Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2025
Lanadelumab's impact on hereditary angioedema control and quality of life across disease activity subgroups: Real-world evidence.
Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Zanichelli Andrea, Wuillemin Walter A, Aygören-Pürsün Emel, Banerji Aleena, Busse Paula J, Betschel Stephen D, Cancian Mauro, Gagnon Remi, Goodyear M Dawn, Kinaciyan Tamar, Kessel Aharon, Magerl Markus, Recke Andreas, Wedner H James, Estepan Daniel Nova, Watt Maureen, Andresen Irmgard, Juethner Salomé, Khutoryansky Natalie, Martinez-Saguer Inmaculada
Аннотация
BACKGROUND: Real-world clinical data support effectiveness and safety of lanadelumab in patients with hereditary angioedema (HAE); however, disease activity between patients can vary substantially in the absence of long-term prophylactic treatment.
OBJECTIVE: To assess the effectiveness of lanadelumab in patients with HAE by baseline HAE attack frequency.
METHODS: Patients with HAE from the phase 4 EMPOWER (NCT03845400) and ENABLE (NCT04130191) studies with available baseline attack rate data were included in this post hoc analysis. Disease activity subgroups were defined per pre-enrollment/lanadelumab (baseline) HAE attack rate (low, <1; moderate, ≥1 to <2; high, ≥2 to <3; very high, ≥3 attacks/mo).
RESULTS: The analysis included 152 patients (low disease activity, n = 29; moderate, n = 29; high, n = 15; very high, n = 79). In all 4 subgroups, mean and median HAE attack rates after lanadelumab initiation were low (0.0-0.5 attacks/mo). Clinically meaningful improvements (≥6-point decreases) in mean Angioedema Quality of Life total scores were observed regardless of pre-lanadelumab attack rates. From month 1 after lanadelumab initiation to the end of follow-up, mean Angioedema Control Test Scores were 10 or more (indicating patient perception of well-controlled disease) in all 4 subgroups.
CONCLUSION: In these real-world data sets, on-treatment lanadelumab attack rates were low regardless of baseline disease activity. Patients from all 4 subgroups experienced improvements in health-related quality of life and disease control. Overall, these findings support long-term prophylaxis with lanadelumab across disease activity levels.
TRIAL REGISTRATION: EMPOWER: ClinicalTrials.gov Identifier: NCT03845400; ENABLE: ClinicalTrials.gov Identifier: NCT04130191.
OBJECTIVE: To assess the effectiveness of lanadelumab in patients with HAE by baseline HAE attack frequency.
METHODS: Patients with HAE from the phase 4 EMPOWER (NCT03845400) and ENABLE (NCT04130191) studies with available baseline attack rate data were included in this post hoc analysis. Disease activity subgroups were defined per pre-enrollment/lanadelumab (baseline) HAE attack rate (low, <1; moderate, ≥1 to <2; high, ≥2 to <3; very high, ≥3 attacks/mo).
RESULTS: The analysis included 152 patients (low disease activity, n = 29; moderate, n = 29; high, n = 15; very high, n = 79). In all 4 subgroups, mean and median HAE attack rates after lanadelumab initiation were low (0.0-0.5 attacks/mo). Clinically meaningful improvements (≥6-point decreases) in mean Angioedema Quality of Life total scores were observed regardless of pre-lanadelumab attack rates. From month 1 after lanadelumab initiation to the end of follow-up, mean Angioedema Control Test Scores were 10 or more (indicating patient perception of well-controlled disease) in all 4 subgroups.
CONCLUSION: In these real-world data sets, on-treatment lanadelumab attack rates were low regardless of baseline disease activity. Patients from all 4 subgroups experienced improvements in health-related quality of life and disease control. Overall, these findings support long-term prophylaxis with lanadelumab across disease activity levels.
TRIAL REGISTRATION: EMPOWER: ClinicalTrials.gov Identifier: NCT03845400; ENABLE: ClinicalTrials.gov Identifier: NCT04130191.