A phase IIIb, multi-centre, 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

Thaci D, Ortonne J P, Chimenti S, Ghislain P D, Arenberger P, Kragballe K, Saurat J H, Khemis A, Sprogel P, Esslinger H U, Unnebrink K, Kupper H 
Br J Dermatol 2010 Published online 02-04-2010 doi:10.1111/j.1365-2133.2010.09791.x

http://dx.doi.org/10.1111/j.1365-2133.2010.09791.x                    
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 psoriasis patients resembling those treated in routine clinical practice.
Patients/Methods: A 16 week, randomized, vehicle-controlled trial was conducted in patients with moderate to severe psoriasis and previous failure, intolerance, or contraindications to ≥2 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 [LEO Pharmaceutical Products Ltd. A/S, Ballerup, Denmark] 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: 730 patients received either ADA + C/B (n = 366) or ADA + vehicle (n = 364). PASI 75 response was initially higher with combination therapy (14.8% for ADA + C/B versus 5.8% for ADA + vehicle at week 2 [p< .001]; and 40.7% versus 32.4%, respectively, at week 4 [p = .021]). After week 4, response trended higher for ADA monotherapy, with no statistical difference in PASI 75 response at week 16 (64.8% [ADA + C/B] versus 70.9% [ADA monotherapy], p = .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, response trended higher with ADA monotherapy. There was no statistical difference in PASI 75 response at week 16. Both treatment regimens were well-tolerated.