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.
RCT Entities:
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.
Authors: Inge M G J Bronckers; Marieke M B Seyger; Dennis P West; Irene Lara-Corrales; Megha Tollefson; Wynnis L Tom; Marcia Hogeling; Leah Belazarian; Claus Zachariae; Emmanuel Mahé; Elaine Siegfried; Sandra Philipp; Zsuzsanna Szalai; Ruth Ann Vleugels; Kristen Holland; Ruth Murphy; Eulalia Baselga; Kelly Cordoro; Jo Lambert; Alex Alexopoulos; Ulrich Mrowietz; Wietske Kievit; Amy S Paller Journal: JAMA Dermatol Date: 2017-11-01 Impact factor: 10.282