Lanadelumab may prove effective prophylactic therapy for hereditary angioedema
Hide et al., and colleagues recently demonstrated the effectiveness of lanadelumab in preventing attacks of hereditary angioedema (HAE) in Japanese patients with HAE type I/II. The safety and Efficacy of lanadelumab in Japanese patients is consistent with the findings from global phase 3 studies of lanadelumab in adults and adolescents.
Dr Isao Ohsawa is the co-author of this study, Efficacy and safety of lanadelumab in Japanese patients with hereditary angioedema: A phase 3 multicenter, open-label study published in the Journal of Dermatology.
There needs to be more data regarding the safety and Efficacy of lanadelumab in preventing HAE in Japanese patients. The present study reported outcomes from a phase 3, multicenter, open-label study of lanadelumab in these Japanese patients.
The study enrolled those Japanese patients with a history of HAE aged ≥12 years with ≥1 investigator-confirmed HAE attack during the 4-week run-in baseline period.
The enrolled patients received lanadelumab 300 mg every two weeks subcutaneously for 52 weeks.
During the second 26-week treatment period, patients with well-controlled symptoms (e.g., attack-free) for six months could have their dose reduced to 300 mg every four weeks. 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.
The key points of this study are:
- Researchers enrolled 12 patients with a mean age of 41 years.
- Five patients, constituting nearly 41 %, were attack-free during the first 26 weeks.
- There was a reduction in mean ± SD HAE attack rate per month by 74.0%, from 3.8 ± 2.4 during baseline to 1.2 ± 2.6 during the overall 52-week treatment period.
- They did not record any deaths or discontinuations.
- There were no recordings of treatment-emergent adverse events (TEAEs), severe or serious TEAEs related to lanadelumab, or positive anti-drug antibody results.
- A total of 37 events occurred in six patients, with the most frequent TEAEs being injection-site reactions of mild severity.
Based on this study's results, they said we support the findings from two global phase 3 studies for lanadelumab use as prophylactic therapy in Japanese patients with a history of HAE.
The study bridged the gap between data on the global lanadelumab outcomes and the outcomes in Japanese patients with HAE.
Our study had limitations like fewer patients, limited interpretation of the dosing subgroup analysis, etc.
Takeda Pharmaceutical Company Limited sponsored the study. The company was involved in designing and conducting the study, data analysis and review.
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