Efficacy and safety of a new immunoglobulin G product, Gammaplex®, in primary immunodeficiency diseases

@article{Moy2010EfficacyAS,
  title={Efficacy and safety of a new immunoglobulin G product, Gammaplex{\textregistered}, in primary immunodeficiency diseases},
  author={James N. Moy and Andrew M. Scharenberg and Mark Stein and Daniel Suez and Robert L. Roberts and Robyn J. Levy and Mark C. Ballow and Mary Beth Fasano and C. H. Dash and Samantha J. Leach},
  journal={Clinical \& Experimental Immunology},
  year={2010},
  volume={162}
}
This open‐label multi‐centre study evaluated a new intravenous immunoglobulin, Gammaplex®, in the treatment of 50 patients with primary immunodeficiency and significant hypogammglobulinaemia. Patients treated previously with other intravenous immunoglobulins received Gammaplex® on their same infusion schedule for 1 year; 22 were on a 21‐day and 28 on a 28‐day regimen (300–800 mg/kg/infusion). There were no serious, acute bacterial infections, whereas six subjects (12·0%) had at least one such… 
Efficacy and safety of Gammaplex® 5% in children and adolescents with primary immunodeficiency diseases
TLDR
Gammaplex 5% is effective in preventing SABIs and well tolerated in children and adolescents with PID and Laboratory test results and adverse‐reaction data showed no evidence of product‐related haemolysis or thromboembolic events.
Efficacy, Safety and Tolerability of a New 10% Intravenous Immunoglobulin for the Treatment of Primary Immunodeficiencies
TLDR
Results of the present study demonstrate that GC5107 is an effective, safe and well-tolerated treatment for patients with primary immunodeficiency.
Efficacy, safety, and tolerability of Kedrion 10% IVIG in primary immunodeficiency
TLDR
Evaluating the safety, efficacy, and pharmacokinetics of a new 10% IVIG produced by Kedrion shows promise in patients with primary immunodeficiency, with only 2 episodes of acute serious bacterial infections over the 12-month study period.
Long-Term Tolerability, Safety, and Efficacy of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Human Immunoglobulin for Primary Immunodeficiency
TLDR
Long-term replacement therapy with IGHy was safe and effective in 83 pediatric and adult subjects with PIDD and there was no difference in AE rates in these subjects before and after the first titer increase to ≥1:160.
Evaluation of the Safety, Tolerability, and Pharmacokinetics of Gammaplex® 10% Versus Gammaplex® 5% in Subjects with Primary Immunodeficiency
TLDR
Based on the results from this bridging study in PID subjects, Gammaplex 10% could be expected to have a therapeutic effect similar to the licensed GammAPlex 5%, which has demonstrated efficacy and tolerability in patients with PID and idiopathic thrombocytopenic purpura.
Gammaplex® 5 and 10% in the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.
TLDR
The availability of Gammaplex 10% provides another option to individualize therapy according to patient needs, allowing a 34% reduction in infusion time without compromising safety and tolerability.
Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update
TLDR
A 20-year comprehensive literature review of currently commercially available immunoglobulin products is summarized, noting important differences in product development and application and allowing informed clinical decisions to match a product with patients' risk factors and comorbidity.
A Study of Tolerability, Satisfaction, and Cost Reduction Using a 10% Immunoglobulin Product at Higher Administration Rates
TLDR
Rapid infusion of Gammaplex 10% was found to be a safe option to reduce the costs of intravenous immunoglobulin treatment while maintaining patient satisfaction and cost savings.
Impact of IVIG vs. SCIG on IgG trough level and infection incidence in primary immunodeficiency diseases: A systematic review and meta-analysis of clinical studies☆
TLDR
In this study, weekly SCIG attained a higher trough level in comparison to monthly IVIG, and higher SCIG troughs were associated with lower infection rates, while IVig troughs demonstrated no relationship.
Is there evidence for recommending specific intravenous immunoglobulin formulations? A systematic review of head-to-head randomized controlled trials.
TLDR
A systematic review of head-to-head RCT comparing different formulations of IVIG, regardless of the target condition and outcomes investigated, finds that direct evidence about the different IVIGs is scarce, and there is no scientific evidence that can be applied for a specific brand or formulation.
...
1
2
...

