P0319 - Safety of crisaborole in patients aged 3 to <24 months with mild-to-moderate atopic dermatitis

Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects 15%–30% of the pediatric population in the United States, with ~60% experiencing first signs and symptoms before 1 year of age. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate AD. CrisADe CARE 1 (NCT03356977) is the first study designed to evaluate the safety (primary endpoint) and efficacy of crisaborole in infants. 137 patients aged 3 to <24 months with mild-to-moderate AD received crisaborole twice daily for 28 days (mean age, 13.6 months [SD, 6.42]; 43 [31.4%] aged 3 to <9 months and 94 [68.6%] aged 9 to <24 months; 88 [64.2%] male; 84 [61.3%] white, 11 [8.0%] black, 27 [19.7%] Asian, and 15 [10.9%] of other race; 52 [38.0%] with mild baseline Investigator’s Static Global Assessment [ISGA] and 84 [61.3%] with moderate baseline ISGA; 70 [51.1%] with baseline percentage of treatable body surface area [%BSA] ≥19.0 [median]). The incidence of treatment-emergent all-cause adverse events (TEAEs) were numerically higher for males (male: 69.3%; female: 55.1%), and white patients (white: 71.4%; black: 54.5%; Asian: 51.9%; other: 53.3%); rates were similar across age groups (3 to <9 months: 60.5%; 9 to <24 months: 66.0%), baseline ISGA (mild: 65.4%; moderate: 63.1%) and baseline %BSA (≥19.0: 67.1%; <19.0: 61.2%). All TEAEs but 1 were mild or moderate. The incidence of treatment-related AEs was higher for black patients (white: 15.5%; black: 27.3%; Asian: 14.8%; other: 13.3%); rates were similar across age groups (3 to <9 months: 14.0%; 9 to <24 months: 17.0%), sex (male: 15.9%; female: 16.3%), baseline ISGA (mild: 17.3%; moderate: 14.3%), and baseline %BSA (≥19.0: 15.7%; <19.0: 16.4%). Treatment-related application site pain and application site discomfort were both reported across age groups (3 to <9 months: 0 and 0, respectively; 9 to <24 months: 5 [5.3%] and 4 [4.3%]), sexes (male: 4 [4.5%] and 2 [2.3%]; female: 1 [2.0%] and 2 [4.1%]), races (white: 3 [3.6%] and 3 [3.6%]; black: 1 [9.1%] and 0; Asian: 1 [3.7%] and 0; other: 0 and 1 [6.7%]), baseline ISGA (mild: 3 [5.8%] and 3 [5.8%]; moderate: 2 [2.4%] and 1 [1.2%]), and baseline %BSA <19.0 (≥19.0: 1 [1.4%] and 1 [1.4%]; <19.0: 4 [6.0%] and 3 [4.5%]). It should be noted that all AEs were reported by the caregiver or investigator observations. Overall, crisaborole was well tolerated in infants aged 3 to <24 months with mild-to-moderate AD across age groups, sex, race, and baseline disease severity (baseline ISGA and baseline %BSA).

Presenting Author(s)

Julie S. Shepard

Principal Investigator for Clinical Trials
Ohio Pediatric Research Association, Dayton, OH, USA
Dayton, Ohio
Disclosure: Pfizer Inc. (Grant/Research Support, Compensated as a principal investigator for this study and was also compensated to serve on an advisory board.)

Co-Author(s)

JS

Joel Schlessinger

Board-Certified Dermatologist and Cosmetic Surgeon
Advanced Skin Research Center, Omaha, NE, USA
Omaha, Nebraska
Disclosure: No Financial Relationships Disclosed
Richard G. Gower

Allergist-Immunologist
Marycliff Clinical Research, Spokane, WA, USA
Spokane, Washington
Disclosure: Pfizer Inc. (Consultant, Grant/Research Support)
John C. Su

Department of Paediatrics
Murdoch Children’s Research Institute, University of Melbourne, Melbourne, VIC, Australia and Department of Dermatology, Monash University, Eastern Health, Melbourne, VIC, Australia
Melbourne, Victoria, Australia
Disclosure: AbbVie (Grant/Research Support)Amgen (Grant/Research Support)Ego Pharmaceuticals (Honorarium)Eli Lilly (Grant/Research Support, Honorarium)GlaxoSmithKline (Honorarium)Janssen (Grant/Research Support, Honorarium)L’Oréal (Honorarium)Novartis (Grant/Research Support, Honorarium)Pfizer Inc. (Grant/Research Support, Honorarium)Pierre Fabre (Grant/Research Support, Honorarium)Sanofi (Grant/Research Support, Honorarium)
CL

Charles Lynde

Department of Medicine, Lynde Institute for Dermatology
University of Toronto, Department of Medicine, Lynderm Research Inc., Markham, ON, Canada
Toronto, Ontario, Canada
Disclosure: AbbVie (Consultant, Grant/Research Support, Served as a principal investigator, consultant, and/or speaker)Bausch Health (Valeant) (Consultant, Grant/Research Support, Served as a principal investigator, consultant, and/or speaker)Celgene (Consultant, Grant/Research Support, Served as a principal investigator, consultant, and/or speaker)Eli Lilly (Consultant, Grant/Research Support, Served as a principal investigator, consultant, and/or speaker)Janssen (Consultant, Grant/Research Support, Served as a principal investigator, consultant, and/or speaker)LEO Pharma (Consultant, Grant/Research Support, Served as a principal investigator, consultant, and/or speaker)Novartis (Consultant, Grant/Research Support, Served as a principal investigator, consultant, and/or speaker)Pfizer Inc. (Consultant, Grant/Research Support, Served as a principal investigator, consultant, and/or speaker)
AC

Amy Cha

Global Medical Affairs
Pfizer Inc., New York, NY, USA
New York, New York
Disclosure: Pfizer Inc. (Employee, Stockholder/Ownership Interest (excluding diversified mutual funds))
DG

Daniela Graham

Global Clinical Development
Pfizer Inc., Groton, CT, USA
Groton, Connecticut
Disclosure: Pfizer Inc. (Employee, Stockholder/Ownership Interest (excluding diversified mutual funds))
LT

Liza Takiya

Medical Affairs
Pfizer Inc., Collegeville, PA, USA
Collegeville, Pennsylvania
Disclosure: Pfizer Inc. (Employee, Stockholder/Ownership Interest (excluding diversified mutual funds))
John L. Werth

Clinical Development and Operations
Pfizer Inc., Collegeville, PA, USA
Collegeville, Pennsylvania
Disclosure: Pfizer Inc. (Employee, Stockholder/Ownership Interest (excluding diversified mutual funds))
CZ

Chuanbo Zang

Biostatistics
Pfizer Inc., Collegeville, PA, USA
Collegeville, Pennsylvania
Disclosure: Pfizer Inc. (Employee, Stockholder/Ownership Interest (excluding diversified mutual funds))
BV

Bonnie Vlahos

Global Clinical Development
Pfizer Inc., Collegeville, PA, USA
Collegeville, Pennsylvania
Disclosure: Pfizer Inc. (Employee, Stockholder/Ownership Interest (excluding diversified mutual funds))