Extended efalizumab therapy improves chronic plaque psoriasis: Results from a randomized phase III trial - 21/08/11
, Kim A. Papp, MD, PhD b, Kenneth B. Gordon, MD c, Alan Menter, MD d, Steven R. Feldman, MD e, Ivor Caro, MD f, Patricia A. Walicke, MD, PhD f, Peter G. Compton, MA, MS f, Alice B. Gottlieb, MD, PhD gfor the Efalizumab Study Group
Reprint requests: Craig L. Leonardi, MD, Central Dermatology, 1034 South Brentwood Boulevard, Suite 600, St. Louis, MO 63117.St. Louis, Missouri; Waterloo, Canada; Maywood, Illinois; Dallas, Texas; Winston-Salem, North Carolina; South San Francisco, California; and New Brunswick, New Jersey
Abstract |
Background |
Efalizumab inhibits multiple T-cell–mediated processes.
Objective |
To evaluate 12- and 24-week efalizumab therapy for psoriasis.
Methods |
In this phase III, randomized, double-blind trial, 498 patients received subcutaneous 1 or 2 mg/kg/wk efalizumab or placebo for 12 weeks. Efalizumab-treated patients who achieved <75% Psoriasis Area and Severity Index improvement (PASI-75) were re-randomized to a second 12-week course of treatment.
Results |
At week 12, 39% and 27% of efalizumab-treated patients (1 and 2 mg/kg, respectively) achieved PASI-75 (vs 2% placebo; P < .001, both dose groups). At week 24, an additional 20% of efalizumab-treated patients achieved PASI-75 (vs placebo 7%, P=.018). Efalizumab was well tolerated.
Conclusion |
Twelve-week efalizumab treatment resulted in significant improvement; extension of therapy to 24 weeks resulted in additional improvement in patients who initially had not achieved PASI-75. There were no significant changes in safety profile during weeks 13-24.
Le texte complet de cet article est disponible en PDF.Abbreviations used : BSA, HAHA, ITT, IVRS, LFA-1, PASI, PASI-50, PASI-75, PASI-90, PGA, PPD, PUVA, SC, sPGA, UVB
Plan
| Genentech, Inc. sponsored this clinical research and was the administrative entity for biostatistical review. All of the authors of this report were members of the Efalizumab Study Group. Drs Feldman, Gordon, Leonardi, and Menter have received grant/research support from, served as consultants for, and served on the speakers bureau for Genentech, Inc. Dr Papp has received grant/research support from and served as consultant to Genentech, Inc., Xoma LLC, and Serono S.A. Dr Walicke was an employee of and is a stock shareholder in Genentech, Inc. Mr Compton is a stock shareholder in and an employee of Genentech, Inc. Dr Gottlieb has received grant/research support from and served as consultant to Genentech, Inc. |
Vol 52 - N° 3
P. 425-433 - mars 2005 Retour au numéro
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- The role of inherited and acquired factors in the development of porphyria cutanea tarda in the Argentinean population
- Manuel Méndez, María V. Rossetti, Alcira M. Del C. Batlle, Victoria E. Parera
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- Tamar Nijsten, David J. Margolis, Steven R. Feldman, Tara Rolstad, Robert S. Stern
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