A randomized, double-blind, placebo-controlled, phase I study of MEDI-545, an anti–interferon-alfa monoclonal antibody, in subjects with chronic psoriasis - 24/04/13
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.
Il testo completo di questo articolo è disponibile in PDF.Abbreviations used : AE, BSA, CL, DLQI, HSV, IFN, IV, PASI, PGA, SLE, TNF, VAS
Mappa
| 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. |
Vol 62 - N° 3
P. 427-436 - marzo 2010 Ritorno al numero
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