TY - JOUR
T1 - Real-World Effectiveness of Dupilumab in Atopic Dermatitis Patients
T2 - Analysis of an Electronic Medical Records Dataset
AU - Eichenfield, Lawrence F.
AU - Armstrong, April
AU - Guttman-Yassky, Emma
AU - Lio, Peter A.
AU - Chen, Chi Chang
AU - Hines, Dionne M.
AU - McGuiness, Catherine B.
AU - Ganguli, Sohini
AU - Delevry, Dimittri
AU - Sierka, Debra
AU - Mallya, Usha G.
N1 - Funding Information:
This study was funded by Regeneron Pharmaceuticals, Inc. and Sanofi. The Rapid Service Fee for this article was funded by Regeneron Pharmaceuticals, Inc. and Sanofi. The study sponsors participated in the study design collection, analysis, and interpretation of data; writing of the report; and the decision to submit the article for publication. Medical writing support was provided by E. Jay Bienen, PhD, and was funded by Regeneron Pharmaceuticals, Inc and Sanofi. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. All named authors (Lawrence F. Eichenfield, April Armstrong, Emma Guttman-Yassky, Peter A. Lio, Chi-Chang Chen, Dionne M. Hines, Catherine B. McGuiness, Sohini Ganguli, Dimittri Delevry, Debra Sierka, and Usha G. Mallya) contributed to the conception and design of the study, data analysis and interpretation, and drafting and revising of the manuscript for important intellectual content. All named authors approved the final version of the manuscript and agree to be accountable for all aspects of the work. This work was previously presented in part at the 24th World Congress of Dermatology (June 10–15, 2019) and the Society for Investigative Dermatology Annual Meeting (May 8–11, 2019). Lawrence F. Eichenfield has received honoraria for consulting services from Almirall, Celgene, Dermira, Dermavant, Eli Lilly and Company, Forté Biosciences, Galderma, Incyte, Glenmark, Leo Pharmaceuticals, Otsuka, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, and Valeant/Ortho Dermatologics; and study support (to institution) from AbbVie, Dermira, Dermavant, Eli Lilly and Company, Galderma, Incyte, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, and Ortho Dermatologics. April Armstrong has received consultancy honoraria from AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, and Pfizer; research funding from AbbVie, Eli Lilly and Janssen; and speaker honoraria from AbbVie. Emma Guttman-Yassky has acted as a consultant for and received grants/honoraria from AbbVie, Anacor, Celgene, Celsus Therapeutics, Dermira, Galderma, Glenmark, Janssen Biotech, LEO Pharmaceuticals MedImmune, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, Stiefel/GlaxoSmithKline, Vitae, Mitsubishi Tanabe, Eli Lilly, Asana Biosciences, Kiowa Kirin; has acted as an investigator for Celgene, Glenmark, Leo Pharmaceuticals, MedImmune, Regeneron Pharmaceuticals, Inc., Eli Lilly; and has participated in advisory boards for Celgene, Celsus Therapeutics, Dermira, Galderma, Glenmark, MedImmune, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, Stiefel/GlaxoSmithKline, Vitae and Asana Biosciences. Peter A. Lio reports research grants/funding from Regeneron/Sanofi Genzyme, and Abbvie; is on the speaker's bureau for Regeneron/Sanofi Genzyme, Pfizer, and Galderma; reports consulting/advisory boards for UCB, Dermavant, Regeneron/Sanofi Genzyme, Dermira, Pfizer, LEO Pharmaceuticals, AbbVie, Kiniksa, Eli Lilly, Menlo Therapeutics, Galderma, IntraDerm, Exeltis, Realm Therapeutics. Chi-Chang Chen, Dionne M. Hines, and Catherine B. McGuiness are employees of IQVIA, which received funding from Regeneron and Sanofi to conduct the study. Debra Sierka is an employee and stockholder of Sanofi. Sohini Ganguli and Usha G. Mallya were employees and stockholders of Sanofi at the time of study. Dimittri Delevry is an employee and stockholder of Regeneron. Since the study did not involve the collection, use, or transmittal of individual identifiable data, Institutional Review Board approval was not required. Not available; data are proprietary.
Funding Information:
This study was funded by Regeneron Pharmaceuticals, Inc. and Sanofi. The Rapid Service Fee for this article was funded by Regeneron Pharmaceuticals, Inc. and Sanofi. The study sponsors participated in the study design collection, analysis, and interpretation of data; writing of the report; and the decision to submit the article for publication.
