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Journal of the American Academy of Dermatology
Volume 43, n° 4
pages 595-604 (octobre 2000)
Doi : 10.1067/mjd.2000.107945
accepted : 13 April 2000
Anti-CD4 monoclonal antibody treatment of moderate to severe psoriasis vulgaris: Results of a pilot, multicenter, multiple-dose, placebo-controlled study
 

Alice B. Gottlieb, MD, PhD a, Mark Lebwohl, MD b, Sophie Shirin, MD a, Amelia Sherr, RN, BSN a, Pat Gilleaudeau, RN, BSN c, Giselle Singer, BS b, Galina Solodkina, MD a, Rachel Grossman, MD d, Elvira Gisoldi d, Steven Phillips, MS d, H.Mike Neisler, PhD e, James G. Krueger, MD, PhD c
New Brunswick and Skillman, New Jersey; New York, New York; and Indianapolis, Indiana 
From the Clinical Research Center, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswicka; the Department of Dermatology, Mt Sinai School of Medicine, New Yorkb; The Rockefeller University, New Yorkc; Johnson and Johnson Consumer Products Worldwide, Skillmand; and Covance Central Laboratory Services, Inc, Indianapolis.e 

Abstract

Background: OKTcdr4a (IMUCLONE) is a humanized anti-CD4 IgG4 monoclonal antibody that retains the binding and in vitro immunosuppressive properties of the parent murine antibody. Psoriasis is a chronic disease for which treatment with multiple doses of monoclonal antibodies is likely to be required for adequate control. Objective: This study was performed to test the efficacy and safety of OKTcdr4a, given in sequential courses over a period of several weeks, in the treatment of moderate to severe psoriasis vulgaris. Methods: Twenty-eight patients (45.6 ± 10.1 years of age) were studied, with a mean pretreatment Psoriasis Area and Severity Index (PASI) score of 18.3. In the first double-blind phase of the study, patients were randomized to receive OKTcdr4a as a 225 mg/course (low dose), 750 mg/course (high dose), or placebo divided into 3 identical infusions over a 5-day period. After 42 days, patients who met the criteria for re-treatment with OKTcdr4a were re-treated with the 750 mg/course in an open phase of the study. Results: After the double-blind course of treatment, the mean PASI decreased by 11% in the placebo group, by 4% in the low-dose group, and by 17% in the high-dose group at 15 days. Twenty patients met the criteria for re-treatment (ie, did not experience a decrease in PASI score of 50% at 42 days). They were re-treated with OKTcdr4a at 43 days with the 750 mg/course in the open phase of the study. By day 99, the mean PASI score decreased from 19.9 at baseline to 17 in those patients who had received either placebo or low-dose OKTcdr4a followed by high-dose OKTcdr4a. In contrast, the mean PASI score decreased from 17.4 at baseline to only 7.7 in those patients who had received high-dose OKTcdr4a for both courses. Sustained CD4 saturation was not necessary for sustained clinical response. No patients had significant changes in circulating CD4+ T-cell counts. The infusions were well tolerated. Conclusion: Targeting CD4 using sequential treatments with a humanized monoclonal antibody (OKTcdr4a) may offer another therapeutic option for the treatment of moderate to severe psoriasis. (J Am Acad Dermatol 2000;43:595-604.).

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Abbreviations : GMFI:, HAMA:, PASI:



 Supported in part by a COSAT grant from Johnson and Johnson (to A. B. G.), the UMDNJ Foundation (to A. B. G.), an endowment from W. H. Conzen (to A. B. G.), National Institutes grants AI39214 and RR00102 (to J. G. K.), and grants from Johnson and Johnson Consumer Products (to A. B. G., M. L., and J. G. K.).
 Reprint requests: Alice Gottlieb MD, PhD, W. H. Conzen Chair in Clinical Pharmacology, UMDNJ-Robert Wood Johnson Medical School, 1 Robert Wood Johnson Place, New Brunswick, NJ 08903. E-mail: gottliab@umdnj.edu.
 J Am Acad Dermatol 2000;43:595-604.



© 2000  American Academy of Dermatology, Inc. Published by Elsevier Masson SAS@@#104157@@
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