Michael J Cork1, Laurent Eckert2, Eric L Simpson3, April Armstrong4, Sébastien Barbarot5, Luis Puig6, Giampiero Girolomoni7, Marjolein de Bruin-Weller8, Andreas Wollenberg9, Yoko Kataoka10, Anita Remitz11, Stefan Beissert12, Vera Mastey13, Marius Ardeleanu13, Zhen Chen13, Abhijit Gadkari13, Jingdong Chao13. 1. Sheffield Dermatology Research, Department of Infection and Immunity, University of Sheffield Medical School, Beech Hill, Sheffield, UK. 2. Sanofi, Chilly-Mazarin, France. 3. Department of Dermatology, Oregon Health & Science University, Portland, OR, USA. 4. Department of Dermatology, Keck School of Medicine at USC, University of Southern California, Los Angeles, CA, USA. 5. Department of Dermatology, CHU Hôtel-Dieu, Nantes, France. 6. Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain. 7. Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy. 8. University Medical Center Utrecht, Utrecht, The Netherlands. 9. Klinikum der Universität München, Klinik und Poliklinik für Dermatologie und Allergologie, Munich, Germany. 10. Department of Dermatology, Osaka Habikino Medical Center, Habikino City, Osaka, Japan. 11. Helsinki University Central Hospital, Helsinki, Finland. 12. Department of Dermatology, Technische Universität Dresden, Dresden, Germany. 13. Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Abstract
Background: Atopic dermatitis (AD) profoundly affects quality of life (QoL). Dupilumab significantly improves clinical outcomes, is well tolerated, and approved to treat inadequately controlled moderate-to-severe AD in adults; however, its effect on patient-reported outcomes (PROs) is not fully characterized.Objective: To evaluate the impact of dupilumab on patient-reported AD symptoms and QoL. Methods: Pooled data were analyzed from two identically designed phase 3 studies, LIBERTY AD SOLO 1 (NCT02277743) and SOLO 2 (NCT02277769), assessing the following PROs: Peak Pruritus Numerical Rating Scale (NRS), Pruritus Categorical Scale, SCORing AD (SCORAD), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), five-dimension EuroQoL questionnaire (EQ-5D), and patient-assessed disease status and treatment effectiveness. Results:Dupilumab rapidly improved (vs. placebo) Peak Pruritus NRS scores by day 2 (p < .05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 (p < .0001). At week 16, more dupilumab-treated than placebo-treated patients reported improvement in SCORAD itch and sleep, and no pain/discomfort (EQ-5D) (p < .0001).Limitations: Cultural differences of translated PROs. Conclusion:Dupilumab had a significant, positive impact on AD symptoms, including itch, sleep, pain, anxiety and depression, and QoL in adults with moderate-to-severe AD.
RCT Entities:
Background: Atopic dermatitis (AD) profoundly affects quality of life (QoL). Dupilumab significantly improves clinical outcomes, is well tolerated, and approved to treat inadequately controlled moderate-to-severe AD in adults; however, its effect on patient-reported outcomes (PROs) is not fully characterized.Objective: To evaluate the impact of dupilumab on patient-reported AD symptoms and QoL. Methods: Pooled data were analyzed from two identically designed phase 3 studies, LIBERTY AD SOLO 1 (NCT02277743) and SOLO 2 (NCT02277769), assessing the following PROs: Peak Pruritus Numerical Rating Scale (NRS), Pruritus Categorical Scale, SCORing AD (SCORAD), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), five-dimension EuroQoL questionnaire (EQ-5D), and patient-assessed disease status and treatment effectiveness. Results:Dupilumab rapidly improved (vs. placebo) Peak Pruritus NRS scores by day 2 (p < .05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 (p < .0001). At week 16, more dupilumab-treated than placebo-treated patients reported improvement in SCORAD itch and sleep, and no pain/discomfort (EQ-5D) (p < .0001).Limitations: Cultural differences of translated PROs. Conclusion:Dupilumab had a significant, positive impact on AD symptoms, including itch, sleep, pain, anxiety and depression, and QoL in adults with moderate-to-severe AD.
Entities:
Keywords:
Atopic dermatitis; dupilumab; patient-reported outcomes; quality of life
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; Usha G Mallya Journal: Dermatol Ther (Heidelb) Date: 2022-05-11
Authors: Piotr K Krajewski; Łukasz Matusiak; Esther von Stebut; Michael Schultheis; Uwe Kirschner; Georgios Nikolakis; Jacek C Szepietowski Journal: Life (Basel) Date: 2021-01-08