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首页> 外文期刊>Allergy >Evaluation of avoralstat, an oral kallikrein inhibitor, in a Phase 3 hereditary angioedema prophylaxis trial: The OPuS OPuS ‐2?study
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Evaluation of avoralstat, an oral kallikrein inhibitor, in a Phase 3 hereditary angioedema prophylaxis trial: The OPuS OPuS ‐2?study

机译：口服Kallikrein抑制剂的Avoralstat评估，在第3期遗传性血管型预防试验中：Opus Opus -2？研究

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摘要

Abstract Background Effective inhibition of plasma kallikrein may have significant benefits for patients with hereditary angioedema due to deficiency of C1 inhibitor (C1‐ INH ‐ HAE ) by reducing the frequency of angioedema attacks. Avoralstat is a small molecule inhibitor of plasma kallikrein. This study ( OP uS‐2) evaluated the efficacy and safety of prophylactic avoralstat 300 or 500?mg compared with placebo. Methods OP uS‐2 was a Phase 3, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study. Subjects were administered avoralstat 300?mg, avoralstat 500?mg, or placebo orally 3?times per day for 12?weeks. The primary efficacy endpoint was the angioedema attack rate based on adjudicator‐confirmed attacks. Results A total of 110 subjects were randomized and dosed. The least squares ( LS ) mean attack rates per week were 0.589, 0.675, and 0.593 for subjects receiving avoralstat 500?mg, avoralstat 300?mg, and placebo, respectively. Overall, 1 subject in each of the avoralstat groups and no subjects in the placebo group were attack‐free during the 84‐day treatment period. The LS mean duration of all confirmed attacks was 25.4, 29.4, and 31.4?hours for the avoralstat 500?mg, avoralstat 300?mg, and placebo groups, respectively. Using the Angioedema Quality of Life Questionnaire ( AE ‐QoL), improved QoL was observed for the avoralstat 500?mg group compared with placebo. Avoralstat was generally safe and well tolerated. Conclusions Although this study did not demonstrate efficacy of avoralstat in preventing angioedema attacks in C1‐ INH ‐ HAE , it provided evidence of shortened angioedema episodes and improved QoL in the avoralstat 500?mg treatment group compared with placebo.
机译：摘要背景血浆Kallikrein的有效抑制可能对遗传性血管后期的患者具有显着益处，由于C1抑制剂（C1-Inh-Hae）的缺乏通过降低血管模型攻击的频率。 Avoralstat是血浆Kallikrein的小分子抑制剂。本研究（OP US-2）评估了与安慰剂相比预防禽类刺激300或500毫克的疗效和安全性。方法OP US-2是第3阶段，多中心，随机，双盲，安慰剂控制，并联群体研究。受试者通过禽流司腊肠300？mg，禽类500〜mg，或安慰剂口服3？每天次为12？周。主要疗效终点是基于审判者证实攻击的血管模型攻击率。结果总共110名受试者随机化并给药。对于接受Avoralstat 500？Mg，Avoralstat 300？Mg和安慰剂的受试者，每周的最小二乘（LS）平均攻击率为0.589,0.675和0.593。总体而言，在每个禽流尔斯特族群体中的1个受试者，安慰剂组中没有受试者在84天治疗期间没有攻击。 LS的平均持续时间为所有确诊的攻击的持续时间为25.4,29.4和31.4？禽类500？mg，禽类300？mg和安慰剂组的时间。使用血管模型质量问卷调查问卷（AE-QOL），与安慰剂相比，为Avoralstat 500？MG组观察到改进的QoL。 Avoralstat通常是安全和耐受性的。结论虽然本研究未表明Avoralstat在预防C1-Inh-Ha中的血管模型攻击方面的疗效，但它提供了缩短的血管模型发作和改进的Avoralstat 500？MG治疗组的提高QoL。

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  • 来源
    《Allergy》 |2018年第9期|共10页
  • 作者

