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Dermatol Ther (Heidelb). 2021 Dec;11(6):2147-2157. doi: 10.1007/s13555-021-00630-9. Epub 2021 Oct 29.

Dupilumab Treatment Provides Sustained Improvements Over 2 Years in Symptoms and Quality of Life in Adults with Atopic Dermatitis.

Dermatology and therapy

Gil Yosipovitch, Marjolein de Bruin-Weller, April Armstrong, Jashin J Wu, Pedro Herranz, Diamant Thaçi, Dimittri Delevry, Gaëlle Bégo-Le Bagousse, Raymond Zhang, Brad Shumel, Ana B Rossi, Jingdong Chao

Affiliations

  1. Department of Dermatology and Itch Center, University of Miami Miller School of Medicine, Miami, FL, USA.
  2. National Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.
  3. Department of Dermatology, Keck School of Medicine at USC, University of Southern California, Los Angeles, CA, USA.
  4. Dermatology Research and Education Foundation, Irvine, CA, USA.
  5. Department of Dermatology, La Paz University Hospital, Madrid, Spain.
  6. Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
  7. Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.
  8. Sanofi, Chilly Mazarin, France.
  9. Sanofi Genzyme, Cambridge, MA, USA.
  10. Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA. [email protected].

PMID: 34714527 PMCID: PMC8611171 DOI: 10.1007/s13555-021-00630-9

Abstract

INTRODUCTION: Atopic dermatitis (AD) can have a profound negative impact on the quality of life (QoL) of patients. We analyzed the long-term changes in AD symptoms, QoL, and patient assessment of treatment effect in adults with moderate-to-severe AD treated for 2 years with dupilumab.

METHODS: LIBERTY AD OLE (NCT01949311) is a multicenter, open-label extension (OLE) study in adults with moderate-to-severe AD who previously participated in dupilumab clinical trials (parent studies). Patients received dupilumab 300 mg weekly. Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), EQ-5D-3L, and the Patient Global Assessment of Treatment Effect (PGATE) were assessed at weeks 48 and 100.

RESULTS: A total of 2677 patients were included in the OLE, and 1028 completed week 100. By weeks 48 and 100, 94.1% and 95.6% of patients achieved a ≥ 4-point change in POEM from the parent study baseline (PSBL), respectively, and 93.3% and 93.4% of patients had achieved a ≥ 4-point change in DLQI from PSBL, respectively. At week 100, 35.1% of patients had a POEM score ≤ 2 (AD clear/almost clear) compared with 0.1% at PSBL, and 49.9% had a DLQI score of 0 or 1 (no effect at all on patient's life) compared with 1.5% at PSBL. At week 100, 74.5-97.3% of patients reported no effect of AD on the individual EQ-5D-3L domains, and 93.8% rated the effect of dupilumab treatment as "excellent," "very good," or "good" according to PGATE.

CONCLUSION: In adults with moderate-to-severe AD, dupilumab treatment over 2 years resulted in sustained improvements in patient-reported symptoms and QoL and a favorable patient perception of treatment effect.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01949311. Supplementary material 1 (MP4 552250 kb).

© 2021. The Author(s).

Keywords: Adult; Atopic dermatitis; Clinical trial; Dermatology Life Quality Index; Dupilumab; EQ-5D; Efficacy; Long term; Patient-oriented eczema measure; Patient-reported outcomes

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