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Journal of the American Academy of Dermatology
Volume 63, n° 5
pages 769-774 (novembre 2010)
Doi : 10.1016/j.jaad.2009.10.046
accepted : 30 October 2009
Original Articles

Intermittent etanercept therapy in pediatric patients with psoriasis
 

Elaine C. Siegfried, MD a, , Lawrence F. Eichenfield, MD b, Amy S. Paller, MD c, David Pariser, MD d, Kara Creamer, MS e, Gregory Kricorian, MD e
a Cardinal Glennon Children’s Hospital and Saint Louis University, Saint Louis, Missouri 
b Rady Children’s Hospital and University of California, San Diego, California 
c Children’s Memorial Hospital and Northwestern University Medical School, Chicago, Illinois 
d Eastern Virginia Medical School and Virginia Clinical Research, Norfolk, Virginia 
e Amgen Inc, Thousand Oaks, California 

Reprint requests: Elaine C. Siegfried, MD, Cardinal Glennon Children’s Hospital and Saint Louis University, 1465 S Grand Ave, St Louis, MO 63104.
Abstract
Background

Stopping and restarting etanercept is well tolerated in adult psoriasis, but little is known about intermittent use in pediatric psoriasis.

Objective

We sought to assess safety and efficacy of etanercept administered intermittently in children with psoriasis.

Methods

At study entry, patients were 4 to 17 years old with moderate to severe stable plaque psoriasis (Psoriasis Area and Severity Index [PASI] score ≥ 12). After an initial 12-week, double-blind period and a 24-week, open-label period, eligible patients (ie, achieved 75% improvement in PASI response from baseline [PASI 75]) were re-randomized to a 12-week, double-blind withdrawal-retreatment period: patients received placebo (withdrawal) or etanercept as long as they maintained PASI 75; otherwise, they were retreated with open-label etanercept (retreatment).

Results

The 138 patients who entered the withdrawal-retreatment period were re-randomized equally between placebo and etanercept. In the group treated with blinded or open-label etanercept, 52 of 65 (80%; observed data) patients maintained or regained PASI 75 at the end of the 12-week period. In all, 45 of 64 (70%) patients on blinded etanercept maintained PASI 75 at every study visit during the 12-week period, compared with 35 of 65 (54%) patients who did so on blinded placebo. No patient had a serious adverse event, serious infection, or withdrew from study because of an adverse event.

Limitations

Small study and short observation period are limitations.

Conclusion

During the final 12-week withdrawal-retreatment period of this 48-week study, intermittent etanercept therapy appeared safe, with no patients experiencing a serious adverse event or serious infection, and effective, with 80% of patients on etanercept maintaining or regaining PASI 75 at the end of the 12-week period.

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

Key words : etanercept, intermittent therapy, pediatric plaque psoriasis

Abbreviations used : AE, PASI, PASI 75, PGA



 Research was funded by Immunex, a wholly owned subsidiary of Amgen Inc, and by Wyeth Pharmaceuticals. Financial support for the preparation of the manuscript was provided by Amgen Inc.
 Disclosure: Dr Siegfried reports serving as a consultant and investigator for Amgen, an investigator for Leo, and a consultant for Abbott Laboratories. Dr Eichenfield reports serving as an investigator and past consultant for Amgen and consultant and receiving honorarium from Centocor. Dr Paller reports serving as an investigator for Amgen and serving as a consultant for and receiving honoraria from Centocor and Abbott Laboratories. Dr Pariser reports serving as an investigator for Amgen, Centocor, and Abbott Laboratories; serving on the advisory board of Amgen; and serving as a speaker and receiving honorarium from Wyeth Pharmaceuticals. Ms Creamer and Dr Kricorian report being Amgen employees and receiving stock/stock options from Amgen.
 This study is registered with ClinicalTrials.gov with the identifier NCT00078819.



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