P0310 - Dupilumab Was Well Tolerated and Significantly Improved Atopic Dermatitis in Children Aged ≥ 6 to < 12 Years: Results From the LIBERTY AD PEDS Phase 3 Trial

Introduction: Clinical trials of dupilumab demonstrated significant clinical improvements with a favorable safety profile in adults and adolescents with moderate-to-severe atopic dermatitis (AD) inadequately controlled with topical medications. Here, we evaluate dupilumab safety and efficacy data in children aged ≥ 6 to < 12 years with severe AD (Investigator’s Global Assessment [IGA] score = 4) inadequately controlled with topical corticosteroids (TCS).

Methods: In the double-blinded, phase 3 LIBERTY AD PEDS trial (NCT03345914), children aged ≥ 6 to < 12 years were randomized 1:1:1 to receive either subcutaneous dupilumab every 4 weeks (q4w, 300 mg regardless of baseline body weight), every 2 weeks (q2w, 100 mg if baseline weight < 30 kg, 200 mg if ≥ 30 kg), or placebo for 16 weeks. All patients received concomitant medium potency TCS from Day –14.

Results: 367 patients were randomized (q4w/q2w/placebo groups, n = 122/n = 122/n = 123). A lower proportion of patients in the dupilumab groups experienced ≥ 1 treatment-emergent adverse event (TEAE) through Week 16, compared with the placebo group (Table 1). Nasopharyngitis, conjunctivitis, and injection-site reactions were more common in patients receiving dupilumab compared with placebo (Table 1). All but one conjunctivitis event were of mild-to-moderate severity. AD exacerbations and asthma (Table 1) were more common in the placebo group than in either dupilumab group. The majority of TEAEs experienced by patients were mild or moderate; severe TEAEs were more frequent in the placebo group (0% q4w, 2.5% q2w, 5.8% placebo, Table 1). Serious AEs and AE related treatment discontinuations were rare (Table 1). At Week 16, significantly higher proportions of patients receiving either dupilumab regimen improved on a wide range of clinical outcomes, including the percent of patients achieving an IGA score of 0 or 1 (Table 2); EASI-75; and both ≥ 3- and ≥ 4-point reduction in weekly average of Peak Pruritus NRS. Dupilumab+TCS also led to significant improvements in the POEM and the CDLQI (Table 2).

Conclusions: Dupilumab+TCS was well-tolerated, and data were consistent with the known safety profile in adults and adolescents. Dupilumab+TCS showed clinically meaningful and statistically significant improvement in AD signs, symptoms, and quality of life in children aged ≥ 6 to < 12 years with severe AD.

Presenting Author(s)

Danielle Marcoux

Clinical Professor
University of Montreal and Sainte-Justine University Hospital
Montreal, Quebec, Canada
Disclosure: AbbVie (Consultant, Grant/Research Support, Speaker's Bureau)Amgen (Consultant, Grant/Research Support, Speaker's Bureau)Celgene (Consultant, Speaker's Bureau)Eli Lilly (Consultant, Grant/Research Support)Janssen (Consultant, Grant/Research Support)LEO Pharma (Consultant, Grant/Research Support)Novartis (Consultant, Grant/Research Support, Speaker's Bureau)Pfizer (Consultant, Grant/Research Support, Speaker's Bureau)Regeneron Pharmaceuticals Inc. (Consultant, Speaker's Bureau)Sanofi Genzyme (Consultant, Speaker's Bureau)UCB (Consultant)

Co-Author(s)

JW

Jashin J. Wu

Director, Dermatology Research
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California
Disclosure: AbbVie (Consultant, Grant/Research Support, Speaker's Bureau)Almirall (Consultant)Amgen (Consultant, Grant/Research Support, Speaker's Bureau)Boehringer Ingelheim (Consultant)Bristol Myers Squibb (Consultant)Celgene (Consultant, Speaker's Bureau)Dermavant (Consultant)Dermira (Consultant)Dr. Reddy's Laboratories (Consultant)Eli Lilly (Consultant, Grant/Research Support)Janssen (Consultant, Grant/Research Support)LEO Pharma (Consultant)Novartis (Consultant, Grant/Research Support, Speaker's Bureau)Regeneron Pharmaceuticals Inc. (Consultant, Speaker's Bureau)Sanofi Genzyme (Consultant, Speaker's Bureau)Sun Pharmaceutical (Consultant, Speaker's Bureau)UCB (Consultant, Speaker's Bureau)Valeant Pharmaceuticals North America LLC (Consultant, Speaker's Bureau)

Senior Author(s)

BS

Brad Shumel

Senior Director, Medical Affairs
Regeneron Pharmaceuticals Inc.
Tarrytown, New York
Disclosure: Regeneron Pharmaceuticals Inc. (Employee, Stockholder/Ownership Interest (excluding diversified mutual funds))

Co-Author(s)

YO

Yukihiro Ohya

Director of Allergy Center
National Center for Child Health and Development
Tokyo, Tokyo, Japan
Disclosure: AbbVie (Consultant, Speaker's Bureau)Bayer (Speaker's Bureau)Chugai (Speaker's Bureau)Eli Lilly (Speaker's Bureau)Kyorin Pharmaceuticals (Speaker's Bureau)Maruho (Consultant, Speaker's Bureau)Mylan (Consultant, Speaker's Bureau)Pola Pharma (Speaker's Bureau)Regeneron Pharmaceuticals Inc. (Consultant)Sanofi (Speaker's Bureau)Torii (Speaker's Bureau)Yakult (Grant/Research Support)
AZ

Annie Zhang

Director, Global Medical Affairs, Atopic Dermatitis
Sanofi Genzyme
Boston, Massachusetts
Disclosure: Sanofi Genzyme (Employee, Stockholder/Ownership Interest (excluding diversified mutual funds))
ZC

Zhen Chen

Associate Director, Medical Analytics
Regeneron Pharmaceuticals Inc.
Tarrytown, New York
Disclosure: Regeneron Pharmaceuticals Inc. (Employee, Stockholder/Ownership Interest (excluding diversified mutual funds))