{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T04:30:27Z","timestamp":1777523427239,"version":"3.51.4"},"reference-count":15,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,5,31]],"date-time":"2020-05-31T00:00:00Z","timestamp":1590883200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>PF\u201006438179\/GP1111 (PF\u2010SZ\u2010IFX) is a biosimilar of reference infliximab (Remicade<jats:sup>\u00ae<\/jats:sup>). This analysis compared the efficacy of PF\u2010SZ\u2010IFX and reference infliximab sourced from the European Union (IFX\u2010EU) in patient subgroups from a randomized, comparative study of PF\u2010SZ\u2010IFX versus IFX\u2010EU.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with rheumatoid arthritis were randomized 1:1 to PF\u2010SZ\u2010IFX (n\u00a0=\u00a0324) or IFX\u2010EU (n\u00a0=\u00a0326); study drug (3\u00a0mg\/kg) was administered intravenously at weeks 0, 2, and 6, then every 8\u00a0weeks thereafter. Subgroup analyses of efficacy endpoints such as American College of Rheumatology criteria for \u226520% clinical improvement (ACR20), change in high\u2010sensitivity C\u2010reactive protein (hs\u2010CRP), and change in Disease Activity Score in 28 joints, four components based on hs\u2010CRP (DAS28\u2010CRP) at weeks 14 and 30 were performed by age, gender, race, region, immunogenicity status, and treatment history.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, ACR20 response rates as well as changes in DAS28\u2010CRP and hs\u2010CRP at week 14 were similar between PF\u2010SZ\u2010IFX and IFX\u2010EU within the subgroups of age, gender, race, region, treatment history, and immunogenicity status. Results to week 30 support overall similarity in efficacy between the two treatment arms in all subgroups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Overall, PF\u2010SZ\u2010IFX and IFX\u2010EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status. The efficacy results from these subgroup analyses were aligned with the previously described results for the overall population up to week 30.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.13846","type":"journal-article","created":{"date-parts":[[2020,6,1]],"date-time":"2020-06-01T02:10:00Z","timestamp":1590977400000},"page":"876-881","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["A comparative study of PF\u201006438179\/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderate to severe active rheumatoid arthritis: A subgroup analysis"],"prefix":"10.1111","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4330-5782","authenticated-orcid":false,"given":"Hideto","family":"Kameda","sequence":"first","affiliation":[{"name":"Division of Rheumatology Department of Internal Medicine Toho University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eishi","family":"Uechi","sequence":"additional","affiliation":[{"name":"Division of Rheumatology Tomishiro Central Hospital Okinawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatsuya","family":"Atsumi","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Endocrinology and Nephrology Faculty of Medicine Hokkaido University Sapporo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos","family":"Abud\u2010Mendoza","sequence":"additional","affiliation":[{"name":"Rheumatology Research Unit Faculty of Medicine Central Hospital Dr. Ignacio Morones Prieto Universidad Aut\u00f3noma de San Luis Potos\u00ed San Luis Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazumasa","family":"Kamei","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology Medical Affairs Pfizer Japan Inc Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tsugumi","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology Medical Affairs Pfizer Japan Inc Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dario","family":"Ponce de Leon","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology Latin America Medical Affairs Pfizer Inc Lima Peru"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Muhammad I.","family":"Rehman","sequence":"additional","affiliation":[{"name":"Clinical Development Pfizer Inc Andover MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Min","family":"Zhang","sequence":"additional","affiliation":[{"name":"Global Biometrics and Data Management Pfizer Inc La Jolla CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastiao C.","family":"Radominski","sequence":"additional","affiliation":[{"name":"Rheumatology Service Clinical Hospital Universidade Federal do Paran\u00e1 Curitiba Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,5,31]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Guideline on Similar Biological Medicinal Products","author":"European Medicines Agency","year":"2014"},{"key":"e_1_2_9_3_1","first-page":".","volume-title":"Scientific Considerations In Demonstrating Biosimilarity To A Reference Product: Guidance For Industry","author":"US Food and Drug Administration","year":"2015"},{"key":"e_1_2_9_4_1","volume-title":"Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets","author":"IMS Institute for Healthcare Informatics","year":"2016"},{"key":"e_1_2_9_5_1","volume-title":"IXIFI (infliximab\u2010qbtx) Prescribing Information","author":"Pfizer Inc","year":"2017"},{"key":"e_1_2_9_6_1","unstructured":"European Medicines Agency.Zessly: European public assessment report 2018."},{"key":"e_1_2_9_7_1","unstructured":"Pharmaceuticals and Medical Devices Agency.New drugs approved in FY 2018. Pharmaceuticals and Medical Devices Agency."},{"key":"e_1_2_9_8_1","unstructured":"(ANVISA) NHSA.Xilfya authorisation details. Lyophilised powder for injectable solution. 1211004480019. National Health Surveillance Agency (ANVISA) 2019."},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-016-0403-9"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/1744666X.2018.1446829"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-018-1646-4"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2018-000876"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27584"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780350502"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/bit.26438"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/14712598.2019.1635583"}],"container-title":["International Journal of Rheumatic Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2F1756-185X.13846","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1756-185X.13846","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1756-185X.13846","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1756-185X.13846","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,4]],"date-time":"2023-09-04T10:07:54Z","timestamp":1693822074000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1756-185X.13846"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5,31]]},"references-count":15,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2020,7]]}},"alternative-id":["10.1111\/1756-185X.13846"],"URL":"https:\/\/doi.org\/10.1111\/1756-185x.13846","archive":["Portico"],"relation":{},"ISSN":["1756-1841","1756-185X"],"issn-type":[{"value":"1756-1841","type":"print"},{"value":"1756-185X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,5,31]]},"assertion":[{"value":"2019-10-31","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-04-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-05-31","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}