Efficacy and safety of a nanofiltered liquid intravenous immunoglobulin product in patients with primary immunodeficiency and idiopathic thrombocytopenic purpura

Abstract

In clinical studies, IVIG-L (Nanogam®) demonstrated to be efficacious, well tolerated and safe.

Efficacy and safety of a new intravenous immunoglobulin (Panzyga®) in chronic immune thrombocytopenia

“…Similar to the results obtained in the present study, the median time to response in the aforementioned studies ranged from 2 to 4 days, whereas the duration of response ranged from 5 to 42 days (Newland et al, 2001;Bussel et al, 2004;Robak et al, 2009;Robak et al, 2010;van der Meer et al, 2011). The range of peak platelet counts in previous studies (Newland et al, 2001;Bussel et al, 2004;Robak et al, 2009;Robak et al, 2010;van der Meer et al, 2011) were also similar to the results obtained in the present cohort (∼160-273 × 10 9 L −1 ). The most frequent AE associated with IVIG 10% (Panzyga ® ) was headache, as reported in a previous study and for other IVIGs (Varga et al, 2006;Debes et al, 2007;Robak et al, 2010).…”

“…In an open-label study of Vigam-S in patients with ITP with either a baseline platelet count of <20 × 10 9 L −1 or >20 × 10 9 L −1 with bleeding complications or requiring surgery, response was defined as an incremental increase of ≥30 × 10 9 L −1 , and 75% of the study population responded to treatment according to this criterion (Newland et al, 2001). Similar to the results obtained in the present study, the median time to response in the aforementioned studies ranged from 2 to 4 days, whereas the duration of response ranged from 5 to 42 days (Newland et al, 2001;Bussel et al, 2004;Robak et al, 2009;Robak et al, 2010;van der Meer et al, 2011). The range of peak platelet counts in previous studies (Newland et al, 2001;Bussel et al, 2004;Robak et al, 2009;Robak et al, 2010;van der Meer et al, 2011) were also similar to the results obtained in the present cohort (∼160-273 × 10 9 L −1 ).…”

“…In an international, multicentre, randomised, double-blind, non-inferiority trial of IVIG-C vs solvent/detergent-treated IVIG-S/D in patients with ITP (platelet count at baseline ≤20 × 10 9 L −1 ), response rates (defined as a platelet count of ≥50 × 10 9 L −1 within 7 days of IVIG administration) were 90 and 83% with IVIG-C and IVIG-S/D, respectively (Bussel et al, 2004). In three open-label, multicentre studies of patients with ITP with platelet counts ≤20 × 10 9 L −1 , 80-83·3% of patients achieved a platelet count of ≥50 × 10 9 L −1 within 6-7 days of treatment with Octagam ® , Nanogam ® and Privigen ® (Robak, Salama et al, 2009;Robak et al, 2010;van der Meer et al, 2011). In an open-label study of Vigam-S in patients with ITP with either a baseline platelet count of <20 × 10 9 L −1 or >20 × 10 9 L −1 with bleeding complications or requiring surgery, response was defined as an incremental increase of ≥30 × 10 9 L −1 , and 75% of the study population responded to treatment according to this criterion (Newland et al, 2001).…”

Human Immunoglobulin (KIOVIG ® /GAMMAGARD LIQUID ® ) for Immunodeficiency and Autoimmune Diseases: An Observational Cohort Study

“…The most frequently documented ADRs to IVIG 10% documented in this study were headache, vomiting, pyrexia and chills, which is consistent with previous studies of IVIG 10% and of other intravenously infused Ig preparations. ADRs occurred more frequently in subjects with ITP (46.2% of subjects) than other autoimmune indications (21.4% of subjects with Guillain-Barré syndrome and no subjects with Kawasaki disease); however, the incidence of ADRs in subjects with ITP was within the range reported in previous clinical studies on intravenously administered Ig preparations in patients with ITP [34][35][36][37]. In agreement with the occurrence of ADRs, the overall tolerability of IVIG 10% in the present study was assessed by the investigators as being very good in the majority of subjects.…”

Tolerability and safety of the intravenous immunoglobulin octagam®10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials

“…Nausea and dizziness were also reported. Such events, together with other minor hypersensitivity reactions involving symptoms such as fevers and chills, are consistent with previously reported studies of octagam® 10% [8], and other ready-to-use liquid preparations of IVIG 10% [9][10][11] and IVIG 5% [12][13][14] in patients with ITP. As was observed with the patients with ITP treated with octagam® 10% in our subgroup analysis, ADRs associated with IVIG are generally transient and of mild-tomoderate severity [8][9][10][11][12][13][14].…”