Article

6 Iconography
Access to the text (HTML) Access to the text (HTML)
PDF Access to the PDF text
Advertising


Access to the full text of this article requires a subscription.
  • If you are a subscriber, please sign in 'My Account' at the top right of the screen.

  • If you want to subscribe to this journal, see our rates



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.
Abstract
Background

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.

Objective

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

Methods

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.

Results

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.

Limitations

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

Conclusions

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@@
EM-CONSULTE.COM is registrered at the CNIL, déclaration n° 1286925.
As per the Law relating to information storage and personal integrity, you have the right to oppose (art 26 of that law), access (art 34 of that law) and rectify (art 36 of that law) your personal data. You may thus request that your data, should it be inaccurate, incomplete, unclear, outdated, not be used or stored, be corrected, clarified, updated or deleted.
Personal information regarding our website's visitors, including their identity, is confidential.
The owners of this website hereby guarantee to respect the legal confidentiality conditions, applicable in France, and not to disclose this data to third parties.
Close
Article Outline