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 betweenplacebo 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.
RCT Entities:
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.