P0312 - Efficacy and safety of crisaborole in patients aged 3 months to 17 years with mild-to-moderate atopic dermatitis

Crisaborole ointment, 2%, is a nonsteroidal, anti-inflammatory phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). We report the efficacy and safety of crisaborole in pediatric patients from the phase 4 study CrisADe CARE 1 (NCT03356977) and the phase 3 studies CrisADe CORE 1 (AD-301; NCT02118766) and CrisADe CORE 2 (AD-302; NCT02118792). Patients aged 3 to <24 months (CARE 1) or ≥2 years (CORE 1/CORE 2) with mild-to-moderate AD received twice-daily crisaborole (or vehicle in CORE 1/CORE 2) for 28 days. Safety was the primary endpoint in the CARE 1 study. ISGA success (defined as clear [0] or almost clear [1] with a ≥2-grade improvement from baseline) at day 29 was an exploratory endpoint in the CARE 1 study and the primary endpoint in the CORE 1/CORE 2studies. The CARE 1 study population consisted of 137 infants (mean age, 13.6 months [SD, 6.42]; 64.2% male; mean ISGA, 2.6 [SD, 0.50]). In the CORE 1/CORE 2 studies, 1016 patients were treated with crisaborole; 874 were aged 2-17 years and included in this analysis (age groups: 2 to <7 years [38.3%], 7 to <12 years [33.4%], 12 to <18 years [28.3%]; 46.7% male; ISGA mild [38.1%], ISGA moderate [61.9%]). In the CARE 1 study, 30.2% of patients achieved ISGA success at day 29, consistent with the rate of ISGA success (32.5%) observed for pediatric patients treated with crisaborole in the CORE 1/CORE 2 studies. ISGA clear or almost clear at day 29 was achieved by 47.3%% in CARE 1 and 50.5% of the pediatric crisaborole patients in CORE 1/CORE 2. The most common treatment-related AE across the studies was application site pain which occurred in 3.6% of patients in CARE 1 and 4.4% in pediatric crisaborole-treated patients in CORE 1/CORE 2; most events were mild or moderate. Application site discomfort was also reported in 2.9% of patients in CARE 1. In total, 2.9% of patients in CARE 1 and 1.5% of pediatric crisaborole-treated patients in CORE 1/CORE 2 discontinued study drug due to an AE. The results of all the studies show that crisaborole was well tolerated and effective in patients aged ≥3 months to 17 years with mild-to-moderate AD.

Presenting Author(s)

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)

Co-Author(s)

LS

Lynda J. Spelman

Principal Investigator of Veracity Clinical Research
Veracity Clinical Research, Woolloongabba, QLD, Australia
Woolloongabba, Queensland, Australia
Disclosure: Abbott (Grant/Research Support, Received sponsor travel (no grant/research support))AbbVie (Grant/Research Support, Served on advisory board and as an investigator)Amgen (Grant/Research Support, Served as an investigator)Anacor (Grant/Research Support, Served as an investigator)Ascend Biopharmaceuticals (Grant/Research Support, Served as an investigator)Astellas (Grant/Research Support, Served as an investigator)Australian Wool Innovation Limited (Grant/Research Support, Served as an investigator)Blaze Bioscience (Grant/Research Support, Served as an investigator)Bristol-Myers Squibb (Grant/Research Support, Served as an investigator)Celgene (Grant/Research Support, Served as an investigator)Demira (Grant/Research Support, Served as an investigator)Eli Lilly (Grant/Research Support, Served on advisory board and as an investigator)Galderma (Grant/Research Support, Served on advisory board and as an investigator)Genentech (Grant/Research Support, Served as an investigator)GlaxoSmithKline (Grant/Research Support, Served as an investigator)Janssen (Grant/Research Support, Served on advisory board and as an investigator; received sponsored travel)Kythera (Grant/Research Support, Served as an investigator)LEO Pharma (Grant/Research Support, Served as an investigator)Merck (Grant/Research Support, Served as an investigator)Novartis (Grant/Research Support, Served on advisory board and as an investigator; received sponsored travel)Phosphagenics (Grant/Research Support, Served as an investigator)Regeneron (Grant/Research Support, Served as an investigator)Sun Pharmaceuticals (Grant/Research Support, Served as an investigator)Trius (Grant/Research Support, Served as an investigator)
Lawrence F. Eichenfield

Professor of Dermatology and Pediatrics; Chief of pediatric and adolescent dermatology; Vice Chair, Dept of Dermatology
UC San Diego School of Medicine and Rady Children's Hospital-San Diego San Diego, CA, USA
San Diego, California
Disclosure: AbbVie (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Almirall (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Amgen (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Asana Biosciences (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Cutanea (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Dermavant (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Dermira (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)DS Biopharma (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Eli Lilly (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Forte Pharma (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Galderma (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Glenmark (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Incyte (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)LEO Pharma (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Matrisys Bioscience (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Novartis (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Ortho Dermatologics/Valeant (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Pfizer Inc. (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Regeneron (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)Sanofi Genzyme (Consultant, Grant/Research Support, Scientific advisor, consultant, and/or clinical study investigator)
LS

Linda F. Stein Gold

Director of Dermatology Clinical Research at Henry Ford Health System
as well as Division Head of Dermatology at Henry Ford Health System, Detroit, MI, USA
Detroit, Michigan
Disclosure: Incyte (Grant/Research Support)LEO Pharma (Grant/Research Support, Grants and payment for lectures)Pfizer Inc. (Grant/Research Support, Grants and payment for lectures)
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))