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Four-Week Daily Calcipotriene/Betamethasone Dipropionate Foam Is Highly Efficacious in Patients With Psoriasis (PSO-LONG Lead-in Phase)

Warren RB, Gold M, Gooderham M, Kircik LH, Lacour JP, Laws P, Liljedahl M, Lynde C, Mørch MH, Sondermann W, Thaçi D (2021)

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Publication Type: Journal article

Publication year: 2021

Journal

Book Volume: 20

Pages Range: 436-441

Journal Issue: 4

DOI: 10.36849/JDD.5728

Abstract

Psoriasis is a chronic disease requiring long-term treatment strategies. Optimal strategies should include initial rapid relief of symptoms followed by long-term management to maintain remission. This 4-week open-label phase of a long-term proactive management phase 3 trial aimed to select responders to once daily, fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis and assess patient-reported outcomes. Method: This phase 3 trial in adults with psoriasis included a 4-week open-label lead-in phase to determine treatment success prior to entering the randomized maintenance phase. Success was defined as Physician Global Assessment (PGA) score 'clear'/'almost clear' (PGA <2) with ≥2-grade improvement from baseline. Those achieving treatment success at week 4 entered the maintenance phase; non-responders were withdrawn from the trial. Results: 650 patients enrolled in the open-label phase, and 623 were treated with Cal/BD foam for 4 weeks; 521 (80%) patients achieved treatment success and were included in the maintenance phase. In those patients achieving success (responders), 21.1% and 78.9% achieved a PGA score of ‘clear’ and ‘almost clear’, respectively. Mean change from baseline in modified Psoriasis Area and Severity Index (± standard deviation [SD]) and body surface area (± SD) in responders at week 4 was -82.1% (16.4%) and -56.6% (38.3%), respectively. Mean Dermatology Life Quality Index score reduced by 6.0 from baseline to week 4 (n=521). 17.7% of patients experienced AEs; with only one severe AE reported. Conclusion: Cal/BD foam was highly efficacious and well tolerated during the 4-week lead-in phase of PSO-LONG.

Involved external institutions

How to cite

APA:

Warren, R.B., Gold, M., Gooderham, M., Kircik, L.H., Lacour, J.P., Laws, P.,... Thaçi, D. (2021). Four-Week Daily Calcipotriene/Betamethasone Dipropionate Foam Is Highly Efficacious in Patients With Psoriasis (PSO-LONG Lead-in Phase). Journal of Drugs in Dermatology, 20(4), 436-441. https://doi.org/10.36849/JDD.5728

MLA:

Warren, Richard B., et al. "Four-Week Daily Calcipotriene/Betamethasone Dipropionate Foam Is Highly Efficacious in Patients With Psoriasis (PSO-LONG Lead-in Phase)." Journal of Drugs in Dermatology 20.4 (2021): 436-441.

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