{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T18:01:05Z","timestamp":1790359265792,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T00:00:00Z","timestamp":1789516800000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Allergy Immunology"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pediatric post\u2010marketing evidence for biologics used for asthma remains limited and uneven across agents. We characterized pediatric spontaneous\u2010reporting patterns for biologics approved or used for asthma in the FDA Adverse Event Reporting System.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We analyzed pediatric reports involving omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab from 2015 through 2025. Reports were summarized by age, sex, reporting year, outcomes, and preferred terms. Serious\u2010outcome and indication\u2010linked classifications were performed. Disproportionality was assessed using reporting odds ratios, proportional reporting ratios, chi\u2010square statistics, and information components. Pediatric signals were compared with adult findings and interpreted according to method agreement, report volume, and sparse\u2010data restrictions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We identified 5155 pediatric reports. Dupilumab accounted for 3787 reports (73.5%) and omalizumab for 1152 (22.3%). Serious outcomes were reported in 1273 reports (24.7%), with substantial variation across biologics. Dupilumab showed prominent injection\u2010site, dermatologic, and ocular reporting, whereas omalizumab showed respiratory, asthma\u2010related, hypersensitivity\u2010related, and vital\u2010sign reporting. Of 43 pediatric signals supported by at least two disproportionality criteria, 31 were also identified in adults. After restricting to terms with at least five reports, 33 signals remained for the main analysis. Narrow anaphylaxis\u2010related domains occurred in 17 dupilumab, 113 omalizumab, 3 mepolizumab, 3 benralizumab, and no tezepelumab reports. Among dupilumab reports, 83.4% were classified as asthma\u2010related and 15.2% as mixed indications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Pediatric FAERS reports showed biologic\u2010specific reporting patterns. These patterns may reflect potential drug\u2010related events, underlying disease activity, treatment failure, indication mix, monitoring, and reporting practices. The findings are hypothesis\u2010generating and do not establish incidence, causality, or asthma\u2010specific safety profiles.<\/jats:p>\n                    <jats:p>\n                      <jats:boxed-text content-type=\"graphic\" position=\"anchor\">\n                        <jats:graphic xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" mimetype=\"image\/png\" position=\"anchor\" specific-use=\"enlarged-web-image\" xlink:href=\"graphic\/pai70495-gra-0001-m.png\">\n                          <jats:alt-text>image<\/jats:alt-text>\n                        <\/jats:graphic>\n                      <\/jats:boxed-text>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pai.70495","type":"journal-article","created":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T17:19:51Z","timestamp":1789579191000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pediatric spontaneous\u2010reporting patterns for biologics approved or used for asthma: Analysis of the\n                    <scp>FDA<\/scp>\n                    adverse event reporting system"],"prefix":"10.1111","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-9976-7732","authenticated-orcid":false,"given":"Yue","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Xiangya Hospital Central South University  Changsha Hunan China"},{"name":"The Center of Respiratory Medicine, Xiangya Hospital Central South University  Changsha Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-6568-389X","authenticated-orcid":false,"given":"Yile","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Xiangya Hospital Central South University  Changsha Hunan China"},{"name":"The Center of Respiratory Medicine, Xiangya Hospital Central South University  Changsha Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lingli","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Xiangya Hospital Central South University  Changsha Hunan China"},{"name":"The Center of Respiratory Medicine, Xiangya Hospital Central South University  Changsha Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7035-9543","authenticated-orcid":false,"given":"Yating","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Xiangya Hospital Central South University  Changsha Hunan China"},{"name":"The Center of Respiratory Medicine, Xiangya Hospital Central South University  Changsha Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangrong","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Xiangya Hospital Central South University  Changsha Hunan 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