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Outcome of pregnancies in women receiving velaglucerase alfa for G aucher disease
Author(s) -
Elstein Deborah,
Hughes Derralynn,
GokerAlpan Ozlem,
Stivel Miriam,
Baris Hagit N.,
Cohen Ian J.,
GranovskyGrisaru Sorina,
Samueloff Ar,
Mehta Atul,
Zimran Ari
Publication year - 2014
Publication title -
journal of obstetrics and gynaecology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.597
H-Index - 50
eISSN - 1447-0756
pISSN - 1341-8076
DOI - 10.1111/jog.12254
Subject(s) - medicine , pregnancy , obstetrics , vaginal bleeding , adverse effect , gestational age , anemia , abortion , genetics , biology
Aim Pregnancy and delivery are affected by and – in turn – impact signs and symptoms of Gaucher disease ( GD ). Prior to enzyme replacement therapy ( ERT ), the reported missed abortions rate was 25%, with worsening of anemia and thrombocytopenia, with increased frequency of post‐partum hemorrhage, puerperal fever and bone crises during pregnancy. ERT with imiglucerase reduced these adverse events. Velaglucerase alfa ( VPRIV ), an ERT approved commercially in F ebruary 2010, had undergone preclinical reproductive toxicity testing and proven to be safe and effective in phase I / II and III clinical trials. The objective of this study was to ascertain pregnancy outcome in women receiving VPRIV . Methods Among records collected from six multinational clinical sites, 21 females (mean age, 32.0 years) with GD received VPRIV . Results There were 25 singleton pregnancies (mean gravidity, 2.7; mean parity, 2.0; mean months VPRIV , 31.2). Two primiparous women suffered three first trimester abortions and one missed abortion occurred in a multigravida female. Live birth rate was 84% (mean gestational age, 39.7 weeks). Mean birthweight was 3234.4 g, with APGAR scores above 9. All but three were vaginal deliveries; elective cesarean sections were performed in two patients with hip arthroplasty and one after previous cesarean. Nine patients received regional analgesia/anesthesia. Post‐partum complications were rare, with only one post‐partum (placental) bleed which resolved without intervention. Mean hemoglobin and platelet counts improved during pregnancy (9.45% and 26.0%, respectively). Conclusion VPRIV is safe for conception and pregnancy with good maternal and neonatal outcomes.