{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T07:22:20Z","timestamp":1784100140763,"version":"3.55.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2020,5,15]],"date-time":"2020-05-15T00:00:00Z","timestamp":1589500800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"public, commercial or not-for-profit sectors"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Recent data have shown a significant efficacy of rituximab (RTX) in SSc. An RTX biosimilar (RTX-B) is a more affordable option. We assessed the safety and efficacy of an RTX-B (CT-P10) in SSc.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>SSc patients treated with RTX-B with at least 6 months of follow-up were retrospectively identified from six Italian referral centres. SSc patients na\u00efve to RTX-B (RTX-Bn) or already treated with RTX originator and switched to an RTX-B (RTX-Bs) were evaluated. A comprehensive assessment of disease characteristics and organ involvement at baseline and after 6\u2009months was obtained.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Thirty-three SSc patients were selected: 29 (87.9%) females, mean age 51.6\u2009years (s.d. 14.2), mean disease duration 9.8\u2009years (s.d. 8.1); 21 (64.5%) with dcSSc, 20 (60.1%) anti-topoisomerase I, 7 (21.2%) anti-RNA polymerase III and 6 (18.2%) anti-centromere positive. Seventeen (51.5%) were RTX-Bn and 16 were on RTX-Bs (48.5%). RTX was introduced because of skin progression in 18 patients (54.5%), interstitial lung disease (ILD) worsening in 11 (33.3%) and arthritis in 12 (36.4%). All patients were previously treated with immunosuppressants. At RTX-B introduction, 21 (63.6%) patients were on concomitant immunosuppressants: 15 (71.4%) on MMF and 6 (28.6%) on MTX. Twenty-three (69.7%) were on low-dose steroids. After 6\u2009months, a significant reduction of the modified Rodnan skin score (mRSS), 28-joint DAS and CRP was observed (P\u2009=\u20090.002, 0.005 and 0.008, respectively); the mRSS significantly improved both in RTX-Bn (P\u2009&amp;lt;\u20090.024) and RTX-Bs patients (P\u2009&amp;lt;\u20090.031). No significant changes were observed for lung function tests, either in the entire cohort or in the subgroup of ILD patients. Only one RTX-Bs patient experienced transient neutropenia.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Our data suggest that RTX-B can represent a cheaper option in SSc patients, as it is effective in improving skin and joint involvement and in stabilizing lung function.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/rheumatology\/keaa136","type":"journal-article","created":{"date-parts":[[2020,2,28]],"date-time":"2020-02-28T20:19:04Z","timestamp":1582921144000},"page":"3731-3736","source":"Crossref","is-referenced-by-count":26,"title":["Safety and efficacy of rituximab biosimilar (CT-P10) in systemic sclerosis: an Italian multicentre study"],"prefix":"10.1093","volume":"59","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6806-3794","authenticated-orcid":false,"given":"Corrado","family":"Campochiaro","sequence":"first","affiliation":[{"name":"Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giacomo","family":"De Luca","sequence":"additional","affiliation":[{"name":"Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Grazia","family":"Lazzaroni","sequence":"additional","affiliation":[{"name":"Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Zanatta","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Medicine, DIMED, University of Padova, Padova"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia Laura","family":"Bosello","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3196-1336","authenticated-orcid":false,"given":"Maria","family":"De Santis","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Clinical Immunology, Humanitas Clinical and Research Center\u2013IRCCS, Rozzano, Milan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriana","family":"Cariddi","sequence":"additional","affiliation":[{"name":"Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2813-2083","authenticated-orcid":false,"given":"Cosimo","family":"Bruni","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Selmi","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Clinical Immunology, Humanitas Clinical and Research Center\u2013IRCCS, Rozzano, Milan"},{"name":"Department of Biomedical Sciences, Humanitas University, Milan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Gremese","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome"},{"name":"Institute of Rheumatology, Universit\u00e0 Cattolica del Sacro