Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease.

To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis. 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. 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. SnMP with PT significantly reduced TSB by 48 h. SnMP may be useful as a treatment for HB in neonates with hemolysis. © 2021. The Author(s), under exclusive licence to Springer Nature America, Inc.

Citation

Warren N Rosenfeld, Mark L Hudak, Nancy Ruiz, Shiva Gautam, Jasmine Study Group. Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease. Journal of perinatology : official journal of the California Perinatal Association. 2022 Jan;42(1):110-115

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PMID: 34635771

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