Dermatologist, Senior Medical Director Sanofi Genzyme Sanofi Genzyme Cambridge, Massachusetts, United States
Background: In children with moderate-to-severe atopic dermatitis (AD), skin lesions often involve a large body surface area (BSA). Patients frequently experience pruritus and sleep disturbance, which impact patient and caregiver quality of life. Scoring AD (SCORAD) is an AD-specific measurement tool recommended by European AD guidelines that evaluates the investigator-assessed affected BSA and severity of signs, as well as patient-reported symptoms of pruritus and sleep loss.
Objective: Here, we report the effect of dupilumab in combination with standardized topical corticosteroid (TCS) treatment on SCORAD and its components in children aged ≥6–<12 years with severe AD.
Design/Methods: In the phase 3 LIBERTY AD PEDS (NCT03345914) trial, 367 patients aged ≥6–<12 years were randomized 1:1:1 to subcutaneous dupilumab every 2 weeks (q2w; 100mg if baseline weight <30kg, 200mg if ≥30kg); every 4 weeks (q4w; 300mg regardless of weight); or placebo for 16 weeks; all with concomitant medium-potency TCS. Here we report FDA-approved doses only (300mg q4w if weight <30kg, or 200mg q2w if ≥30kg) and weight-matched placebo (q4w+TCS/placebo+TCS<30kg/q2w+TCS/placebo+TCS ≥30kg groups, n=61/61/59/62). We report least squares (LS) mean (standard error [SE]) total SCORAD/component scores: BSA affected by AD; objective SCORAD (o-SCORAD); SCORAD pruritus Visual Analog Scale (VAS); and SCORAD sleep loss VAS. All reported P values are nominal. Multiple imputation method was used with censoring after rescue treatment use.
Results: Baseline disease characteristics are presented in Table. Treatment with dupilumab+TCS resulted in a significant improvement in total SCORAD score as early as Week (Wk) 1 (q4w+TCS) or Wk2 (q2w+TCS), with further improvement through end of treatment at Wk16 (Figure 1, Table). Significant improvement across the multidimensional SCORAD subcomponents (BSA affected by AD, o-SCORAD, SCORAD pruritus VAS, and SCORAD sleep loss VAS) was seen as early as Wk1 or Wk2 upon treatment with dupilumab+TCS, with the exception of improvement in BSA affected by AD in the q4w+TCS group, which improved significantly at Wk16 (Figure 2,Table). In this study, the dupilumab safety profile was consistent with the known safety profile. Conclusion(s): In children aged ≥6–<12 years with severe AD, dupilumab+TCS treatment resulted in a significant reduction in BSA affected by AD, and rapid improvements in AD signs, pruritus, and sleep loss as assessed by total SCORAD and SCORAD components.
Dupilumab rapidly and significantly reduces total SCORAD score
Dupilumab consistently reduced investigator-assessed and patient-reported AD signs and symptoms
Baseline characteristics and efficacy outcomes at Week 1, Week 2, and Week 16 for total SCORAD and SCORAD components
Authors/Institutions: Sebastien Barbarot, Service de Dermatologie, Centre Hospitalier Universitaire de Nantes, Nantes, , France; Danielle Marcoux, University of Montreal, and Centre Hospitalier Universitaire Sainte-Justine, Montreal, Montreal, Quebec, Canada; Melinda Gooderham, SKiN Centre for Dermatology, and Queen’s University, Peterborough, Ontario, Canada; Amy Paller, Feinberg School of Medicine at Northwestern University, Chicago, Illinois, United States; Brad Shumel, Regeneron Pharmaceuticals Inc., Tarrytown, New York, United States; Zhen Chen, Regeneron Pharmaceuticals Inc., Tarrytown, New York, United States; Ana Rossi, Sanofi Genzyme, Cambridge, Massachusetts, United States
