{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T18:06:58Z","timestamp":1776276418953,"version":"3.50.1"},"reference-count":35,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010780","name":"Celltrion Healthcare","doi-asserted-by":"publisher","award":["NA"],"award-info":[{"award-number":["NA"]}],"id":[{"id":"10.13039\/100010780","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>CT-P13 is an infliximab biosimilar approved for indications including ankylosing spondylitis (AS); the approved maintenance regimen is 5 mg\/kg infused every 6\u20138 weeks. In clinical practice, modifications to infliximab dose and\/or infusion interval can be beneficial to the patient. For CT-P13, real-world data on dose and\/or interval adjustment are lacking. This analysis investigated the impact of such treatment pattern changes on effectiveness and drug survival up to five years for adult (\u226518 years old) patients with AS in the Korean, real-world, retrospective rheumatoid arthritis and ankylosing spondylitis (RAAS) study. Overall, 337 patients with AS were identified: 219 who initiated infliximab treatment with CT-P13 (\u2018na\u00efve\u2019) and 118 who switched from reference infliximab to CT-P13 (\u2018switched\u2019). Overall, 18\/235 (7.7%), 110\/224 (49.1%), and 101\/186 (54.3%) evaluable patients had dose, infusion interval, or combined treatment pattern changes, respectively. More na\u00efve (61.0%) versus switched (42.6%) patients had treatment pattern changes. Overall, Bath Ankylosing Spondylitis Disease Activity Index scores decreased from baseline to week 54, then remained stable; improvements were greater for patients with than without treatment pattern changes. Drug survival did not differ significantly between patients with or without treatment pattern changes. Findings suggest that adjusting dose and\/or infusion interval can improve clinical outcomes for CT-P13-treated patients with AS.<\/jats:p>","DOI":"10.3390\/jcm10194568","type":"journal-article","created":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T10:55:40Z","timestamp":1633085740000},"page":"4568","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Impact of Infliximab Biosimilar CT-P13 Dose and Infusion Interval on Real-World Drug Survival and Effectiveness in Patients with Ankylosing Spondylitis"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6810-7355","authenticated-orcid":false,"given":"Shin-Seok","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Rheumatology, Chonnam National University Medical School and Hospital, 42 Jebong-ro, Dong-gu, Gwangju 61469, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3542-2276","authenticated-orcid":false,"given":"Tae-Hwan","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-ro, Seongdong-gu, Seoul 04763, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0004-8034","authenticated-orcid":false,"given":"Won","family":"Park","sequence":"additional","affiliation":[{"name":"School of Medicine, Inha University, Jung-Seok Building C Dong, 605 Ho. 366 Seohae-daero, Jung-gu, Incheon 22332, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5384-3437","authenticated-orcid":false,"given":"Yeong-Wook","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Rheumatology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 110-744, Korea"},{"name":"Medical Research Center, Institute of Human-Environment Interface Biology, Seoul National University, 103 Daehak-ro, Ihwa-dong, Jongno-gu, Seoul 03080, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6156-393X","authenticated-orcid":false,"given":"Chang-Hee","family":"Suh","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Ajou University School of Medicine, 164 Worldcup-ro, Yeongtong-gu, Suwon 16499, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soo-Kyoung","family":"Kim","sequence":"additional","affiliation":[{"name":"Medical Affairs Department, Celltrion Healthcare Co., Ltd., 4th Floor, 19 Academy-ro, 51 beon gil, Yeonsu-gu, Incheon 22014, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0643-4008","authenticated-orcid":false,"given":"Dae-Hyun","family":"Yoo","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-ro, Seongdong-gu, Seoul 04763, Korea"},{"name":"Hanyang University Institute for Rheumatology Research, 222-1 Wangsimni-ro, Seongdong-gu, Seoul 04763, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,10,1]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1605","DOI":"10.1136\/annrheumdis-2012-203091","article-title":"A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: The PLANETAS study","volume":"72","author":"Park","year":"2013","journal-title":"Ann. Rheum. Dis."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"346","DOI":"10.1136\/annrheumdis-2015-208783","article-title":"Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study","volume":"76","author":"Park","year":"2017","journal-title":"Ann. Rheum. Dis."},{"key":"ref_3","unstructured":"US Food and Drug Administration (2021, February 16). Inflectra Prescribing Information, Available online: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/125544s009lbl.pdf."