Long-term effectiveness and safety of dupilumab treatment in patients with moderate-to-severe atopic dermatitis: Up to 5-year results from the BioDay registry

Introduction: Limited data is available on the long-term effectiveness and safety of dupilumab for atopic dermatitis (AD) in daily practice.

Objectives: To evaluate effectiveness and safety of dupilumab treatment in AD patients up to 5 years in daily practice.

Methods: Data were extracted from the prospective, multicenter BioDay registry (October 2017–October 2022/December 2022) of patients with moderate-to-severe AD treated with dupilumab.

Results: In a study on clinical outcomes, 1286 patients were included (n = 130 children; n = 1025 adults; n = 131 elderly). The median follow-up time was 87.5 weeks (inter-quartile range (IQR) 32.0–157.0). Most patients maintained controlled AD with Eczema Area and Severity Index (EASI) ≤ 7 varying between 78.6–92.3% up to 5 years, while up to 70.5% of patients prolonged the dupilumab interval to mostly every 3/4 weeks. Significant differences in effect over time between age groups were found for EASI and Investigator Global Assessment (p = 0.046 and p = 0.010, respectively), however differences were rather small. In total, 306 patients (23.8%) discontinued dupilumab after a median of 54.0 weeks (IQR 29.0–110.00) with adverse events (AEs) (n = 98, 7.6%) and ineffectiveness (n = 85, 6.6%) as most frequently reported reasons.

In the Patient Reported Outcome Measures (PROMs) study, 1223 patients were included (n = 115 children; n = 1108 adults). After ≥1 year of treatment, mean Patient-Oriented Eczema Measure, Dermatology Life Quality Index, Numeric rating scale-pruritus ranged between 7.8–8.7, 3.5–4.2, and 2.9–3.1 in adults, respectively, whilst these PROMs ranged between 8.9–10.9, 4.4–6.4, and 3.0–3.7 in children, respectively. Of all patients, 66.8% reported ≥1 AE, with conjunctivitis being the most common (33.7%).

Conclusion: Up to 5 years, dupilumab maintained its effectiveness while two-thirds of the patients tapered to an interval of every 3/4 weeks. Treatment was discontinued in 23.8% of the patients mainly due to AEs and/or ineffectiveness. Overall, dupilumab showed a favourable safety profile. Additionally, dupilumab has demonstrated sustained effectiveness across various PROMs.