Dupilumab shows long-term effectiveness in a large cohort of treatment-refractory atopic dermatitis patients in daily practice:52-Week results from the Dutch BioDay registry

Background Real-life data on long-term effectiveness and safety of dupilumab in atopic dermatitis patients are limited. Objective To study 52-week effectiveness and safety of dupilumab in a prospective multicenter cohort of adult patients with treatment-refractory atopic dermatitis. Methods Patients treated with dupilumab and participating in the Dutch BioDay registry were included. Clinical effectiveness and safety were evaluated. Results Two hundred ten atopic dermatitis patients were included. Mean percentage change in Eczema Area and Severity Index score after 16 weeks was –70.0% (standard deviation 33.2%) and further decreased to –76.6% (standard deviation 30.6%) by week 52. A greater than or equal to 75% improvement in the score was achieved by 59.9% of individuals by week 16 and by 70.3% by week 52. The most reported adverse effect was conjunctivitis (34%). Limited patients (17; 8.1%) discontinued dupilumab treatment. Limitations Because of the lack of a control group and observational design, factors of bias may have been induced. Conclusion Treatment with dupilumab resulted in a rapid improvement in clinical outcome measures, and effectiveness further improved during the 52-week follow-up period

Dupilumab in atopic dermatitis : rationale, latest evidence and place in therapy

Atopic dermatitis (AD) is one of the most common chronic inflammatory skin diseases. The prevalence of AD is increasing and is currently estimated at 10–20% in adults worldwide. In the majority of patients, AD can be adequately controlled with topical treatment or ultraviolet light therapy, but there is a high unmet need for effective and safe therapeutics in patients with more severe or difficult to treat AD. During the past decade, new advances in the understanding of the underlying immune pathogenesis of AD have led to the development of new, more targeted therapies. Dupilumab, a fully human monoclonal antibody targeting the interleukin (IL)-4 receptor α, thereby blocking the IL-4 and IL-13 pathway, is one of the first biologics that has been developed for AD. Dupilumab has shown promising results in phase III trials and has recently been approved by the US Food and Drug Administration and the European Commission for the treatment of moderate to severe AD. With the approval of dupilumab, we are entering a new era of biological therapeutics in AD management. The place of dupilumab should be established in the current treatment standards. Based on current treatment guidelines and experts’ opinions in the management of AD, we have built a proposal for a treatment algorithm for systemic treatment of AD in European countries

Dupilumab : Eerste resultaten vanuit het BioDay-register

The effectiveness and safety of dupilumab for the treatment of moderate to severe atopic dermatitis (AD) has been demonstrated in phase III clinical trials. At this moment, daily practice data on dupilumab treatment with respect to clinical effectiveness and safety are scarce. The objective of this study was to study the clinical effectiveness of 16 weeks treatment with dupilumab in adult patients with moderate to severe AD in daily practice. Data were extracted from the BioDay registry, a prospective multicenter registry. Sixteen-weeks clinical effectiveness of dupilumab was expressed as number of patients achieving EASI-50, EASI-75 as well as patient reported outcome measures (POEM, DLQI, NRS-pruritus). A clinically relevant response was defined based on thresholds in one or more outcomes of the 3 major AD domains (EASI, NRS-pruritus, DLQI). In total, 138 patients treated with dupilumab in daily practice were included. This cohort included patients with very difficult- to-treat AD with 84 patients (61%) who failed treatment on ≥2 immunosuppressive drugs. At week 16, the mean percent change in EASI score was 73%. The EASI-50 and EASI-75 was achieved by 114 (86%) and 82 (62%) patients after 16 weeks of treatment. Also patient-reported outcomes including sleep, itch and quality of life significantly improved during dupilumab treatment. A clinically relevant response was achieved by 89% of the patients after 16 weeks of treatment. The most reported side effects were conjunctivitis in 47 (34%) and eosinophilia in 78 (57%) patients. In conclusion, treatment with dupilumab significantly improved signs and symptoms of AD in patients with very difficult-to-treat AD in a daily practice setting with the majority of patients achieving a clinically relevant response after 16 weeks of treatment

Dupilumab : Eerste resultaten vanuit het BioDay-register

The effectiveness and safety of dupilumab for the treatment of moderate to severe atopic dermatitis (AD) has been demonstrated in phase III clinical trials. At this moment, daily practice data on dupilumab treatment with respect to clinical effectiveness and safety are scarce. The objective of this study was to study the clinical effectiveness of 16 weeks treatment with dupilumab in adult patients with moderate to severe AD in daily practice. Data were extracted from the BioDay registry, a prospective multicenter registry. Sixteen-weeks clinical effectiveness of dupilumab was expressed as number of patients achieving EASI-50, EASI-75 as well as patient reported outcome measures (POEM, DLQI, NRS-pruritus). A clinically relevant response was defined based on thresholds in one or more outcomes of the 3 major AD domains (EASI, NRS-pruritus, DLQI). In total, 138 patients treated with dupilumab in daily practice were included. This cohort included patients with very difficult- to-treat AD with 84 patients (61%) who failed treatment on ≥2 immunosuppressive drugs. At week 16, the mean percent change in EASI score was 73%. The EASI-50 and EASI-75 was achieved by 114 (86%) and 82 (62%) patients after 16 weeks of treatment. Also patient-reported outcomes including sleep, itch and quality of life significantly improved during dupilumab treatment. A clinically relevant response was achieved by 89% of the patients after 16 weeks of treatment. The most reported side effects were conjunctivitis in 47 (34%) and eosinophilia in 78 (57%) patients. In conclusion, treatment with dupilumab significantly improved signs and symptoms of AD in patients with very difficult-to-treat AD in a daily practice setting with the majority of patients achieving a clinically relevant response after 16 weeks of treatment