College of Osteopathic Medicine, New York Institute of Technology, Glen Head, NY, USA.
Advanced Dermatology and Cosmetic Surgery, Maitland, FL, USA.
Ann Pharmacother. 2023 Dec;57(12):1449-1454. doi: 10.1177/10600280231161592. Epub 2023 Mar 28.
To review the safety and efficacy of avacopan for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
A systematic review of the literature was performed using the terms OR OR OR in PubMed and Google Scholar. Articles between January 2016 and January 2023 were considered for inclusion. Bibliographies and ClinicalTrials.gov were also searched for completion.
Relative English language and human studies related to pharmacology, clinical trials, and safety were included.
The 52-week ADVOCATE and 12-week CLEAR clinical trials evaluated the safety and efficacy of avacopan. The remission rate was 65.7% and 54.9% in the avacopan and placebo group, respectively, in the ADVOCATE trial. The Birmingham Vasculitis Activity Score improved by ≥50% in 86.4% of avacopan treated patients and 70% of prednisone treated patients in the CLEAR trial.
Glucocorticoids in combination with cyclophosphamide, azathioprine, and/or rituximab have been a mainstay of ANCA-associated vasculitis treatment. However, short- and long-term medication-related adverse effects risk negative outcomes for patients. Avacopan may provide equivalent to better treatment with fewer side effects due to a reduction, if not elimination, of glucocorticoids.
Avacopan used in isolation or combination is safe and effective for ANCA-associated vasculitis.
综述 avacopan 治疗抗中性粒细胞胞质抗体(ANCA)相关性血管炎的安全性和疗效。
在 PubMed 和 Google Scholar 中使用术语“avacopan”“ANCA”“vasculitis”进行系统文献复习。纳入了 2016 年 1 月至 2023 年 1 月期间的相关文章。还查阅了参考文献和 ClinicalTrials.gov 以获取完整信息。
纳入了与药理学、临床试验和安全性相关的相对英语语言和人类研究。
ADVOCATE 为期 52 周和 CLEAR 为期 12 周的临床试验评估了 avacopan 的安全性和疗效。ADVOCATE 试验中,avacopan 组和安慰剂组的缓解率分别为 65.7%和 54.9%。CLEAR 试验中,86.4%接受 avacopan 治疗的患者和 70%接受泼尼松治疗的患者的伯明翰血管炎活动评分改善≥50%。
与现有药物相比,对患者护理和临床实践的重要性:糖皮质激素联合环磷酰胺、硫唑嘌呤和/或利妥昔单抗一直是 ANCA 相关性血管炎治疗的主要方法。然而,短期和长期药物相关不良反应风险对患者产生负面结果。由于糖皮质激素的减少(如果不是消除),avacopan 可能提供等效或更好的治疗效果,同时副作用更少。
avacopan 单独或联合使用治疗 ANCA 相关性血管炎是安全有效的。