Eric Rondeau1, Gianluigi Ardissino2, Marie-Pierre Caby-Tosi3, Imad Al-Dakkak4, Fadi Fakhouri5, Benjamin Miller6, Marie Scully7. 1. Intensive Care Nephrology and Transplantation Department, Hôpital Tenon, APHP, Sorbonne Université, Paris, France. 2. Centro per la Cura e lo Studio della Sindrome Emolitico-Uremica, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. 3. Global Data Science, Alexion Pharmaceuticals, Inc., Boston, Massachusetts, USA. 4. Epidemiology, Alexion Pharmaceuticals, Inc., Boston, Massachusetts, USA. 5. Service de Néphrologie et Immunologie Clinique, CHU de Nantes - Hôtel Dieu, Nantes, France. 6. Employee at the Time of Study, of Alexion Pharmaceuticals, Inc., Boston, Massachusetts, USA. 7. Department of Haematology, University College London Hospital, Cardiometabolic Programme-NIHR UCLH/UCL BRC, London, United Kingdom.
Abstract
BACKGROUND: Pregnancy outcomes in patients with atypical hemolytic uremic syndrome (aHUS) are not well-documented. Here, we present characteristics of and outcomes for patients with aHUS who became pregnant while enrolled in the Global aHUS Registry. METHODS: The observational Global aHUS Registry (NCT01522183), initiated in April 2012, collects demographics, disease history, treatment, and outcomes data for patients with aHUS, regardless of treatment approach. This descriptive analysis includes patients from the Registry with evaluable pregnancy data supplemented with pharmacovigilance information; the number of pregnancies, outcomes, and exposure to eculizumab were evaluated. RESULTS: As of April 1, 2019, 44 pregnancies were recorded in 41 patients, with 24 pregnancies exposed to eculizumab. Pathogenic variants were identified in 48.8% of patients. Three patients were on dialysis and 6 patients had a kidney graft at the time of pregnancy. Excluding elective terminations, 85.3% of pregnancies resulted in live births. Elective terminations were recorded in 22.7% of pregnancies, miscarriages occurred in 9.1% of pregnancies, and late fetal death in 2.3% of pregnancies. No malformations or anomalies were reported. CONCLUSIONS: Our results show that in women with aHUS, even on dialysis or with a kidney graft, pregnancy is possible with careful monitoring for aHUS flares and prematurity. Prophylactic or therapeutic eculizumab offers disease control with low-risk of fetal abnormalities. The Author(s). Published by S. Karger AG, Basel.
BACKGROUND: Pregnancy outcomes in patients with atypical hemolytic uremic syndrome (aHUS) are not well-documented. Here, we present characteristics of and outcomes for patients with aHUS who became pregnant while enrolled in the Global aHUS Registry. METHODS: The observational Global aHUS Registry (NCT01522183), initiated in April 2012, collects demographics, disease history, treatment, and outcomes data for patients with aHUS, regardless of treatment approach. This descriptive analysis includes patients from the Registry with evaluable pregnancy data supplemented with pharmacovigilance information; the number of pregnancies, outcomes, and exposure to eculizumab were evaluated. RESULTS: As of April 1, 2019, 44 pregnancies were recorded in 41 patients, with 24 pregnancies exposed to eculizumab. Pathogenic variants were identified in 48.8% of patients. Three patients were on dialysis and 6 patients had a kidney graft at the time of pregnancy. Excluding elective terminations, 85.3% of pregnancies resulted in live births. Elective terminations were recorded in 22.7% of pregnancies, miscarriages occurred in 9.1% of pregnancies, and late fetal death in 2.3% of pregnancies. No malformations or anomalies were reported. CONCLUSIONS: Our results show that in women with aHUS, even on dialysis or with a kidney graft, pregnancy is possible with careful monitoring for aHUS flares and prematurity. Prophylactic or therapeutic eculizumab offers disease control with low-risk of fetal abnormalities. The Author(s). Published by S. Karger AG, Basel.
Authors: Allison Tong; Shilpa Jesudason; Jonathan C Craig; Wolfgang C Winkelmayer Journal: Nephrol Dial Transplant Date: 2014-12-18 Impact factor: 5.992
Authors: Christoph Licht; Gianluigi Ardissino; Gema Ariceta; David Cohen; J Alexander Cole; Christoph Gasteyger; Larry A Greenbaum; Sally Johnson; Masayo Ogawa; Franz Schaefer; Johan Vande Walle; Véronique Frémeaux-Bacchi Journal: BMC Nephrol Date: 2015-12-10 Impact factor: 2.388