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.
Michael J CorkLaurent EckertEric L SimpsonApril ArmstrongSébastien BarbarotLluis L PuigGiampiero GirolomoniMarjolein de Bruin-WellerAndreas WollenbergYoko KataokaAnita RemitzStefan BeissertVera MasteyMarius ArdeleanuZhen ChenAbhijit GadkariJingdong ChaoPublished in: The Journal of dermatological treatment (2019)
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.
Keyphrases
- atopic dermatitis
- patient reported
- patient reported outcomes
- sleep quality
- chronic pain
- end stage renal disease
- newly diagnosed
- pain management
- high intensity
- early onset
- case report
- physical activity
- healthcare
- systematic review
- electronic health record
- placebo controlled
- chronic kidney disease
- phase iii
- prognostic factors
- peritoneal dialysis
- emergency department
- double blind
- clinical trial
- depressive symptoms
- cross sectional
- spinal cord
- study protocol