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.
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