{"title":"Avacopan (Tavneos)","authors":"Cadth","doi":"10.51731/cjht.2023.723","DOIUrl":null,"url":null,"abstract":"\nCADTH recommends that Tavneos not be reimbursed by public drug plans as adjunctive treatment for adults with severe active antineutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-AV) (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]). \nOne clinical trial demonstrated that Tavneos in combination with ANCA-AV background therapy (including glucocorticoids and drugs that reduce immune system function) was as good as oral prednisone (60 mg dose reduced over 20 weeks) in combination with ANCA-AV background therapy for showing a reduction in disease symptoms at week 26 and was better than oral prednisone for maintaining symptom improvement at week 52. However, it was unclear if Tavneos offered a meaningful clinical benefit over other treatments used for ANCA-AV mainly because rituximab was not used as maintenance therapy in the trial, as is currently recommended by Canadian guidelines, and there is uncertainty around the clinical meaningfulness of the differences between the treatment groups for outcomes that assessed renal function, relapse, and Short Form [36] Health Survey version 2 (SF-36v2). \nThere was not enough evidence to conclude that Tavneos met patients’ needs for a treatment that reduces or eliminates the use of glucocorticoids and their side effects as well as improves their health-related quality of life (HRQoL). \n","PeriodicalId":9437,"journal":{"name":"Canadian Journal of Health Technologies","volume":"51 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Canadian Journal of Health Technologies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.51731/cjht.2023.723","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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摘要

CADTH建议,对于患有严重活动性抗中性粒细胞细胞质自身抗体相关性血管炎(ANCA-AV)(肉芽肿伴多血管炎[GPA]和显微镜下多血管炎[MPA])的成人患者,公共药物计划不报销Tavneos。一项临床试验表明,Tavneos联合ANCA-AV背景疗法(包括糖皮质激素和降低免疫系统功能的药物)与口服强的松(在20周内减少60mg剂量)联合ANCA-AV背景疗法在第26周显示疾病症状的减轻,并且在第52周维持症状改善方面优于口服强的松。然而,目前尚不清楚Tavneos是否比用于ANCA-AV的其他治疗提供了有意义的临床益处,主要是因为在试验中没有像目前加拿大指南推荐的那样使用利妥昔单抗作为维持治疗,并且在评估肾功能、复发和简短形式[36]健康调查版本2 (SF-36v2)的结果方面,治疗组之间差异的临床意义存在不确定性。没有足够的证据表明Tavneos满足了患者对减少或消除糖皮质激素使用及其副作用以及改善其健康相关生活质量(HRQoL)的治疗需求。
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Avacopan (Tavneos)
CADTH recommends that Tavneos not be reimbursed by public drug plans as adjunctive treatment for adults with severe active antineutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-AV) (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]). One clinical trial demonstrated that Tavneos in combination with ANCA-AV background therapy (including glucocorticoids and drugs that reduce immune system function) was as good as oral prednisone (60 mg dose reduced over 20 weeks) in combination with ANCA-AV background therapy for showing a reduction in disease symptoms at week 26 and was better than oral prednisone for maintaining symptom improvement at week 52. However, it was unclear if Tavneos offered a meaningful clinical benefit over other treatments used for ANCA-AV mainly because rituximab was not used as maintenance therapy in the trial, as is currently recommended by Canadian guidelines, and there is uncertainty around the clinical meaningfulness of the differences between the treatment groups for outcomes that assessed renal function, relapse, and Short Form [36] Health Survey version 2 (SF-36v2). There was not enough evidence to conclude that Tavneos met patients’ needs for a treatment that reduces or eliminates the use of glucocorticoids and their side effects as well as improves their health-related quality of life (HRQoL).
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