Dupilumab improves patient-reported symptoms of atopic dermatitis, symptoms of anxiety and depression, and health-related quality of life in moderate-to-severe atopic dermatitis: analysis of pooled data from the randomized trials SOLO 1 and SOLO 2
Por:
Cork, MJ, Eckert, L, Simpson, EL, Armstrong, A, Barbarot, S, Puig, L, Girolomoni, G, de Bruin-Weller, M, Wollenberg, A, Kataoka, Y, Remitz, A, Beissert, S, Mastey, V, Ardeleanu, M, Chen, Z, Gadkari, A, Chao, JD
Publicada:
17 ago 2020
Ahead of Print:
1 jun 2019
Resumen:
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.
Filiaciones:
Cork, MJ:
Univ Sheffield, Med Sch, Dept Infect & Immun, Sheffield Dermatol Res, Beech Hill, Sheffield, S Yorkshire, England
Eckert, L:
Sanofi, Chilly Mazarin, France
Simpson, EL:
Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97201 USA
Armstrong, A:
Univ Southern Calif, Keck Sch Med, Dept Dermatol, Los Angeles, CA USA
Barbarot, S:
CHU Hotel Dieu, Dept Dermatol, Nantes, France
Puig, L:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Dept Dermatol, Barcelona, Spain
Girolomoni, G:
Univ Verona, Sect Dermatol & Venereol, Dept Med, Verona, Italy
de Bruin-Weller, M:
Univ Med Ctr Utrecht, Utrecht, Netherlands
Wollenberg, A:
Klinikum Univ Munchen, Klin & Poliklin Dermatol & Allergol, Munich, Germany
Kataoka, Y:
Osaka Habikino Med Ctr, Dept Dermatol, Osaka, Japan
Remitz, A:
Univ Helsinki, Cent Hosp, Helsinki, Finland
Beissert, S:
Tech Univ Dresden, Dept Dermatol, Dresden, Germany
Mastey, V:
Regeneron Pharmaceut Inc, Tarrytown, NY 12533 USA
Ardeleanu, M:
Regeneron Pharmaceut Inc, Tarrytown, NY 12533 USA
Chen, Z:
Regeneron Pharmaceut Inc, Tarrytown, NY 12533 USA
Gadkari, A:
Regeneron Pharmaceut Inc, Tarrytown, NY 12533 USA
Chao, JD:
Regeneron Pharmaceut Inc, Tarrytown, NY 12533 USA
Green Published, Green Accepted, Hybrid Gold
|