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Nipocalimab in Early-Onset Severe Hemolytic Disease of the Fetus and Newborn.
Moise, Kenneth J; Ling, Leona E; Oepkes, Dick; Tiblad, Eleonor; Verweij, E J T Joanne; Lopriore, Enrico; Smoleniec, John; Sachs, Ulrich J; Bein, Gregor; Kilby, Mark D; Miller, Russell S; Devlieger, Roland; Audibert, François; Emery, Stephen P; Markham, Kara; Norton, Mary E; Ocón-Hernández, Olga; Pandya, Pranav; Pereira, Leonardo; Silver, Robert M; Windrim, Rory; Streisand, James B; Leu, Jocelyn H; Mirza, Arpana; Smith, Valerie; Schwartz, Lisa B; Tjoa, May Lee; Saeed-Khawaja, Shumyla; Komatsu, Yosuke; Bussel, James B.
Afiliación
  • Moise KJ; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Ling LE; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Oepkes D; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Tiblad E; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Verweij EJTJ; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Lopriore E; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Smoleniec J; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Sachs UJ; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Bein G; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Kilby MD; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Miller RS; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Devlieger R; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Audibert F; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Emery SP; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Markham K; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Norton ME; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Ocón-Hernández O; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Pandya P; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Pereira L; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Silver RM; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Windrim R; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Streisand JB; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Leu JH; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Mirza A; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Smith V; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Schwartz LB; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Tjoa ML; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Saeed-Khawaja S; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Komatsu Y; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
  • Bussel JB; From Dell Medical School, University of Texas at Austin, and the Comprehensive Fetal Care Center, Dell Children's Medical Center - both in Austin (K.J.M.); Janssen Pharmaceuticals, Cambridge, MA (L.E.L., J.H.L., A.M., V.S., L.B.S., M.L.T., S.S.-K., Y.K.); the Departments of Obstetrics (D.O., E.J.T.J
N Engl J Med ; 391(6): 526-537, 2024 Aug 08.
Article en En | MEDLINE | ID: mdl-39115062
ABSTRACT

BACKGROUND:

In early-onset severe hemolytic disease of the fetus and newborn (HDFN), transplacental transfer of maternal antierythrocyte IgG alloantibodies causes fetal anemia that leads to the use of high-risk intrauterine transfusions in order to avoid fetal hydrops and fetal death. Nipocalimab, an anti-neonatal Fc receptor blocker, inhibits transplacental IgG transfer and lowers maternal IgG levels.

METHODS:

In an international, open-label, single-group, phase 2 study, we assessed treatment with intravenous nipocalimab (30 or 45 mg per kilogram of body weight per week) administered from 14 to 35 weeks' gestation in participants with pregnancies at high risk for recurrent early-onset severe HDFN. The primary end point was live birth at 32 weeks' gestation or later without intrauterine transfusions as assessed against a historical benchmark (0%; clinically meaningful difference, 10%).

RESULTS:

Live birth at 32 weeks' gestation or later without intrauterine transfusions occurred in 7 of 13 pregnancies (54%; 95% confidence interval, 25 to 81) in the study. No cases of fetal hydrops occurred, and 6 participants (46%) did not receive any antenatal or neonatal transfusions. Six fetuses received an intrauterine transfusion five fetuses at 24 weeks' gestation or later and one fetus before fetal loss at 22 weeks and 5 days' gestation. Live birth occurred in 12 pregnancies. The median gestational age at delivery was 36 weeks and 4 days. Of the 12 live-born infants, 1 received one exchange transfusion and one simple transfusion and 5 received only simple transfusions. Treatment-related decreases in the alloantibody titer and IgG level were observed in maternal samples and cord blood. No unusual maternal or pediatric infections were observed. Serious adverse events were consistent with HDFN, pregnancy, or prematurity.

CONCLUSIONS:

Nipocalimab treatment delayed or prevented fetal anemia or intrauterine transfusions, as compared with the historical benchmark, in pregnancies at high risk for early-onset severe HDFN. (Funded by Janssen Research and Development; UNITY ClinicalTrials.gov number, NCT03842189.).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Transfusión de Sangre Intrauterina / Inmunoglobulina G / Eritroblastosis Fetal / Anticuerpos Monoclonales Humanizados Límite: Adult / Female / Humans / Newborn / Pregnancy Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Transfusión de Sangre Intrauterina / Inmunoglobulina G / Eritroblastosis Fetal / Anticuerpos Monoclonales Humanizados Límite: Adult / Female / Humans / Newborn / Pregnancy Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article