Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label Phase III Study.

Autor: Brunner HI; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA; hermine.brunner@cchmc.org., Pacheco-Tena C; C. Pacheco-Tena, MD, MSc, PhD, Investig y Biomedicina de Chihuahua, Facultad de Medicina, Universidad Autónoma de Chihuahua, Circuito Universitario Campus II, Chihuahua, México., Louw I; I. Louw, MD, Panorama Medical Centre, Cape Town, South Africa., Vega-Cornejo G; G. Vega-Cornejo, MD, Centro de Reumatología y Autoinmunidad (CREA)/Hospital México Americano, Pediatric Rheumatology, Guadalajara, México., Alexeeva E; E. Alexeeva, MD, PhD, National Medical Research Center for Children's Health Federal State Autonomous Institution of the Russian Federation Ministry of Health, Moscow, and I.M. Sechenov First Moscow State Medical University (Sechenovskiy University), Moscow, Russia., Appenzeller S; S. Appenzeller, MD, PhD, Department of Orthopedics, Rheumatology and Traumatology, University of Campinas, UNICAMP, Campinas, Brazil., Chasnyk V; V. Chasnyk, MD, GВOU VPO, Saint-Petersburg State Pediatric Medical University, St. Petersburg, Russia., Griffin T; T. Griffin, MD, Division of Rheumatology, Levine Children's Specialty Center, Charlotte, North Carolina, USA., Suarez CN; C. Navarrete Suarez, MD, Rheumatology, Hospital Roberto del Rio, Santiago, Chile., Knupp-Oliveira S; S. Knupp-Oliveira, MD, Universidade Federal of Rio de Janeiro, Instituto de Puericultura e Pediatria Martagão Gesteira, Rio de Janeiro, Brazil., Zeft A; A. Zeft, MD, Cleveland Clinic, Department of Pediatric Rheumatology and Immunology, Cleveland, Ohio, USA., Aviel YB; Y. Butbul Aviel, MD, Rambam Health Care Campus, Haifa, Israel., De Ranieri D; D. De Ranieri, MD, Division of Rheumatology, Comer Children's Hospital, Department of Pediatrics, University of Chicago Medicine, Chicago, now with Division of Rheumatology, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern Feinberg School of Medicine, Chicago, Illinois, USA., Gottlieb BS; B.S. Gottlieb, MD, MS, Northwell Health, Cohen Children's Medical Center, Division of Pediatric Rheumatology, New Hyde Park, New York, USA., Levy DM; D.M. Levy, MD, MS, The Hospital for Sick Children (SickKids), Toronto, and the University of Toronto, Toronto, Ontario, Canada., Rabinovich CE; C.E. Rabinovich, MD, Duke University, Durham, North Carolina, USA., Silva CA; C. Artur Silva, MD, Instituto da Criança e Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., Spivakovsky Y; Y. Spivakovsky, MD, Saratov State Medical University n.a. V.I. Razumovsky of Ministry of Health of the Russian Federation, Saratov, Russia., Uziel Y; Y. Uziel, MD, Pediatric Rheumatology Unit, Department of Pediatrics, Meir Medical Center, Kfar-Saba, Tel Aviv School of Medicine, Tel Aviv University, Tel Aviv, Israel., Ringold S; S. Ringold, MD, MS, X.L. Xu, PhD, J.H. Leu, PharmD, PhD, E. Lam, PharmD, Y. Wang, PhD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA., Xu XL; S. Ringold, MD, MS, X.L. Xu, PhD, J.H. Leu, PharmD, PhD, E. Lam, PharmD, Y. Wang, PhD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA., Leu JH; S. Ringold, MD, MS, X.L. Xu, PhD, J.H. Leu, PharmD, PhD, E. Lam, PharmD, Y. Wang, PhD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA., Lam E; S. Ringold, MD, MS, X.L. Xu, PhD, J.H. Leu, PharmD, PhD, E. Lam, PharmD, Y. Wang, PhD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA., Wang Y; S. Ringold, MD, MS, X.L. Xu, PhD, J.H. Leu, PharmD, PhD, E. Lam, PharmD, Y. Wang, PhD, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA., Lovell DJ; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA., Martini A; A. Martini, MD, Università degli Studi di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Genova, Italy., Ruperto N

Publikováno v: The Journal of rheumatology [J Rheumatol] 2024 Nov 01; Vol. 51 (11), pp. 1125-1134. Date of Electronic Publication: 2024 Nov 01.

Nipocalimab in Early-Onset Severe Hemolytic Disease of the Fetus and Newborn.

