Human Immunoglobulin 10 % with Recombinant Human Hyaluronidase: Replacement Therapy in Patients with Primary Immunodeficiency Disorders

@article{Sanford2014HumanI1,
  title={Human Immunoglobulin 10 \% with Recombinant Human Hyaluronidase: Replacement Therapy in Patients with Primary Immunodeficiency Disorders},
  author={Mark Rep Sanford},
  journal={BioDrugs},
  year={2014},
  volume={28},
  pages={411-420}
}
Human immunoglobulin is an established replacement therapy for patients with primary immunodeficiency disorders (PIDs). Recombinant human hyaluronidase (rHuPH20) is a spreading factor that temporarily digests hyaluronan in the skin interstitium enabling large volumes of fluid or drug solutions to be infused and absorbed subcutaneously. HyQvia® (IGHy) is a new combination product whereby rHuPH20 is injected subcutaneously, followed by human immunoglobulin 10 % infused through the same needle… Expand
Self-administered hyaluronidase-facilitated subcutaneous immunoglobulin therapy in complicated primary antibody deficiencies.
TLDR
It is concluded that fSCIg could be a feasible option to improve the adherence to replacement therapy also by patients with severe PAD. Expand
Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy
TLDR
Treatment with fSCIg can be considered a safe alternative for patients with MMN on IVIg treatment and could be a favorable option in patients who prefer self-treatment and more independency, and in Patients who experience systemic adverse events onIVIg or have difficult intravenous access. Expand
[Colombian Guidelines of clinical practice for the use of immunoglobulins in the treatment of replacement and immunomodulation].
TLDR
Recommendations were issued on the use of intravenous immunoglobulin in pathologies that include primary and secondary immunodeficiencies, autoimmune diseas es, neurological disorders, infections, transplants and miscellaneous conditions. Expand
Update on the use of immunoglobulin in human disease: A review of evidence
TLDR
This work provides an update of the evidence‐based guideline on immunoglobulin therapy, last published in 2006, and suggests that careful consideration of its indications and administration is warranted. Expand
Common variable immune deficiency with mutated TNFSRF13B gene presenting with autoimmune hematologic manifestations
TLDR
A 14-year-old boy with Evans syndrome, who presented at the age of 11.5 years with autoimmune hemolysis and was successfully managed with corticosteroids, definitely fulfilled the diagnostic criteria for CVID, despite a negative history for serious infections. Expand
Long-term follow-up of facilitated subcutaneous immunoglobulin therapy in multifocal motor neuropathy
OBJECTIVE To assess the feasibility, efficacy and patient satisfaction of long-term facilitated subcutaneous immunoglobulin therapy (fSCIG) in multifocal motor neuropathy (MMN). METHODS TwelveExpand
Immune Gamma Globulin Therapeutic Indications in Immune Deficiency and Autoimmunity
TLDR
This review encompasses a historical perspective as well as current and future implications of human immune globulin for the treatment of immune-mediated illness. Expand
Randomized trial of facilitated subcutaneous immunoglobulin in multifocal motor neuropathy
To optimize subcutaneous therapy with immunoglobulins, large volume infusion of immunoglobulin G facilitated by pretreatment with hyaluronidase (fSCIG) was compared to conventional infusion ofExpand
A Missed Opportunity.
The author reflects on the need to include pregnant and lactating women in medical research and clinical trials Topics include how the medical sector missed an opportunity for not including saidExpand
Consenso Mexicano para la prescripción de inmunoglobulina G como tratamiento de reemplazo e inmunomodulación
INTRODUCCION: La disponibilidad y comercializacion de la inmunoglobulina G humana ha modificado el curso y pronostico de diversas enfermedades. Hoy en dia representa el tratamiento de primera lineaExpand
...
1
2
...

References

SHOWING 1-10 OF 30 REFERENCES
Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency.
TLDR
IGHy was effective, safe, and pharmacokinetically equivalent to IGIV at the same administration intervals, but it caused fewer systemic reactions and tolerability was good despite high infusion volumes and rates. Expand
Immune Globulin (Human) 10 % Liquid: A Review of its Use in Primary Immunodeficiency Disorders
TLDR
IG 10 % liquid is an effective and generally well-tolerated preparation for both intravenous and subcutaneous IgG replacement therapy in patients with primary immunodeficiency disorders involving antibody deficiency. Expand
Progress in Gammaglobulin Therapy for Immunodeficiency: From Subcutaneous to Intravenous Infusions and Back Again
TLDR
Results from a phase III clinical trial indicate that subcutaneous immunoglobulin infusion, facilitated by recombinant human hyaluronidase, is well tolerated, and delivers infusion volumes at treatment intervals and rates equivalent to intravenous administration. Expand
Overview of recombinant human hyaluronidase-facilitated subcutaneous infusion of IgG in primary immunodeficiencies.
TLDR
Results from a Phase III, prospective, open-label, noncontrolled study of patients with primary immunodeficiencies indicated that IGSC infusion, facilitated by rHuPH20, is well tolerated and delivers infusion volumes at treatment intervals and rates equivalent to intravenous administration. Expand
Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22 years.
TLDR
These data offer guidance regarding optimal doses and target trough IgG levels in individual patients with CVIDs with or without bronchiectasis and for particular clinical phenotypes. Expand
A randomized clinical trial of recombinant human hyaluronidase-facilitated subcutaneous versus intravenous rehydration in mild to moderately dehydrated children in the emergency department.
TLDR
In mild to moderately dehydrated children, r HFSC was inferior to IV hydration for the primary outcome measure, however, rHFSC was noninferior in the ED phase of hydration. Expand
Subcutaneous immunoglobulin: opportunities and outlook
TLDR
Subcutaneous immunoglobulin (SCIg) treatment may further be beneficial in the treatment of autoimmune neurological conditions, such as multi‐focal motor neuropathy; however, controlled trials directly comparing the s.c. and i.v. routes are still to be performed for this indication. Expand
Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase
TLDR
Coformulation with rHuPH20 may enable effective, well-tolerated, cost-effective, and convenient SC administration of rituximab and trastuzumab. Expand
Clinical uses of intravenous immunoglobulin
TLDR
It will be important to increase the evidence base for IVIG in many conditions to define its therapeutic role, and future studies will need to address questions of efficacy, pharmacoeconomics, dose, adjunctive therapies and mechanism of action. Expand
A recombinant human enzyme for enhanced interstitial transport of therapeutics.
TLDR
Depolymerization of the viscoelastic component of the interstitial matrix in animal models with a highly purified recombinant human hyaluronidase enzyme (rHuPH20) increased the dispersion of locally injected drugs, across a broad range of molecular weights without tissue distortion. Expand
...
1
2
3
...