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Intermittent etanercept therapy in pediatric patients with psoriasis.
J Am Acad Dermatol. 2010 Nov; 63(5):769-74.JA

Abstract

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.

Authors+Show Affiliations

Cardinal Glennon Children's Hospital and Saint Louis University, Saint Louis, Missouri 63104, USA. esiegfri@slu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20833444

Citation

Siegfried, Elaine C., et al. "Intermittent Etanercept Therapy in Pediatric Patients With Psoriasis." Journal of the American Academy of Dermatology, vol. 63, no. 5, 2010, pp. 769-74.
Siegfried EC, Eichenfield LF, Paller AS, et al. Intermittent etanercept therapy in pediatric patients with psoriasis. J Am Acad Dermatol. 2010;63(5):769-74.
Siegfried, E. C., Eichenfield, L. F., Paller, A. S., Pariser, D., Creamer, K., & Kricorian, G. (2010). Intermittent etanercept therapy in pediatric patients with psoriasis. Journal of the American Academy of Dermatology, 63(5), 769-74. https://doi.org/10.1016/j.jaad.2009.10.046
Siegfried EC, et al. Intermittent Etanercept Therapy in Pediatric Patients With Psoriasis. J Am Acad Dermatol. 2010;63(5):769-74. PubMed PMID: 20833444.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intermittent etanercept therapy in pediatric patients with psoriasis. AU - Siegfried,Elaine C, AU - Eichenfield,Lawrence F, AU - Paller,Amy S, AU - Pariser,David, AU - Creamer,Kara, AU - Kricorian,Gregory, Y1 - 2010/09/15/ PY - 2009/07/23/received PY - 2009/10/27/revised PY - 2009/10/30/accepted PY - 2010/9/14/entrez PY - 2010/9/14/pubmed PY - 2010/11/17/medline SP - 769 EP - 74 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 63 IS - 5 N2 - 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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/20833444/Intermittent_etanercept_therapy_in_pediatric_patients_with_psoriasis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(09)01483-2 DB - PRIME DP - Unbound Medicine ER -