{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T05:37:03Z","timestamp":1773812223760,"version":"3.50.1"},"reference-count":19,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2021,4,21]],"date-time":"2021-04-21T00:00:00Z","timestamp":1618963200000},"content-version":"unspecified","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/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":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2021,3,25]]},"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To investigate the efficacy, safety, immunogenicity and pharmacokinetics of biosimilar adalimumab (ADL) PF-06410293 (ADL-PF; adalimumab-afzb) versus EU-sourced reference ADL (ADL-EU) in patients with active rheumatoid arthritis (RA) on longer-term treatment and after being switched from ADL-EU to ADL-PF.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this multinational, double-blind study, patients with active RA were initially randomised to ADL-PF or ADL-EU for 26 weeks (treatment period (TP) 1). At the start of TP2 (weeks 26\u201352), patients in the ADL-EU arm were blindly re-randomised 1:1 to remain on ADL-EU (ADL-EU\/ADL-EU; n=135) or switched to ADL-PF (ADL-EU\/ADL-PF; n=134); patients receiving ADL-PF continued blinded treatment (ADL-PF\/ADL-PF; n=283).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The American College of Rheumatology 20% improvement (ACR20) response rates were comparable between treatment groups at all visits during TP2. At week 52, ACR20 response rates were 82.7% (ADL-PF\/ADL-PF), 79.3% (ADL-EU\/ADL-EU) and 84.3% (ADL-EU\/ADL-PF). Other measures of deep response (ACR50\/70, ACR\/EULAR-defined remission, EULAR good response, and Disease Activity Score in 28 Joints Based on High-Sensitivity C-Reactive Protein &lt;2.6) and Health Assessment Questionnaire\u2212Disability Index were maintained over TP2 and comparable between groups. Treatment-emergent adverse events were reported in 43.5% (ADL-PF\/ADL-PF), 44.4% (ADL-EU\/ADL-EU) and 38.3% (ADL-EU\/ADL-PF) of patients; there were no clinically meaningful differences in the safety profiles between groups. The percentage of patients who were antidrug antibody positive was comparable overall among ADL-PF\/ADL-PF (47.3%), ADL-EU\/ADL-EU (54.1%) and ADL-EU\/ADL-PF (45.9%).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The similar efficacy, safety, immunogenicity and pharmacokinetics of ADL-PF and ADL-EU, maintained up to week 52, were unaffected by blinded treatment switch from ADL-EU to ADL-PF at week 26.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>ClinicalTrials.gov identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02480153\">NCT02480153<\/jats:ext-link>; EudraCT number: 2014-000352-29.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2021-001578","type":"journal-article","created":{"date-parts":[[2021,4,21]],"date-time":"2021-04-21T12:26:29Z","timestamp":1619007989000},"page":"e001578","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":18,"title":["Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26\u201352, including a treatment switch from reference ADL to PF-06410293"],"prefix":"10.1136","volume":"7","clinical-trial-number":[{"clinical-trial-number":"nct02480153","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02480153","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6630-1477","authenticated-orcid":false,"given":"Roy M","family":"Fleischmann","sequence":"first","affiliation":[{"name":"Metroplex Clinical Research Center, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel F","family":"Alvarez","sequence":"additional","affiliation":[{"name":"Global Product Development, Inflammation and Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy E","family":"Bock","sequence":"additional","affiliation":[{"name":"Global Product Development, Clinical Development and Operations, Pfizer Inc, Cambridge, Massachusetts, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carol","family":"Cronenberger","sequence":"additional","affiliation":[{"name":"Global Product Development, Inflammation and Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ivana","family":"Vranic","sequence":"additional","affiliation":[{"name":"Worldwide R&D, Safety Surveillance Risk Management, Pfizer Inc, Tadworth, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wuyan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Global Product Development, Biometrics and Data Management, Pfizer Inc, Lake Forest, Illinois, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3395-4412","authenticated-orcid":false,"given":"Rieke","family":"Alten","sequence":"additional","affiliation":[{"name":"University Medicine, Schlosspark Klinik, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,4,21]]},"reference":[{"key":"2025090313491434000_7.2.e001578.1","unstructured":"AbbVie. Humira (adalimumab) prescribing information, 2002. Available: http:\/\/www.rxabbvie.com\/pdf\/humira.pdf [Accessed 26 Feb 2020]."