Long-term etanercept in pediatric patients with plaque psoriasis - 24/04/13
, 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
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.
Le texte complet de cet article est disponible en PDF.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
Plan
| Supported by Immunex Corp, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer Inc in October 2009. |
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| 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. |
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| This study is registered with ClinicalTrials.gov with the identifier NCT00078819. |
Vol 63 - N° 5
P. 762-768 - novembre 2010 Retour au numéro
Article précédent
- Announcing a New Online Feature
- Intermittent etanercept therapy in pediatric patients with psoriasis
- Elaine C. Siegfried, Lawrence F. Eichenfield, Amy S. Paller, David Pariser, Kara Creamer, Gregory Kricorian
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