{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T04:36:27Z","timestamp":1771994187760,"version":"3.50.1"},"reference-count":54,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,8,26]],"date-time":"2022-08-26T00:00:00Z","timestamp":1661472000000},"content-version":"vor","delay-in-days":237,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Hikma Pharmaceuticals","award":["20160456"],"award-info":[{"award-number":["20160456"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Clinical Practice"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:p><jats:italic>Background<\/jats:italic>. Infliximab (IFX) biosimilar was the first biosimilar approved in Jordan in 2014, with limited evidence of its safety and effectiveness from the Middle East and North Africa (MENA) region. Thus, this study aimed to evaluate the safety and effectiveness of IFX biosimilar in active rheumatoid arthritis (RA) patients over 34\u2009weeks by investigating (1) the adverse events (AEs), serious adverse events (SAEs), and therapy discontinuation and (2) the score changes of the 28\u2010Joint Disease Activity Score (DAS28) and the Health Assessment Questionnaire Disability Index (HAQ\u2010DI). <jats:italic>Methods<\/jats:italic>. This multicenter prospective cohort study collected clinical parameters within hospital settings every four weeks. The numbers and percentages of observed AEs and SAEs were informed. The DAS28 utilizing Erythrocyte Sedimentation Rate (ESR), HAQ\u2010DI, and ESR were reported at baseline and 14th and 30th weeks; thus, they were reported as means (SD). <jats:italic>Results<\/jats:italic>. A total of 22 RA patients were enrolled and initiated IFX biosimilar, of which nine (41.0%) discontinued the study, but their data were analyzed up to the point of withdrawal. A total of 35 AEs were reported in 14 patients, including two (5.7%) SAEs. None of the participants discontinued treatment due to AEs. The mean (SD) score of DAS28\u2010ESR significantly decreased from 6.55 (1.16) at baseline to 4.59 (1.45) at week 14 (<jats:italic>p<\/jats:italic> &lt; 0.0001) and to 4.77 (1.09) at week 30 (<jats:italic>p<\/jats:italic> &lt; 0.0001). Similarly, the mean (SD) HAQ\u2010DI score significantly decreased from 0.95 (0.74) at baseline to 0.48 (0.62) at week 14 (<jats:italic>p<\/jats:italic> = 0.008) and to 0.71 (0.78) at week 30 (<jats:italic>p<\/jats:italic> = 0.483). The mean (SD) value of ESR decreased from 58.75 (26.94) at baseline to 47.92 (33.89) at week 14 (<jats:italic>p<\/jats:italic> = 0.082) and to 39.83 (17.38) at week 30 (<jats:italic>p<\/jats:italic> = 0.005). <jats:italic>Conclusion<\/jats:italic>. IFX biosimilar demonstrated safety and effectiveness in managing RA patients bringing real\u2010world clinical support for biosimilars\u2019 role in rheumatology.<\/jats:p>","DOI":"10.1155\/2022\/3406783","type":"journal-article","created":{"date-parts":[[2022,8,26]],"date-time":"2022-08-26T12:05:34Z","timestamp":1661515534000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["The Safety and Effectiveness of Infliximab Biosimilar in Managing Rheumatoid Arthritis: A Real\u2010Life Experience from Jordan"],"prefix":"10.1155","volume":"2022","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5505-3183","authenticated-orcid":false,"given":"Khaldoon","family":"Alawneh","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4713-8536","authenticated-orcid":false,"given":"Abdel-Hameed","family":"Al-Mistarehi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ali","family":"Qandeel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9084-1580","authenticated-orcid":false,"given":"Ruba","family":"Jaber","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7368-0404","authenticated-orcid":false,"given":"Safwan","family":"Alomari","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4504-4472","authenticated-orcid":false,"given":"Khalid A.","family":"Kheirallah","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,8,26]]},"reference":[{"key":"e_1_2_11_1_2","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-216655"},{"key":"e_1_2_11_2_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-016-0981-6"},{"key":"e_1_2_11_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD003785"},{"key":"e_1_2_11_4_2","first-page":"315","article-title":"The early clinical course of infliximab treatment in rheumatoid arthritis: results from the REMARK observational study","volume":"32","author":"Westhovens R.","year":"2014","journal-title":"Clinical & Experimental Rheumatology"},{"key":"e_1_2_11_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2005.01.029"},{"key":"e_1_2_11_6_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0208240"},{"key":"e_1_2_11_7_2","doi-asserted-by":"publisher","DOI":"10.2147\/tcrm.s62954"},{"key":"e_1_2_11_8_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-018-3982-9"},{"key":"e_1_2_11_9_2","unstructured":"Remsima\u00ae. celltrion healthcare.Korea 2019 https:\/\/www.celltrionhealthcare.com\/en-us\/products\/product?pkey=5#:%7E:text=Remsima%C2%AE%20is%20the%20world's and%20Drug%20Administration."},{"key":"e_1_2_11_10_2","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204573"},{"key":"e_1_2_11_11_2","unstructured":"EMA\/CHMP Remsima assessment report 2013 https:\/\/www.ema.europa.eu\/en\/documents\/assessment-report\/remsima-epar-public-assessment-report_en-0.pdf."},{"key":"e_1_2_11_12_2","unstructured":"JFDA The Jordan food and drug administration 2021 https:\/\/www.jfda.jo\/Pages\/viewpage.aspx?pageID=184."},{"key":"e_1_2_11_13_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.27584"},{"key":"e_1_2_11_14_2","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-199920020-00002"},{"key":"e_1_2_11_15_2","unstructured":"FDA E6(R2) good clinical practice: integrated addendum to ICH E6(R1) 2018 https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1."},{"key":"e_1_2_11_16_2","unstructured":"OHRP reviewing and reporting unanticipated problems involving risks to subjects or others and adverse events: OHRP guidance 2007 https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/reviewing-unanticipated-problems\/index.html."},{"key":"e_1_2_11_17_2","volume-title":"Adverse Event Detection, Processing, and Reporting - 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