2012
DOI: 10.1007/s10875-011-9641-4
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Efficacy, Safety and Pharmacokinetics of a Novel Subcutaneous Immunoglobulin, Evogam®, in Primary Immunodeficiency

Abstract: This phase III, open-label, multi-centre study investigated the efficacy, safety, pharmacokinetics and quality of life impact of Evogam(®), a new chromatographically fractionated 16% subcutaneous immunoglobulin, utilising a 1:1 dose transition ratio from previous immunoglobulin therapy. Thirty-five previously treated patients with primary immunodeficiency received weekly Evogam over 36 weeks. Primary endpoints were rate of serious bacterial infections (SBIs) and steady-state serum immunoglobulin G (IgG) trough… Show more

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Cited by 6 publications
(2 citation statements)
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“…Although IVIG replacement therapy has been used for many years, there have been more than 25 years of accumulated experience with SCIG therapy in Europe, especially in the Nordic countries. SCIG is now widely available in Europe, the United States and a steadily growing number of other countries [24,[32][33][34][35][36][37].…”
Section: Routes Of Administration: Ivig and Scig For Individualized Tmentioning
confidence: 99%
See 1 more Smart Citation
“…Although IVIG replacement therapy has been used for many years, there have been more than 25 years of accumulated experience with SCIG therapy in Europe, especially in the Nordic countries. SCIG is now widely available in Europe, the United States and a steadily growing number of other countries [24,[32][33][34][35][36][37].…”
Section: Routes Of Administration: Ivig and Scig For Individualized Tmentioning
confidence: 99%
“…2) is associated with a substantially reduced incidence of systemic and severe AEs [38]. In addition, the near steady-state serum IgG levels achieved with weekly or more frequent SCIG administration confer comparable protection against infections [5,11,12,34,[42][43][44]. In contrast, recent pooled analyses showed that the incidence of infection increases as the IgG level falls towards the end of each 3-or 4-week IVIG dosing cycle [45].…”
Section: Routes Of Administration: Ivig and Scig For Individualized Tmentioning
confidence: 99%