References

SHOWING 1-10 OF 25 REFERENCES
Safety and Efficacy of Privigen®, a Novel 10% Liquid Immunoglobulin Preparation for Intravenous Use, in Patients with Primary Immunodeficiencies
TLDR
Privigen® is well tolerated and effective for the treatment of primary immunodeficiency and may be related to study drug, possibly or probably related toStudy drug.
Efficacy, Safety and Tolerability of a New 10% Liquid Intravenous Immune Globulin [IGIV 10%] in Patients with Primary Immunodeficiency
TLDR
The study met the primary endpoint for efficacy and demonstrated excellent tolerability of the new 10% liquid intravenous imunoglobulin preparation, which is designed to treat primary immunodeficiency diseases.
Octagam® 5%, an Intravenous IgG Product, Is Efficacious and Well Tolerated in Subjects with Primary Immunodeficiency Diseases
TLDR
Octagam® treatment is safe and resulted in 0.1 serious infections/subject/year in primary immunodeficient subjects, and was well tolerated.
Safety, Efficacy, and Pharmacokinetics of Flebogamma® 5% [Immune Globulin Intravenous (Human)] for Replacement Therapy in Primary Immunodeficiency Diseases
TLDR
FFlebogamma® 5% is efficacious, safe, and well-tolerated, and does not put subjects at increased risk of adverse events other than those that could be reasonably expected in primary immunodeficient subjects who are receiving any immune globulin product.
High- vs low-dose immunoglobulin therapy in the long-term treatment of X-linked agammaglobulinemia.
TLDR
Patients who received high-dose intravenous immunoglobulin replacement (greater than 400 mg/kg every 3 weeks) showed a significant increase in trough serum IgG levels and a significant decrease in the incidence of pneumonias and the number of days spent in the hospital.
The effect of two different dosages of intravenous immunoglobulin on the incidence of recurrent infections in patients with primary hypogammaglobulinemia. A randomized, double-blind, multicenter crossover trial.
TLDR
In patients with hypogammaglobulinemia, doubling the standard dose of intravenous immunoglobulin significantly reduced the number and duration of infections.
The Effect of Two Different Dosages of Intravenous Immunoglobulin on the Incidence of Recurrent Infections in Patients with Primary Hypogammaglobulinemia
TLDR
Whether doubling the commonly advised (standard) dose of intravenous immunoglobulin (300 mg/kg of body weight every 4 weeks in adults, 400mg/kg every 4 months in children) decreases the incidence and duration of infections is determined.
Efficacy of intravenous immunoglobulin in primary humoral immunodeficiency disease.
TLDR
A substantial reduction of specific acute illnesses and antibiotic use was found for 18 of the 21 patients, particularly during the second 6 months of treatment, and IgG levels before intravenous infusion were increased 243 mg/dL over previous intramuscular pre-injection levels.
Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV‐C, 10% (Gamunex™, 10%)
TLDR
Two clinical studies were conducted to compare the pharmacokinetics of the new product, IGIV‐C, 10% (Gamunex™, 10%), formulated with glycine, with the licensed solvent–detergent (SD)‐treated intravenous immunoglobulin IG IV‐SD, 10%.
A history of immune globulin therapy, from the harvard crash program to monoclonal antibodies
  • M. Berger
  • Medicine
    Current allergy and asthma reports
  • 2002
TLDR
Although it took 40 years to develop preparations of gamma globulin that could be safely given intravenously, the eventual accomplishment of that goal has led to better treatment of antibody deficiency syndromes and also the wide use of high-dose intravenous immunoglobulin in autoimmune and inflammatory diseases.
...
1
2
3
...