OBJECTIVES: This work aims to prospectively assess the long-term effects of intravenous immunoglobulin (IVIG Flebogamma®) in a small cohort of patients affected by primary or secondary antiphospholipid syndrome (APS), in addition to conventional therapy. METHODS: Three primary and four secondary APS patients (6 women and 1 man), aged between 40 and 62 years, were treated with IVIG in addition to conventional therapy with anticoagulants or antiplatelets, while six primary and one secondary APS patients (6 women and 1 man), aged between 31 and 61 years, continued their regular conventional therapy. One infusion of IVIG was administered at a dose of 0.4 g/kg/day every month to the first group of patients for two years. Patients were assessed at baseline, after 1 year and 2 years from the beginning of the study and were evaluated for the occurrence of any thromboembolic events and by laboratory measurement of antiphospholipides antibodies (aPL). RESULTS: No venous or arterial thromboses occurred in patients treated with IVIG, whereas in the control group two patients presented cerebral ischaemic attacks and one patient reported a deep vein thrombosis during the follow-up. At the end of the study, in the group treated with IVIG, we observed a statistically significant decrease of anticardiolipin antibodies (IgG and IgM) and of IgM anti-β2-glycoprotein I antibodies. CONCLUSIONS: Our results show the efficacy of IVIG in addition to conventional therapy, in primary and secondary APS patients, preventing the occurrence of thromboembolic events. However, further clinical studies on a larger group of patients are necessary to fully understand the mechanisms of action and the optimal doses of IVIG in APS.
OBJECTIVES: This work aims to prospectively assess the long-term effects of intravenous immunoglobulin (IVIG Flebogamma®) in a small cohort of patients affected by primary or secondary antiphospholipid syndrome (APS), in addition to conventional therapy. METHODS: Three primary and four secondary APSpatients (6 women and 1 man), aged between 40 and 62 years, were treated with IVIG in addition to conventional therapy with anticoagulants or antiplatelets, while six primary and one secondary APSpatients (6 women and 1 man), aged between 31 and 61 years, continued their regular conventional therapy. One infusion of IVIG was administered at a dose of 0.4 g/kg/day every month to the first group of patients for two years. Patients were assessed at baseline, after 1 year and 2 years from the beginning of the study and were evaluated for the occurrence of any thromboembolic events and by laboratory measurement of antiphospholipides antibodies (aPL). RESULTS: No venous or arterial thromboses occurred in patients treated with IVIG, whereas in the control group two patients presented cerebral ischaemic attacks and one patient reported a deep vein thrombosis during the follow-up. At the end of the study, in the group treated with IVIG, we observed a statistically significant decrease of anticardiolipin antibodies (IgG and IgM) and of IgM anti-β2-glycoprotein I antibodies. CONCLUSIONS: Our results show the efficacy of IVIG in addition to conventional therapy, in primary and secondary APSpatients, preventing the occurrence of thromboembolic events. However, further clinical studies on a larger group of patients are necessary to fully understand the mechanisms of action and the optimal doses of IVIG in APS.
Authors: Marteen Limper; Carlo Alberto Scirè; Rosaria Talarico; Zahir Amoura; Tadej Avcin; Martina Basile; Gerd Burmester; Linda Carli; Ricard Cervera; Nathalie Costedoat-Chalumeau; Andrea Doria; Thomas Dörner; João Eurico Fonseca; Ilaria Galetti; Eric Hachulla; David Launay; Filipa Lourenco; Carla Macieira; Pierluigi Meroni; Carlo Maurizio Montecucco; Maria Francisca Moraes-Fontes; Luc Mouthon; Cecilia Nalli; Veronique Ramoni; Maria Tektonidou; Jacob M van Laar; Stefano Bombardieri; Matthias Schneider; Vanessa Smith; Ana Vieira; Maurizio Cutolo; Marta Mosca; Angela Tincani Journal: RMD Open Date: 2018-10-18