Cuore, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Matucci-Cerinic","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0548-4983","authenticated-orcid":false,"given":"Andrea","family":"Doria","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Medicine, DIMED, University of Padova, Padova"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Air\u00f2","sequence":"additional","affiliation":[{"name":"Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenzo","family":"Dagna","sequence":"additional","affiliation":[{"name":"Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,5,15]]},"reference":[{"key":"2020121319240655700_keaa136-B1","doi-asserted-by":"crossref","first-page":"1685","DOI":"10.1016\/S0140-6736(17)30933-9","article-title":"Systemic sclerosis","volume":"390","author":"Denton","year":"2017","journal-title":"Lancet"},{"key":"2020121319240655700_keaa136-B2","doi-asserted-by":"crossref","first-page":"137","DOI":"10.5301\/jsrd.5000249","article-title":"Pathogenesis of systemic sclerosis: recent insights of molecular and cellular mechanisms and therapeutic opportunities","volume":"2","author":"Varga","year":"2017","journal-title":"J Scleroderma Relat Disord"},{"key":"2020121319240655700_keaa136-B3","doi-asserted-by":"crossref","first-page":"1017","DOI":"10.1093\/rheumatology\/ker269","article-title":"Trends in mortality in patients with systemic sclerosis over 40 years: a systematic review and meta-analysis of cohort studies","volume":"51","author":"Elhai","year":"2012","journal-title":"Rheumatology (Oxford)"},{"key":"2020121319240655700_keaa136-B4","doi-asserted-by":"crossref","first-page":"2518","DOI":"10.1056\/NEJMoa1903076","article-title":"Nintedanib for systemic sclerosis-associated interstitial lung disease","volume":"380","author":"Distler","year":"2019","journal-title":"N Engl J Med"},{"key":"2020121319240655700_keaa136-B5","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1016\/j.semarthrit.2016.10.003","article-title":"A multicenter, open-label, comparative study of B-cell depletion therapy with rituximab for systemic sclerosis-associated interstitial lung disease","volume":"46","author":"Daoussis","year":"2017","journal-title":"Semin Arthritis Rheum"},{"key":"2020121319240655700_keaa136-B6","doi-asserted-by":"crossref","first-page":"428","DOI":"10.1016\/j.semarthrit.2014.09.002","article-title":"Long-term efficacy of B cell depletion therapy on lung and skin involvement in diffuse systemic sclerosis","volume":"44","author":"Bosello","year":"2015","journal-title":"Semin Arthritis Rheum"},{"key":"2020121319240655700_keaa136-B7","doi-asserted-by":"crossref","first-page":"979","DOI":"10.1136\/annrheumdis-2018-214816","article-title":"Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study","volume":"78","author":"Elhai","year":"2019","journal-title":"Ann Rheum Dis"},{"key":"2020121319240655700_keaa136-B8","doi-asserted-by":"crossref","first-page":"934","DOI":"10.1080\/19420862.2018.1487912","article-title":"Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled phase 3 trial","volume":"10","author":"Park","year":"2018","journal-title":"MAbs"},{"key":"2020121319240655700_keaa136-B9","doi-asserted-by":"crossref","first-page":"974","DOI":"10.1136\/annrheumdis-2016-209166","article-title":"The changing landscape of biosimilars in rheumatology","volume":"75","author":"D\u00f6rner","year":"2016","journal-title":"Ann Rheum Dis"},{"key":"2020121319240655700_keaa136-B10","doi-asserted-by":"crossref","first-page":"923","DOI":"10.1080\/17512433.2017.1359537","article-title":"Pharmacokinetics, efficacy and safety of the rituximab biosimilar CT-P10","volume":"10","author":"Coiffier","year":"2017","journal-title":"Expert Rev Clin Pharmacol"},{"key":"2020121319240655700_keaa136-B11","doi-asserted-by":"crossref","first-page":"979","DOI":"10.1080\/14712598.2019.1665018","article-title":"Rituximab biosimilar CT-P10 for the treatment of rheumatoid arthritis","volume":"19","author":"Jung","year":"2019","journal-title":"Expert Opin Biol Ther"},{"key":"2020121319240655700_keaa136-B12","doi-asserted-by":"crossref","first-page":"1747","DOI":"10.1136\/annrheumdis-2013-204424","article-title":"2013 classification criteria for systemic sclerosis: an American College of Rheumatology\/European League Against Rheumatism collaborative initiative","volume":"72","author":"van den Hoogen","year":"2013","journal-title":"Ann Rheum Dis"},{"key":"2020121319240655700_keaa136-B13","doi-asserted-by":"crossref","first-page":"11","DOI":"10.5301\/jsrd.5000231","article-title":"Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis","volume":"2","author":"Khanna","year":"2017","journal-title":"J Scleroderma Relat