亲爱的研友该休息了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!身体可是革命的本钱,早点休息,好梦!

Randomized Controlled Trial of Rituximab and Cost‐Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjögren's Syndrome

医学 美罗华 安慰剂 可视模拟标度 内科学 风湿病 随机对照试验 临床终点 痹症科 物理疗法 外科 淋巴瘤 病理 替代医学
作者
Simon Bowman,Colin Everett,John O’Dwyer,Paul Emery,Costantino Pitzalis,Wan‐Fai Ng,Colin S. Gillespie,Elizabeth Price,Nurhan Sutcliffe,Nagui Gendi,Frances Hall,Sharon Ruddock,Catherine Fernandez,Catherine Reynolds,Claire Hulme,Kevin Davies,Christopher J Edwards,Peter Lanyon,Robert J. Moots,Euthalia Roussou,Ian Giles,Linda Sharples,Stefano Bombardieri
出处
期刊:Arthritis & rheumatology [Wiley]
卷期号:69 (7): 1440-1450 被引量:213
标识
DOI:10.1002/art.40093
摘要

To investigate whether rituximab, an anti-B cell therapy, improves symptoms of fatigue and oral dryness in patients with primary Sjögren's syndrome (SS).We conducted a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial that included health economic analysis. Anti-Ro-positive patients with primary SS, symptomatic fatigue, and oral dryness were recruited from 25 UK rheumatology clinics from August 2011 to January 2014. Patients were centrally randomized to receive either intravenous (IV) placebo (250 ml saline) or IV rituximab (1,000 mg in 250 ml saline) in 2 courses at weeks 0, 2, 24, and 26, with pre- and postinfusion medication including corticosteroids. The primary end point was the proportion of patients achieving a 30% reduction in either fatigue or oral dryness at 48 weeks, as measured by visual analog scale. Other outcome measures included salivary and lacrimal flow rates, quality of life, scores on the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient Reported Index and EULAR Sjögren's Syndrome Disease Activity Index, symptoms of ocular and overall dryness, pain, globally assessed disease activity, and cost-effectiveness.All 133 patients who were randomized to receive placebo (n = 66) or rituximab (n = 67) were included in the primary analysis. Among patients with complete data, 21 of 56 placebo-treated patients and 24 of 61 rituximab-treated patients achieved the primary end point. After multiple imputation of missing outcomes, response rates in the placebo and rituximab groups were 36.8% and 39.8%, respectively (adjusted odds ratio 1.13 [95% confidence interval 0.50, 2.55]). There were no significant improvements in any outcome measure except for unstimulated salivary flow. The mean ± SD costs per patient for rituximab and placebo were £10,752 ± 264.75 and £2,672 ± 241.71, respectively. There were slightly more adverse events (AEs) reported in total for rituximab, but there was no difference in serious AEs (10 in each group).The results of this study indicate that rituximab is neither clinically effective nor cost-effective in this patient population.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
5秒前
12秒前
12秒前
一杆长空发布了新的文献求助10
17秒前
21秒前
Djnsbj发布了新的文献求助10
23秒前
孙孙发布了新的文献求助50
25秒前
29秒前
31秒前
33秒前
123发布了新的文献求助20
35秒前
科目三应助lan采纳,获得10
36秒前
临水思长发布了新的文献求助10
37秒前
kdjm688发布了新的文献求助10
40秒前
雪白的面包完成签到 ,获得积分10
44秒前
47秒前
lan发布了新的文献求助10
51秒前
52秒前
一杆长空完成签到,获得积分10
54秒前
热情的未来完成签到,获得积分20
1分钟前
义气的蝴蝶完成签到,获得积分10
1分钟前
1分钟前
临水思长完成签到,获得积分10
1分钟前
Lyuhng+1完成签到 ,获得积分10
1分钟前
jyy应助薄红采纳,获得10
1分钟前
1分钟前
量子星尘发布了新的文献求助10
1分钟前
kdjm688发布了新的文献求助10
1分钟前
科研通AI2S应助cos采纳,获得10
1分钟前
FashionBoy应助cos采纳,获得10
1分钟前
多情的忆之完成签到,获得积分10
1分钟前
pamper完成签到 ,获得积分10
1分钟前
1分钟前
1分钟前
零度完成签到 ,获得积分10
1分钟前
kdjm688发布了新的文献求助10
1分钟前
超级微笑完成签到 ,获得积分10
1分钟前
1分钟前
领导范儿应助完美的流沙采纳,获得10
1分钟前
酷酷的枕头完成签到,获得积分10
2分钟前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 700
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3976608
求助须知:如何正确求助?哪些是违规求助? 3520700
关于积分的说明 11204542
捐赠科研通 3257350
什么是DOI,文献DOI怎么找? 1798716
邀请新用户注册赠送积分活动 877881
科研通“疑难数据库(出版商)”最低求助积分说明 806613