{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T03:15:04Z","timestamp":1788491704884,"version":"build-2803163510"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2017,12,7]],"date-time":"2017-12-07T00:00:00Z","timestamp":1512604800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis & Rheumatology"],"published-print":{"date-parts":[[2018,1]]},"abstract":"\n Objective<\/jats:title>\n \n To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity, and safety in daily practice after transitioning treatment from original reference infliximab (Remicade [\n REM<\/jats:styled-content>\n ]) to a biosimilar infliximab (\n CT<\/jats:styled-content>\n \u2010P13 [Remsima; Inflectra]) in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Of the initial 222\n REM<\/jats:styled-content>\n \u2010treated patients, 192 agreed to transition to\n CT<\/jats:styled-content>\n \u2010P13 and were included in this multicenter prospective cohort study. Changes in the Disease Activity Score in 28 joints using the C\u2010reactive protein level (\n DAS<\/jats:styled-content>\n 28\u2010\n CRP<\/jats:styled-content>\n ) and the Bath Ankylosing Spondylitis Disease Activity Index (\n BASDAI<\/jats:styled-content>\n ) and changes in the CRP levels, infliximab trough levels, and anti\u2010infliximab antibody levels were assessed after 6 months, and adverse events (\n AE<\/jats:styled-content>\n s) were documented. Drug survival and prognostic factors were analyzed using Kaplan\u2010Meier and Cox regression analyses.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n During 6 months follow\u2010up, 24% of the patients (n = 47) discontinued\n CT<\/jats:styled-content>\n \u2010P13. Thirty\u2010seven patients restarted\n REM<\/jats:styled-content>\n , 7 switched to another biologic drug, and 3 continued without a biologic drug. The\n DAS<\/jats:styled-content>\n 28\u2010\n CRP<\/jats:styled-content>\n remained stable from baseline to month 6, with a mean \u00b1\n SD<\/jats:styled-content>\n score of 2.2 \u00b1 0.9 at baseline to 2.2 \u00b1 0.8 at 6 months (difference of 0.0 [95% confidence interval (95%\n CI<\/jats:styled-content>\n ) \u20130.1, 0.2]). The\n BASDAI<\/jats:styled-content>\n increased from a mean \u00b1\n SD<\/jats:styled-content>\n of 3.8 \u00b1 2.0 at baseline to 4.3 \u00b1 2.1 at 6 months (difference of +0.5 [95%\n CI<\/jats:styled-content>\n 0.1, 0.9]). The\n CRP<\/jats:styled-content>\n levels, infliximab trough levels, and anti\u2010infliximab antibody levels did not change. Just prior to\n CT<\/jats:styled-content>\n \u2010P13 discontinuation, the\n DAS<\/jats:styled-content>\n 28\u2010\n CRP<\/jats:styled-content>\n components tender joint count and patient's global assessment of disease activity, as well as the\n BASDAI<\/jats:styled-content>\n were increased compared to baseline. The most frequently reported\n AE<\/jats:styled-content>\n s were arthralgia, fatigue, pruritus, and myalgia. A shorter\n REM<\/jats:styled-content>\n infusion interval (hazard ratio: 0.77 [95%\n CI<\/jats:styled-content>\n 0.62, 0.95]) at baseline was predictive of discontinuing\n CT<\/jats:styled-content>\n \u2010P13.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n In our cohort, one\u2010fourth of patients discontinued\n CT<\/jats:styled-content>\n \u2010P13 during 6 months of follow\u2010up, mainly due to an increase in the subjective features of the tender joint count and the patient's global assessment of disease activity and\/or subjective\n AE<\/jats:styled-content>\n s, possibly explained by nocebo effects and\/or incorrect causal attribution effects.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/art.40324","type":"journal-article","created":{"date-parts":[[2017,10,18]],"date-time":"2017-10-18T01:02:43Z","timestamp":1508288563000},"page":"60-68","source":"Crossref","is-referenced-by-count":153,"title":["Subjective Complaints as the Main Reason for Biosimilar Discontinuation After Open\u2010Label Transition From Reference Infliximab to Biosimilar Infliximab"],"prefix":"10.1002","volume":"70","author":[{"given":"Lieke","family":"Tweehuysen","sequence":"first","affiliation":[{"name":"Sint Maartenskliniek Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bart J. F.","family":"van den Bemt","sequence":"additional","affiliation":[{"name":"Sint Maartenskliniek and Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris L.","family":"van Ingen","sequence":"additional","affiliation":[{"name":"Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alphons J. L.","family":"de Jong","sequence":"additional","affiliation":[{"name":"Rijnstate Arnhem The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Willemijn H.","family":"van der Laan","sequence":"additional","affiliation":[{"name":"Maartenskliniek Woerden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank H. J.","family":"van den Hoogen","sequence":"additional","affiliation":[{"name":"Sint Maartenskliniek and Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfons A.","family":"den Broeder","sequence":"additional","affiliation":[{"name":"Sint Maartenskliniek and Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,12,7]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"European Medicines Agency.Remsima (infliximab). October 2013. URL:http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/002576\/human_med_001682.jsp&mid=WC0b01ac058001d124."