Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical t

Abstract

This summary relates to https://doi.org/10.1111/bjd.16156British Journal of Dermatology, 178, 1083-1101, May 2018 Summary Atopic dermatitis (also called AD or eczema) is a chronic skin disease found in up to 1 in 10 adults, causing itchy rashes that may cover most of the body. Ciclosporin, an oral treatment (taken by mouth) commonly used for AD, doesn't always work and can have significant side effects. Other broadly-acting oral medications are sometimes used, but not approved, for AD. Dupilumab is a new medication approved in many countries for adults with inadequately controlled moderate-to-severe AD. Dupilumab specifically targets pathways in the body that drive AD. Researchers in Europe evaluated how well dupilumab injections improved rashes, itch, and daily lives of people whose AD required ciclosporin, but for whom ciclosporin wasn't working or caused intolerable side effects, or whose medical conditions prevented its use. Among 325 participants, 110 received 300 mg dupilumab once-weekly, 107 received it every two weeks, and 108 received placebo (dummy drug) once-weekly. All participants used topical (applied to the skin) corticosteroids during the 16-week study. Dupilumab improved AD rashes: at Week 0, participants' Eczema Area and Severity Index (EASI) scores were about 31 (scale: 0-72), but by Week 16, 59% to 62% of dupilumabtreated participants achieved 75% or greater improvement in EASI, versus 29.6% of people on placebo. Dupilumab also improved itch, other symptoms, mood, and quality of life. Conjunctivitis and injection-site reactions were more frequent among dupilumab-treated patients; skin infections (excluding herpes) and AD exacerbations (worsening) were more frequent with placebo. The authors conclude that dupilumab plus topical corticosteroids significantly improved AD even in adults with AD who had previously failed treatment with or were unable to use ciclosporin.

Treatment of atopic dermatitis with dupilumab: experience from a tertiary referral centre

“…Although these results also include some patients transferred from other systemic treatments with initial EASI score values below 16, the results are in accordance with the previously reported results on efficacy of dupilumab in phase 3 clinical trials (SOLO 1, SOLO 2, CHRONOS and CAFÉ) . In the present study, the effectiveness of dupilumab evaluated by percentage reduction in EASI score, EASI‐50 and EASI‐75 at week 12 was similar to results obtained from clinical trials of dupilumab in combination with topical corticosteroids (CAFÉ, EASI‐75: 62% and CHRONOS, EASI‐75: 69%) and was slightly higher than the efficacy in trials with dupilumab as monotherapy (SOLO 1, EASI‐75: 51.3% and SOLO 2, EASI‐75: 44.2%) . This was expected, as concomitant treatment with topical anti‐inflammatory agents is common practice in the clinical setting and to a major degree self‐administered in this group of chronic patients.…”

Fifty‐two week follow‐up safety and effectiveness results of dupilumab treatment of moderate‐to‐severe atopic dermatitis from a retrospective, multicentric series

“…The clinical safety and effectiveness of dupilumab in our series were consistent with those observed in clinical trials (Beck et al, ; Blauvelt et al, ; de Bruin‐Weller et al, ; Simpson, Bieber, et al, ; Simpson, Gadkari, et al, ; Thaçi et al, ). Dupilumab significantly improved the signs and symptoms of AD, measured by SCORAD and pruritus VAS, as well as QoL.…”

“…Dupilumab is a fully human monoclonal antibody that targets the common IL‐4 receptor α (IL‐4 Rα), blocking both IL‐4 and IL‐13 signaling. Dupilumab is the first targeted therapy approved by the U.S. Food and Drug Administration and European Medicines Agency for the treatment of moderate‐to‐severe AD in adults, and has shown to be effective to control the signs and symptoms of AD in previous clinical trials (Beck et al, ; Blauvelt et al, ; de Bruin‐Weller et al, ; Serra‐Baldrich et al, ; Simpson, Gadkari, et al, ; Simpson, Bieber, et al, ; Thaçi et al, ). Its compassionate use has recently been approved in our country.…”

Could conjunctivitis in patients with atopic dermatitis treated with dupilumab be caused by colonization with Demodex and increased interleukin-17 levels?: reply from the authors

“…Dear Editor , In studies in atopic dermatitis (AD), dupilumab has been associated with higher rates of conjunctivitis than placebo. Consistent with previous studies, in LIBERTY AD CAFÉ (ClinicalTrials.gov Identifier: NCT02755649), all cases of conjunctivitis but one were mild or moderate, most (62–89%) were recovered/resolved or recovering/resolving by the end of treatment and no patients permanently discontinued the study treatment because of conjunctivitis . No patients reported atopic keratoconjunctivitis in this study.…”