},{"key":"ref_4","unstructured":"European Medicines Agency (2021, February 16). Remsima Summary of Product Characteristics. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/remsima-epar-product-information_en.pdf."},{"key":"ref_5","unstructured":"US Food and Drug Administration (2021, February 16). Remicade Prescribing Information, Available online: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/103772s5389s5391s5394lbl.pdf."},{"key":"ref_6","unstructured":"European Medicines Agency (2021, February 16). Inflectra Summary of Product Characteristics. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/inflectra-epar-product-information_en.pdf."},{"key":"ref_7","unstructured":"European Medicines Agency (2021, February 16). Remicade Prescribing Information. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/remicade-epar-product-information_en.pdf."},{"key":"ref_8","unstructured":"Ministry of Food and Drug Safety (2021, February 23). Biological products (recombinant DNA products): Celltrion, Inc., Available online: https:\/\/www.mfds.go.kr\/eng\/brd\/m_30\/view.do?seq=69797."},{"key":"ref_9","first-page":"959","article-title":"Infliximab in ankylosing spondylitis: A prospective observational inception cohort analysis of efficacy and safety","volume":"29","author":"Maksymowych","year":"2002","journal-title":"J. Rheumatol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1728","DOI":"10.3899\/jrheum.091043","article-title":"Low-dose infliximab (3 mg\/kg) significantly reduces spinal inflammation on magnetic resonance imaging in patients with ankylosing spondylitis: A randomized placebo-controlled study","volume":"37","author":"Maksymowych","year":"2010","journal-title":"J. Rheumatol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"162","DOI":"10.1097\/01.rhu.0000135551.47780.ba","article-title":"Infliximab therapy for patients with active and refractory spondyloarthropathies at the dose of 3 mg\/kg: A 20-month open treatment","volume":"10","author":"Cherouvim","year":"2004","journal-title":"J. Clin. Rheumatol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1016\/j.jbspin.2010.04.017","article-title":"A 3 mg\/kg starting dose of infliximab in active spondyloarthritis resistant to conventional treatments is efficient, safe and lowers costs","volume":"78","author":"Tenga","year":"2011","journal-title":"Jt. Bone Spine"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1203","DOI":"10.3899\/jrheum.091042","article-title":"A double-blind, placebo-controlled trial of low dose infliximab in ankylosing spondylitis","volume":"37","author":"Inman","year":"2010","journal-title":"J. Rheumatol."},{"key":"ref_14","first-page":"558","article-title":"Prospective observational analysis of the efficacy and safety of low-dose (3 mg\/kg) infliximab in ankylosing spondylitis: 4-year followup","volume":"33","author":"Keeling","year":"2006","journal-title":"J. Rheumatol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1566","DOI":"10.1093\/rheumatology\/kel156","article-title":"Low-dose infliximab treatment for ankylosing spondylitis\u2014clinically- and cost-effective","volume":"45","author":"Jois","year":"2006","journal-title":"Rheumatology (Oxford)"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"2100","DOI":"10.1093\/rheumatology\/keu252","article-title":"Impact of different infliximab dose regimens on treatment response and drug survival in 462 patients with psoriatic arthritis: Results from the nationwide registries DANBIO and ICEBIO","volume":"53","author":"Glintborg","year":"2014","journal-title":"Rheumatology"},{"key":"ref_17","first-page":"13","article-title":"Low starting dosage of infliximab with possible escalating dosage in psoriatic arthritis gives the same treatment results as standard dosage of adalimumab or etanercept: Results from the nationwide Icelandic ICEBIO registry","volume":"8","author":"Gudbjornsson","year":"2018","journal-title":"Psoriasis (Auckl)"},{"key":"ref_18","first-page":"171","article-title":"Infliximab dose adjustment can improve the clinical and radiographic outcomes of rheumatoid arthritis patients: REVIVE study results","volume":"12","author":"Nozaki","year":"2018","journal-title":"Biologics"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"2501","DOI":"10.1007\/s10067-019-04543-z","article-title":"Outcomes of infliximab dose escalation in patients with rheumatoid arthritis","volume":"38","author":"Cohen","year":"2019","journal-title":"Clin. Rheumatol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"541","DOI":"10.1007\/s40261-020-00907-5","article-title":"A 5-year retrospective analysis of drug survival, safety, and effectiveness of the infliximab biosimilar CT-P13 in patients with rheumatoid arthritis and ankylosing spondylitis","volume":"40","author":"Kim","year":"2020","journal-title":"Clin. Drug Investig."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"716","DOI":"10.1136\/annrheumdis-2021-eular.1055","article-title":"POS0911\u2005Similar clinical responses achieved with lower versus standard doses of infliximab biosimilar CT-P13 in patients with ankylosing spondylitis: Real-world results from the RAAS study","volume":"80","author":"Lee","year":"2021","journal-title":"Ann. Rheum. Dis."