Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis (PEXIVAS): protocol for a randomized controlled trial.
Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis (PEXIVAS): protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-14-73
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发表时间：
2013-03-14
期刊：
影响因子：
2.5
通讯作者：
PEXIVAS Investigators
中科院分区：
文献类型：
--
作者：
Walsh M;Merkel PA;Peh CA;Szpirt W;Guillevin L;Pusey CD;De Zoysa J;Ives N;Clark WF;Quillen K;Winters JL;Wheatley K;Jayne D;PEXIVAS Investigators
伴有多血管炎的肉芽肿病（GPA，韦格纳氏）和显微镜下多血管炎（MPA）是小血管炎，统称为抗中性粒细胞胞质抗体相关血管炎（AV）。由于不受控制的疾病和治疗毒性，AAV与高发病率和死亡率相关。小型随机试验表明，连续性血浆置换可改善疾病控制，而观察证据表明，目前口服糖皮质激素剂量与AAV患者的严重感染相关。需要对血浆置换和糖皮质激素进行随机研究，以评估AAV患者的血浆置换和口服糖皮质激素剂量。PEXIVAS是一项2 × 2因子随机试验，评价重度AAV患者的连续血浆置换和两种口服糖皮质激素方案。500名患者在欧洲、北美、亚洲和澳大拉西亚的中心随机接受血浆置换或不接受血浆置换，并接受标准或减少口服糖皮质激素剂量。所有患者均接受环磷酰胺或利妥昔单抗免疫抑制。主要结局是至全因死亡和终末期肾病复合终点的时间。PEXIVAS由国家健康研究所（英国）、食品药品监督管理局（美国）、国家卫生研究院（美国）、加拿大健康研究所（加拿大）、国家健康和医学研究理事会（澳大利亚）和公共援助（法国）资助。行业合作伙伴（TerumoBCT、Gambro Australia和Fresenius Australia）提供了用于血浆置换的其他实物供应。这是迄今为止进行的最大规模的AAV试验。PEXIVAS将为重度AAV患者的未来标准治疗提供信息。研究人员、资助机构和行业之间的合作为开展罕见疾病研究提供了模式。当前对照试验：（ISRCTN 07757494）和clinicaltrials.gov：（NCT 00987389）
Granulomatosis with polyangiitis (GPA, Wegener’s) and microscopic polyangiitis (MPA) are small vessel vasculitides collectively referred to as anti-neutrophil cytoplasm antibody-associated vasculitis (AAV). AAV is associated with high rates of morbidity and mortality due to uncontrolled disease and treatment toxicity. Small randomized trials suggest adjunctive plasma exchange may improve disease control, while observational evidence suggests that current oral glucocorticoid doses are associated with severe infections in patients with AAV. A randomized study of both plasma exchange and glucocorticoids is required to evaluate plasma exchange and oral glucocorticoid dosing in patients with AAV. PEXIVAS is a two-by-two factorial randomized trial evaluating adjunctive plasma exchange and two oral glucocorticoid regimens in severe AAV. Five hundred patients are being randomized at centers across Europe, North America, Asia, and Australasia to receive plasma exchange or no plasma exchange, and to receive standard or reduced oral glucocorticoid dosing. All patients receive immunosuppression with either cyclophosphamide or rituximab. The primary outcome is the time to the composite of all-cause mortality and end-stage renal disease. PEXIVAS is funded by the National Institute of Health Research (UK), the Food and Drug Administration (USA), the National Institutes of Health (USA), the Canadian Institute of Health Research (Canada), the National Health and Medical Research Council (Australia), and Assistance Publique (France). Additional in-kind supplies for plasma exchange are provided by industry partners (TerumoBCT, Gambro Australia, and Fresenius Australia). This is the largest trial in AAV undertaken to date. PEXIVAS will inform the future standard of care for patients with severe AAV. The cooperation between investigators, funding agencies, and industry provides a model for conducting studies in rare diseases. Current Controlled Trials: (ISRCTN07757494) and clinicaltrials.gov: (NCT00987389)
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