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

Abstract

Summary Background Dupilumab is the first biologic registered for the treatment of moderate‐to‐severe atopic dermatitis (AD), and efficacy was shown in phase III clinical trials (primary outcome at week 16 was reached in 38% of patients). Currently, there are limited daily practice data available for dupilumab, especially when it is combined with systemic immunosuppressants. Objectives To evaluate dupilumab treatment in daily practice in patients with AD. Methods In this observational cohort study, we prospectively included all adult patients with AD who had been treated with dupilumab in two university hospitals in the Netherlands. Concomitant systemic immunosuppressive treatment was monitored. Physician‐reported outcome measures and patient‐reported outcome measures (PROMs) after ≥ 12 weeks of follow‐up were analysed. We used a linear mixed‐effects model to determine changes in scores during follow‐up. Results Ninety‐five patients were included. Of these, 62 patients were using systemic immunosuppressants at baseline; the use of systemic immunosuppressants was continued during dupilumab treatment in 43 patients. From baseline to 16 weeks of treatment, the estimated mean Eczema Area and Severity Index score (0–72) decreased from 18·6 [95% confidence interval (CI) 16·0–21·4)] to 7·3 (95% CI 5·4–10·0), and the estimated mean PROMs showed a decrease of 41–66%. Investigator's Global Assessment 0 or 1 (clear/almost clear) was reached in 38% of the patients. Five patients discontinued dupilumab treatment due to side‐effects or ineffectiveness. Eye symptoms and orofacial (nonocular) herpes simplex virus (HSV) reactivation were reported in 62% and 8% of the patients, respectively. Conclusions Dupilumab treatment in daily practice shows a clinically relevant improvement of physician‐reported outcome measures and PROMs, which is in line with efficacy data from clinical trials. Besides frequently reported eye symptoms and orofacial (nonocular) HSV reactivation, there were no apparent safety concerns. What's already known about this topic? Dupilumab has been shown to be an efficacious treatment for atopic dermatitis in several clinical trials. However, it is known that there may be considerable differences in patient characteristics and treatment responses between clinical trials and daily practice. What does this study add? This study presents the first experience with dupilumab treatment in 95 patients with atopic dermatitis in daily practice in two Dutch university hospitals. Less stringent inclusion and exclusion criteria and follow‐up schedules, in contrast to those used in clinical trials, might better represent daily practice. Dupilumab treatment shows a clinically relevant improvement of physician‐ and patient‐reported outcome measures; besides patient‐reported eye symptoms (in 59 of 95 patients; 62%) and an apparent increase in orofacial (nonocular) herpes simplex virus reactivation (eight of 95 patients; 8%), there were no other safety concerns during follow‐up up to 16 weeks of dupilumab treatment.

Clinical Response and Quality of Life in Patients with Severe Atopic Dermatitis Treated with Dupilumab: A Single-Center Real-Life Experience

“…Dupilumab was well tolerated in most patients, with only 11.9% of patients suffering from blepharoconjunctivitis, a finding which is in contrast to studies reporting eye symptoms in up to 62% of cases [18]. Although the underlying mechanism of blepharoconjunctivitis in AD patients is still not completely elucidated, some authors have suggested that the blockade of IL-4 and IL-13 may increase the activity of specific ligands, such as OX40 ligand, involved in atopic keratoconjunctivitis [31].…”

“…In this regard, dupilumab (Dupixent ® ), a fully human monoclonal antibody inhibiting the interleukin (IL)-4/IL-13 signaling through the blockade of the IL-4 receptor α subunit, has been recently approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of patients with moderate-to-severe inadequately controlled AD [6]. However, although dupilumab has been demonstrated to be an effective and safe therapeutic option by the two identical phase-3 SOLO1 and SOLO2 trials [7] and the LIBERTY AD CHRONOS [8] and LIBERTY AD CAFÉ [9] phase-3 trials, literature data resulting from a real-life daily practice setting are limited [10][11][12][13][14][15][16][17][18]. Therefore, with the aim of identifying possible predictors of response to dupilumab and assessing the clinical response to this drug in terms of quality of life and disease severity improvement, we retrospectively assessed cases of severe AD treated with dupilumab for a period of at least 16 weeks at our Department.…”

Efficacy of dupilumab in atopic comorbidities associated with moderate‐to‐severe adult atopic dermatitis

“…The performance of new AD treatments to date has been demonstrated primarily in clinical trial settings [25][26][27] rather than in real-life studies. 20,[28][29][30][31][32][33][34] Given the indicators that suggest the use of dupilumab to treat AD, we must now also study the associated atopic comorbidities. Indeed, the European Medicines Agency recently approved the use of dupilumab to treat bronchial asthma Th2 inflammation in patients over 12 years of age, given the failure of CSI/LABA/LAMA as an add-on therapy.…”

Dermatomyositis: A diagnostic dilemma

“…In the paper by deWijs et al 3 in this issue of the BJD, the first-year clinical real-life experience with dupilumab, an antiinterleukin (IL)-13/IL-4R antibody, in 95 patients with atopic dermatitis (AD) is described. Patients were recruited from two academic dermatology centres in the Netherlands among patients suffering from moderate-to-severe AD, of whom 62 were already on active systemic immune suppressive therapy.…”