ABSTRACT
Dupilumab is a monoclonal antibody approved by the National Institute for Health and Care Excellence for the treatment of moderate-to-severe atopic dermatitis (AD) in 2018. It is indicated for patients who have not responded to at least one systemic medication or in whom these are contraindicated or not tolerated. Response criteria to allow continued treatment include at least a 50% reduction of Eczema Area and Severity Score (EASI) and/or at least a 4-point reduction in the Dermatology Life Quality Index (DLQI) score. Phase III clinical trials of dupilumab in AD reported a 75% reduction in EASI (EASI 75) of 51% in SOLO1 and 44% in SOLO2. Real clinic responses may differ from trials so we performed a retrospective review of 100 patients between June and August 2020 who had received dupilumab (44% female, 56% male;mean age 41 years). Fifty-eight per cent had a recorded diagnosis of asthma and 39% had a recorded diagnosis of allergic rhinitis. Seventy-six per cent of patients had received previous phototherapy. Ninety-seven per cent of patients received at least one systemic medication prior to commencing dupilumab. Thirty per cent (n = 29) received one, 33% (n = 32) received two, 33% (n = 32) received three and 4% (n = 4) received four prior to starting dupilumab. The most common were methotrexate (61%), followed by ciclosporin (22%) azathioprine (16%) and alitretinoin (1%). EASI scores were documented at baseline. The target time for EASI response assessment was 16 weeks, but we included outcome data recorded between 8 and 16 weeks, using the score nearest to 16 weeks where multiple scores were available. Seventy-five patients had response data recorded, 18 had stopped dupilumab and seven had missing data. Outcomes were 50% reduction in EASI [EASI 50;84% (n = 62)], EASI 75 [61% (n = 45)] and a 90% reduction in EASI [EASI 90;35% (n = 26)]. Mean (SE) EASI score pretreatment was 22 2 (1 2);at 16 weeks it was 5 8 (0 9). Sixty-five per cent of patients had a documented DLQI score at 8 and/or 16 weeks. Mean (SE) DLQI scores were 17 5 (0 7) predupilumab, 5 5 (1 1) at 8 weeks and 3 7 (0 8) at 16 weeks. Mean reduction was 13 8 (1 0). Eighty-six per cent (n = 56) had a reduction of four or more. Fifty-nine per cent of patients had Patient-Oriented Eczema Measure scores recorded. Mean (SE) values were 22 5 (0 5) predupilumab, 6 2 (1 2) at 8 weeks and 7 1 (1 1) at 16 weeks. Mean reduction was 15 4 (1 0). Compared with prospective clinical trials, real-world data have the limitations of missing data and slight scoring date variations, including the impact of the COVID-19 pandemic on missed appointments. Sixteen-week outcome data are not available for patients who withdrew from treatment. However, for the 75 patients with outcome data the proportion achieving EASI 75 and a 4-point reduction in DLQI is encouraging and similar to data from phase III trials.