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

Abstract

Atopic dermatitis (AD) is a chronic, systemic disease that has a multifactorial etiology, where immune system disorders and epidermal barrier dysfunction are added to the influence of genetic and environmental factors. Dupilumab has been approved by United States and the European Union regulatory agencies in 2017 for the treatment of moderate‐to‐severe AD in adult patients who are candidates for systemic treatment. In this short report, we present a retrospective, multicentric study, in which five hospitals in Andalusia, Spain, have taken part. Our objective is to evaluate the safety and effectiveness of dupilumab in patients with moderate‐to‐severe AD treated with dupilumab with at least 52 weeks of follow‐up.

Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data

“…Although Dutch regulations do not require patients to have a minimum severity score to warrant dupilumab treatment, they do require patients to have failed treatment with at least one systemic immunosuppressant in a sufficient dose for at least 4 months with intensive guidance and instructions (Appendix S1; see Supporting Information). The majority of patients in our study (72%), and a similar proportion of patients in the daily practice studies available, had been treated with at least two different conventional systemic immunosuppressants, in contrast to a minority (26–28%) who used at least one systemic immunosuppressant in the SOLO trials . This suggests that patients in daily practice are at the end of the ‘severity spectrum’.…”

“…18 Although the methodology and follow-up visits used in our study, clinical trials and the limited daily practice literature available were different, we tried to compare results. 11,[33][34][35][36][37] Overall, patients in the current study had lower baseline EASI scores than patients in previous dupilumab studies and trials (Table S2; see Supporting Information). 11 In our study, patients were not asked to discontinue topical steroids or systemic immunosuppressants before the start of dupilumab treatment, resulting in lower baseline EASI scores than those from clinical trials that required a minimum washout period of 2 and 4 weeks, respectively.…”

“…In our cohort, 62% (59 of 95) of the patients presented with eye symptoms suggestive for conjunctivitis, sicca and/or blepharitis, whereas conjunctivitis was observed in only 4–5% of the patients in the SOLO trials . However, the limited daily practice literature available also showed conjunctivitis incidence ranges up to 50% in patients treated with dupilumab . Literature on ocular comorbidities in AD shows that several ocular comorbidities are more prevalent among patients with AD than among the general population .…”

“…Although the methodology and follow‐up visits used in our study, clinical trials and the limited daily practice literature available were different, we tried to compare results …”

“…immunosuppressants, in contrast to a minority (26-28%) who used at least one systemic immunosuppressant in the SOLO trials. 11,[33][34][35][36][37] This suggests that patients in daily practice are at the end of the 'severity spectrum'. Because a long-term severity measure is not available, surrogate markers such as previous treatment with systemic immunosuppressants may be used.…”