The Relationship Between Objective Disease Control at Baseline and Change in Subjective Disease Control and Quality of Life in Patients with Hereditary Angioedema Receiving Donidalorsen

Document Type

Conference Proceeding

Publication Date

2-10-2026

Publication Title

J Allergy Clin Immunol

Keywords

donidalorsen, adult, angioneurotic edema, cohort analysis, conference abstract, controlled study, disease control, disease management, drug therapy, human, major clinical study, observational study, phase 3 clinical trial, post hoc analysis, quality of life, questionnaire

Abstract

Rationale: Hereditary angioedema (HAE) is a disease characterized by potentially life-threatening swelling attacks which impact quality of life (QoL). This study evaluated whether change in subjective disease control and QoL varied by baseline objective disease control in 2 cohorts of HAE patients treated with donidalorsen. Methods: Separate post-hoc analyses were performed using data from 2 study cohorts: a 24-week, Phase 3 study of donidalorsen (OASIS-HAE, NCT05139810, n=90) followed by a 52-week, open label extension study (OASISplus, NCT05392114, n=72). Objective disease control subgroups, measured by time-normalized, investigator-confirmed, HAE 28-day attack rate at baseline, were defined as low (≤2.0), moderate (2.01-5.0) and high (>5.0) subgroups. Subjective disease control was assessed using the Angioedema Control Test (AECT), while QoL was assessed using the Angioedema Quality of Life Questionnaire (AE-QoL) total and domain scores. Analysis of variance (ANOVA) models were used to compare mean change in AECT and AE-QoL scores by baseline HAE attack rate subgroups. Results: Substantial improvements in AECT and AE-QoL scores were observed across all subgroups and study cohorts. Improvements in AECT and AE-QoL scores were similar across subgroups based on baseline HAE attack rate in the OASIS-HAE cohort, and similar improvements in the AE-QoL scores in the OASISplus cohort (all p>0.10). AECT mean change across subgroups was statistically significant in OASISplus (p=0.049 for omnibus ANOVA), but pairwise comparisons were not significant (all p>0.05). Conclusions: Findings suggest that patients with HAE who were treated with donidalorsen experienced large improvements in subjective disease control and QoL regardless of baseline HAE attack rate.

Volume

157

Issue

2

First Page

AB52

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