TY - JOUR
T1 - Efficacy and safety of crisaborole in patients with mild-tomoderate atopic dermatitis and other atopic comorbidities
AU - Spergel, Jonathan M.
AU - Blaiss, Michael S.
AU - Lio, Peter
AU - Kessel, Aharon
AU - Cantrell, Wendy C.
AU - Takiya, Liza
AU - Werth, John L.
AU - O'Connell, Michael A.
AU - Zang, Chuanbo
AU - Cork, Michael J.
N1 - Funding Information:
From the 1Division of Allergy and Immunology, Department of Pediatrics, Children's has received financial compensation for the development of educational presentations from Rafa Hospital of Philadelphia, Perelman School of Medicine at University of Pennsylvania, and Takeda. W.C. Cantrell has received consulting fees or honoraria from LEO Pharma and Philadelphia, Pennsylvania; 2Department of Pediatrics, Medical College of Georgia at Sanofi Genzyme, and has served on an advisory board for Pfizer Inc. L. Takiya, J.L. Werth, M. Augusta University, Augusta, Georgia; 3Department of Dermatology and Pediatrics, A. O’Connell, and C. Zang are employees and stockholders of Pfizer Inc. M.J. Cork has served Northwestern University Feinberg School of Medicine, Chicago, Illinois; 4Chicago as a clinical trial investigator for Pfizer Inc., Astellas, Atopix, Galapagos NV, Harvey Water Integrative Eczema Center, Chicago, Illinois; 5Division of AllergyNOT and Clinical Softeners, Hyphens Pharma, Johnson & Johnson, Kymab, LEO Pharma, L’Oréal, Novartis, Immunology, Bnai Zion Medical Center, Haifa, Israel; 6The Ruth and Bruce Oxagen, Perrigo, Reckitt Benckiser, Regeneron, and Sanofi Genzyme; and has served as a con-Rappaport Faculty of Medicine, Technion, Haifa, Israel, 7Village Dermatology, sultant for Pfizer Inc., Astellas, Atopix, Boots, Dermavant, Eli Lilly, Galapagos, Galderma, Birmingham, Alabama; 8Medical Affairs, Pfizer Inc., Collegeville, Pennsylvania; and Harvey Water Softeners, Hyphens Pharma, Johnson & Johnson, Kymab, LEO Pharma, 9Department of Infection, Immunity, and Cardiovascular Disease, Sheffield L’Oréal, Menlo Therapeutics, Novartis, Oxagen, Perrigo, Procter & Gamble, Reckitt Dermatology Research, University of Sheffield, Sheffield Children’s Hospital, Sheffield, Benckiser, Regeneron, Sanofi Genzyme, and UCB Pharma. United Kingdom Presented, in part, as electronic posters at the 2020 American College of Allergy, Asthma & This study was funded by Pfizer Inc. Immunology 2020 Annual Scientific Meeting, November 13–15, 2020; the 2021 Winter J.M. Spergel has received research grants from Food Allergy Research and Education, the Clinical Dermatology Conference, January 16–24, 2021; the 2021 Maui Derm Meeting,
Funding Information:
PfizerInc.,DBVTechnologies,NovNationalInstitutesofHealth,NovarDO artis,Sanofi,Regeneron,and Takeda;receivedroyalties Annual Meeting, February26–March1,2021.Allmeetings wereheldvirtually.tis,andSanofi-Regeneron;hasservedasaconsultantforJanuary25–29, 2021;andthe2021AmericanAcademyofAllergyAsthma&Immunology from UpToDate; and has served as a member of the Data Safety and Monitoring Board for Medical writing and editorial assistance under the guidance of the authors was provided Alladapt and the National Institutes of Health. M.S. Blaiss has served as a consultant for ALK, by Stephanie Agbu, Ph.D., and Robert J. Schoen, Pharm.D., of ApotheCom, San Covis Pharma, and Merck; and has received consulting fees or honoraria from Pfizer Inc. and Francisco, California, and was funded by Pfizer Inc., New York, New York, in accord-Sanofi-Regeneron. P. Lio has received research grants from Pfizer Inc., AbbVie, AOBiome, and ance with Good Publication Practice guidelines (Battisti WP, Wager E, Baltzer L, et al. Sanofi-Regeneron; has served on consulting/advisory boards for AbbVie, Altus Labs, Amyris, Good Publication Practice for Communicating Company-Sponsored Medical Research: AOBiome, Arbonne, Bodewell, Burt’s Bees, Dermavant, Eli Lilly, Exeltis, Galderma, GPP3. Ann Intern Med. 2015; 163:461–464). IntraDerm, Johnson & Johnson, LEO Pharma, L’Oréal, Menlo Therapeutics, Micreos, Pierre Supplemental data available at www.IngentaConnect.com Fabre, Realm Therapeutics, Sanofi-Regeneron, Theraplex, Unilever, and Verrica Address correspondence to Liza Takiya, Pharm.D., Pfizer Inc. 500 Arcola Dr., F5217, Pharmaceuticals; has served on speaker bureaus for Pfizer Inc., Eli Lilly, Galderma, LEO Collegeville, PA 19426 Pharma, and Sanofi-Regeneron; has a patent pending with royalties paid by Theraplex; has E-mail address: liza.takiya@pfizer.com served as a board and scientific advisory committee member of the National Eczema Copyright © 2021, OceanSide Publications, Inc., U.S.A. Association; and is a stockholder of Altus Labs and Micreos. A. Kessel has served on an advisory board for and received honoraria from Pfizer Inc.; has served on speaker bureaus for AstraZeneca, GlaxoSmithKline, Kamada, Novartis, Rafa, Sanofi Genzyme, and Takeda; and
Publisher Copyright:
Copyright © 2021, OceanSide Publications, Inc., U.S.A.
