Bowman, SJ, Everett, CC orcid.org/0000-0002-9788-840X, O'Dwyer, JL orcid.org/0000-0002-7212-6089 et al. (21 more authors) (2017) Randomized Controlled Trial of Rituximab and Cost‐Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjögren's Syndrome. Arthritis & Rheumatology, 69 (7). pp. 1440-1450. ISSN 2326-5191
Abstract
Objective: To investigate whether rituximab, an anti–B cell therapy, improves symptoms of fatigue and oral dryness in patients with primary Sjögren's syndrome (SS).
Methods: 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.
Results: 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).
Conclusions: The results of this study indicate that rituximab is neither clinically effective nor cost‐effective in this patient populatio
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2017, American College of Rheumatology. This is the peer reviewed version of the following article: Bowman, SJ, Everett, CC , O'Dwyer, JL et al. (21 more authors) (2017) Randomized Controlled Trial of Rituximab and Cost‐Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjögren's Syndrome. Arthritis & Rheumatology, 69 (7). pp. 1440-1450. ISSN 2326-5191, which has been published in final form at https://doi.org/10.1002/art.40093. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. Uploaded in accordance with the publisher's self-archiving policy. |
Dates: |
|
Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Inflammatory Arthritis (Leeds) The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Health Sciences (Leeds) > Academic Unit of Health Economics (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 09 Mar 2017 11:19 |
Last Modified: | 27 Aug 2020 08:35 |
Status: | Published |
Publisher: | Wiley |
Identification Number: | 10.1002/art.40093 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:113397 |