Trial reportAdvances in therapy2025
Sustained Effectiveness, Tolerability, and Safety of Long-Term Prophylaxis with Lanadelumab in Hereditary Angioedema: The Prospective, Phase 4, Noninterventional EMPOWER Real-World Study.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03845400 (An Observational, Non-interventional, Study of Patients With Hereditary Angioedema in the United States and Canada), which is not on this map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Observational, Non-interventional, Study of Patients With Hereditary Angioedema in the United States and Canada (EMPOWER Study)
Who cites it
11 citing papers in PubMed.
- Lanadelumab safety, efficacy, and pharmacokinetics in patients aged ≥12 with hereditary angioedema in China: an open-label, multicenter study.Frontiers in immunology · 2026Trial
- Lanadelumab Use for Hereditary Angioedema Long-Term Prophylaxis Over the Last 7 Years: A Narrative Review of Clinical and Real-World Data.Clinical reviews in allergy & immunology · 2026Review
- Sustained Effectiveness of Lanadelumab in Preventing Hereditary Angioedema Attacks: The ENABLE Study.Clinical and translational allergy · 2026Article
- Hereditary angioedema attack trends among patients maintained on lanadelumab long-term prophylaxis.The journal of allergy and clinical immunology. Global · 2026Article
- Lanadelumab in Hereditary Angioedema: Extending Dose Intervals from Every 2 Weeks to Every 4 Weeks.International archives of allergy and immunology · 2026Review
- The Neglected Older Adults in Hereditary Angioedema: Insights From the ITACA Registry.Clinical and translational allergy · 2026Article
- Lanadelumab's Enduring Effectiveness and Safety in the Management of Hereditary Angioedema for Patients from Puerto Rico: Data from EMPOWER.International archives of allergy and immunology · 2026Article
- Long-term effectiveness and safety of lanadelumab in Canadian patients with hereditary angioedema: a subanalysis of the EMPOWER study.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2026Article
- Hereditary angioedema: on-demand treatment and long-term prophylaxis-a global reality.Clinical and experimental immunology · 2026Review
- Efficacy and acceptability of lanadelumab for long-term prophylaxis in hereditary angioedema: A Chinese multicenter real-world analysis.The World Allergy Organization journal · 2026Article
- Lanadelumab in Hereditary Angioedema: Real-World Outcomes and Implications for Access Practices in Europe.Journal of clinical medicine · 2025Article
Corrections and comments
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionLanadelumab is approved for long-term prophylaxis of hereditary angioedema (HAE) attacks in patients aged ≥ 2 years in the USA and aged ≥ 12 years in Canada. The EMPOWER Study (NCT03845400) evaluated the real-world effectiveness and safety of lanadelumab in male and female patients with HAE due to C1 inhibitor deficiency type 1 or 2 from the USA and Canada. Here, we report final, up to 36-month, data.
methodsPatients aged ≥ 12 years were classified as newly treated with lanadelumab or established on lanadelumab (receiving < 4 and ≥ 4 lanadelumab doses at enrollment, respectively). The primary objective was effectiveness of lanadelumab as measured by HAE attack rate before and after lanadelumab initiation. Safety data were collected.
resultsA total of 109 patients received ≥ 1 lanadelumab dose and had ≥ 1 post-baseline safety assessment. Patients were 40.9 (17.4) years of age (mean [standard deviation (SD)]), majority (72/109; 66.1%) female, 37/109 (33.9%) male, and over 90% white. Patients newly treated with and established on lanadelumab received lanadelumab for 737.7 (374.5) (mean [SD]) and 907.1 (469.3) days, respectively, during the study. In patients newly treated with lanadelumab, the mean (95% confidence interval) observed attack rate (attacks/month) decreased by 85% after lanadelumab initiation, from 1.42 (0.34-2.50) pre-lanadelumab to 0.20 (0.02-0.38) post-lanadelumab initiation (cumulative period). Patients established on lanadelumab had an observed attack rate of 0.20 (0.10-0.30) during 36 months' follow-up. Of 154 treatment-emergent adverse events (TEAEs), no injection site reactions were reported and 6 (in 2 patients) were considered related to lanadelumab; no lanadelumab-related TEAEs were serious.
conclusionReal-world data from EMPOWER showed marked HAE attack rate reduction up to 36 months after initiating lanadelumab in patients newly treated with lanadelumab and maintenance of low attack rates in patients established on lanadelumab. No new safety signals were identified.
trial registrationClinicalTrials.gov, identifier NCT03845400. Graphical abstract available for this article.
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