420 - Dupilumab: A Comparison of Infection Rates across Atopic Dermatitis Trials in Adults, Adolescents, Children, and Infants

Monday, May 1, 2023

9:30 AM – 11:30 AM ET

Poster Number: 420
Publication Number: 420.418

Peter Lio, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Lisa A. Beck, University of Rochester School of Medicine and Dentistry, Rochester, NY, United States; Vivian Y. Shi, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, United States; zhen chen, Regeneron pharma, Riverside, CT, United States; Faisal A. Khokhar, Regeneron, Tarrytown, NY, United States; Sonya L. Cyr, Regeneron Pharmaceuticals, Piermont, NY, United States; Tayler Gonzalez, Sanofi, Davie, FL, United States

Presenting Author(s)

Sonya L. Cyr, PhD (she/her/hers)

Sr Director Medical Affairs
Regeneron Pharmaceuticals
Piermont, New York, United States

Background: Moderate-to-severe atopic dermatitis (AD) is associated with increased frequency of infections which can lead to hospitalizations. Some treatments can be associated with increased risk of infection, limiting their long-term use.

Objective:

To compare infection rates in dupilumab (DPL) AD trials in adults, adolescents, children, and infants.

Design/Methods:

We analyzed exposure-adjusted infection rates (number of patients [pts] per 100 pts-years, nP/100PY) during study treatment periods for MedDRA terms Infections and Infestations (overall infections; System Organ Class), including adjudicated skin infections (excluding herpetic infections) and High Level Term Herpes Virus Infections. Pts with moderate-to-severe AD in phase 2 (adults) or phase 3 clinical studies received: young children (6months-5years, NCT03346434 part B): DPL 200/300mg (n=83) every 4 weeks (q4w) or placebo (PBO; n=78) with topical corticosteroids (TCS); children (6–11years, NCT03345914): DPL 300mg q4w (n=120), 100/200mg q2w (n=122), or PBO (n=120) with TCS; adolescents (12-17years, NCT03054428): DPL 300 q4w (n=83), 200/300mg q2w (n=82), or PBO (n=85); adults (NCT01548404/NCT02210780/NCT01859988/NCT02277743/NCT02277769,NCT02260986,NCT02755649): DPL 300mg q2w (n=746), 300mg qw (n=1095), or PBO (n=1091). Rates for DPL are provided in the order specified above. Post-hoc nominal P-values are for DPL vs PBO.

Results:

Overall infection rates with DPL were numerically lower vs PBO in young children (PBO: 246/DPL: 185) and children (PBO: 244/DPL: 184, 171) and similar between groups in adolescents (PBO: 204/DPL: 210, 181), and adults (PBO: 129/DPL: 134, 126). Adjudicated non-herpetic skin infection rates were significantly lower for DPL vs PBO in young children (PBO: 93/DPL: 43 [P< 0.05]), children (PBO: 48/DPL: 20 [P< 0.05], 28 [n.s.]), and adults (PBO: 27/DPL: 16 [P< 0.01], 14 [P< 0.0001]) and numerically lower in adolescents (PBO: 70/DPL: 34, 34). Herpes infection rates were similar for DPL vs PBO in young children (PBO: 17/DPL: 20), children (PBO: 17/DPL: 5, 11), adolescents (PBO: 12/DPL: 16, 4), and adults (PBO: 10/DPL: 15, 11). Rates of eczema herpeticum and herpes zoster, were numerically lower with DPL in young children (PBO: 4/DPL: 0), adolescents (PBO: 4/DPL: 0,0), and adults (PBO: 4/DPL: 2 [n.s.], 1 [P< 0.01]), and numerically higher in children (PBO: 0/DPL: 3, 3).

Conclusion(s):

Dupilumab treatment in children (≥6 months old), adolescents and adults with AD is generally associated with lower rates of non-herpetic skin infections vs PBO and did not increase risk of overall infections in these data sets.