{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T09:51:53Z","timestamp":1791971513168,"version":"4.3.4"},"reference-count":30,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T00:00:00Z","timestamp":1789084800000},"content-version":"vor","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"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":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Nipocalimab, a neonatal Fc receptor (FcRn) blocker, is under evaluation for severe hemolytic disease of the fetus and newborn (HDFN). In the Phase 2 UNITY trial, weekly intravenous antenatal treatment with nipocalimab at dose regimens of 30 and 45 mg\/kg prevented fetal anemia requiring intrauterine transfusion (IUT) in 54% of high\u2010risk pregnancies and delayed the need for IUTs versus their previous pregnancies in the remaining 46% of pregnancies. This analysis aimed to select a weekly dose regimen of nipocalimab for the Phase 3 study in severe HDFN (NCT05912517) that maintains FcRn blockade throughout antenatal treatment, including with an unplanned dosing delay of up to 3 days. Observed pharmacokinetic\/pharmacodynamic (PK\/PD) data from UNITY (i.e., nipocalimab concentrations, FcRn occupancy, and serum IgG) were analyzed using a model\u2010based approach. A PK\/PD model originally developed in nonpregnant participants was updated to incorporate gestational weight gain. Nipocalimab PK and FcRn occupancy were described by a two\u2010compartment model with nonlinear, dose\u2010dependent PK, which captured longitudinal PK, FcRn occupancy, and IgG profiles during dosing and return toward baseline postpartum after discontinuation. Both 30 and 45 mg\/kg achieved \u223c80%\u201385% reductions in maternal IgG; however, 30 mg\/kg showed greater variability in predose trough concentrations, increasing the risk of falling below concentrations required for full FcRn occupancy across antenatal treatment. Simulations incorporating PK\/PD variability indicated that 45 mg\/kg weekly per current weight maintained full FcRn occupancy in &gt;95% of pregnant individuals, even with dosing delays up to 3 days. Exploratory exposure\u2013response analyses supported 45 mg\/kg for the Phase 3 HDFN study.<\/jats:p>","DOI":"10.1002\/jcph.70259","type":"journal-article","created":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T15:30:58Z","timestamp":1789140658000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Nipocalimab Phase 3 Dose Selection for Severe Hemolytic Disease of the Fetus and Newborn"],"prefix":"10.1002","volume":"66","author":[{"given":"Jie","family":"Zhou","sequence":"first","affiliation":[{"name":"Johnson &amp; Johnson  Spring House PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-9873-2669","authenticated-orcid":false,"given":"Yuan","family":"Xiong","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House PA 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