title: Safety of high-dose intravenous immunoglobulin in systemic autoimmune diseases.
abstract: It is reported that the usage of high-dose intravenous immunoglobulin (HD-IVIG) in systemic autoimmune diseases is associated with various adverse events in a wide range of severity. We aimed to investigate the frequency and profile of adverse events in a group of patients with diffuse connective tissue diseases and Wegener's granulomatosis (WG) who were administrated HD-IVIG for different indications. We recorded the data of 38 patients (25 females and 13 males) aged 38 +/- 15 (12-75) years who were followed up with the diagnosis of systemic autoimmune diseases between 1994 and 2006 according to a predefined protocol. Patients with active disease were treated with HD-IVIG and standard immunosuppressives concomitantly. We evaluated the occurrence of allergy, acute renal failure, thromboembolic events, neutropenia, hemolytic anemia, aseptic meningitis, and vasculitis during infusion therapy of HD-IVIG and in the following 3 weeks. We commenced a total of 130 infusions of HD-IVIG. Patients were administrated 1-12 (3.4 +/- 2.6) infusions of HD-IVIG as needed. Indications for HD-IVIG were unresponsiveness or partial response to standard treatment, severe infections along with disease activity, and severe thrombocytopenia in the preoperative period in 97, 23, and 5% of patients, respectively. Minor adverse events were seen in two patients during HD-IVIG infusions. One patient with WG developed rapidly progressive renal failure during severe disease flare between HD-IVIG infusions. Another patient with WG developed recurrence of deep-vein thrombosis during severe disease flare 3 months after HD-IVIG. Both events were attributed to severe disease activity. Adverse events like allergy, acute renal failure, thromboembolic events, hematological problems, aseptic meningitis, and vasculitis are reported in different frequencies (1-81%) in patients who were administered HD-IVIG for systemic autoimmune diseases. HD-IVIG is considered a safe treatment in selected patients assuring adequate infusion precautions.
authors.affiliation: Department of Internal Medicine, Istanbul Medical Faculty, Istanbul University, Istanbul, Turkey. fatihtufan@gmail.com
authors.forename: Fatih
authors.initials: F
authors.lastname: Tufan
authors.forename: Sevil
authors.initials: S
authors.lastname: Kamali
authors.forename: Burak
authors.initials: B
authors.lastname: Erer
authors.forename: Ahmet
authors.initials: A
authors.lastname: Gul
authors.forename: Murat
authors.initials: M
authors.lastname: Inanc
authors.forename: Lale
authors.initials: L
authors.lastname: Ocal
authors.forename: Meral
authors.initials: M
authors.lastname: Konice
authors.forename: Orhan
authors.initials: O
authors.lastname: Aral
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001327:Autoimmune Diseases / Q000276:immunology / Q000628:therapy; D002648:Child; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects* / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000276:immunology / Q000628:therapy; D007155:Immunologic Factors / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012449:Safety; D016896:Treatment Outcome
chemical_list: D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors