Treatment with dupilumab plus concomitant topical corticosteroids (TCS) significantly improved the signs and symptoms of atopic dermatitis and health-related quality of life (HRQOL) in adults with atopic dermatitis that is inadequately controlled with or intolerant to cyclosporin A (CsA), or in whom CsA treatment is not recommended, according to the results of a recent placebo-controlled, randomized, phase 3 trial (ClinicalTrials.gov identifier: NCT02755649) published in the British Journal of Dermatology.
A total of 325 patients age ≥18 with chronic AD were randomly assigned in a 1:1:1 ratio to one of three treatment regimens: (1) 16 weeks of subcutaneous (SC) dupilumab weekly (QW) plus TCS (n=110); (2) 16 weeks of SC dupilumab 300 mg every 2 week (Q2W) plus TCS (n=107); or (3) placebo plus TCS (n=108).
Patients received a loading dose of dupilumab 600 mg or matching placebo at baseline followed by SC dupilumab 300 mg QW, Q2W, or placebo. The primary end point was the percentage of patients with ≥75% improvement from baseline in Eczema Area Severity Index score (EASI-75).
Significantly more patients in the dupilumab QW plus TCS group (59.1%) and the dupilumab Q2W plus TCS group (62.6%) achieved EASI-75 vs patients in the placebo plus TCS group (29.6%; P <.0001). Moreover, dupilumab QW plus TCS and dupilumab Q2W plus TCS significantly improved other clinical outcomes and symptoms of AD, including pruritus, pain, sleep disturbance, anxiety and depression symptoms, and HRQOL.
Similar rates of adverse events (69.1%, 72.0%, and 69.4%) and serious adverse events (1.8%, 1.9%, and 1.9%) were reported in the dupilumab QW plus TCS group, the dupilumab Q2W plus TCS group, and the placebo plus TCS group, respectively. Conjunctivitis occurred more often in the dupilumab plus TCS groups, whereas skin infections were more common in the placebo plus TCS group.
The investigators concluded that 16 weeks of treatment with dupilumab plus TCS was associated with significant improvements in the signs and symptoms of AD and HRQOL, decreased the use of concomitant TCS and rescue medications, and had an acceptable safety profile. These data support the use of this regimen as a targeted biologic therapy in adults with tough-to-treat AD.
de Bruin-Weller M, Thaçi D, Smith CH, et al. Dupilumab with concomitant topical corticosteroids in adult patients with atopic dermatitis who are not adequately controlled with or are intolerant to ciclosporin A, or when this treatment is medically inadvisable: a placebo-controlled, randomized phase 3 clinical trial (LIBERTY AD CAFÉ) [published online November 28, 2017]. Br J Dermatol. doi: 10.1111/bjd.16156