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Journal of the American Academy of Dermatology
Volume 62, n° 3
pages 427-436 (mars 2010)
Doi : 10.1016/j.jaad.2009.05.042
accepted : 14 May 2009
Original Articles

A randomized, double-blind, placebo-controlled, phase I study of MEDI-545, an anti–interferon-alfa monoclonal antibody, in subjects with chronic psoriasis
 

Robert Bissonnette, MD a, Kim Papp, MD b, Catherine Maari, MD c, Yihong Yao, PhD d, Gabriel Robbie, PhD d, Wendy I. White, PhD d, Chenxiong Le, PhD d, Barbara White, MD d,
a Innovaderm Research, Inc, Montreal, Quebec, Canada 
b Probity Medical Research, Waterloo, Ontario, Canada 
c Innovaderm Research, Inc, Laval, Quebec, Canada 
d MedImmune, LLC, Gaithersburg, Maryland 

Reprint requests: Barbara White, MD, MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878.
Abstract
Background

Interferon-alfa (IFN-⍺) has been implicated in the pathogenesis of psoriasis.

Objective

To evaluate the safety profile of MEDI-545, a fully human anti–IFN-⍺ monoclonal antibody and to explore its effect on the involvement of type I IFN-⍺ activity in the maintenance of established plaque psoriasis.

Methods

We conducted an 18-week, randomized, double-blind, placebo-controlled, dose-escalating study in 36 subjects with chronic plaque psoriasis. Subjects received one intravenous dose of MEDI-545 (0.3-30.0 mg/kg) or placebo. Study outcomes were safety profile, pharmacokinetics, immunogenicity, and clinical effects.

Results

There was no difference in adverse events between MEDI-545 and placebo. Two serious adverse events were reported; one drug-related hypotensive infusion reaction occurred in one subject in the 30.0 mg/kg MEDI-545 dose group, causing discontinuation of study drug in that subject and study dismissal of the other subjects in the same cohort; and a myocardial infarction occurred in one subject in the 10 mg/kg MEDI-545 dose group, which was considered to be unrelated to treatment. MEDI-545 was nonimmunogenic, had a half-life of 21 days, showed no significant inhibition of the type I IFN gene signature, and had no clinical activity.

Limitations

The study addressed only IFN-⍺ and chronic psoriatic lesions.

Conclusion

The safety profile of MEDI-545 supports further clinical development. IFN-⍺ does not appear to be significantly involved in the maintenance of established plaque psoriasis.

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

Abbreviations used : AE, BSA, CL, DLQI, HSV, IFN, IV, PASI, PGA, SLE, TNF, VAS



 Supported by MedImmune, LLC.
 Disclosure: Drs Yao, Robbie, White, Le, and White are employees of MedImmune. Dr Bissonnette received research funding from MedImmune for this study; has received research funding, is a consultant, and/or has received honoraria from MedImmune, LLC, Amgen, Inc, Wyeth, Inc, Centocor/Schering-Plough, Ortho-Biotech, Abbott Laboratories, Astellas, and EMD Serono, Inc. Dr Papp received research funding from MedImmune for this study; has received research funding, is a consultant, Speaker Bureau, and/or investigator for MedImmune, Abbott Laboratories, Amgen, Inc, Celgene Corporation, Merck-Serono, Schering-Plough, and Wyeth, Inc. Dr Maari received research funding from MedImmune for this study; is a consultant and/or has received honoraria from Amgen, Inc, Wyeth, Inc, Centocor/Schering-Plough, Ortho-Biotech, Abbott Laboratories, Astellas, and Galderma.



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