美罗华
医学
贝里穆马布
临床终点
低丙种球蛋白血症
内科学
不利影响
CD20
免疫学
抗体
B细胞激活因子
临床试验
B细胞
作者
Matthieu Mahévas,Imane Azzaoui,Étienne Crickx,Florence Canouï‐Poitrine,Delphine Gobert,Laetitia Languille,Nicolas Limal,Constance Guillaud,Laure Croisille,Mohamed Jeljeli,Frédéric Batteux,Samia Baloul,Olivier Fain,France Pirenne,Jean‐Claude Weill,Claude‐Agnès Reynaud,Bertrand Godeau,Marc Michel
出处
期刊:Haematologica
[Ferrata Storti Foundation]
日期:2020-08-13
卷期号:106 (9): 2449-2457
被引量:39
标识
DOI:10.3324/haematol.2020.259481
摘要
B-cell activating factor may be involved in the failure of B-cell depleting therapy with rituximab in immune thrombocytopenia (ITP) by promoting the emergence of splenic long-lived plasma cells. From results obtained in mouse models, we hypothesized that combining rituximab with sequential injections of belimumab could increase the rate of response at one year in patients with persistent or chronic ITP by preventing the emergence of these long-lived plasma cells. The study was a single-center, single arm, prospective phase 2b trial (RITUX-PLUS, NCT03154385) investigating the safety and efficacy of rituximab given at a fixed dose of 1,000 mg, two weeks apart, combined with five infusions of belimumab, 10 mg/kg at week 0 (W0)+2 days, W2+2 days, W4, W8 and W12 for adults with primary persistent or chronic ITP. The primary endpoint was the total number of patients achieving an overall response (complete response + response) at W52 according to a standard definition. In total, 15 non-splenectomized adults, nine (60%) with persistent IPT and six (40%) with chronic ITP, were included. No severe adverse event, infection, or severe hypogammaglobulinemia was observed. Thirteen patients achieved an initial overall response. At W52, 12 (80%) patients achieved an overall response, including ten (66.7%) with complete response. When compared with a cohort of patients receiving rituximab alone, the kinetics of B-cell repopulation appeared similar, but the number of circulating T follicular helper cells was significantly decreased with belimumab combination therapy. Combining rituximab and belimumab seems a promising strategy in ITP, with high efficacy and acceptable safety.
科研通智能强力驱动
Strongly Powered by AbleSci AI