Long-term continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: Updated results from an ongoing trial - 09/08/11
, Tiffani Hamilton, MD b, Ivor Caro, MD c, Paul Kwon, MD c, Peter G. Compton, MA c, Craig L. Leonardi, MD dfor the Efalizumab Study Group
Reprint requests: Alice B. Gottlieb, MD, PhD, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Clinical Research Center, 51 French St, New Brunswick, NJ 08901-0019.New Brunswick, New Jersey; Atlanta, Georgia; South San Francisco, California; and St. Louis, Missouri
Abstract |
Background |
Efalizumab is a T cell–targeted therapy for psoriasis.
Objective |
We sought to evaluate the efficacy and safety of long-term, continuous efalizumab therapy.
Methods |
Of 339 patients enrolled in this ongoing, open-label, phase III study, after 3 months 290 qualified for and entered the maintenance treatment phase.
Results |
Results for the first 27 months of this 36-month continuous therapy trial are available. At month 3, 41% of patients achieved at least a 75% reduction in Psoriasis Area and Severity Index (PASI) score; at month 27, 47% achieved at least a 75% reduction in PASI score (intent to treat, n = 339). Among patients eligible for maintenance therapy (n = 290), 56% achieved at least a 75% reduction in PASI score at month 27. Moreover, the at least 90% reduction in PASI score rate increased through 18 months (33%). The safety profile with efalizumab was sustained throughout 27 months of continuous treatment with no new common events over time.
Limitations |
Because the extended treatment period was not a randomized clinical trial, no formal comparative analyses versus placebo were conducted. Three-month placebo data from randomized, parallel, placebo-controlled studies are briefly discussed.
Conclusions |
These results suggest that efalizumab maintains, and in some patients continues to improve, efficacy during long-term therapy.
Le texte complet de cet article est disponible en PDF.Abbreviations used : ITT, LOCF, PASI, PASI-50, PASI-75, PASI-90
Plan
| Supported by Genentech Inc and Serono International SA. Disclosures: Dr Gottlieb is an investigator and consultant for Genentech Inc. Dr Hamilton has received research support from Genentech Inc. Dr Caro, Dr Kwon, and Mr Compton are stock shareholders and employees of Genentech Inc. Dr Leonardi has received educational grant support from and served on the speakers bureau and advisory board for Genentech Inc. Presented in part as posters at the 62nd Annual Meeting of the American Association of Dermatology; Washington, DC; February 6-11, 2004; and the 11th International Psoriasis Symposium; Toronto, Ontario, Canada; June 14-19, 2004. |
Vol 54 - N° 4S
P. S154-S163 - avril 2006 Retour au numéro
Article précédent
- Practical guidelines for the long-term treatment of psoriasis with efalizumab
- Craig L. Leonardi, Kim A. Papp, Jan D. Bos
- Efalizumab retreatment in patients with moderate to severe chronic plaque psoriasis
- Kim A. Papp, Bruce Miller, Kenneth B. Gordon, Ivor Caro, Paul Kwon, Peter G. Compton, Craig L. Leonardi, for the Efalizumab Study Group
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