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Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (ClinicalTrials.gov--NCT02247141).

Dash C, Gascoigne E, Gillanders K, Gooi H - PLoS ONE (2015)

Bottom Line: Only 34 post-licensing adverse reactions have been received in 30 patients over a period of 10 years; fourteen were classed as serious as defined by the ICH guidelines on good clinical practice.There were also reports of anaphylaxis (2 reports) and 8 other adverse events (including headache).In conclusion, Subgam is effective and well tolerated in the treatment of PID.

View Article: PubMed Central - PubMed

Affiliation: CD Consultants, St Albans, United Kingdom.

ABSTRACT

Background and objectives: A multi-centre, non-comparative study examining the efficacy and safety of Subgam, a normal immunoglobulin (IgG) given weekly as a rapid subcutaneous infusion to patients with primary immune deficiency (PID), is reported. Also included is a summary of adverse drug reactions associated with the use of marketed Subgam in the UK.

Materials and methods: 50 patients with stable PID on IgG therapy were enrolled: Stage 1 included three infusions with prior IgG product followed by 6 months with Subgam, Stage 2 involved long-term Subgam therapy up to 4 years.

Results: Stage 1, 85% of the subjects aged >12 years and 93% of the subjects aged <12 years achieved IgG levels ≥6 and ≥4 g/L, respectively at all observations. There were 3.62 infections/patient/year during Subgam treatment. The most common product-related events were infusion site reactions (50% of patients). Recent post-hoc pharmacokinetics analysis of the post-infusion serum total IgG concentration indicated that the mean dose-normalised incremental IgG AUCτ following intravenous dosing (120.5 g.day/L) was 1.64-fold that of the dose-normalised mean incremental IgG AUCτ following subcutaneous dosing (73.6 g.day/L), corresponding to an estimated IgG bioavailability for subcutaneous dosing of 61%. Only 34 post-licensing adverse reactions have been received in 30 patients over a period of 10 years; fourteen were classed as serious as defined by the ICH guidelines on good clinical practice. The most common post-licensing adverse reaction was infusion site reaction (7 reports). There were 7 reports of flu-like symptoms (pyrexia/shivering/rigors/feeling hot or cold), 2 other reports of combined flu-like symptoms and infusion site reactions, 5 reports of generalised skin reactions, and 3 reports of combined infusion site and skin reactions. There were also reports of anaphylaxis (2 reports) and 8 other adverse events (including headache). In conclusion, Subgam is effective and well tolerated in the treatment of PID.

Trial registration: ClinicalTrials.gov NCT02247141.

No MeSH data available.


Related in: MedlinePlus

This is the graph showing Subgam IgG levels (g/L).
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pone.0131565.g003: This is the graph showing Subgam IgG levels (g/L).

Mentions: Mean serum IgG level increased from 9.2 g/L to 9.75 g/L by the end of Stage 1 with Subgam treatment and was maintained above the pre-Subgam level for 30 months of treatment (Fig 3). The overall mean serum IgG value was sustained for the 30–36 month period.


Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (ClinicalTrials.gov--NCT02247141).

Dash C, Gascoigne E, Gillanders K, Gooi H - PLoS ONE (2015)

This is the graph showing Subgam IgG levels (g/L).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4519338&req=5

pone.0131565.g003: This is the graph showing Subgam IgG levels (g/L).
Mentions: Mean serum IgG level increased from 9.2 g/L to 9.75 g/L by the end of Stage 1 with Subgam treatment and was maintained above the pre-Subgam level for 30 months of treatment (Fig 3). The overall mean serum IgG value was sustained for the 30–36 month period.

Bottom Line: Only 34 post-licensing adverse reactions have been received in 30 patients over a period of 10 years; fourteen were classed as serious as defined by the ICH guidelines on good clinical practice.There were also reports of anaphylaxis (2 reports) and 8 other adverse events (including headache).In conclusion, Subgam is effective and well tolerated in the treatment of PID.

View Article: PubMed Central - PubMed

Affiliation: CD Consultants, St Albans, United Kingdom.

ABSTRACT

Background and objectives: A multi-centre, non-comparative study examining the efficacy and safety of Subgam, a normal immunoglobulin (IgG) given weekly as a rapid subcutaneous infusion to patients with primary immune deficiency (PID), is reported. Also included is a summary of adverse drug reactions associated with the use of marketed Subgam in the UK.

Materials and methods: 50 patients with stable PID on IgG therapy were enrolled: Stage 1 included three infusions with prior IgG product followed by 6 months with Subgam, Stage 2 involved long-term Subgam therapy up to 4 years.

Results: Stage 1, 85% of the subjects aged >12 years and 93% of the subjects aged <12 years achieved IgG levels ≥6 and ≥4 g/L, respectively at all observations. There were 3.62 infections/patient/year during Subgam treatment. The most common product-related events were infusion site reactions (50% of patients). Recent post-hoc pharmacokinetics analysis of the post-infusion serum total IgG concentration indicated that the mean dose-normalised incremental IgG AUCτ following intravenous dosing (120.5 g.day/L) was 1.64-fold that of the dose-normalised mean incremental IgG AUCτ following subcutaneous dosing (73.6 g.day/L), corresponding to an estimated IgG bioavailability for subcutaneous dosing of 61%. Only 34 post-licensing adverse reactions have been received in 30 patients over a period of 10 years; fourteen were classed as serious as defined by the ICH guidelines on good clinical practice. The most common post-licensing adverse reaction was infusion site reaction (7 reports). There were 7 reports of flu-like symptoms (pyrexia/shivering/rigors/feeling hot or cold), 2 other reports of combined flu-like symptoms and infusion site reactions, 5 reports of generalised skin reactions, and 3 reports of combined infusion site and skin reactions. There were also reports of anaphylaxis (2 reports) and 8 other adverse events (including headache). In conclusion, Subgam is effective and well tolerated in the treatment of PID.

Trial registration: ClinicalTrials.gov NCT02247141.

No MeSH data available.


Related in: MedlinePlus