},{"key":"e_1_2_7_3_1","unstructured":"European Medicines Agency.Inflectra (infliximab). October 2013. URL:http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/002778\/human_med_001677.jsp&mid=WC0b01ac058001d124."},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(99)05246-0"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-016-0981-6"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-016-0930-4"},{"key":"e_1_2_7_7_1","unstructured":"World Health Organization.Expert Committee on Biological Standardization. Guidelines on evaluation of Similar Biotherapeutic Products (SBPs). URL:http:\/\/www.who.int\/biologicals\/areas\/biological_therapeutics\/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf."},{"key":"e_1_2_7_8_1","first-page":"4","article-title":"Switching to biosimilar infliximab (CT\u2010P13): evidence of clinical safety, effectiveness and impact on public health","volume":"44","author":"Brown J","year":"2016","journal-title":"Biologicals"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209166"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)30068-5"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1517\/14712598.2015.1103733"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/14712598.2016.1198765"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjw087"},{"key":"e_1_2_7_14_1","unstructured":"Dutch Medicines Evaluation Board.CBG's position on prescribing \u201cbiosimilars.\u201d March 31 2015. In Dutch. URL:https:\/\/www.cbg-meb.nl\/actueel\/nieuws\/2015\/03\/31\/standpunt-cbg-over-voorschrijven-van-biosimilars."},{"key":"e_1_2_7_15_1","unstructured":"Dutch Trial Register.The effect of switching treatment from innovator infliximab to infliximab biosimilar on efficacy safety and immunogenicity in patients with rheumatoid arthritis spondyloarthritis or psoriatic arthritis in daily clinical care. Nederlands Trial Register identifier: NTR5279; 2015."},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380107"},{"key":"e_1_2_7_17_1","first-page":"2286","article-title":"A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index","volume":"21","author":"Garrett S","year":"1994","journal-title":"J Rheumatol"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12030"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2004.030452"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.21671"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1207\/s15327558ijbm0402_1"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204128"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27227"},{"issue":"10","key":"e_1_2_7_24_1","article-title":"A nationwide non\u2010medical switch from originator to biosimilar infliximab in patients with inflammatory arthritis: eleven months\u2019 clinical outcomes from the DANBIO registry [abstract]","volume":"68","author":"Glintborg B","year":"2016","journal-title":"Arthritis Rheumatol"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjw138"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1177\/1932296813515132"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1037\/0003-066X.40.11.1189"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3999(99)00058-6"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1097\/PSY.0b013e3182294a50"},{"key":"e_1_2_7_30_1","first-page":"91","volume-title":"Cognitive foundations of clinical psychology","author":"Brewin CR","year":"2014"}],"container-title":["Arthritis & Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fart.40324","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.40324","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/art.40324","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.40324","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T17:34:13Z","timestamp":1759944853000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/art.40324"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,12,7]]},"references-count":29,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,1]]}},"alternative-id":["10.1002\/art.40324"],"URL":"https:\/\/doi.org\/10.1002\/art.40324","archive":["Portico"],"relation":{},"ISSN":["2326-5191","2326-5205"],"issn-type":[{"value":"2326-5191","type":"print"},{"value":"2326-5205","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,12,7]]}}}