Experience With the Use of Rituximab for the Treatment of Rheumatoid Arthritis in a Tertiary Hospital in Spain: RITAR Study.
Experience With the Use of Rituximab for the Treatment of Rheumatoid Arthritis in a Tertiary Hospital in Spain: RITAR Study.
复制标题
DOI：
10.1097/rhu.0000000000000845
复制
发表时间：
2019-09
期刊：
影响因子：
--
通讯作者：
González-Álvaro I
中科院分区：
文献类型：
--
作者：
Cañamares I;Merino L;López J;Llorente I;García-Vadillo A;Ramirez E;López-Bote JP;Benedí J;Muñoz-Calleja C;Álvaro-Gracia JM;Castañeda S;González-Álvaro I
补充的数字内容可在文本中找到。有证据表明，在类风湿性关节炎（RA）患者的临床试验中，每周期给药1000 mg或2000 mg的利妥昔单抗没有相关的临床差异，低剂量周期似乎具有更好的安全性。我们的目的是描述利妥昔单抗在现实生活实践条件下的使用模式。利妥昔单抗治疗RA临床实践（RITAR）研究是一项2005 - 2015年的回顾性队列研究。入选标准为接受利妥昔单抗治疗活动性关节疾病的RA成人。反应持续时间是主要结果，定义为从首次输注利妥昔单抗到耀斑发生的时间。进行多变量分析以确定与反应持续时间相关的变量。114例患者，409个周期，93.0%血清阳性，80.7%为女性。利妥昔单抗主要作为二线生物治疗。按需再治疗占94.6%，而固定6个月再治疗占5.4%。按需利妥昔单抗周期的中位反应持续时间为10个月（四分位数范围为7-13）。多变量分析显示，年龄大于65岁、利妥昔单抗周期数、血清阳性、一线或二线治疗与较长的反应持续时间相关。每个周期给药剂量与反应持续时间无显著相关。我们的经验表明，对于第一周期后反应良好的患者，特别是血清阳性患者以及作为一线或二线生物疗法应用时，1000mg美罗华单次按需输注是一个合理的长期治疗方案。
Supplemental digital content is available in the text. There is evidence supporting that there are no relevant clinical differences between dosing rituximab 1000 mg or 2000 mg per cycle in rheumatoid arthritis (RA) patients in clinical trials, and low-dose cycles seem to have a better safety profile. Our objective was to describe the pattern of use of rituximab in real-life practice conditions. Rituximab for RA in clinical practice (RITAR) study is a retrospective cohort study from 2005 to 2015. Eligibility criteria were RA adults treated with rituximab for active articular disease. Response duration was the main outcome defined as months elapsed from the date of rituximab first infusion to the date of flare. A multivariable analysis was performed to determine the variables associated with response duration. A total of 114 patients and 409 cycles were described, 93.0% seropositive and 80.7% women. Rituximab was mainly used as second-line biological therapy. On demand retreatment was used in 94.6% of cases versus fixed 6 months retreatment in 5.4%. Median response duration to on demand rituximab cycles was 10 months (interquartile range, 7–13). Multivariable analysis showed that age older than 65 years, number of rituximab cycles, seropositivity, and first- or second-line therapy were associated with longer response duration. The dose administered at each cycle was not significantly associated with response duration. Our experience suggests that 1000 mg rituximab single infusion on demand is a reasonable schedule for long-term treatment of those patients with good response after the first cycles, especially in seropositive patients and when it is applied as a first- or second-line biological therapy.