Randomized controlled trial of rituximab and cost-effectiveness analysis in treating fatigue and oral dryness in primary Sjogren's syndrome
Open accessAbstract
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). CONCLUSION: The results of this study indicate that rituximab is neither clinically effective nor cost-effective in this patient population.
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One randomized controlled trial reported statistically significant placebo differences at week 36 (P=0.03) and a statistically significant trend at week 48 (P=0.07) in the log-transformed ESSDAI score.
“Moreover, one RCT 138 reported statistically significant placebo differences at week 36 (P ¼ 0.03) and a statistically significant trend at week 48 (P ¼ 0.07) in the logtransformed ESSDAI score.”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [138]
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- Authors
- Bowman, S. J., Everett, C. C., O'Dwyer, J. L., Emery, P., Pitzalis, C., Ng, W., Pease, C. T., Price, E. J., Sutcliffe, N., Gendi, N. S. T., Hall, F. C., Ruddock, S. P., Fernandez, C., Reynolds, C., Hulme, C. T., Davies, K. A., Edwards, C. J., Lanyon, P. C., Moots, R. J., Roussou, E., Giles, I. P., Sharples, L. D., & Bombardieri, M.
- Affiliations
- University Hospitals Birmingham NHS Foundation Trust (GB)
- University of Leeds (GB)
- Brighton and Sussex Medical School (GB)
- Queen Mary University of London (GB)
- Newcastle University (GB)
- Chapel Allerton Hospital (GB)
- Basildon and Thurrock University Hospitals NHS Foundation Trust (GB)
- University Hospital Southampton NHS Foundation Trust (GB)
- Aintree University Hospitals NHS Foundation Trust (GB)
- University College Hospital (GB)
- London School of Hygiene & Tropical Medicine (GB)
- Corresponding author
- Bowman, Simon J.
- ORCID
- Venue
- Arthritis & Rheumatology
- Publisher
- Wiley
- Published
- 2017-06-05
- Volume
- 69
- Issue
- 7
- Pages
- 1440-1450
- ISSN
- 2326-5191 (ISSN-L)
- 2326-5205
- OpenAlex
- W2592697450
- Cited by
- 276
- References
- 32
- Citations by year
- 2026: 30 · 2025: 25 · 2024: 28 · 2023: 25 · 2022: 32 · 2021: 43 · 2020: 27 · 2019: 27 · 2018: 28 · 2017: 11
- FWCI
- 19.01
- Type
- journal article
- Language
- en
- Update notices
- erratum (2020-09-26)
- Open access
- green
- figshare.com
- Locations
- Arthritis & Rheumatology (publishedVersion)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Sussex Research Online (University of Sussex) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- Arthritis Research UK
- Topics
- Health Sciences › Medicine › Physiology › Salivary Gland Disorders and Functions
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ocular Surface and Contact Lens
- Keywords
- rituximab, primary Sjögren's syndrome, fatigue, xerostomia, anti-B-cell therapy, cost-effectiveness, salivary flow, quality of life, adverse events, anti-SSA antibodies, disease activity, health economic evaluation, adverse drug reactions, patient-reported outcomes
- MeSH terms
- Rituximab, Patient Reported Outcome Measures, Adult, Aged, Cost-Benefit Analysis, Double-Blind Method, Fatigue, Female, United Kingdom, Humans, Male, Middle Aged, Quality of Life, Sjogren's Syndrome, Xerostomia, Odds Ratio, Treatment Outcome, Antirheumatic Agents, Quality-Adjusted Life Years, Visual Analog Scale
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