Intermittent etanercept therapy in pediatric patients with psoriasis - 24/04/13
, Lawrence F. Eichenfield, MD b, Amy S. Paller, MD c, David Pariser, MD d, Kara Creamer, MS e, Gregory Kricorian, MD e
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.
Le texte complet de cet article est disponible en PDF.Key words : etanercept, intermittent therapy, pediatric plaque psoriasis
Abbreviations used : AE, PASI, PASI 75, PGA
Plan
| 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. |
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| 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. |
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| This study is registered with ClinicalTrials.gov with the identifier NCT00078819. |
Vol 63 - N° 5
P. 769-774 - novembre 2010 Retour au numéro
Article précédent
- Long-term etanercept in pediatric patients with plaque psoriasis
- Amy S. Paller, Elaine C. Siegfried, Lawrence F. Eichenfield, David Pariser, Richard G. Langley, Kara Creamer, Greg Kricorian
- Pilot, multicenter, double-blind, randomized placebo-controlled bilateral comparative study of a combination of calcipotriene and nicotinamide for the treatment of psoriasis
- Danielle Levine, Zeev Even-Chen, Irina Lipets, Olga A. Pritulo, Tetyana V. Svyatenko, Yuri Andrashko, Mark Lebwohl, Alice Gottlieb
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