title: Efficacy and safety of subcutaneous vivaglobin® replacement therapy in previously untreated patients with primary immunodeficiency: a prospective, multicenter study.
abstract: Treatment of primary immunodeficiency (PI) is typically initiated with intravenous immunoglobulin (IVIG) loading and then continued with IVIG or subcutaneous IgG (SCIG). This prospective, open-label, multicenter, 6-month study evaluated a new regimen of initiating IgG therapy with SCIG in 18 previously untreated patients. In the loading phase, SCIG 100 mg/kg was administered for five consecutive days (total loading dose 500 mg/kg). During the maintenance phase, patients self-infused SCIG 100 mg/kg/week at home. The primary efficacy endpoint of IgG levels ≥5 g/L on day 12 was achieved in 17 patients (94.4%; 95% CI 0.727, 0.999). The rate of infections was 3.95 episodes/patient/year. Improvement was found in many subscales of the health-related quality of life questionnaires. SCIG treatment was well tolerated, with no related serious adverse events (AEs). Nine (50%) patients experienced related AEs, including local reactions (rate 0.105 events/infusion). The results suggest that therapy of newly diagnosed patients with PI can be initiated directly with SCIG.
authors.affiliation: Hospital St. Georg, GmbH Leipzig, Academic Teaching Hospital of the University of Leipzig, Delitzscher Straße 141, 04129, Leipzig, Germany. Michael.Borte@sanktgeorg.de
authors.forename: Michael
authors.initials: M
authors.lastname: Borte
authors.forename: Isabella
authors.initials: I
authors.lastname: Quinti
authors.forename: Annarosa
authors.initials: A
authors.lastname: Soresina
authors.forename: Eduardo
authors.initials: E
authors.lastname: Fernández-Cruz
authors.forename: Bruce
authors.initials: B
authors.lastname: Ritchie
authors.forename: Dirk S
authors.initials: DS
authors.lastname: Schmidt
authors.forename: Christine
authors.initials: C
authors.lastname: McCusker
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000009:adverse effects; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects; D007153:Immunologic Deficiency Syndromes / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D007223:Infant; D007279:Injections, Subcutaneous; D007558:Italy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000890:Anti-Infective Agents; D007074:Immunoglobulin G; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; C510539:Vivaglobin