Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease

• Published in: Journal of perinatology Vol. 42; no. 1; pp. 110 - 115
• Main Authors: Rosenfeld, Warren N., Hudak, Mark L., Ruiz, Nancy, Gautam, Shiva
• Format: Journal Article
• Language: English
• Published: New York Nature Publishing Group US 01.01.2022; Nature Publishing Group
• Subjects: 692/699/1541; 692/700/1720; Erythroblastosis, Fetal - therapy; Female; Heme Oxygenase (Decyclizing); Hemolysis; Hemolytic disease; Humans; Hyperbilirubinemia; Hyperbilirubinemia - therapy; Hyperbilirubinemia, Neonatal - therapy; Infant, Newborn; Jaundice; Light therapy; Medicine; Medicine & Public Health; Metalloporphyrins; Neonates; Newborn babies; Pediatric Surgery; Pediatrics; Phototherapy; Placebos; Tin
• ISSN: 0743-8346; 1476-5543
• DOI: 10.1038/s41372-021-01223-2

Objective To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis. Study Design This multicenter, placebo-controlled phase 2b study (NCT01887327) randomized newborns (35–42 weeks) with hemolysis started on phototherapy (PT) to placebo (Ctrl), SnMP 3.0 mg/kg, or SnMP 4.5 mg/kg given once IM within 30 min of initiation of PT. Results In all, 91 patients were randomized (Ctrl: n  = 30; 3 mg/kg SnMP: n  = 30; 4.5 mg/kg SnMP: n  = 31). At 48 h TSB significantly increased in Ctrl by 17.5% (95% CI 5.6–30.7; p  = 0.004) and significantly decreased by −13% (95% CI −21.7 to −3.2; p  = 0.013) in the 3.0 mg/kg and by −10.5% (95% CI −19.4 to −0.6; p  = 0.041) in the 4.5 mg/kg group. Decreases in SnMP groups were significant ( p  < 0.0001) vs Ctrl. Conclusion SnMP with PT significantly reduced TSB by 48 h. SnMP may be useful as a treatment for HB in neonates with hemolysis.