{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T10:43:52Z","timestamp":1766486632965,"version":"3.44.0"},"reference-count":40,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2019,2,24]]},"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To investigate the efficacy, safety and immunogenicity of PF-06438179\/GP1111 (PF-SZ-IFX) compared with European reference infliximab (Remicade<jats:sup>\u00ae<\/jats:sup>; ref-IFX) in patients with moderate-to-severe, active rheumatoid arthritis after continued long-term use of PF-SZ-IFX, and in patients who were switched from ref-IFX to PF-SZ-IFX.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>REFLECTIONS B537-02 was a double-blind, active-controlled, multinational study in which patients (N=650) were initially randomised to PF-SZ-IFX or ref-IFX for 30 weeks (treatment period [TP] 1). During weeks 30\u201354 (TP2), the PF-SZ-IFX group (n=280) continued treatment with PF-SZ-IFX (PF-SZ-IFX\/PF-SZ-IFX) and patients in the ref-IFX group (n=286) were rerandomised (1:1) to continue ref-IFX (ref-IFX\/ref-IFX) (n=143) or switch to PF-SZ-IFX (ref-IFX\/PF-SZ-IFX) (n=143) for a further 24 weeks. Efficacy, safety, immunogenicity and pharmacokinetics were evaluated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>During TP2, patients in all three treatment groups continued to maintain comparable treatment response. At week 54, the American College of Rheumatology (ACR20) response rates were 71.1% (PF-SZ-IFX\/PF-SZ-IFX), 64.3% (ref-IFX\/ref-IFX) and 70.6% (ref-IFX\/PF-SZ-IFX). Observations for other endpoints, including ACR50\/70, Disease Activity Score in 28 Joints Based on High-Sensitivity C Reactive Protein(DAS28-CRP) remission, and mean change in DAS28-CRP and Health Assessment Questionnaire-Disability Index, were also comparable. Treatment-emergent adverse events were reported in 36.8% (PF-SZ-IFX\/PF-SZ-IFX), 33.6% (ref-IFX\/ref-IFX) and 37.8% (ref-IFX\/PF-SZ-IFX) of patients; there were no clinically meaningful differences in the safety profiles between groups. The percentage of patients who were antidrug antibody-positive was generally stable through the treatment period and comparable overall between the PF-SZ-IFX\/PF-SZ-IFX (52.1%; neutralising: 80.8%), ref-IFX\/ref-IFX (60.1%; neutralising: 84.9%) and ref-IFX\/PF-SZ-IFX (58.0%; neutralising 78.3%) groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The similar efficacy, safety and immunogenicity of PF-SZ-IFX compared with ref-IFX were maintained for up to 54 weeks and were not affected by blinded treatment switch from ref-IFX to PF-SZ-IFX at week 30.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02222493\">NCT02222493<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2018-000876","type":"journal-article","created":{"date-parts":[[2019,3,29]],"date-time":"2019-03-29T05:59:12Z","timestamp":1553839152000},"page":"e000876","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":23,"title":["Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179\/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54"],"prefix":"10.1136","volume":"5","clinical-trial-number":[{"clinical-trial-number":"nct02222493","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3395-4412","authenticated-orcid":false,"given":"Rieke","family":"Alten","sequence":"first","affiliation":[{"name":"University Medicine, Schlosspark Klinik, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bogdan","family":"Batko","sequence":"additional","affiliation":[{"name":"J Dietl Specialist Hospital, Krakow, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomas","family":"Hala","sequence":"additional","affiliation":[{"name":"Center for Clinical and Basic Research, Pardubice, Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideto","family":"Kameda","sequence":"additional","affiliation":[{"name":"Toho University Ohashi Medical Center, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastiao C","family":"Radominski","sequence":"additional","affiliation":[{"name":"Universidade Federal do Paran\u00e1, Curitiba, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vira","family":"Tseluyko","sequence":"additional","affiliation":[{"name":"Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Goran","family":"Babic","sequence":"additional","affiliation":[{"name":"Sandoz Biopharmaceuticals, Hexal (a Sandoz company), Holzkirchen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carol","family":"Cronenberger","sequence":"additional","affiliation":[{"name":"Pfizer, Collegeville, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Hackley","sequence":"additional","affiliation":[{"name":"Pfizer, Sandwich, Kent, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Muhammad","family":"Rehman","sequence":"additional","affiliation":[{"name":"Pfizer, Andover, Massachusetts, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oliver","family":"von Richter","sequence":"additional","affiliation":[{"name":"Sandoz Biopharmaceuticals, Hexal (a Sandoz company), Holzkirchen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Min","family":"Zhang","sequence":"additional","affiliation":[{"name":"Pfizer, La Jolla, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stanley","family":"Cohen","sequence":"additional","affiliation":[{"name":"Metroplex Clinical Research Center, Dallas, Texas, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,3,28]]},"reference":[{"unstructured":"European Medicines Agency (EMA) . 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