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A phase IIIb, multicentre, randomized, double-blind, vehicle-controlled study of the efficacy and safety of adalimumab with and without calcipotriol/betamethasone topical treatment in patients with moderate to severe psoriasis: the BELIEVE study.

Author(s): Thaci D, Ortonne JP, Chimenti S, Ghislain PD, Arenberger P, Kragballe K, Saurat JH, Khemis A, Sprogel P, Esslinger HU, Unnebrink K, Kupper H

Affiliation(s): Department of Dermatology, Johann Wolfgang Goethe-University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany. thaci@em.uni-frankfurt.de

Publication date & source: 2010-08, Br J Dermatol., 163(2):402-11. Epub 2010 Apr 2.

Publication type: Research Support, Non-U.S. Gov't

BACKGROUND: Data are lacking on the use of topical therapies in combination with tumour necrosis factor blockers for the treatment of psoriasis. OBJECTIVES: To assess the efficacy and safety of adalimumab (ADA) with topical calcipotriol/betamethasone (C/B) in patients with psoriasis resembling those treated in routine clinical practice. METHODS: A 16-week, randomized, vehicle-controlled trial was conducted in patients with moderate to severe psoriasis and previous failure, intolerance or contraindications to two or more systemic treatments. All patients received ADA (80 mg, week 0; 40 mg every other week, weeks 1-15) in addition to either topical C/B or drug-free vehicle applied once daily for 4 weeks, and as needed thereafter. The primary endpoint was 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75) at week 16. RESULTS: A total of 730 patients received either ADA + C/B (n = 366) or ADA + vehicle (n = 364). PASI 75 response was initially higher with the combination therapy [14.8% for ADA + C/B vs. 5.8% for ADA + vehicle at week 2 (P < 0.001); and 40.7% vs. 32.4%, respectively, at week 4 (P = 0.021)]. After week 4, the trend was towards a higher response with ADA monotherapy, with no statistical difference in the PASI 75 response at week 16 (64.8% for ADA + C/B vs. 70.9% for ADA monotherapy, P = 0.086). Safety findings were consistent with previous ADA trials. CONCLUSIONS: ADA + C/B resulted in more rapid and higher efficacy within the first 4 weeks; thereafter, the trend was towards a higher response with ADA monotherapy. There was no statistical difference in the PASI 75 response at week 16. Both treatment regimens were well tolerated.

Page last updated: 2010-10-05

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