Funding Information:
Medical writing support was provided by E. Jay Bienen, PhD, and was funded by Regeneron Pharmaceuticals, Inc and Sanofi.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/6
Y1 - 2022/6
N2 - Introduction: While the efficacy of dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) has been demonstrated in several clinical trials, patients in such trials may not necessarily reflect the real-world clinical practice setting. This study evaluated the real-world effectiveness of dupilumab in adults with moderate-to-severe AD based on physician global assessment, percent body surface area affected, and patient-reported itch. Methods: From Modernizing Medicine’s Electronic Medical Assistant dermatology-specific electronic medical records, adults (≥ 18 years) were identified with a diagnosis of AD and ≥ 1 dupilumab prescription (index event) between 1 April 2017 and 31 January 2019. Three cohorts were identified based on 3-month pre-index (1) Investigator Global Assessment (IGA) score ≥ 3, (2) an itch severity numerical rating scale (NRS) score ≥ 3, and (3) body surface area (BSA) affected ≥ 10%. Changes from pre-index on the outcome within each cohort were evaluated at 4 months post-index. Patients were also stratified for evaluation of outcomes by baseline demographic (sex, age) and prior AD treatments (topical therapy only or no treatment, any systemic therapy). Results: More than 70% of the 435 AD patients with baseline IGA score ≥ 3 improved to an IGA score of ≤ 2 at month 4 post-dupilumab initiation, including 42.8% who achieved IGA 0/1 (clear/minimal). Among 112 patients with a pre-index itch severity NRS ≥ 3, scores were reduced from mean (SD) 7.0 (2.4) pre-index to 2.8 (2.8) at month 4 (p < 0.0001); 70.5% of patients had a reduction ≥ 3 points. In the BSA cohort (n = 387), affected BSA was significantly reduced from a pre-index mean (SD) of 39.3% (26.1%) to 16.3% (21.2%) at month 4 (p < 0.0001). Significant improvements in IGA, itch NRS, and BSA were observed regardless of demographic (age and sex) or clinical characteristics such as treatment history (all p < 0.0001 compared with pre-index). Conclusions: Consistent with outcomes observed in clinical trials, patients treated with dupilumab in real-world clinical settings achieved clinically meaningful improvements in severity and extent of AD and severity of itch comparable to those reported in clinical trials at a similar time point.
AB - Introduction: While the efficacy of dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) has been demonstrated in several clinical trials, patients in such trials may not necessarily reflect the real-world clinical practice setting. This study evaluated the real-world effectiveness of dupilumab in adults with moderate-to-severe AD based on physician global assessment, percent body surface area affected, and patient-reported itch. Methods: From Modernizing Medicine’s Electronic Medical Assistant dermatology-specific electronic medical records, adults (≥ 18 years) were identified with a diagnosis of AD and ≥ 1 dupilumab prescription (index event) between 1 April 2017 and 31 January 2019. Three cohorts were identified based on 3-month pre-index (1) Investigator Global Assessment (IGA) score ≥ 3, (2) an itch severity numerical rating scale (NRS) score ≥ 3, and (3) body surface area (BSA) affected ≥ 10%. Changes from pre-index on the outcome within each cohort were evaluated at 4 months post-index. Patients were also stratified for evaluation of outcomes by baseline demographic (sex, age) and prior AD treatments (topical therapy only or no treatment, any systemic therapy). Results: More than 70% of the 435 AD patients with baseline IGA score ≥ 3 improved to an IGA score of ≤ 2 at month 4 post-dupilumab initiation, including 42.8% who achieved IGA 0/1 (clear/minimal). Among 112 patients with a pre-index itch severity NRS ≥ 3, scores were reduced from mean (SD) 7.0 (2.4) pre-index to 2.8 (2.8) at month 4 (p < 0.0001); 70.5% of patients had a reduction ≥ 3 points. In the BSA cohort (n = 387), affected BSA was significantly reduced from a pre-index mean (SD) of 39.3% (26.1%) to 16.3% (21.2%) at month 4 (p < 0.0001). Significant improvements in IGA, itch NRS, and BSA were observed regardless of demographic (age and sex) or clinical characteristics such as treatment history (all p < 0.0001 compared with pre-index). Conclusions: Consistent with outcomes observed in clinical trials, patients treated with dupilumab in real-world clinical settings achieved clinically meaningful improvements in severity and extent of AD and severity of itch comparable to those reported in clinical trials at a similar time point.
KW - Atopic dermatitis
KW - Body surface area affected
KW - Dupilumab
KW - Investigator global assessment
KW - Itch
KW - Real-world effectiveness
UR - http://www.scopus.com/inward/record.url?scp=85129811186&partnerID=8YFLogxK
U2 - 10.1007/s13555-022-00731-z
DO - 10.1007/s13555-022-00731-z
M3 - Article
AN - SCOPUS:85129811186
SN - 2190-9172
VL - 12
SP - 1337
EP - 1350
JO - Dermatology and Therapy
JF - Dermatology and Therapy
IS - 6
ER -