Autor: Moise KJ Jr; 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.)., 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.V.) and Pediatrics (E.L.), Leiden University Medical Center, Leiden, the Netherlands; the Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm (E.T.); the Feto-Maternal Unit, Liverpool Hospital, Liverpool, NSW, Australia (J.S.); the Institute for Clinical Immunology and Transfusion Medicine, Justus Liebig University (U.J.S., G.B.), and the Department of Thrombosis and Hemostasis, Giessen University Hospital (U.J.S.) - both in Giessen, Germany; the University of Birmingham and the Fetal Medicine Center, Birmingham Women's and Children's NHS Foundation Trust, Birmingham (M.D.K.), and University College London Hospitals NHS Foundation Trust, London (P.P.) - all in the United Kingdom; the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center (R.S.M.), the Department of Pediatrics, Division of Hematology-Oncology, Weill Cornell Medical College (J.B.B.), and NewYork-Presbyterian Hospital (J.B.B.) - all in New York; the Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, and the Department of Obstetrics, Gynecology, and Fertility, GZA Campus Sint-Augustinus, Wilrijk - both in Belgium (R.D.); Centre Hospitalier Universitaire Sainte-Justine Research Center, Université de Montréal, Montreal (F.A.), and Mount Sinai Hospital Toronto and University of Toronto, Toronto (R.W.) - both in Canada; UPMC Magee-Womens Hospital, Pittsburgh (S.P.E.); the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Cincinnati Medical Center, Cincinnati (K.M.); the Department of Obstetrics and Gynecology, University of California, San Francisco, and Zuckerberg San Francisco General Hospital - both in San Francisco (M.E.N.); San Cecilio University Hospital, Granada, Spain (O.O.-H.); the Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland (L.P.); University of Utah Health, Salt Lake City (R.M.S.); and Streisand Biomedical Consulting, Wayland, MA (J.B.S.).

Publikováno v: The New England journal of medicine [N Engl J Med] 2024 Aug 08; Vol. 391 (6), pp. 526-537.

Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study.

Autor: Taylor PC; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK peter.taylor@kennedy.ox.ac.uk., Schett G; Department of Medicine 3, Rheumatology and Immunology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität (FAU), Nürnberg, Germany., Huizinga TW; Leiden University Medical Center, Leiden, The Netherlands., Wang Q; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Ibrahim F; Janssen Research & Development, LLC, Wycombe, UK., Zhou B; Janssen Research & Development, LLC, Chesterbrook, Pennsylvania, USA., Liva SG; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Shaik JSB; Janssen Research & Development, LLC, Chesterbrook, Pennsylvania, USA., Xiong Y; Janssen Research & Development, LLC, Raritan, New Jersey, USA., Leu JH; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Panchakshari RA; Janssen Research & Development, LLC, La Jolla, California, USA., Loza MJ; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Ma K; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Dhatt H; Janssen Pharmaceutical Companies of Johnson & Johnson, Scottsdale, Arizona, USA., Rojo Cella R; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Karyekar CS; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Cuff CA; Janssen Research & Development, LLC, Cambridge, Massachusetts, USA., Gao S; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Fei K; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.

Publikováno v: RMD open [RMD Open] 2024 Jun 28; Vol. 10 (2). Date of Electronic Publication: 2024 Jun 28.

Pharmacokinetics and pharmacodynamics across infusion rates of intravenously administered nipocalimab: results of a phase 1, placebo-controlled study.

Autor: Leu JH; Janssen Research & Development, LLC, Spring House, PA, United States., Vermeulen A; Janssen Research & Development, LLC, a Division of Janssen Pharmaceutica NV, Beerse, Belgium., Abbes C; Momenta Pharmaceuticals, Inc., Cambridge, MA, United States., Arroyo S; Momenta Pharmaceuticals, Inc., Cambridge, MA, United States., Denney WS; Human Predictions, LLC, Boston, MA, United States., Ling LE; Janssen Research & Development, LLC, Cambridge, MA, United States.

Publikováno v: Frontiers in neuroscience [Front Neurosci] 2024 Feb 01; Vol. 18, pp. 1302714. Date of Electronic Publication: 2024 Feb 01 (Print Publication: 2024).

Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.

Autor: Schanberg LE; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina., Mulugeta LY; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Akinlade B; Regeneron Pharmaceuticals, Inc., Tarrytown, New York., Brunner HI; Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio., Chen J; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Colbert RA; Intramural Research Program, National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland., Delgaizo V; CARRA, Inc., Washington, DC., Gastonguay MR; Metrum Research Group, Tariffville, Connecticut., Glaser R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Imundo L; Columbia University Irving Medical Center, New York, New York., Lovell DJ; Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio., Leu JH; Janssen Research and Development, Spring House, Pennsylvania., Mostafa NM; AbbVie, North Chicago, Illinois., Nelson RM; Johnson & Johnson, New Brunswick, New Jersey., Nigrovic PA; Division of Immunology, Boston Children's Hospital, Department of Pediatrics, Harvard Medical School and Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Department of Medicine, Harvard Medical School, Boston, Massachusetts., Nikolov NP; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Rider LG; Environmental Autoimmunity Group, Clinical Research Branch, National Institute of Environmental Health Sciences, NIH, Bethesda, Maryland., Rothwell R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Sahajwalla C; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Singh R; Gilead Sciences, Foster City, California., Sinha V; Novartis Pharmaceutical Corporation, One Health Plaza, East Hanover NJ, 07936, USA., Yancey CL; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Yao L; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Arthritis & rheumatology (Hoboken, N.J.) [Arthritis Rheumatol] 2023 Oct; Vol. 75 (10), pp. 1856-1866. Date of Electronic Publication: 2023 Aug 03.