Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis - 15/01/16
, Elaine C. Siegfried, MD b, David M. Pariser, MD c, Kara Creamer Rice, MS d, Mona Trivedi, MD d, Jan Iles, MD d, David H. Collier, MD d, Greg Kricorian, MD d, Richard G. Langley, MD eAbstract |
Background |
There are no systemic therapies approved in the United States to treat pediatric psoriasis.
Objective |
We sought to evaluate long-term safety and efficacy of etanercept in children and adolescents with moderate to severe plaque psoriasis.
Methods |
This 5-year, open-label extension study enrolled patients aged 4 to 17 years who had participated in a 48-week parent study. End points included occurrence of adverse events (AEs) and serious AEs including infections, and rates of 75% and 90% improvement in Psoriasis Area and Severity Index score and clear/almost clear on static physician global assessment.
Results |
Of 182 patients enrolled, 181 received etanercept and 69 completed 264 weeks. Through week 264, 161 (89.0%) patients reported an AE, most commonly upper respiratory tract infection (37.6%), nasopharyngitis (26.0%), and headache (21.5%). Seven patients reported 8 serious AEs; only 1 (cellulitis) was considered treatment-related. No cases of opportunistic infections or malignancy were reported. Rates of 75% improvement in Psoriasis Area and Severity Index score (∼60%–70%) and 90% improvement in Psoriasis Area and Severity Index score (∼30%–40%) and static physician global assessment status clear/almost clear (∼40%–50%) were maintained through week 264.
Limitations |
The number of patients remaining on study at week 264 was small.
Conclusion |
Etanercept in pediatric patients was generally well tolerated and efficacy was maintained in those who remained in the study for up to 264 weeks.
Le texte complet de cet article est disponible en PDF.Key words : etanercept, long-term safety, open-label, pediatric population, plaque psoriasis
Abbreviations used : AE, CDC, FDA, HRQOL, JIA, OLE, PASI, PASI 75, PASI 90, SAE, sPGA
Plan
| This study was sponsored by Immunex, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer in October 2009. |
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| Disclosure: Dr Paller is an investigator for Amgen Inc (without honorarium), an investigator and consultant for Anacor Pharmaceuticals Inc and AbbVie Inc, and a consultant for Novartis Pharmaceuticals Corp. Dr Pariser has been a consultant and/or investigator for Abbott Laboratories; Amgen Inc; Astellas Pharma US Inc; Asubio Pharmaceuticals Inc; Basliea Pharmaceutica Ltd; Bickel Biotechnology; Biofrontera AG; Celgene Corp; Dermira; Dow Pharmaceutical Sciences Inc; DUSA Pharmaceuticals Inc; Eli Lilly and Company; Galderma Laboratories LP; Genentech Inc; Graceway Pharmaceuticals LLC; Intendis Inc; Janssen-Ortho Inc; Johnson & Johnson Consumer Products Company; LEO Pharma Inc; Medicis Pharmaceutical Corporation; MelaSciences; Novartis Pharmaceuticals Corp; Novo Nordisk A/S; Ortho Dermatologics Inc; Peplin Inc; Pfizer Inc; Photocure ASA; Procter & Gamble Company; Stiefel, a GSK Company; and Valeant Pharmaceuticals International Inc. Ms Rice, Dr Trivedi, Dr Iles, Dr Collier, and Dr Kricorian are employees and shareholders of Amgen Inc. Dr Langley has served as an investigator, participated in advisory boards, and/or participated on speakers' bureaus for AbbVie Inc, Amgen Inc, Celgene Corp, LEO Pharma Inc, Eli Lilly and Company, Merck & Co Inc, Novartis Pharmaceuticals Corp, and Pfizer Inc. Dr Siegfried has no conflicts of interest to declare. |
Vol 74 - N° 2
P. 280 - février 2016 Retour au numéro
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