Article

3 Iconography
Access to the text (HTML) Access to the text (HTML)
PDF Access to the PDF text
Advertising


Access to the full text of this article requires a subscription.
  • If you are a subscriber, please sign in 'My Account' at the top right of the screen.

  • If you want to subscribe to this journal, see our rates



Journal of the American Academy of Dermatology
Volume 63, n° 5
pages 762-768 (novembre 2010)
Doi : 10.1016/j.jaad.2010.04.004
accepted : 2 April 2010
Original Articles

Long-term etanercept in pediatric patients with plaque psoriasis
 

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

Reprint requests: Amy S. Paller, MD, Department of Dermatology, Northwestern University Medical School, 676 N Saint Clair St, Suite 1600, Chicago, IL 60611-2997.
Abstract
Background

No systemic therapies are approved by the US Food and Drug Administration for the treatment of psoriasis in children and adolescents.

Objective

We sought to evaluate the long-term safety and efficacy of etanercept in pediatric patients (aged 4-17 years) with moderate to severe plaque psoriasis.

Methods

Patients who completed or received substantial treatment benefit in a 48-week, randomized, double-blind, placebo-controlled study (N = 211) evaluating the efficacy and safety of once-weekly etanercept (0.8 mg/kg) were enrolled in this 264-week open-label extension study. The primary end point was the occurrence of adverse events. Secondary end points included Psoriasis Area and Severity Index 50%, 75%, and 90% responses compared with baseline; static Physician Global Assessment; and clear and clear/almost clear static Physician Global Assessment status. Results from a 96-week interim analysis are presented.

Results

Of 182 enrolled patients, 181 received treatment and 140 (76.9%) completed week 96. A total of 145 patients (80.1%) reported adverse events; 5 serious adverse events occurred in 3 patients, none of which were treatment related. Observed Psoriasis Area and Severity Index 50% (89%), 75% (61%), and 90% (30%) responses compared with baseline at week 96 were similar to those observed in the double-blind trial. The static Physician Global Assessment was maintained through week 96, when 47% of patients achieved clear/almost clear status.

Limitations

This is an interim analysis from an open-label study.

Conclusion

Extended treatment with etanercept in pediatric patients with moderate to severe plaque psoriasis was generally well tolerated, and efficacy was maintained through 96 weeks.

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

Key words : efficacy, etanercept, long-term treatment, pediatric patients, plaque psoriasis, safety

Abbreviations used : AE, ANA, CDLQI, LOCF, OC, PASI, PASI 50, PASI 75, PASI 90, SAE, sPGA



 Supported by Immunex Corp, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer Inc in October 2009.
 Disclosure: Dr Paller has served as an investigator for Amgen without compensation but has received honoraria from Abbott and Centocor as a consultant. Dr Siegfried has served as an investigator for Amgen without compensation but has received honoraria from Abbott and Amgen as a consultant. Dr Eichenfield has served as an investigator for Amgen without compensation but has received honoraria from Amgen and Centocor/Johnson & Johnson as a consultant. Dr Pariser has received investigator grants from Amgen, Abbott, Centocor, Novartis, and Pfizer and has received honoraria for serving on scientific advisory boards for Amgen and Centocor and as a speaker for Wyeth. Dr Langley has received investigator grants from Abbott, Amgen, Biogen Idec, Centocor, LEO Pharma, Celgene, Ortho Biotec, Pfizer, and Wyeth and has received honoraria for serving on the scientific advisory boards for Abbott, Amgen, Centocor, Ortho Biotec, and Wyeth and as a speaker for Abbott, Amgen, Centocor, Ortho Biotec, and Wyeth. Ms Creamer and Dr Kricorian are Amgen employees and have Amgen stock and stock options.
 This study is registered with ClinicalTrials.gov with the identifier NCT00078819.



© 2010  American Academy of Dermatology, Inc.@@#104156@@
EM-CONSULTE.COM is registrered at the CNIL, déclaration n° 1286925.
As per the Law relating to information storage and personal integrity, you have the right to oppose (art 26 of that law), access (art 34 of that law) and rectify (art 36 of that law) your personal data. You may thus request that your data, should it be inaccurate, incomplete, unclear, outdated, not be used or stored, be corrected, clarified, updated or deleted.
Personal information regarding our website's visitors, including their identity, is confidential.
The owners of this website hereby guarantee to respect the legal confidentiality conditions, applicable in France, and not to disclose this data to third parties.
Close
Article Outline