},{"key":"2025090313491434000_7.2.e001578.2","doi-asserted-by":"publisher","DOI":"10.1002\/art.21519"},{"key":"2025090313491434000_7.2.e001578.3","doi-asserted-by":"publisher","DOI":"10.1002\/art.20217"},{"key":"2025090313491434000_7.2.e001578.4","doi-asserted-by":"publisher","DOI":"10.1002\/art.10697"},{"key":"2025090313491434000_7.2.e001578.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2011.05.044"},{"key":"2025090313491434000_7.2.e001578.6","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202603"},{"key":"2025090313491434000_7.2.e001578.7","unstructured":"European Medicines Agency . Guideline on similar biological medicinal products containing monoclonal antibodies \u2013 non-clinical and clinical issues, 2012. Available: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf [Accessed 26 Feb 2020]."},{"key":"2025090313491434000_7.2.e001578.8","unstructured":"US Food and Drug Administration . Scientific considerations in demonstrating Biosimilarity to a reference product: guidance for industry, 2015. https:\/\/www.fda.gov\/media\/82647\/download. (Accessed 26 February 2020)."},{"key":"2025090313491434000_7.2.e001578.9","unstructured":"Pfizer Inc . Abrilada\u2122 (adalimumab-afzb) prescribing information, 2019. Available: http:\/\/labeling.pfizer.com\/ShowLabeling.aspx?id=12780 [Accessed 26 Feb 2020]."},{"key":"2025090313491434000_7.2.e001578.10","unstructured":"European Medicines Agency . Amsparity: summary of product characteristics, 2020. Available: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/amsparity-epar-product-information_en.pdf [Accessed 26 Feb 2020]."},{"key":"2025090313491434000_7.2.e001578.11","doi-asserted-by":"crossref","first-page":"178","DOI":"10.1186\/s13075-018-1676-y","article-title":"A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira\u00ae) in the treatment of active rheumatoid arthritis","volume":"20","author":"Fleischmann","year":"2018","journal-title":"Arthritis Res Ther"},{"key":"2025090313491434000_7.2.e001578.12","doi-asserted-by":"publisher","DOI":"10.1002\/art.27584"},{"key":"2025090313491434000_7.2.e001578.13","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202220"},{"key":"2025090313491434000_7.2.e001578.14","doi-asserted-by":"publisher","DOI":"10.1186\/ar3147"},{"key":"2025090313491434000_7.2.e001578.15","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kev277"},{"key":"2025090313491434000_7.2.e001578.16","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(199809)41:9<1552::AID-ART5>3.0.CO;2-W"},{"key":"2025090313491434000_7.2.e001578.17","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2018-000876"},{"key":"2025090313491434000_7.2.e001578.18","doi-asserted-by":"crossref","first-page":"397","DOI":"10.1007\/s40259-018-0306-1","article-title":"Non-Pharmacological effects in switching medication: the nocebo effect in switching from originator to biosimilar agent","volume":"32","author":"Kristensen","year":"2018","journal-title":"BioDrugs"},{"key":"2025090313491434000_7.2.e001578.19","doi-asserted-by":"crossref","first-page":"749","DOI":"10.1007\/s12325-018-0719-8","article-title":"To see or NOsee: the debate on the nocebo effect and optimizing the use of biosimilars","volume":"35","author":"Rezk","year":"2018","journal-title":"Adv Ther"}],"container-title":["RMD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rmdopen-2021-001578","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T20:49:26Z","timestamp":1756932566000},"score":1,"resource":{"primary":{"URL":"https:\/\/rmdopen.bmj.com\/lookup\/doi\/10.1136\/rmdopen-2021-001578"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4]]},"references-count":19,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2021,4,21]]},"published-print":{"date-parts":[[2021,4]]}},"alternative-id":["10.1136\/rmdopen-2021-001578"],"URL":"https:\/\/doi.org\/10.1136\/rmdopen-2021-001578","relation":{},"ISSN":["2056-5933"],"issn-type":[{"value":"2056-5933","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,4]]}}}