    Riedl M. A.; Ayg?ren‐Pürsün E.; Baker J.; Farkas H.; Anderson J.; Bernstein J.?A.; Bouillet L.; Busse P.; Manning M.; Magerl M.; Gompels M.; Huissoon A. P.; Longhurst H.; Lumry W.; Ritchie B.; Shapiro R.; Soteres D.; Banerji A.; Cancian M.; Johnston D. T.; Craig T.?J.; Launay D.; Li H. H.; Liebhaber M.; Nickel T.; Offenberger J.; Rae W.; Schrijvers R.; Triggiani M.; Wedner H. J.; Dobo S.; Cornpropst M.; Clemons D.; Fang L.; Collis P.; Sheridan W.?P.; Maurer M.;

  • 作者单位

    Division of RheumatologyUniversity of California San DiegoSan Diego CA USA;

    Department for Children and AdolescentsUniversity Hospital FrankfurtFrankfurt Germany;

    Baker Allergy Asthma Dermatology Research CenterPortland OR USA;

    3rd Department of Internal MedicineSemmelweis UniversityBudapest Hungary;

    Clinical Research Center of AlabamaBirmingham AL USA;

    Department of Internal MedicineUniversity of CincinnatiCincinnati OH USA;

    Internal MedicineGrenoble University HospitalGrenoble France;

    Division of Clinical Immunology and AllergyIcahn School of Medicine at Mount SinaiNew York NY USA;

    Medical Research of ArizonaAsthma &

    Immunology AssociatesScottsdale AZ USA;

    Dermatology Venerology and AllergologyCharite ‐ Universit?tsmedizin BerlinBerlin Germany;

    ImmunologyNorth Bristol NHS TrustBristol UK;

    Department of Allergy and ImmunologyHeartlands HospitalBirmingham UK;

    ImmunologyAddenbrookes HospitalCambridge UK;

    Allergy and Asthma Research Associates Research CenterDallas TX USA;

    Division of HematologyUniversity of AlbertaEdmonton AB Canada;

    ImmunologyMidwest Immunology ClinicPlymouth MN USA;

    Asthma and Allergy Associates PCColorado Springs CO USA;

    Division of RheumatologyMassachusetts General HospitalBoston MA USA;

    Department of MedicineUniversity of PadovaPadova Italy;

    Asthma &

    Allergy Specialists P.A.Charlotte NC USA;

    Department of Medicine and PediatricsPenn State Hershey Allergy Asthma and ImmunologyHershey PA USA;

    Internal MedicineCHRU LilleFrance France;

    Institute for Asthma and AllergyChevy Chase MD USA;

    Allergy and ImmunologySansum ClinicSanta Barbara CA USA;

    Allergy &

    ImmunologyAllergy Clinic of TulsaTulsa OK USA;

    Allergy and Asthma Relief ExpertsGrenada Hills CA USA;

    Allergy &

    Clinical ImmunologyUniversity Hospital Southampton NHS Foundation TrustSouthampton UK;

    Laboratory of Clinical ImmunologyKU LeuvenLeuven Belgium;

    Division of Allergy and Clinical ImmunologyUniversity of SalernoSalerno Italy;

    Division of Allergy and ImmunologyWashington University School of MedicineSt. Louis MO USA;

    Biocryst PharmaceuticalsDurham NC USA;

    Biocryst PharmaceuticalsDurham NC USA;

    Biocryst PharmaceuticalsDurham NC USA;

    StatisticsPharStat Inc.Raleigh NC USA;

    Biocryst PharmaceuticalsDurham NC USA;

    Biocryst PharmaceuticalsDurham NC USA;

    Department of Dermatology and AllergyCharité ‐ Universit?tsmedizin BerlinBerlin Germany;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 医学免疫学;
  • 关键词

    C1 inhibitor; hereditary angioedema; oral kallikrein inhibitor; prophylaxis;

    机译：C1抑制剂;遗传性血统肿瘤;口服Kallikrein抑制剂;预防;

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