Real-World Effectiveness and Safety of Nemolizumab in Moderate-to-Severe Atopic Dermatitis: A Phase IV, Prospective, Non-Interventional Study Design From RE-UNITE-AD (NCT06988605)

Abstract

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by intense itch and eczematous lesions. Nemolizumab, an interleukin-31 receptor alpha antagonist, has shown efficacy and safety with background topical corticosteroids and/or topical calcineurin inhibitors in the ARCADIA 1&2 phase 3 trials, and is approved for the treatment of moderate-to-severe AD in individuals aged ≥12 years in several countries including, the US and Europe. However, there is a need for a study that better reflects real-world settings and routine clinical practice beyond the limitations of controlled trials.

Objective: To report key design features of RE-UNITE-AD study.

Methods: RE-UNITE-AD (NCT06988605) is a prospective, multicenter, non-interventional study (NIS) in adults and adolescents with moderate-to-severe AD who are newly initiated on nemolizumab per physician’s discretion in accordance with the local label. This AD study aims to enroll 1000 participants across 200 sites in Europe and North America. AD patients with peak pruritus numerical rating scale (PP-NRS) score ≥7 without prior biologic/Janus kinase inhibitors (JAKi) (or use more than 3 months before baseline) or PP-NRS ≥4 for those with recent discontinuation of biologic/JAK inhibitors (less than 3 months before baseline) are eligible for this study. Patients with any PP-NRS score may be enrolled if the reason for discontinuation of prior biologic/JAKi is safety-related. Patients who have contraindication(s) for the use of nemolizumab per the local label and/or treatment with a drug under clinical development/investigation within 3 months prior to baseline are excluded. Primary endpoints evaluated Investigator’s Global Assessment (IGA) and PP-NRS scores in clinical practice at month 6. Secondary endpoints evaluated Eczema Area and Severity Index, Scoring Atopic Dermatitis, IGA, PP-NRS, Average Pruritus-NRS, Sleep Disturbance-NRS, and Pain-NRS scores through month 12. Additional assessments include itch-scratch behaviour, quality of life, and patient-perceived benefit. Safety endpoints include serious adverse events regardless of causality and non-serious adverse drug reactions.

Conclusion: This NIS reflects real-world clinical practice and is expected to complement the existing evidence from pivotal trials on the clinical effectiveness and safety of nemolizumab in patients with moderate-to-severe AD.