Amelia Ruffatti1, Marta Tonello2, Maria Favaro2, Teresa Del Ross2, Antonia Calligaro2, Alessandra Teresa Ruffatti3, Maria Teresa Gervasi3, Ariela Hoxha4. 1. Rheumatology Unit, Department of Medicine, University Hospital of Padua, Padua Italy. Electronic address: amelia.ruffatti@unipd.it. 2. Rheumatology Unit, Department of Medicine, University Hospital of Padua, Padua Italy. 3. Gynaecology and Obstetrics Unit, Department of Woman and Child Health, University Hospital of Padua, Padua, Italy. 4. Rheumatology Unit, Department of Medicine, University Hospital of Padua, Padua Italy; Internal Medicine Unit, Department of Medicine, San Bortolo Hospital, Vicenza, Italy.
Abstract
OBJECTIVE: The most efficacious strategy to manage pregnant patients with antiphospholipid syndrome (APS) refractory to conventional heparin/low-dose aspirin treatment or at high risk of adverse pregnancy outcomes has not been determined with any degree of certainty. The study set out to evaluate the efficacy and safety of the second-line treatments most frequently used in addition to conventional therapy, and the data were analyzed to identify which is/are associated to the best pregnancy outcomes. METHODS: A systematic review of the literature on studies concerning second-line treatments for refractory and/or high risk pregnant APS women published between February 2006 and February 2020 was conducted. The records were retrieved by searching Medline via Pubmed, the Web of Science platform, the Cochrane library database and clinicaltrials.gov. RESULTS: Fourteen studies met the eligibility criteria of the review: six retrospective cohort studies, one case-control, one case-series and six case reports. The results of single treatment protocols based upon hydroxychloroquine (HCQ), low-dose steroids (LDS), intravenous immunoglobulins (IVIG), plasma exchange (PE) or pravastatin and of combination protocols based upon HCQ+LDS, IVIG+LDS, PE+LDS and PE+IVIG used during 313 pregnancies in 303 APS women were analyzed and compared. The second-line treatments produced 261/313 (83.4%) live births; severe pregnancy complications were registered in 75/313 (24%) pregnancies. Drug side-effects were observed in 3/313 (0.9%) pregnancies. Statistical analysis identified a significantly higher live birth rate and/or a significantly lower number of severe complications in the pregnancies treated with IVIG, HCQ, pravastatin, PE+IVIG and PE+LDS. CONCLUSION: Our results suggest using low-dose IVIG (< 2 g/Kg/month) or HCQ 400 mg/day starting before pregnancy in women with APS refractory to conventional therapy, while high-dose IVIG (2 g/Kg/month) associated with PE or alone in those with high risk±refractory APS.
OBJECTIVE: The most efficacious strategy to manage pregnant patients with antiphospholipid syndrome (APS) refractory to conventional heparin/low-dose aspirin treatment or at high risk of adverse pregnancy outcomes has not been determined with any degree of certainty. The study set out to evaluate the efficacy and safety of the second-line treatments most frequently used in addition to conventional therapy, and the data were analyzed to identify which is/are associated to the best pregnancy outcomes. METHODS: A systematic review of the literature on studies concerning second-line treatments for refractory and/or high risk pregnant APS women published between February 2006 and February 2020 was conducted. The records were retrieved by searching Medline via Pubmed, the Web of Science platform, the Cochrane library database and clinicaltrials.gov. RESULTS: Fourteen studies met the eligibility criteria of the review: six retrospective cohort studies, one case-control, one case-series and six case reports. The results of single treatment protocols based upon hydroxychloroquine (HCQ), low-dose steroids (LDS), intravenous immunoglobulins (IVIG), plasma exchange (PE) or pravastatin and of combination protocols based upon HCQ+LDS, IVIG+LDS, PE+LDS and PE+IVIG used during 313 pregnancies in 303 APS women were analyzed and compared. The second-line treatments produced 261/313 (83.4%) live births; severe pregnancy complications were registered in 75/313 (24%) pregnancies. Drug side-effects were observed in 3/313 (0.9%) pregnancies. Statistical analysis identified a significantly higher live birth rate and/or a significantly lower number of severe complications in the pregnancies treated with IVIG, HCQ, pravastatin, PE+IVIG and PE+LDS. CONCLUSION: Our results suggest using low-dose IVIG (< 2 g/Kg/month) or HCQ 400 mg/day starting before pregnancy in women with APS refractory to conventional therapy, while high-dose IVIG (2 g/Kg/month) associated with PE or alone in those with high risk±refractory APS.
Authors: Megan E B Clowse; Amanda M Eudy; Stephen Balevic; Gillian Sanders-Schmidler; Andrzej Kosinski; Rebecca Fischer-Betz; Dafna D Gladman; Yair Molad; Cecilia Nalli; Abir Mokbel; Angela Tincani; Murray Urowitz; Caroline Bay; Megan van Noord; Michelle Petri Journal: Lupus Sci Med Date: 2022-03
Authors: Daniel E Pleguezuelo; Oscar Cabrera-Marante; Magdalena Abad; Edgard Alfonso Rodriguez-Frias; Laura Naranjo; Alicia Vazquez; Olga Villar; Francisco Javier Gil-Etayo; Manuel Serrano; Alfredo Perez-Rivilla; Laura de la Fuente-Bitaine; Antonio Serrano Journal: J Clin Med Date: 2021-05-13 Impact factor: 4.241