Efficacy and safety of lanadelumab in Japanese patients with hereditary angioedema: A phase 3 multicenter, open-label study.
Japanese
hereditary angioedema
lanadelumab
prophylaxis
subcutaneous injections
Journal
The Journal of dermatology
ISSN: 1346-8138
Titre abrégé: J Dermatol
Pays: England
ID NLM: 7600545
Informations de publication
Date de publication:
Nov 2023
Nov 2023
Historique:
revised:
20
06
2023
received:
03
03
2023
accepted:
13
07
2023
medline:
6
11
2023
pubmed:
14
8
2023
entrez:
14
8
2023
Statut:
ppublish
Résumé
The safety and efficacy of lanadelumab for the prevention of hereditary angioedema (HAE) attacks have not been studied in Japanese patients. We report outcomes from a phase 3, multicenter, open-label study (NCT04180163) of lanadelumab in Japanese patients with HAE. Japanese patients with HAE aged ≥12 years with ≥1 investigator-confirmed HAE attack during the 4-week run-in baseline period were enrolled into the study and received lanadelumab 300 mg every 2 weeks subcutaneously for 52 weeks. Dosing could be reduced to 300 mg every 4 weeks during the second 26-week treatment period if patients had well-controlled symptoms (e.g., attack-free) for 6 months. The primary efficacy endpoint was no investigator-confirmed HAE attacks (attack-free status) during days 0-182. Other outcomes included the rate of investigator-confirmed HAE attacks per month (28 days) and lanadelumab safety. Twelve patients (mean ± SD age 41.9 ± 12.4 years) were enrolled. During the first 26 weeks (days 0-182), five (41.7%) patients were attack-free. The mean ± SD HAE attack rate per month decreased by 74.0%, from 3.8 ± 2.4 during baseline to 1.2 ± 2.6 during the overall 52-week treatment period. There were no deaths or discontinuations due to treatment-emergent adverse events (TEAEs), no severe or serious TEAEs related to lanadelumab, and no positive anti-drug antibody results. The most frequent TEAEs were injection-site reactions (37 events in six patients). Most of the injection-site reaction adverse events were mild in severity. Results of this study support the findings from two global phase 3 studies for lanadelumab use as prophylactic therapy in Japanese patients with HAE.
Identifiants
pubmed: 37574953
doi: 10.1111/1346-8138.16909
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Complement C1 Inhibitor Protein
0
lanadelumab
2372V1TKXK
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1381-1391Subventions
Organisme : Takeda Pharmaceutical Company Limited
Informations de copyright
© 2023 Takeda Pharmaceuticals and The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.
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