{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T03:17:27Z","timestamp":1792207047962,"version":"4.4.0"},"reference-count":34,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2017,6,5]],"date-time":"2017-06-05T00:00:00Z","timestamp":1496620800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100000341","name":"Arthritis Research UK","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000341","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2017,7]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To investigate whether rituximab, an anti\u2013B cell therapy, improves symptoms of fatigue and oral dryness in patients with primary Sj\u00f6gren's syndrome (SS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a multicenter, randomized, double\u2010blind, placebo\u2010controlled, parallel\u2010group trial that included health economic analysis. Anti\u2010Ro\u2013positive 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\u2010 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) Sj\u00f6gren's Syndrome Patient Reported Index and EULAR Sj\u00f6gren's Syndrome Disease Activity Index, symptoms of ocular and overall dryness, pain, globally assessed disease activity, and cost\u2010effectiveness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>All 133 patients who were randomized to receive placebo (n\u2009=\u200966) or rituximab (n\u2009=\u200967) were included in the primary analysis. Among patients with complete data, 21 of 56 placebo\u2010treated patients and 24 of 61 rituximab\u2010treated 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\u2009\u00b1\u2009SD costs per patient for rituximab and placebo were \u00a310,752\u2009\u00b1\u2009264.75 and \u00a32,672\u2009\u00b1\u2009241.71, 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The results of this study indicate that rituximab is neither clinically effective nor cost\u2010effective in this patient population.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.40093","type":"journal-article","created":{"date-parts":[[2017,3,10]],"date-time":"2017-03-10T13:37:30Z","timestamp":1489153050000},"page":"1440-1450","source":"Crossref","is-referenced-by-count":265,"title":["Randomized Controlled Trial of Rituximab and Cost\u2010Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sj\u00f6gren's Syndrome"],"prefix":"10.1002","volume":"69","author":[{"given":"Simon J.","family":"Bowman","sequence":"first","affiliation":[{"name":"University Hospitals Birmingham NHS Foundation Trust Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9788-840X","authenticated-orcid":false,"given":"Colin C.","family":"Everett","sequence":"additional","affiliation":[{"name":"University of Leeds Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John L.","family":"O'Dwyer","sequence":"additional","affiliation":[{"name":"University of Leeds Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Emery","sequence":"additional","affiliation":[{"name":"Chapel Allerton Hospital Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Costantino","family":"Pitzalis","sequence":"additional","affiliation":[{"name":"Barts and The London School of Medicine and Dentistry London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5539-388X","authenticated-orcid":false,"given":"Wan\u2010Fai","family":"Ng","sequence":"additional","affiliation":[{"name":"University of Newcastle Newcastle\u2010upon\u2010Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin T.","family":"Pease","sequence":"additional","affiliation":[{"name":"Chapel Allerton Hospital Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth J.","family":"Price","sequence":"additional","affiliation":[{"name":"Great Western Hospital Swindon UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nurhan","family":"Sutcliffe","sequence":"additional","affiliation":[{"name":"Royal London Hospital (Mile End) London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nagui S. T.","family":"Gendi","sequence":"additional","affiliation":[{"name":"Basildon and Thurrock University Hospital Essex UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances C.","family":"Hall","sequence":"additional","affiliation":[{"name":"University of Cambridge, Addenbrookes Hospital Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon P.","family":"Ruddock","sequence":"additional","affiliation":[{"name":"University of Leeds Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Fernandez","sequence":"additional","affiliation":[{"name":"University of Leeds Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Reynolds","sequence":"additional","affiliation":[{"name":"University of Leeds Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire T.","family":"Hulme","sequence":"additional","affiliation":[{"name":"University of Leeds Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin A.","family":"Davies","sequence":"additional","affiliation":[{"name":"University of Sussex Brighton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher J.","family":"Edwards","sequence":"additional","affiliation":[{"name":"NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter C.","family":"Lanyon","sequence":"additional","affiliation":[{"name":"University of Nottingham and Circle Nottingham, Nottingham NHS Treatment Centre Nottingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert J.","family":"Moots","sequence":"additional","affiliation":[{"name":"Aintree University Hospital Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Euthalia","family":"Roussou","sequence":"additional","affiliation":[{"name":"King George Hospital, Barking Havering and Redbridge University Hospitals NHS Trust Essex UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian P.","family":"Giles","sequence":"additional","affiliation":[{"name":"University College London Hospital London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda D.","family":"Sharples","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Bombardieri","sequence":"additional","affiliation":[{"name":"Barts and The London School of Medicine and Dentistry London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,6,5]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/00002281-200009000-00007"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keh170"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.159.2.174"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.rhu.0000135553.08057.21"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.7682"},{"key":"e_1_2_7_7_1","volume-title":"SF\u201036 health survey: manual and interpretation guide","author":"Ware JE","year":"1993"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22536"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.21260"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.37850"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar4359"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.083865"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27314"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.7326\/M13-1085"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2474-15-21"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.143743"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/ken426"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/36.5.551"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.110619"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22658"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/ken164"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kem280"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4067"},{"key":"e_1_2_7_24_1","volume-title":"Multiple imputation for nonresponse in surveys","author":"Rubin DB.","year":"2008"},{"key":"e_1_2_7_25_1","unstructured":"National Institute for Health and Care Excellence. 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