78 - Dupilumab's Long-Term Lab Safety in Young Patients With AD: 3-Year Phase 3 Data

Publication Number: 2074.78

Amy S. Paller, Northwestern University The Feinberg School of Medicine, Wilmette, IL, United States; John C.. Su, Monash University, Eastern Health and MCRI, Royal Children’s Hospital, Melbourne, Victoria, Australia; Elaine Siegfried, Saint Louis University and Cardinal Glennon Children's Hospital, St Louis, MO, United States; Michael J.. Cork, University of Sheffield + Sheffield Children's NHS FT, Sheffield, England, United Kingdom; Lawrence F.. Eichenfield, University of California, San Diego and Rady Children’s Hospital, San Diego, San Diego, CA, United States; Hideaki Morita, National Research Institute for Child Health and Development, Tokyo, Tokyo, Japan; Michael P. Van Spall, Sanofi, Montreal, PQ, Canada; Faisal A. Khokhar, Regeneron Pharmaceuticals Inc., New York, NY, United States; Yonghao Ma, Regeneron Pharmaceuticals Inc., Dripping Springs, TX, United States; Thu Tong, Regeneron Pharmaceuticals Inc., NY, NY, United States; Randy Prescilla, Sanofi, Cambridge, MA, United States

Background: Previous studies of dupilumab for the treatment of moderate-to-severe atopic dermatitis (AD) over 16 weeks demonstrated no clinically important changes in laboratory parameters in young patients.

Objective: We assessed laboratory outcomes in children aged < 12 years for up to 3 years of dupilumab treatment.

Design/Methods: Children aged 6 months to < 12 years with moderate-to-severe AD were enrolled in the open-label extension study, LIBERTY AD PED-OLE (NCT02612454). Patients aged 6 months to < 6 years (n=180) received dupilumab 200 mg q4w (5– < 15 kg) or 300 mg q4w (15– < 30 kg); patients aged 6 to < 12 years (n=383) received dupilumab 200 mg q2w (30– < 60 kg) or 300 mg q2w (≥60 kg). Topical corticosteroid treatment was permitted. Hematology and serum chemistry parameters were recorded at baseline, and Weeks 52, 104, and 152.

Results: Of 180 patients aged 6 months to < 6 years, 163/148/101 completed up to 52/104/152 weeks of treatment; 383 patients aged 6 to < 12 years, 327/267/250 completed up to 52/104/152 weeks of treatment. For patients completing Week 152, hematology (hemoglobin, platelets, leukocytes, neutrophils, and eosinophils) and serum chemistry markers (aspartate transferase, alanine aminotransferase, alkaline phosphatase, and lactate dehydrogenase [LDH]) remained stable over 152 weeks of treatment in both 6-month- to < 6-year-olds and 6- to < 12-year-olds. Laboratory abnormalities reported as treatment-emergent adverse events (≥1% of patients) were (MedDRA Preferred Terms) Eosinophilia, Thrombocytopenia, Hematology test abnormal, and Hypothyroidism (all 1%) in 6-month- to < 6-year-olds and Neutropenia (1.6%) and Eosinophilia (1.2%) in 6- to < 12-year-olds.

Conclusion(s): Our results of up to three years of dupilumab treatment in children 6 months to < 12 years demonstrate safety was consistent with the known dupilumab safety profile, supporting no need for routine laboratory monitoring.