TY - JOUR
T1 - Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease
AU - The Jasmine Study Group
AU - Rosenfeld, Warren N.
AU - Hudak, Mark L.
AU - Ruiz, Nancy
AU - Gautam, Shiva
AU - Alissa, R.
AU - Banfro, F.
AU - Barringham, A.
AU - Bettica, L.
AU - Bimbi, R.
AU - Brown, A.
AU - Camp, L. G.
AU - Chakraborty, B.
AU - Clark, L.
AU - Crawford, S.
AU - Dhanireddy, R.
AU - Eldemerdash, A.
AU - Fofah, O.
AU - Rhodes Ryan, G.
AU - Hanna, N.
AU - Hudak, M.
AU - Jewell, A.
AU - Katof, N.
AU - Kehinde, F. D.
AU - Kicklighter, S.
AU - Kim, J.
AU - Lowery, V.
AU - Maddox, A.
AU - Maduekwe, E.
AU - Meloy, L.
AU - Nason, J.
AU - Pollock, K.
AU - Reyes, D.
AU - Richter, S.
AU - Rosenfeld, W.
AU - Shafi, N.
AU - Shattuck, K.
AU - Smith, P.
AU - Stewart, D.
AU - Thomas, M.
AU - Wagner, C.
AU - Wong, W.
N1 - Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Nature America, Inc.
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85117142931
U2 - 10.1038/s41372-021-01223-2
DO - 10.1038/s41372-021-01223-2
M3 - Article
C2 - 34635771
AN - SCOPUS:85117142931
SN - 0743-8346
VL - 42
SP - 110
EP - 115
JO - Journal of Perinatology
JF - Journal of Perinatology
IS - 1
ER -