Disord"},{"key":"2020121319240655700_keaa136-B14","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1177\/2397198318783926","article-title":"An interim report of the Scleroderma Clinical Trials Consortium working groups","volume":"4","author":"Baron","year":"2019","journal-title":"J Scleroderma Relat Disord"},{"key":"2020121319240655700_keaa136-B15","doi-asserted-by":"crossref","first-page":"R54","DOI":"10.1186\/ar2965","article-title":"B cell depletion in diffuse progressive systemic sclerosis: safety, skin score modification and IL-6 modulation in an up to thirty-six months follow-up open-label trial","volume":"12","author":"Bosello","year":"2010","journal-title":"Arthritis Res Ther"},{"key":"2020121319240655700_keaa136-B16","doi-asserted-by":"crossref","first-page":"2168","DOI":"10.3899\/jrheum.141182","article-title":"Connective tissue disease-associated interstitial lung diseases (CTD-ILD) \u2013 report from OMERACT CTD-ILD working group","volume":"42","author":"Khanna","year":"2015","journal-title":"J Rheumatol"},{"key":"2020121319240655700_keaa136-B17","doi-asserted-by":"crossref","first-page":"1410","DOI":"10.1136\/ard.2005.037333","article-title":"Is DAS28 an appropriate tool to assess remission in rheumatoid arthritis?","volume":"64","author":"M\u00e4kinen","year":"2005","journal-title":"Ann Rheum Dis"},{"key":"2020121319240655700_keaa136-B18","doi-asserted-by":"crossref","first-page":"624","DOI":"10.1016\/j.autrev.2011.04.013","article-title":"B cells in systemic sclerosis: a possible target for therapy","volume":"10","author":"Bosello","year":"2011","journal-title":"Autoimmun Rev"},{"key":"2020121319240655700_keaa136-B19","doi-asserted-by":"crossref","first-page":"12319","DOI":"10.1073\/pnas.1635114100","article-title":"Systemic and cell type-specific gene expression patterns in scleroderma skin","volume":"100","author":"Whitfield","year":"2003","journal-title":"Proc Natl Acad Sci USA"},{"key":"2020121319240655700_keaa136-B20","doi-asserted-by":"crossref","first-page":"3167","DOI":"10.1002\/art.22847","article-title":"B cell infiltration in systemic sclerosis-associated interstitial lung disease","volume":"56","author":"Lafyatis","year":"2007","journal-title":"Arthritis Rheum"},{"key":"2020121319240655700_keaa136-B21","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1186\/s13075-018-1569-0","article-title":"Characterization of inflammatory cell infiltrate of scleroderma skin: B cells and skin score progression","volume":"20","author":"Bosello","year":"2018","journal-title":"Arthritis Res Ther"},{"key":"2020121319240655700_keaa136-B22","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1007\/s40259-017-0232-7","article-title":"Efficacy, safety and pharmacokinetics of up to two courses of the rituximab biosimilar CT-P10 versus innovator rituximab in patients with rheumatoid arthritis: results up to week 72 of a phase i randomized controlled trial","volume":"31","author":"Yoo","year":"2017","journal-title":"BioDrugs"},{"key":"2020121319240655700_keaa136-B23","doi-asserted-by":"crossref","first-page":"212","DOI":"10.1177\/2397198319841842","article-title":"Rationale for the evaluation of nintedanib as a treatment for systemic sclerosis\u2013associated interstitial lung disease","volume":"4","author":"Wollin","year":"2019","journal-title":"J Scleroderma Relat Disord"},{"key":"2020121319240655700_keaa136-B24","article-title":"Systemic sclerosis: recent insight in clinical management","author":"Zanatta","year":"2019","journal-title":"Joint Bone Spine"},{"key":"2020121319240655700_keaa136-B25","first-page":"1","article-title":"Budget impact analysis of rituximab biosimilar in Italy from the hospital and payer perspectives","author":"Rognoni","year":"2018","journal-title":"Glob Reg Health Technol Assess"}],"container-title":["Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/rheumatology\/article-pdf\/59\/12\/3731\/34890105\/keaa136.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/rheumatology\/article-pdf\/59\/12\/3731\/34890105\/keaa136.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,12,14]],"date-time":"2020-12-14T00:24:36Z","timestamp":1607905476000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/rheumatology\/article\/59\/12\/3731\/5837752"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5,15]]},"references-count":25,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2020,5,15]]},"published-print":{"date-parts":[[2020,12,1]]}},"URL":"https:\/\/doi.org\/10.1093\/rheumatology\/keaa136","relation":{},"ISSN":["1462-0324","1462-0332"],"issn-type":[{"value":"1462-0324","type":"print"},{"value":"1462-0332","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2020,12]]},"published":{"date-parts":[[2020,5,15]]}}}