Abstract
Hereditary angioedema (HAE) is associated with substantial disease burden. Lanadelumab reduced the HAE attack rate during 132 weeks' follow-up in the HELP open-label extension (OLE) Study (NCT02741596). To measure the impact of long-term lanadelumab treatment on patient-reported outcomes (PROs). Rollover patients (completed the 26-week HELP Study [NCT02586805]) and nonrollovers (newly enrolled) received lanadelumab 300 mg every 2 weeks. PROs (Angioedema Quality of Life Questionnaire [AE-QoL], Short Form v2 Health Survey 12 Item version 2, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment-General Health Questionnaire, and EQ-5D-5L questionnaire) were assessed at baseline (day 0 of HELP OLE) and various time points until the end-of-study (EOS) visit. The Angioedema Control Test (AECT), Treatment Satisfaction Questionnaire for Medication, and Global Impression of Treatment Response were administered starting at week 52. The mean (SD) change in AE-QoL total score from baseline to EOS for rollovers (n = 90) was -10.2 (17.9), demonstrating further improvement from HELP in health-related quality of life (HRQoL); 48.9% of rollovers achieved the previously defined 6-point minimal clinically important difference. Nonrollovers (n = 81) reported a change of -19.5 (21.3). Controlled disease (AECT total score ≥10) was reported by 90.2% of rollovers and 95.9% of nonrollovers at EOS. Excellent treatment response was reported by 78.7% of patients and 82.4% of investigators. Results from other PROs indicated a slight improvement in anxiety, high level of satisfaction with treatment, and increased work productivity/activity. Clinically meaningful improvement in HRQoL was demonstrated with long-term lanadelumab treatment, supporting the benefit of lanadelumab therapy associated with attack prevention.
Published Version
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