Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease.

Abstract

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.

• Authors: Warren N Rosenfeld, Mark L Hudak, Nancy Ruiz, Shiva Gautam, Jasmine Study Group
• Journal: Journal of perinatology : official journal of the California Perinatal Association (J Perinatol) Vol. 42 Issue 1 Pg. 110-115 (Jan 2022) ISSN: 1476-5543 [Electronic] United States
• PMID: 34635771 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2021. The Author(s), under exclusive licence to Springer Nature America, Inc.

Chemical References

• Metalloporphyrins
• tin mesoporphyrin
• Heme Oxygenase (Decyclizing)

Topics

• Erythroblastosis, Fetal (therapy)
• Female
• Heme Oxygenase (Decyclizing)
• Hemolysis
• Humans
• Hyperbilirubinemia (therapy)
• Hyperbilirubinemia, Neonatal (therapy)
• Infant, Newborn
• Metalloporphyrins
• Phototherapy