Reduced-dose versus high-dose glucocorticoids added to rituximab on remission induction in ANCA-associated vasculitis: predefined 2-year follow-up study

医学 美罗华 泼尼松龙 内科学 血管炎 胃肠病学 不利影响 抗中性粒细胞胞浆抗体 强的松 皮质类固醇 甲基强的松龙 维持剂量 外科 淋巴瘤 疾病
作者
Shunsuke Furuta,Daiki Nakagomi,Y Kobayashi,Masaki Hiraguri,Takao Sugiyama,Koichi Amano,Takeshi Umibe,Hajime Kono,Kazuhiro Kurasawa,Yasuhiko Kita,Ryutaro Matsumura,Yuko Kaneko,Keita Ninagawa,Keiju Hiromura,Shin‐ichiro Kagami,Yosuke Inaba,Hideki Hanaoka,Kei Ikeda,Hiroshi Nakajima
出处
期刊:Annals of the Rheumatic Diseases [BMJ]
卷期号:83 (1): 96-102 被引量:12
标识
DOI:10.1136/ard-2023-224343
摘要

Objectives The LoVAS trial reported non-inferiority in remission induction rates between the reduced-dose and conventional high-dose glucocorticoid regimens plus rituximab for antineutrophil cytoplasm antibody (ANCA)-associated vasculitis at 6 months; however, maintenance glucocorticoid requirements and long-term outcomes are unknown. Methods A total of 140 patients with new-onset ANCA-associated vasculitis without severe glomerulonephritis or alveolar haemorrhage were randomised to receive reduced-dose prednisolone (0.5 mg/kg/day) plus rituximab (375 mg/m 2 /week×4) or high-dose prednisolone (1 mg/kg/day) plus rituximab. After achieving remission, patients received the rituximab maintenance therapy (1 g/6 months). Results A total of 134 patients were analysed. Among patients who achieved remission with the protocolised treatments, the majority of patients in the reduced-dose group (89.7%) and 15.5% in the high-dose group discontinued prednisolone (median time to withdrawal, 150 and 375 days, respectively). During 24-month trial period, two patients in the reduced-dose group (2.8%) died, while five patients in the high-dose group (7.6%) died (p=0.225). Relapse occurred in nine patients in the reduced-dose group (13.0%) (two major and seven minor) and five in the high-dose group (7.6%) (two major and three minor) (p=0.311). Serious adverse events (SAEs) were less frequent in the reduced-dose group (36 events in 19 patients, 27.5%) than in the high-dose group (54 events in 30 patients, 46.2%) (p=0.025). Conclusion At 24 months, frequencies of relapse did not differ between the groups, and SAEs were less frequent in the reduced-dose group due to the lower event rate in the 6-month induction phase. The bias to myeloperoxidase-ANCA positivity (85.8%) in the trial population should be noted. Trial registration number NCT02198248 .
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