Dupilumab Demonstrates Rapid Onset of Action in Improving Signs, Symptoms and Quality of Life in Adults with Atopic Dermatitis

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Matthias Augustin - , University Hospital Hamburg Eppendorf (Author)
  • Andrea Bauer - , Department of Dermatology, University Allergy Centre (Author)
  • Konstantin Ertner - , Practice Dr. Med. Konstantin Ertner (Author)
  • Ralph von Kiedrowski - , Company for Medical Study and Service Selters (Author)
  • Florian Schenck - , Dermatology Center Hannover (Author)
  • Jutta Ramaker-Brunke - , Wehrmann Dermatological Group Practice (Author)
  • Sophie Möller - , Sanofi-Aventis (Author)
  • Anja Fait - , Sanofi-Aventis (Author)
  • Mike Bastian - , Sanofi-Aventis (Author)
  • Diamant Thaçi - , University of Music Lübeck (Author)

Abstract

INTRODUCTION: Dupilumab has significantly improved the signs, symptoms and quality of life (QoL) of patients with moderate-to-severe atopic dermatitis (AD) in randomised, controlled clinical trials. However, there is a need to assess the effectiveness and safety of dupilumab in real-world clinical practice. The PROLEAD study was designed to examine the effectiveness and safety of dupilumab in moderate-to-severe AD in a real-world setting in Germany. Here, we present 12-week effectiveness and safety results with dupilumab from PROLEAD.

METHODS: PROLEAD is a multicentre, prospective, non-interventional study being conducted at 126 routine care sites across Germany. Adults with moderate-to-severe AD who require systemic therapy were treated with dupilumab as indicated by the Summary of Product Characteristics. Data collected included physician assessments (EASI, BSA, SCORAD, and IGA) and patient-reported outcomes (PROs [POEM, DLQI, EQ-5D-5L, Peak Pruritus NRS and MOS Sleep Scale]).

RESULTS: Of 839 patients assessed for eligibility, 828 were included. The full analysis and safety analysis sets comprised 775 and 818 patients, respectively. The number of patients receiving concomitant therapy decreased from baseline to Week 12. Mean (standard deviation [SD]) percentage change in EASI score from baseline to Week 12 was -67.5% (48.4%) and was comparable across the four body regions. The proportion of patients achieving EASI-75 was 59.4% at Week 12. Mean (SD) Peak Pruritus NRS decreased from 7.4 (2.3) at baseline to 3.4 (2.6) at Week 12. Improvements from baseline to Week 12 were reported in all PROs assessed. No new safety signals were observed.

DISCUSSION: Improvements in efficacy outcomes and adverse event rates in a real-world setting were more favourable than in phase 3 clinical trials.

CONCLUSIONS: The 12-week findings of PROLEAD demonstrate that treatment with dupilumab is effective and well tolerated, with rapid onset of action in signs, symptoms and QoL in patients with moderate-to-severe AD in the real world.

TRIAL REGISTRATION NUMBER: DUPILL08907; NIS-Nr. 433.

Details

Original languageEnglish
Pages (from-to)803-816
Number of pages14
JournalDermatology and therapy
Volume13
Issue number3
Publication statusPublished - Mar 2023
Peer-reviewedYes

External IDs

PubMedCentral PMC9984619
Scopus 85147378690
ORCID /0000-0002-4411-3088/work/148145495

Keywords