Real-World Effectiveness of Dupilumab in Atopic Dermatitis Patients: Analysis of an Electronic Medical Records Dataset

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; Usha G Mallya

doi:10.1007/s13555-022-00731-z

Real-World Effectiveness of Dupilumab in Atopic Dermatitis Patients: Analysis of an Electronic Medical Records Dataset

Dermatol Ther (Heidelb). 2022 Jun;12(6):1337-1350. doi: 10.1007/s13555-022-00731-z. Epub 2022 May 11.

Authors

Affiliations

¹ Departments of Dermatology and Pediatrics, University of California, San Diego School of Medicine, 3020 Children's Way, Mail Code 5092, San Diego, CA, 92123, USA. leichenfield@ucsd.edu.
² Department of Dermatology, Keck School of Medicine at University of Southern California, Los Angeles, CA, USA.
³ Mount Sinai Health System, New York, NY, USA.
⁴ Northwestern University, Chicago, IL, USA.
⁵ , Plymouth Meeting, PA, USA.
⁶ Sanofi, Cambridge, MA, USA.
⁷ Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.

Abstract

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.

Keywords: Atopic dermatitis; Body surface area affected; Dupilumab; Investigator global assessment; Itch; Real-world effectiveness.