{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T04:53:32Z","timestamp":1781585612448,"version":"3.54.5"},"reference-count":29,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T00:00:00Z","timestamp":1776384000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T00:00:00Z","timestamp":1776384000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100008235","name":"Peking Union Medical College Hospital","doi-asserted-by":"publisher","award":["2026ZD01909605"],"award-info":[{"award-number":["2026ZD01909605"]}],"id":[{"id":"10.13039\/501100008235","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100001547","name":"China Medical Board","doi-asserted-by":"publisher","award":["20\u2010384"],"award-info":[{"award-number":["20\u2010384"]}],"id":[{"id":"10.13039\/100001547","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res &amp; Perspec"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    While the efficacy of canakinumab, an anti\u2010interleukin\u20101\u03b2 monoclonal antibody, is well\u2010established, its safety profile, particularly across different age groups, remains inadequately explored. Using the FDA Adverse Event Reporting System (FAERS) database, this study evaluated postmarketing safety by analyzing adverse event (AE) reports from 2010 onward, with canakinumab as the primary suspected drug. Disproportionality analysis employed four algorithms\u2014reporting odds ratio (ROR), proportional reporting ratio, multi\u2010item gamma Poisson shrinker, and Bayesian confidence propagation neural network\u2014to detect safety signals, and the Weibull distribution was used to model the temporal risk of AEs. 9262 canakinumab\u2010related AE reports were analyzed. Significant signals were detected across multiple system organ classes (SOCs), most prominently general disorders and administration site conditions (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20096765; ROR 1.47) and infections and infestations (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20093532; ROR 2.54). Age\u2010stratified analyses revealed distinct AE profiles: pyrexia, inappropriate schedule or dose of administration, and gastrointestinal and hepatobiliary disorders (e.g., abdominal pain, hepatitis) were most frequently reported in individuals &lt;\u200912\u2009years, as well as leukopenia in adolescents (12\u201317\u2009years). Older patients (\u2265\u200965\u2009years) most frequently reported pneumonia, sepsis, and cellulitis, with strong signals for neoplasms. Temporal analysis revealed an early failure pattern, but ~40% of AEs occurred after 1\u2009year. These findings underscore significant safety signals associated with canakinumab, including infections, gastrointestinal\/hepatobiliary disorders in children, and neoplasms in older patients. The dual temporal pattern of AEs underscores the need for both short\u2010 and long\u2010term surveillance.\n                  <\/jats:p>","DOI":"10.1002\/prp2.70251","type":"journal-article","created":{"date-parts":[[2026,4,18]],"date-time":"2026-04-18T04:45:09Z","timestamp":1776487509000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Age\u2010Dependent Differences in Canakinumab Safety: A Comprehensive Pharmacovigilance Analysis Using the\n                    <scp>FAERS<\/scp>\n                    Database"],"prefix":"10.1002","volume":"14","author":[{"given":"Youyang","family":"Wang","sequence":"first","affiliation":[{"name":"Department of General Practice (General Internal Medicine) Peking Union Medical College Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ngasin","family":"Lam","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Caritas Medical Centre  Hongkong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoming","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of General Practice (General Internal Medicine) Peking Union Medical College Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3957-3829","authenticated-orcid":false,"given":"Yang","family":"Jiao","sequence":"additional","affiliation":[{"name":"Department of General Practice (General Internal Medicine) Peking Union Medical College Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,17]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev\u2010immunol\u2010032414\u2010112306"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41584\u2010022\u201000797\u20101"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.4161\/mabs.2.1.10328"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms20081898"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264\u2010024\u201001423\u20107"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/20420986241311231"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2024.10.001"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10067\u2010021\u201005617\u20107"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen\u20102021\u2010001663"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13023\u2010015\u20100228\u20107"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2024.07.025"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen\u20102023\u2010003890"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2011.152728"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2023.1114207"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2023.1257045"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.23.00910"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmb.2021.167335"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2020.03.065"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1707914"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008\u20105472.CAN\u201019\u20103176"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1172\/jci.insight.157788"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41586\u2010023\u201006685\u20102"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.phrs.2019.01.023"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2013.92"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgs.14198"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbspin.2014.10.012"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(17)32247\u2010X"},{"issue":"2","key":"e_1_2_11_29_1","first-page":"15","article-title":"FDA Adverse Event Reporting System (FAERS) Database: A Comprehensive Analysis of Its Structure, Functionality, and Limitations","volume":"5","author":"Ismail M.","year":"2022","journal-title":"Sage Science Review of Applied Machine Learning"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3701"}],"container-title":["Pharmacology Research &amp; 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