{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T04:44:19Z","timestamp":1769834659405,"version":"3.49.0"},"reference-count":20,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,10,17]],"date-time":"2022-10-17T00:00:00Z","timestamp":1665964800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>YLB113 biosimilar was evaluated in an open\u2010label extension single\u2010arm study to assess long\u2010term safety, efficacy, and immunogenicity in patients with rheumatoid arthritis (RA). We also report post\u2010hoc results on the incidence of injection\u2010site reactions (ISRs) and injection\u2010site erythema (ISE) from a phase III study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>Participants from the phase III, double\u2010blind, randomized, 96 week equivalence study who completed the final visit received 50\u2009mg YLB113 subcutaneously every 2\u2009weeks. Key safety end points were assessed through adverse events (AEs), ISRs, ISE, and anti\u2010drug antibody (ADA) incidence. The efficacy end point was change from baseline in Disease Activity Score 28\u2010joint count (DAS28) over time.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 201 participants, 184 (91.5%) completed the study. Treatment\u2010emergent AEs were experienced by 93.5% and severe AEs by 10.0% of participants. The discontinuation rate due to AEs was 2.0%. Overall, 20.0% of participants reported an incidence of ISRs throughout the open\u2010label extension study. Two participants developed ADAs, and none developed neutralizing ADAs at any time after study drug administration. The overall DAS28 (mean\u2009\u00b1\u2009SD) change was 2.22\u2009\u00b1\u20090.95 at the study transition, 2.10\u2009\u00b1\u20090.91 at week 72, and 2.06\u2009\u00b1\u20090.89 at the end of the study. In the post\u2010hoc analysis, YLB113 showed a statistically significant lower incidence of ISRs (10 [3.8%], <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001) and ISE (5 [1.9%], <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001) compared with the reference product Enbrel\u00ae.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>YLB113 demonstrated long\u2010term safety and sustained efficacy for up to 96\u2009weeks. Patients on YLB113 experienced significantly lower ISRs and ISE in a post\u2010hoc analysis of the phase III study when compared with reference product.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.14462","type":"journal-article","created":{"date-parts":[[2022,10,18]],"date-time":"2022-10-18T00:53:56Z","timestamp":1666054436000},"page":"108-115","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Lower injection\u2010site reactions and long\u2010term safety, immunogenicity, and efficacy of etanercept biosimilar <scp>YLB113<\/scp>: Results from a post\u2010hoc analysis of a double\u2010blind, randomized, phase <scp>III<\/scp> comparative study and its open\u2010label extension in patients with rheumatoid arthritis"],"prefix":"10.1111","volume":"26","author":[{"given":"Hisashi","family":"Yamanaka","sequence":"first","affiliation":[{"name":"Sanno Medical Center  Tokyo Japan"},{"name":"Women's Medical University School of Medicine  Tokyo Japan"},{"name":"International University of Health and Welfare  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0807-7139","authenticated-orcid":false,"given":"Yoshiya","family":"Tanaka","sequence":"additional","affiliation":[{"name":"University of Occupational and Environmental Health  Kitakyushu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshihiko","family":"Hibino","sequence":"additional","affiliation":[{"name":"YL Biologics Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gopalakrishnan","family":"Unmesh","sequence":"additional","affiliation":[{"name":"Viatris  Bengaluru India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chirag","family":"Shah","sequence":"additional","affiliation":[{"name":"Lupin LTD  Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dhananjay","family":"Bakhle","sequence":"additional","affiliation":[{"name":"Lupin LTD  Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9018-981X","authenticated-orcid":false,"given":"Dimitris","family":"Stefanidis","sequence":"additional","affiliation":[{"name":"Viatris GmbH  Bad Homburg vor der H\u00f6he Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,10,17]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1159\/000493390"},{"key":"e_1_2_11_3_1","unstructured":"European Medicines Agency(2014).Guideline on similar biological medicinal products (2014).http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2014\/10\/WC500176768.pdf."},{"key":"e_1_2_11_4_1","unstructured":"US Department of Health and Human Services;US Food and Drug Administration;Center for Drug Evaluation and Research (CDER);Center for Biologics Evaluation and Research (CBER).2015.Scientific considerations in demonstrating bio similarity to a reference product: guidance for industry.http:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm291128.pdf"},{"key":"e_1_2_11_5_1","unstructured":"Center for Drug Evaluation and Research (CDER);Center for Biologics Evaluation and Research (CBER).2015.Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry.http:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm291128.pdf"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210715"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209166"},{"key":"e_1_2_11_8_1","unstructured":"Committee for Medicinal Products for Human Use (CHMP).Assessment Report. 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