PY - 2021/9/1
Y1 - 2021/9/1
N2 - Background: Crisaborole is a nonsteroidal anti-inflammatory phosphodiesterase 4 inhibitor that is approved for the treatment of patients with mild-to-moderate atopic dermatitis (AD); however, the efficacy and safety of crisaborole in patients with AD and other atopic comorbidities have not been investigated. Objective: This post hoc pooled analysis of the pivotal phase III studies (CrisADe CORE 1 and CORE 2) assessed the efficacy and safety of crisaborole versus vehicle in patients aged ≥ 2 years with mild-to-moderate AD and other atopic comorbidities. Methods: Patients with mild-to-moderate AD and a medical history of asthma, allergic rhinitis, or food allergies were identified. Efficacy assessments included the proportion of patients who achieved Investigator's Static Global Assessment (ISGA) success at day 29, ISGA clear or almost clear at day 29, and improvement in the Severity of Pruritus Scale score at week 4. Safety was assessed via treatment-emergent adverse events (TEAEs). Results: This analysis included 1522 patients (crisaborole, 1016; vehicle, 506); 26.2, 15.9, and 16.5% had a medical history of asthma, allergic rhinitis, and food allergies, respectively. The mean age was 12.2 years. A significantly greater proportion of patients treated with crisaborole achieved ISGA success at day 29 compared with patients treated with vehicle for most subgroups analyzed. Furthermore, a significantly greater proportion of patients treated with crisaborole achieved ISGA clear or almost clear at day 29 across all subgroups and demonstrated improvement in the Severity of Pruritus Scale score at week 4 versus patients treated with vehicle in most of the subgroups. Overall,most TEAEs weremild ormoderate in severity; themost common treatment-related TEAE in patients with atopic comorbiditieswas application-site pain (crisaborole, 5.1%; vehicle, 1.7%). Conclusion: Crisaborole was efficacious and well tolerated in patients with mild-to-moderate AD and other atopic comorbidities, which suggested that crisaborole should be considered for the management of AD in this population.
AB - Background: Crisaborole is a nonsteroidal anti-inflammatory phosphodiesterase 4 inhibitor that is approved for the treatment of patients with mild-to-moderate atopic dermatitis (AD); however, the efficacy and safety of crisaborole in patients with AD and other atopic comorbidities have not been investigated. Objective: This post hoc pooled analysis of the pivotal phase III studies (CrisADe CORE 1 and CORE 2) assessed the efficacy and safety of crisaborole versus vehicle in patients aged ≥ 2 years with mild-to-moderate AD and other atopic comorbidities. Methods: Patients with mild-to-moderate AD and a medical history of asthma, allergic rhinitis, or food allergies were identified. Efficacy assessments included the proportion of patients who achieved Investigator's Static Global Assessment (ISGA) success at day 29, ISGA clear or almost clear at day 29, and improvement in the Severity of Pruritus Scale score at week 4. Safety was assessed via treatment-emergent adverse events (TEAEs). Results: This analysis included 1522 patients (crisaborole, 1016; vehicle, 506); 26.2, 15.9, and 16.5% had a medical history of asthma, allergic rhinitis, and food allergies, respectively. The mean age was 12.2 years. A significantly greater proportion of patients treated with crisaborole achieved ISGA success at day 29 compared with patients treated with vehicle for most subgroups analyzed. Furthermore, a significantly greater proportion of patients treated with crisaborole achieved ISGA clear or almost clear at day 29 across all subgroups and demonstrated improvement in the Severity of Pruritus Scale score at week 4 versus patients treated with vehicle in most of the subgroups. Overall,most TEAEs weremild ormoderate in severity; themost common treatment-related TEAE in patients with atopic comorbiditieswas application-site pain (crisaborole, 5.1%; vehicle, 1.7%). Conclusion: Crisaborole was efficacious and well tolerated in patients with mild-to-moderate AD and other atopic comorbidities, which suggested that crisaborole should be considered for the management of AD in this population.
UR - http://www.scopus.com/inward/record.url?scp=85114427903&partnerID=8YFLogxK
U2 - 10.2500/aap.2021.42.210064
DO - 10.2500/aap.2021.42.210064
M3 - Article
C2 - 34474712
AN - SCOPUS:85114427903
SN - 1088-5412
VL - 42
SP - 425
EP - 431
JO - Allergy and Asthma Proceedings
JF - Allergy and Asthma Proceedings
IS - 5
ER -