Efficacy of Dupilumab in Atopic Dermatitis: The Patient's Perspective

Marjolein de Bruin-Weller; Joseph F Merola; Chih-Ho Hong; Esther Serra Baldrich; Karel Ettler; Debra Sierka; Dimittri Delevry; Zhen Chen; Ana B Rossi

doi:10.1007/s13555-021-00621-w

Efficacy of Dupilumab in Atopic Dermatitis: The Patient's Perspective

Dermatol Ther (Heidelb). 2021 Dec;11(6):2123-2131. doi: 10.1007/s13555-021-00621-w. Epub 2021 Nov 12.

Authors

Marjolein de Bruin-Weller¹, Joseph F Merola², Chih-Ho Hong^{3

4}, Esther Serra Baldrich⁵, Karel Ettler⁶, Debra Sierka⁷, Dimittri Delevry⁸, Zhen Chen⁸, Ana B Rossi⁹

Affiliations

¹ Department of Dermatology and Allergology, National Expertise Center of Atopic Dermatitis, University Medical Center, Utrecht, The Netherlands.
² Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
³ Department of Dermatology and Skin Science, University of British Columbia, Surrey, BC, Canada.
⁴ Probity Medical Research, Waterloo, ON, Canada.
⁵ Hospital Sant Pau, Universitat Autonoma Barcelona, Barcelona, Spain.
⁶ University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.
⁷ Sanofi Genzyme, Cambridge, MA, USA.
⁸ Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
⁹ Sanofi Genzyme, Cambridge, MA, USA. Ana.Rossi@sanofi.com.

Abstract

Introduction: Atopic dermatitis (AD), a predominantly type 2 inflammatory skin disease, affects approximately 2-5% of adults, with a high burden of disease. In moderate-to-severe AD, lesions can be extensive and pruritus intense with patients experiencing skin pain, sleep and mental health disturbances, and diminished quality of life (QoL).

Methods: The objective of this study was to evaluate the efficacy of dupilumab for the treatment of AD from the patients' perspective using patient-reported outcome data from four clinical trials (CHRONOS, SOLO 1&2, and CAFÉ) in patients (N = 1553) receiving either the approved 300 mg q2w dupilumab with/without topical corticosteroids (TCS) dose or control (placebo or placebo + TCS). Patient Global Assessment of Disease Status (PGADS) was used to measure patients' well-being and Patient Global Assessment of Treatment Effect (PGATE) was used to measure treatment efficacy. Patients were asked "Considering all the ways in which your eczema affects you, indicate how well you are doing" to assess their perception of well-being and "How would you rate the way your eczema responded to the study medication?" to assess their perception of treatment effect. Possible responses for both metrics included poor, fair, good, very good, and excellent.

Results: In all four studies, a significantly higher proportion of dupilumab-treated patients reported "Good"/"Very Good"/"Excellent" disease status from week 2 through study end versus control (CHRONOS, 52 weeks: 69.8% vs. 25.1%; SOLO 1&2, 16 weeks: 59.5% vs. 24.6%; CAFÉ, 16 weeks: 84.1% vs. 45.4%; all P < 0.0001), and significantly more dupilumab-treated patients reported "Good"/"Very Good"/"Excellent" treatment efficacy versus control (CHRONOS: 72.6% vs. 24.8%; SOLO 1&2: 65.0% vs. 21.1%; CAFÉ, 16 weeks: 85.0% vs. 36.1%; all P < 0.0001).

Conclusion: Adult patients with AD perceived that dupilumab with/without concomitant TCS was highly efficacious and improved overall disease status and well-being as early as week 2 and throughout treatment periods up to 1 year. Video Abstract (MP4 90521 kb).

Keywords: Atopic dermatitis; Dupilumab; Patient perception; Patient-reported outcomes; Treatment efficacy.