Introduction: Atopic dermatitis (AD) can have a profound negative impact on the quality of life (QoL) of patients. We analyzed the long-term changes in AD symptoms, QoL, and patient assessment of treatment effect in adults with moderate-to-severe AD treated for 2 years with dupilumab.
Methods: LIBERTY AD OLE (NCT01949311) is a multicenter, open-label extension (OLE) study in adults with moderate-to-severe AD who previously participated in dupilumab clinical trials (parent studies). Patients received dupilumab 300 mg weekly. Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), EQ-5D-3L, and the Patient Global Assessment of Treatment Effect (PGATE) were assessed at weeks 48 and 100.
Results: A total of 2677 patients were included in the OLE, and 1028 completed week 100. By weeks 48 and 100, 94.1% and 95.6% of patients achieved a ≥ 4-point change in POEM from the parent study baseline (PSBL), respectively, and 93.3% and 93.4% of patients had achieved a ≥ 4-point change in DLQI from PSBL, respectively. At week 100, 35.1% of patients had a POEM score ≤ 2 (AD clear/almost clear) compared with 0.1% at PSBL, and 49.9% had a DLQI score of 0 or 1 (no effect at all on patient's life) compared with 1.5% at PSBL. At week 100, 74.5-97.3% of patients reported no effect of AD on the individual EQ-5D-3L domains, and 93.8% rated the effect of dupilumab treatment as "excellent," "very good," or "good" according to PGATE.
Conclusion: In adults with moderate-to-severe AD, dupilumab treatment over 2 years resulted in sustained improvements in patient-reported symptoms and QoL and a favorable patient perception of treatment effect.
Trial registration: ClinicalTrials.gov Identifier: NCT01949311. Supplementary material 1 (MP4 552250 kb).
Keywords: Adult; Atopic dermatitis; Clinical trial; Dermatology Life Quality Index; Dupilumab; EQ-5D; Efficacy; Long term; Patient-oriented eczema measure; Patient-reported outcomes.
Atopic dermatitis is a common skin disease that causes scaly, itchy skin. It can have a profoundly negative effect on a patient’s quality of life (QoL). In short-term clinical trials, dupilumab treatment resulted in significant improvements in signs and symptoms of atopic dermatitis, and in the QoL reported by patients, together with acceptable safety. In this study, adults with moderate-to-severe atopic dermatitis who had completed one of the short-term clinical trials continued dupilumab treatment, including those who had taken placebo. This study allowed researchers to continue to evaluate how dupilumab worked in the long term, including its impact on patient-reported outcomes, which measure the success of treatment from the patient’s own perspective. The results were evaluated at approximately 1 and 2 years of this open-label extension study and were compared with the period just before the patient was first treated with dupilumab so that the effect of dupilumab could be seen. At approximately 1 and 2 years, most patients had achieved clinically meaningful improvements in two measures: Patient Oriented Eczema Measure, a tool used by patients to self-report the severity of their symptoms, and Dermatology Life Quality Index, which allows patients to report the effect of the disease on their QoL. Additionally, in this open-label extension study, most patients described their experience of being treated with dupilumab as “excellent,” “very good,” or “good” using the Patient Global Assessment of Treatment Effect questionnaire. Dupilumab treatment resulted in sustained improvements in atopic dermatitis and was regarded favorably by patients.
© 2021. The Author(s).