title: Long-term treatment of antiphospholipid syndrome with intravenous immunoglobulin in addition to conventional therapy.
abstract: OBJECTIVE
  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.
authors.affiliation: Rheumatology Unit, Department of Clinical Medicine and Immunological Sciences, University of Siena, Italy. sara_tenti@hotmail.it.
authors.forename: Sara
authors.initials: S
authors.lastname: Tenti
authors.forename: Giacomo Maria
authors.initials: GM
authors.lastname: Guidelli
authors.forename: Francesca
authors.initials: F
authors.lastname: Bellisai
authors.forename: Mauro
authors.initials: M
authors.lastname: Galeazzi
authors.forename: Antonella
authors.initials: A
authors.lastname: Fioravanti
mesh_terms: D000328:Adult; D017152:Antibodies, Antiphospholipid / Q000097:blood; D000925:Anticoagulants / Q000627:therapeutic use; D016736:Antiphospholipid Syndrome / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000008:administration & dosage / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D017152:Antibodies, Antiphospholipid; D000925:Anticoagulants; D015415:Biomarkers; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors; D010975:Platelet Aggregation Inhibitors