PMID- 28296257 OWN - NLM STAT- MEDLINE DCOM- 20170821 LR - 20231115 IS - 2326-5205 (Electronic) IS - 2326-5191 (Linking) VI - 69 IP - 7 DP - 2017 Jul TI - Randomized Controlled Trial of Rituximab and Cost-Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjogren's Syndrome. PG - 1440-1450 LID - 10.1002/art.40093 [doi] AB - OBJECTIVE: To investigate whether rituximab, an anti-B cell therapy, improves symptoms of fatigue and oral dryness in patients with primary Sjogren'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) Sjogren's Syndrome Patient Reported Index and EULAR Sjogren'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 pound10,752 +/- 264.75 and pound2,672 +/- 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. CI - (c) 2017, American College of Rheumatology. FAU - Bowman, Simon J AU - Bowman SJ AD - University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. FAU - Everett, Colin C AU - Everett CC AUID- ORCID: 0000-0002-9788-840X AD - University of Leeds, Leeds, UK. FAU - O'Dwyer, John L AU - O'Dwyer JL AD - University of Leeds, Leeds, UK. FAU - Emery, Paul AU - Emery P AD - Chapel Allerton Hospital, Leeds, UK. FAU - Pitzalis, Costantino AU - Pitzalis C AD - Barts and The London School of Medicine and Dentistry, London, UK. FAU - Ng, Wan-Fai AU - Ng WF AUID- ORCID: 0000-0002-5539-388X AD - University of Newcastle, Newcastle-upon-Tyne, UK. FAU - Pease, Colin T AU - Pease CT AD - Chapel Allerton Hospital, Leeds, UK. FAU - Price, Elizabeth J AU - Price EJ AD - Great Western Hospital, Swindon, UK. FAU - Sutcliffe, Nurhan AU - Sutcliffe N AD - Royal London Hospital (Mile End), London, UK. FAU - Gendi, Nagui S T AU - Gendi NST AD - Basildon and Thurrock University Hospital, Essex, UK. FAU - Hall, Frances C AU - Hall FC AD - University of Cambridge, Addenbrookes Hospital, Cambridge, UK. FAU - Ruddock, Sharon P AU - Ruddock SP AD - University of Leeds, Leeds, UK. FAU - Fernandez, Catherine AU - Fernandez C AD - University of Leeds, Leeds, UK. FAU - Reynolds, Catherine AU - Reynolds C AD - University of Leeds, Leeds, UK. FAU - Hulme, Claire T AU - Hulme CT AD - University of Leeds, Leeds, UK. FAU - Davies, Kevin A AU - Davies KA AD - University of Sussex, Brighton, UK. FAU - Edwards, Christopher J AU - Edwards CJ AD - NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, Southampton, UK. FAU - Lanyon, Peter C AU - Lanyon PC AD - University of Nottingham and Circle Nottingham, Nottingham NHS Treatment Centre, Nottingham, UK. FAU - Moots, Robert J AU - Moots RJ AD - Aintree University Hospital, Liverpool, UK. FAU - Roussou, Euthalia AU - Roussou E AD - King George Hospital, Barking Havering and Redbridge University Hospitals NHS Trust, Essex, UK. FAU - Giles, Ian P AU - Giles IP AD - University College London Hospital, London, UK. FAU - Sharples, Linda D AU - Sharples LD AD - London School of Hygiene and Tropical Medicine, London, UK. FAU - Bombardieri, Michele AU - Bombardieri M AD - Barts and The London School of Medicine and Dentistry, London, UK. LA - eng SI - EudraCT/2010-021430-64 SI - ISRCTN/65360827 GR - 21268/VAC_/Versus Arthritis/United Kingdom GR - 20639/VAC_/Versus Arthritis/United Kingdom GR - 18475/ARC_/Arthritis Research UK/United Kingdom GR - G0800629/MRC_/Medical Research Council/United Kingdom GR - 18810/VAC_/Versus Arthritis/United Kingdom GR - MR/N003063/1/MRC_/Medical Research Council/United Kingdom GR - RC-PG-0407-10054/DH_/Department of Health/United Kingdom PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20170605 PL - United States TA - Arthritis Rheumatol JT - Arthritis & rheumatology (Hoboken, N.J.) JID - 101623795 RN - 0 (Antirheumatic Agents) RN - 4F4X42SYQ6 (Rituximab) SB - IM CIN - Arthritis Rheumatol. 2017 Jul;69(7):1346-1349. PMID: 28296253 EIN - Arthritis Rheumatol. 2020 Oct;72(10):1748. PMID: 33460295 MH - Adult MH - Aged MH - Antirheumatic Agents/economics/*therapeutic use MH - Cost-Benefit Analysis MH - Double-Blind Method MH - Fatigue/*drug therapy/etiology MH - Female MH - Humans MH - Male MH - Middle Aged MH - Odds Ratio MH - Patient Reported Outcome Measures MH - Quality of Life MH - Quality-Adjusted Life Years MH - Rituximab/economics/*therapeutic use MH - Sjogren's Syndrome/complications/*drug therapy MH - Treatment Outcome MH - United Kingdom MH - Visual Analog Scale MH - Xerostomia/*drug therapy/etiology EDAT- 2017/03/16 06:00 MHDA- 2017/08/22 06:00 CRDT- 2017/03/16 06:00 PHST- 2016/07/28 00:00 [received] PHST- 2017/03/07 00:00 [accepted] PHST- 2017/03/16 06:00 [pubmed] PHST- 2017/08/22 06:00 [medline] PHST- 2017/03/16 06:00 [entrez] AID - 10.1002/art.40093 [doi] PST - ppublish SO - Arthritis Rheumatol. 2017 Jul;69(7):1440-1450. doi: 10.1002/art.40093. Epub 2017 Jun 5.