Intermittent etanercept therapy in pediatric patients with psoriasis.
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.


CONCLUSIONS
Small study and short observation period are limitations.


CONCLUSIONS
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.
Siegfried
Elaine C
EC
Cardinal Glennon Children's Hospital and Saint Louis University, Saint Louis, Missouri 63104, USA. esiegfri@slu.edu
Eichenfield
Lawrence F
LF
Paller
Amy S
AS
Pariser
David
D
Creamer
Kara
K
Kricorian
Gregory
G
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects*; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage*; D012720:Severity of Illness Index; D012867:Skin / Q000473:pathology; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis*; D016896:Treatment Outcome
D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept