Fifty-seven percent of patients treated with etanercept in this study achieved PASI 75 at week 12; this rate is higher than the 12-week PASI 75 response reported for adult patients with psoriasis who were treated with 25 mg of etanercept twice weekly (response rates, 30 to 34%) but is consistent with rates reported in trials involving adults who received 50 mg of etanercept twice weekly (response rates, 47 to 49%). The mean trough etanercept concentration at week 12 in our study was similar to that observed in adults receiving 25 mg twice weekly.26 Thus, whereas the dosage in our study was equivalent to the 25-mg twice-weekly dosage used in adults, the clinical response was similar to that achieved with the 50-mg twice-weekly dosage.
In studies in adults, about 70% of patients were overweight (BMI >25), as compared with 37% of the patients (32% of children and 41% of adolescents) in our study (BMI ≥95th percentile of age- and sex-matched population).28 In addition, the disease severity at baseline was higher and the duration of disease was longer in the studies in adults than in our study. In our study, patients who received weight-based dosing had a better response than did patients who received the maximum dose. However, the disease characteristics at baseline were different as well, because the patients treated with the maximum dose of etanercept weighed more, were older, and had a longer history of psoriasis than those receiving smaller doses. All these factors can confound the analysis of any benefit of weight-based dosing in this study. After withdrawal of etanercept therapy, more than half of the patients maintained PASI 75 until the end of the study. Future studies should assess whether the frequency of administration could be decreased during remission with maintenance of control.
Four serious adverse events occurred in three patients: ovarian cyst removal in one patient, gastroenteritis and gastroenteritis-associated dehydration in one patient, and pneumonia in one patient (the latter three events were considered infectious). All occurred in patients receiving open-label treatment, and all resolved without sequelae. Longer-term data are needed to fully assess the safety profile of etanercept in this patient population. In children and adolescents with polyarticular juvenile rheumatoid arthritis who received etanercept treatment (0.4 mg per kilogram twice weekly) for up to 8 years, the rates of serious adverse events did not increase with long-term exposure to etanercept.
This randomized, placebo-controlled trial demonstrated that etanercept was effective in children and adolescents with moderate-to-severe plaque psoriasis. The results of this study implicated TNF in the pathogenesis of pediatric psoriasis and demonstrated that etanercept significantly reduced disease severity.
Supported by Immunex, a wholly owned subsidiary of Amgen, and by Wyeth Pharmaceuticals.
Dr. Paller reports serving as a consultant and investigator for Amgen and as an advisory board member for Johnson & Johnson. Dr. Siegfried reports serving as a consultant or advisory board member for Amgen and Genentech and on speakers' bureaus for Amgen, Genentech, and Novartis. Dr. Langley reports serving on the scientific advisory boards of Amgen, Wyeth, Centocor, Serono, and Abbott Laboratories; serving on speakers' bureaus for Amgen, Wyeth, Abbott Laboratories, Serono, and Biogen Idec; receiving research support from Amgen, Wyeth, Centocor, Serono, and Abbott Laboratories; and receiving other grant support from Abbott Laboratories, Amgen, Biogen Idec, Boehringer Ingelheim, Centocor, Celgene, Isotechnika, and Serono. Dr. Gottlieb reports serving on speakers' bureaus for Amgen and Wyeth; having consulting or advisory-board agreements with Amgen, Biogen Idec, Centocor, Wyeth, Schering-Plough, Eisai, Celgene, Bristol-Myers Squibb, Beiersdorf, Warner Chilcott, Abbott Laboratories, Roche, Daiichi Sankyo, Medarex, Kémia, Celera, Teva Pharmaceuticals, Actelion, UCB, Novo Nordisk, Almirall, Immune Control, RxClinical, DermiPsor, MEDACorp, Incyte, DermiPsori, and Can-Fite; and receiving research or educational grants from Centocor, Amgen, Wyeth, Immune Control, Genentech, Abbott Laboratories, and PharmaCare (all funds are paid directly to her employer). Dr. Pariser reports serving as a consultant or advisory board member for Amgen, Abbott Laboratories, and Genentech and receiving grant support from Amgen, Abbott Laboratories, Genentech, LEO Pharma, and Galderma. Dr. Landells reports serving as a consultant or advisory board member for Amgen, Wyeth, Biogen Idec, Astellas Pharma, Schering-Plough, and Serono and serving on the speakers' bureaus of Amgen, Wyeth Pharmaceuticals, Biogen Idec, Astellas Pharma, Schering-Plough, and Serono. Dr. Hebert reports serving as an investigator and consultant or advisory board member for Amgen. Dr. Eichenfield reports serving as a consultant and investigator for Amgen and Immunex and as a consultant for Abbott Laboratories. Dr. Patel, Ms. Creamer, and Dr. Jahreis report being Amgen employees and receiving stocks or stock options from Amgen. No other potential conflict of interest relevant to this article was reported.
We thank Ting Chang, Ph.D., and Julie Wang, D.P.M., of Amgen for assistance with writing the manuscript; Kaari Bolen and Yuni Kim for study management; and the National Psoriasis Foundation for creating awareness of this study.
Source Information
From Children's Memorial Hospital and Northwestern University Medical School, Chicago (A.S.P.); Cardinal Glennon Children's Hospital and Saint Louis University, St. Louis (E.C.S.); Dalhousie Medical School, Halifax, NS, Canada (R.G.L.); Tufts–New England Medical Center, Boston (A.B.G.); Eastern Virginia Medical School and Virginia Clinical Research, Norfolk (D.P.); Nexus Clinical Research, St. John's, NL, Canada (I.L.); University of Texas Dermatology Clinical Research Center, Houston (A.A.H.); Rady Children's Hospital and University of California, San Diego — both in San Diego (L.F.E.); and Amgen, Thousand Oaks, CA (V.P., K.C., A.J.).
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