Journal of clinical lipidology · 2025
Efficacy of evinacumab in patients with severe hypertriglyceridemia and a history of severe hypertriglyceridemia-related acute pancreatitis: A phase 2b trial.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Rosenson Robert S, George Richard T, Sanchez Robert J, Zhao Xue-Qiao, Ponda Manish P, Waldron Alpana, Pordy Robert
Аннотация
BACKGROUND: Severe hypertriglyceridemia (sHTG) is an established risk factor for acute pancreatitis (AP).
OBJECTIVE: To evaluate the efficacy of a 20 mg/kg dose of intravenous evinacumab vs placebo on sHTG-associated episodes of AP.
METHODS: This phase 2b study (NCT04863014) enrolled adults with sHTG and a history of hypertriglyceridemia-associated AP. Eligible patients were randomly assigned to intravenous evinacumab 20 mg/kg or placebo every 4 weeks over a 52-week double-blind treatment period.
RESULTS: Forty patients were screened; 21 patients received either evinacumab (n = 11) or placebo (n = 10). Twelve (57.1%) patients completed the study. The proportion of patients with ≥1 positively adjudicated AP episode during the 52-week treatment period (primary endpoint) was 27.3% (n = 3) with evinacumab vs 10.0% (n = 1) with placebo. All positively adjudicated AP episodes occurred ≥58 days after the last evinacumab dose, when evinacumab concentrations were mostly near or below the limit of quantitation. The median percentage change in triglycerides from baseline to week 4 was -55.3% with evinacumab vs +1.5% with placebo. By week 16, evinacumab reduced triglycerides by 95.7%; the effect was maintained in 1 patient who received treatment through week 52. Incidence of treatment-emergent adverse events was lower with evinacumab (63.6%) than with placebo (100.0%).
CONCLUSION: Although the sample size was too small to determine whether evinacumab can prevent AP, the data suggest evinacumab may be efficacious in lowering triglyceride concentrations in patients with sHTG and a history of sHTG-associated AP. Tolerability and safety of evinacumab was consistent with previous studies.
OBJECTIVE: To evaluate the efficacy of a 20 mg/kg dose of intravenous evinacumab vs placebo on sHTG-associated episodes of AP.
METHODS: This phase 2b study (NCT04863014) enrolled adults with sHTG and a history of hypertriglyceridemia-associated AP. Eligible patients were randomly assigned to intravenous evinacumab 20 mg/kg or placebo every 4 weeks over a 52-week double-blind treatment period.
RESULTS: Forty patients were screened; 21 patients received either evinacumab (n = 11) or placebo (n = 10). Twelve (57.1%) patients completed the study. The proportion of patients with ≥1 positively adjudicated AP episode during the 52-week treatment period (primary endpoint) was 27.3% (n = 3) with evinacumab vs 10.0% (n = 1) with placebo. All positively adjudicated AP episodes occurred ≥58 days after the last evinacumab dose, when evinacumab concentrations were mostly near or below the limit of quantitation. The median percentage change in triglycerides from baseline to week 4 was -55.3% with evinacumab vs +1.5% with placebo. By week 16, evinacumab reduced triglycerides by 95.7%; the effect was maintained in 1 patient who received treatment through week 52. Incidence of treatment-emergent adverse events was lower with evinacumab (63.6%) than with placebo (100.0%).
CONCLUSION: Although the sample size was too small to determine whether evinacumab can prevent AP, the data suggest evinacumab may be efficacious in lowering triglyceride concentrations in patients with sHTG and a history of sHTG-associated AP. Tolerability and safety of evinacumab was consistent with previous studies.