland, OR.

Safety and efficacy of up to 3 courses of alefacept intramuscular (IM) in the treatment of chronic plaque psoriasis have been demonstrated in earlier trials.


We sought to determine the safety and efficacy of up to 5 courses of alefacept IM in treating plaque psoriasis.


A standard treatment course was defined as 15 mg of alefacept IM once weekly for 12 weeks, followed by 12 weeks of treatment-free observation. Patients with chronic plaque psoriasis, who had previously received alefacept IM, received up to 3 additional courses (A, B, and C). Efficacy was evaluated by Physician Global Assessment.


Safety profiles were similar to those for a single course of treatment. There were no cumulative adverse effects. At 2 weeks postdosing, 16%, 22%, and 19% of patients were rated clear or almost clear by Physician Global Assessment in courses A, B, and C, respectively, with 35%, 42%, and 42% achieving this response at any time during these courses. Patients who achieved clear or almost clear at 2 weeks postdosing remained so for a median duration of 214 and 126 days after courses A and B, respectively.


This was an extension study and therefore contained no control group.


Up to 5 courses of alefacept IM may provide extended treatment-free, symptom-free periods in responders while maintaining the safety profile.

The full text of this article is available in PDF format.

Key words : alefacept, duration of response, open-label extension study, remission

Abbreviations used : C/AC, CI, Emax , IM, LLN, MOB, PASI, PASI 50, PASI 75, PGA, PUVA, UV

 Astellas Pharma US, Inc acquired ownership of Amevive from Biogen-Idec effective April 14, 2006, and has subsequently supported the publication of this study.
 Disclosure: Dr Roberts has participated in clinical trials for Biogen-Idec and is currently participating in a clinical trial for Abbott. Dr Ortonne is a speaker and consultant for Wyeth, Abbott, and Janssen-Cilag, and a speaker for Schering-Plough. Dr Tan has been a speaker and advisor for Biogen-Idec and Astellas and has conducted clinical trials for these companies. Dr Jaracz is a full-time employee of Astellas Pharma US, Inc. Dr Frankel, at Clinical Partners, LLC, is doing research for Abbott, Amgen, Astellas, Connectics, and Stiefel, and has received compensation from these companies for the trials. She is on the speakers’ bureau for the above companies and for Collagenex and Triax.
 Reprints not available from the authors.

© 2009  American Academy of Dermatology, Inc.@@#104156@@
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