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A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis.
J Am Acad Dermatol. 2013 Sep; 69(3):385-92.JA

Abstract

BACKGROUND

Few clinical trials have evaluated the combination of topical corticosteroids plus systemic therapies for psoriasis.

OBJECTIVE

We sought to evaluate efficacy and safety of etanercept plus topical clobetasol propionate (CP) foam versus etanercept monotherapy for treatment of moderate to severe plaque psoriasis.

METHODS

Adults with Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and psoriasis-affected body surface area greater than or equal to 10% were randomized to etanercept with CP as needed to clear (2 up-to-2-week courses, weeks 11-12 and 23-24) or etanercept alone (each arm at 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks).

RESULTS

A total of 592 patients enrolled (295 etanercept + CP arm; 297 etanercept arm). At week 12, significant differences were observed for response of 75% improvement in PASI score (primary end point, 65.2% vs 48.3% in the etanercept + CP vs etanercept arms, respectively; P < .001), response of 90% improvement in PASI score (29.7% vs 19.4%; P = .009), percentage PASI score improvement (76.5% vs 68.2%; P < .001), static physician global assessment of clear/almost clear (63.1% vs 47.3%; P < .001), and patient satisfaction with treatment (P = .006). Response of 75% improvement in PASI score and static physician global assessment of clear/almost clear were not significantly different between arms at week 24. Patient satisfaction with treatment (P = .001) and percentage improvement in PASI score (P = .031) were also greater in the etanercept + CP arm compared with etanercept only at week 24. Comparable numbers of adverse events occurred in each arm.

LIMITATIONS

No placebo for CP foam was provided in the etanercept arm.

CONCLUSIONS

Addition of CP to etanercept yielded increased efficacy compared with etanercept alone at week 12 without an increase in treatment-related adverse events.

Authors+Show Affiliations

Mount Sinai Medical Center, New York, New York, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23643256

Citation

Lebwohl, Mark G., et al. "A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Patients With Moderate to Severe Plaque Psoriasis." Journal of the American Academy of Dermatology, vol. 69, no. 3, 2013, pp. 385-92.
Lebwohl MG, Kircik L, Callis Duffin K, et al. A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2013;69(3):385-92.
Lebwohl, M. G., Kircik, L., Callis Duffin, K., Pariser, D., Hooper, M., Wenkert, D., Thompson, E. H., Yang, J., Kricorian, G., & Koo, J. (2013). A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis. Journal of the American Academy of Dermatology, 69(3), 385-92. https://doi.org/10.1016/j.jaad.2013.03.031
Lebwohl MG, et al. A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Patients With Moderate to Severe Plaque Psoriasis. J Am Acad Dermatol. 2013;69(3):385-92. PubMed PMID: 23643256.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis. AU - Lebwohl,Mark G, AU - Kircik,Leon, AU - Callis Duffin,Kristina, AU - Pariser,David, AU - Hooper,Michele, AU - Wenkert,Deborah, AU - Thompson,Elizabeth H Z, AU - Yang,Jun, AU - Kricorian,Greg, AU - Koo,John, Y1 - 2013/05/01/ PY - 2012/12/11/received PY - 2013/03/18/revised PY - 2013/03/25/accepted PY - 2013/5/7/entrez PY - 2013/5/7/pubmed PY - 2013/12/16/medline KW - BSA KW - CP KW - PASI KW - PASI 100 KW - PASI 50 KW - PASI 75 KW - PASI 90 KW - Psoriasis Area and Severity Index KW - TNF KW - body surface area KW - clobetasol propionate KW - combination therapy KW - efficacy KW - etanercept KW - plaque psoriasis KW - response of 100% improvement in Psoriasis Area and Severity Index score KW - response of 50% improvement in Psoriasis Area and Severity Index score KW - response of 75% improvement in Psoriasis Area and Severity Index score KW - response of 90% improvement in Psoriasis Area and Severity Index score KW - sPGA KW - safety KW - static physician global assessment KW - tumor necrosis factor SP - 385 EP - 92 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 69 IS - 3 N2 - BACKGROUND: Few clinical trials have evaluated the combination of topical corticosteroids plus systemic therapies for psoriasis. OBJECTIVE: We sought to evaluate efficacy and safety of etanercept plus topical clobetasol propionate (CP) foam versus etanercept monotherapy for treatment of moderate to severe plaque psoriasis. METHODS: Adults with Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and psoriasis-affected body surface area greater than or equal to 10% were randomized to etanercept with CP as needed to clear (2 up-to-2-week courses, weeks 11-12 and 23-24) or etanercept alone (each arm at 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks). RESULTS: A total of 592 patients enrolled (295 etanercept + CP arm; 297 etanercept arm). At week 12, significant differences were observed for response of 75% improvement in PASI score (primary end point, 65.2% vs 48.3% in the etanercept + CP vs etanercept arms, respectively; P < .001), response of 90% improvement in PASI score (29.7% vs 19.4%; P = .009), percentage PASI score improvement (76.5% vs 68.2%; P < .001), static physician global assessment of clear/almost clear (63.1% vs 47.3%; P < .001), and patient satisfaction with treatment (P = .006). Response of 75% improvement in PASI score and static physician global assessment of clear/almost clear were not significantly different between arms at week 24. Patient satisfaction with treatment (P = .001) and percentage improvement in PASI score (P = .031) were also greater in the etanercept + CP arm compared with etanercept only at week 24. Comparable numbers of adverse events occurred in each arm. LIMITATIONS: No placebo for CP foam was provided in the etanercept arm. CONCLUSIONS: Addition of CP to etanercept yielded increased efficacy compared with etanercept alone at week 12 without an increase in treatment-related adverse events. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/23643256/A_randomized_study_to_evaluate_the_efficacy_and_safety_of_adding_topical_therapy_to_etanercept_in_patients_with_moderate_to_severe_plaque_psoriasis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(13)00312-5 DB - PRIME DP - Unbound Medicine ER -