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- Title
Patient‐level indirect treatment comparison of lanadelumab versus pdC1‐INH i.v. in hereditary angioedema patients: PATCH study.
- Authors
Magerl, Markus; Schiffhorst, Guido; Fanter, Lena; Müller, Gerrit; Hirche, Christoph; Berkemeier, Fabian; Aygören, Emel
- Abstract
Background: Hereditary angioedema (HAE) is an autosomal dominant inherited disease in which patients suffer from local attacks primarily affecting skin and gastrointestinal tract, and sometimes even the upper respiratory tract leading to asphyxiation. Since head‐to‐head trials between authorized treatments are lacking, this study compares efficacy and safety of lanadelumab and intravenous plasma‐derived C1‐esterase inhibitor (pdC1‐INH i.v.) in HAE patients on long‐term prophylaxis by means of an indirect treatment comparison. Methods: Efficacy and safety of lanadelumab against pdC1‐INH i.v. were analyzed in a fully prespecified indirect comparison based on individual patient data (n = 231) from the HELP and CHANGE clinical trials. Primary and secondary efficacy endpoints were compared using a generalized linear model for count data. Confounding variables were identified a priori via systematic literature research and validated by clinical experts. Adjustment of confounders was implemented using a conditional regression model. Results: Lanadelumab showed a statistically significant improvement in reduction of HAE attack rates compared to pdC1‐INH i.v. across multiple endpoints: Monthly attack rate of patients treated with lanadelumab was less than half compared to pdC1‐INH i.v. (Rate ratio: 0.486; 95% CI: 0.253, 0.932). Monthly rate of laryngeal attacks was found to be five times lower for lanadelumab (Rate ratio: 0.2; 95% CI: 0.044, 0.915) and monthly rate of acute treated HAE attacks among lanadelumab patients was about one third of the attack rate of pdC1‐INH i.v. patients (Rate ratio: 0.366; 95% CI: 0.185, 0.727). Conclusion: This study contributes to current knowledge in the treatment of HAE by indicating a statistically significant reduction of HAE attacks under lanadelumab compared to pdC1‐INH i.v.
- Subjects
ANGIONEUROTIC edema; CONFOUNDING variables; GENETIC disorders; GASTROINTESTINAL system; REGRESSION analysis
- Publication
Allergy, 2024, Vol 79, Issue 1, p215
- ISSN
0105-4538
- Publication type
Article
- DOI
10.1111/all.15861