{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T05:16:01Z","timestamp":1790486161462,"version":"4.1.0"},"reference-count":56,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2017,5,15]],"date-time":"2017-05-15T00:00:00Z","timestamp":1494806400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Birth Defects Research"],"published-print":{"date-parts":[[2017,7,3]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>SA237 is a humanized anti\u2010interleukin\u20106 receptor (IL\u20106R) monoclonal antibody in which the constant and variable regions have been engineered for a longer plasma half\u2010life. According to literature, blocking of IL\u20106 related functions could have an influence on pregnancy sustainment, development of the immune system, and brain growth.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>SA237 effects on dams, embryo\u2010fetal development, parturition and postnatal development were investigated in an enhanced pre\u2010 and postnatal development study, in which SA237 was subcutaneously administered to pregnant cynomolgus monkeys at dose levels of 2 or 50 mg\/kg once weekly from gestation day 20 until parturition. Infant development, including immune function and learning ability tests, was comprehensively assessed at multiple examinations until approximately 10 months after birth.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>SA237 plasma concentrations were almost equivalent between dams and their infants and dropped throughout the postnatal period, pharmacologically relevant exposure was maintained for 147 days after birth at 50 mg\/kg. Because the binding of SA237 to IL\u20106R inhibited IL\u20106R\u2010mediated clearance of IL\u20106, serum IL\u20106 increased in dams and infants. However, there were no SA237\u2010related adverse effects on dams, embryos, fetuses, or infants. SA237 pharmacological effects contributed to the suppression of plasma cell differentiation and antibody production by inhibiting IL\u20106 signaling, and T cell\u2010dependent antibody reaction was minimally suppressed in infants, but physiological immunoglobulin class switching and general antibody production against a T cell\u2010dependent antigen were maintained.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The exposure to SA237 did not adversely affect dams, embryo\u2010fetal development, parturition, and postnatal development, including immune function and neuronal development. Birth Defects Research 109:843\u2013856, 2017. \u00a9 2017 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/bdr2.1036","type":"journal-article","created":{"date-parts":[[2017,5,15]],"date-time":"2017-05-15T10:26:54Z","timestamp":1494844014000},"page":"843-856","source":"Crossref","is-referenced-by-count":8,"title":["Effects of SA237, a humanized anti\u2010interleukin\u20106 receptor monoclonal antibody, on pre\u2010 and postnatal development in cynomolgus monkey"],"prefix":"10.1002","volume":"109","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5481-4064","authenticated-orcid":false,"given":"Ryuichi","family":"Katagiri","sequence":"first","affiliation":[{"name":"Research Division Chugai Pharmaceutical Co., Ltd. Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kana","family":"Ishihara\u2010Hattori","sequence":"additional","affiliation":[{"name":"Research Division Chugai Pharmaceutical Co., Ltd. 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