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Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks
Filename | 404. Riedl et al., HELP Lanadelumab, Allergy 2020.pdf |
Filesize | 691,86 kB |
Version | o.404 |
Date added | November 14, 2020 |
Downloaded | 2 times |
Category | Original Work |
Tags | durable efficacy, Hereditary Angioedema, long-term prophylaxis, onset of action |
Authors | Riedl, M. A., Maurer, M., Bernstein, J. A., Banerji, A., Longhurst, H. J., Henry Li, H., Lu, P., Hao, J., Juethner, S., and Lumry, W. R. |
Citation | Riedl, M. A., Maurer, M., Bernstein, J. A., Banerji, A., Longhurst, H. J., Henry Li, H., Lu, P., Hao, J., Juethner, S., and Lumry, W. R.: Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks. Allergy 2020: 75; 2879-2887. |
Corresponding authors | Riedl, M. A. |
DocNum | o.404 |
DocType | |
IF | 13.15 |
Publisher | Allergy |
ReleaseDate | 2020 |
Background: Lanadelumab demonstrated efficacy in preventing hereditary angioedema (HAE) attacks in the phase 3 HELP Study.
Objective: To assess time to onset of effect and long-term efficacy of lanadelumab, based on exploratory findings from the HELP Study.
Methods: Eligible patients with HAE type I/II received lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo. Ad hoc analyses evaluated day 0-69 findings using a Poisson regression model accounting for overdispersion. Least-squares mean monthly HAE attack rate for lanadelumab was compared with placebo. Intrapatient comparisons for days 0-69 versus steady state (days 70-182) used a paired t test for continuous endpoints or Kappa statistics for categorical endpoints.
Results: One hundred twenty-five patients were randomized and treated. During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) vs placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs 1.66) and moderate/severe attacks (0.31-0.48 vs 1.33, all P ≤ .001). More patients receiving lanadelumab vs placebo were attack free (37.9%-48.1% vs 7.3%) and responders (85.7%-100% vs 26.8%). During steady state, the efficacy of lanadelumab vs placebo was similar or improved vs days 0-69. Intrapatient differences were significant with lanadelumab 300 mg q4wks for select outcomes. Lanadelumab efficacy was durable—HAE attack rate was consistently lower vs placebo, from the first 2 weeks of treatment through study end. Treatment emergent adverse events were comparable during days 0-69 and 70-182.
Conclusion: Protection with lanadelumab started from the first dose and continued throughout the entire study period.
(Last update: 12.2023)
Number of original publications in peer-reviewed journals: | 580 |
Number of reviews in peer-reviewed journals: | 210 |
Number of publications (original work and reviews) in peer-reviewed journals: | 790 |
Cumulative IF for original publications in peer-reviewed journals: | 4196.39 |
Cumulative IF for reviews in peer-reviewed journals: | 1409.32 |
Cumulative IF of publications (original work & reviews) in peer-reviewed journals: | 5605.71 |
Total number of citations: 36,836, h-index: 99 (Web of Science December 2023) | 36836 |
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