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Recombinant human C1 inhibitor for the prophylaxis of hereditary angioedema attacks: A pilot study

机译：重组人C1抑制剂可预防遗传性血管性水肿发作：一项初步研究

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Background Hereditary angioedema (HAE) is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study evaluated the safety and prophylactic effect of weekly administrations of recombinant C1INH (rhC1INH). Methods Patients with a history of HAE attacks occurring ≥every 2 weeks received a once weekly administration of 50 U/kg rhC1INH. Hereditary angioedema attack history was collected at screening. Breakthrough attacks during the study were recorded at each visit. Following a 2-week run-in period, HAE patients received 8 weekly rhC1INH administrations and were followed-up for an additional 6 weeks. Efficacy was evaluated by comparing the HAE attack incidence during the treatment period to the historical attacks over the previous 2 years. Safety evaluation was based on clinical laboratory and adverse events (AEs) reports. Results The 25 participants reported a mean of 0.9 attacks/week over the past 2 years. The mean breakthrough attack rate during the treatment period was 0.4 attacks/week (95% CI 0.28-0.56). A total of 30 treatment-emergent-AEs were reported in 13 patients, all mild to moderate. One patient died from a laryngeal attack 25 days after last study drug administration. The only possible drug related AEs reported were dry mouth, dizziness and anxiety in one patient and hypotension in another. There were no allergic AEs and no neutralizing antibodies observed. Conclusions Weekly administrations of 50 U/kg rhC1INH appeared to reduce the frequency of HAE attacks and were generally safe and well tolerated.
机译：背景遗传性血管性水肿（HAE）是一种疾病，其特征是复发性组织肿胀影响身体各个部位。最近的文献表明，频繁发作的患者可从长期预防中受益。这项研究评估了每周一次重组C1INH（rhC1INH）的安全性和预防作用。方法≥2周有HAE发作史的患者，每周一次给予50 U / kg rhC1INH。筛选时收集遗传性血管性水肿发作史。每次访视时记录研究期间的突破性攻击。经过2周的磨合期后，HAE患者每周接受8次rhC1INH给药，并再随访6周。通过将治疗期间的HAE发作率与过去2年的历史发作进行比较来评估疗效。安全性评估基于临床实验室和不良事件（AE）报告。结果在过去2年中，这25名参与者报告平均每周有0.9次攻击。治疗期间的平均突破发作率为0.4次/周（95％CI 0.28-0.56）。在13例轻度至中度患者中总共报告了30例治疗性AE。上次服用药物后25天，一名患者因喉咙发作死亡。据报道，唯一可能的药物相关不良事件是一名患者的口干，头晕和焦虑，另一名患者的低血压。没有观察到过敏性AE，也没有观察到中和抗体。结论每周施用50 U / kg rhC1INH似乎可以减少HAE发作的频率，并且通常是安全且耐受性良好的。

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