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"369","DOI":"10.2217\/cer-2017-0076","article-title":"Treatment patterns of biologics in US patients with ankylosing spondylitis: Descriptive analyses from a claims database","volume":"7","author":"Walsh","year":"2018","journal-title":"J. Comp. Eff. Res."},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Kaltsonoudis, E., Pelechas, E., Voulgari, P.V., and Drosos, A.A. (2019). Maintained clinical remission in ankylosing spondylitis patients switched from reference infliximab to its biosimilar: An 18-month comparative open-label study. J. Clin. Med., 8.","DOI":"10.3390\/jcm8070956"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"419","DOI":"10.1007\/s12026-016-8843-5","article-title":"Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: A 6-month real-life observational study","volume":"65","author":"Benucci","year":"2017","journal-title":"Immunol. Res."},{"key":"ref_25","first-page":"303","article-title":"Efficacy, immunogenicity and cost analysis of a systematic switch from originator infliximab to biosimilar CT-P13 of all patients with inflammatory arthritis from a single center","volume":"44","author":"Valido","year":"2019","journal-title":"Acta Reumatol. Port."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1426","DOI":"10.1136\/annrheumdis-2016-210742","article-title":"A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry","volume":"76","author":"Glintborg","year":"2017","journal-title":"Ann. Rheum. Dis."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"2304","DOI":"10.1016\/S0140-6736(17)30068-5","article-title":"Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): A 52-week, randomised, double-blind, non-inferiority trial","volume":"389","author":"Olsen","year":"2017","journal-title":"Lancet"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"970","DOI":"10.1136\/annrheumdis-2014-206616","article-title":"The effect of comedication with conventional synthetic disease modifying antirheumatic drugs on TNF inhibitor drug survival in patients with ankylosing spondylitis and undifferentiated spondyloarthritis: Results from a nationwide prospective study","volume":"74","author":"Lie","year":"2015","journal-title":"Ann. Rheum. Dis."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1205","DOI":"10.3346\/jkms.2014.29.9.1205","article-title":"Drug survival rates of tumor necrosis factor inhibitors in patients with rheumatoid arthritis and ankylosing spondylitis","volume":"29","author":"Kang","year":"2014","journal-title":"J. Korean Med. Sci."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"325","DOI":"10.1016\/j.jbspin.2010.02.014","article-title":"Maintained clinical response of infliximab treatment in ankylosing spondylitis: A 6-year long-term study","volume":"77","author":"Saougou","year":"2010","journal-title":"Jt. Bone Spine"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"407","DOI":"10.3904\/kjim.2016.042","article-title":"Drug survival of tumor necrosis factor \u03b1 inhibitors in patients with ankylosing spondylitis in Korea","volume":"33","author":"Jeong","year":"2018","journal-title":"Korean J. Intern. Med."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"166","DOI":"10.1186\/s12891-015-0620-4","article-title":"Predictors of response and drug survival in ankylosing spondylitis patients treated with infliximab","volume":"16","author":"Lorenzin","year":"2015","journal-title":"BMC Musculoskelet. Disord."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"935","DOI":"10.1007\/s00296-007-0330-9","article-title":"Persistent clinical response of infliximab treatment, over a 4-year period in ankylosing spondylitis","volume":"27","author":"Venetsanopoulou","year":"2007","journal-title":"Rheumatol. Int."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1007\/s40259-020-00432-z","article-title":"Retention rate and efficacy of the biosimilar CT-P13 versus reference infliximab in patients with ankylosing spondylitis: A propensity score-matched analysis from the Korean College of Rheumatology Biologics registry","volume":"34","author":"Kim","year":"2020","journal-title":"BioDrugs"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"513","DOI":"10.1007\/s40259-020-00421-2","article-title":"Post-marketing pooled safety analysis for CT-P13 treatment of patients with immune-mediated inflammatory diseases in observational cohort studies","volume":"34","author":"Lee","year":"2020","journal-title":"BioDrugs"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/19\/4568\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T07:08:22Z","timestamp":1760166502000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/19\/4568"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,10,1]]},"references-count":35,"journal-issue":{"issue":"19","published-online":{"date-parts":[[2021,10]]}},"alternative-id":["jcm10194568"],"URL":"https:\/\/doi.org\/10.3390\/jcm10194568","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,10,1]]}}}