Real-World Use of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Immunoglobulin G (IG) (IGHy) in Patients with Primary Immunodeficiency Disorders (PIDD)

Rosenbach, K.; Hughes, Siân; Rozen, Leon

doi:10.1016/j.jaci.2015.12.853

Cited by 2 publications

(5 citation statements)

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“…Factors contributing to treatment adoption and retention were examined in a series of 50 patients with PIDD from a single-practice cohort who were treatment naive (n = 7) or who transitioned from IVIG (n = 4) or conventional SCIG (n = 39) to IGHy [47]. Patients transitioning from IVIG cited poor venous access (n = 3) or the desire to self-infuse (n = 1).…”

Section: Anti-ph20 Immunogenic Responsementioning

confidence: 99%

“…change the number and location of infusion sites, increase dosing frequency and use longer needles to optimize their patient experience and treatment continuation [47]. Local AEs that may occur during subcutaneous IgG administration include swelling, erythema, discomfort, pruritus and infusion-site leakage [16,48].…”

Section: Anti-ph20 Immunogenic Responsementioning

confidence: 99%

“…The management of PIDD will continue to improve as clinicians and patients gain experience with IGHy therapy. Real-world data are emerging that are demonstrating that healthcare provider training and patient education are critical to improving adherence, optimizing clinical outcomes and fostering an environment where patients and their caregivers can individualize treatment [47,48].…”

Section: Future Perspectivementioning

confidence: 99%

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Recombinant Human Hyaluronidase-Facilitated Subcutaneous Immunoglobulin Infusion in Primary Immunodeficiency Diseases

Wasserman

2017

Immunotherapy

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Most primary immunodeficiency diseases (PIDDs) resulting in antibody deficiency require intravenous or subcutaneous immunoglobulin G (SCIG) replacement therapy. The flow and distribution of SCIG to the vasculature is impeded by the glycosaminoglycan hyaluronan in the extracellular matrix, which limits the infusion rate and volume per site, necessitating frequent infusions and multiple infusion sites. Hyaluronidase depolymerizes hyaluronan and is a spreading factor for injectable biologics. Recombinant human hyaluronidase (rHuPH20) increases SCIG absorption and dispersion. In patients with PIDD, SCIG facilitated with rHuPH20 (IGHy) has been shown to prevent infections, be well-tolerated and reduce infusion frequency and number of infusion sites as compared with conventional SCIG. This article reviews IGHy clinical studies and real-world practice data in patients with PIDD.

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Section: Anti-ph20 Immunogenic Responsementioning

confidence: 99%

Section: Anti-ph20 Immunogenic Responsementioning

confidence: 99%

Section: Future Perspectivementioning

confidence: 99%

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Recombinant Human Hyaluronidase-Facilitated Subcutaneous Immunoglobulin Infusion in Primary Immunodeficiency Diseases

Wasserman

2017

Immunotherapy

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“…Most patients (61%) progressed from one to two infusion sites, while 16% used two sites for every infusion. In another real-world study, only 62% of patients using HyQvia initiated treatment using a single infusion site, seven of whom increased the number of infusion sites after completing dose ramp-up to lessen the volume per infusion site [25]. A preference to use two sites for larger HyQvia doses may also reflect a desire for shorter infusion duration, improved patient comfort, or both.…”

Section: Discussionmentioning

confidence: 99%

“…Recommendations in the USA are also mainly limited to adults, with little information regarding its use in children. To date, there are two retrospective studies addressing the use of HyQvia in adults and pediatric patients in a real-world setting, but these studies included fewer than 20 patients each and provide little detail on tailored HyQvia therapy [25,26]. Thus, a need exists to further examine real-world clinical experience with administration of HyQvia at variance with current guidelines and use in children.…”

Section: Introductionmentioning

confidence: 99%

Clinical Practice Experience with HyQvia in Adults Using Alternative Dosing Regimens and Pediatric Patients: A Retrospective Study

Wasserman

2020

Adv Ther

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Introduction: HyQvia (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase) was developed to combine the advantages of intravenous and subcutaneous immune globulin (SCIG), allowing administration of larger volumes at a single subcutaneous site with less frequent dosing when compared to other SCIG products. Current US prescribing guidelines for HyQvia are limited to adults and do not encompass the flexibility required to achieve success in all patients with primary immunodeficiency (PID). Methods: This retrospective study was designed to evaluate the clinical experience of treating patients with PID with HyQvia regimens outside of package insert recommendations as well as in pediatric patients. Data were abstracted from 38 patient records (317 HyQvia infusions), including five patients less than 16 years of age, from seven US immunology clinics. Results: Among 37 patients receiving HyQvia regimens differing from prescribing guidelines, the most notable variations included shorter ramp-up periods, use of two rather than one infusion site, and slower than maximal infusion rates to mitigate local adverse events (AEs). The medication volume infused for single site doses ranged from 75 to 200 mL and doses split between two sites ranged from 100 to 750 mL. The most common type of regimen variation was a condensed ramp-up phase (shorter schedule, higher doses), and 96% (24/25) of patients managed in this way completed rampup. The most common ramp-up schedule was three infusions (one at 25-45%, another at 50-75%, and the final at 100% of target dose) spread over 2-4 weeks. Conclusions: A shorter ramp-up schedule did not appear to increase the number of AEs compared to standard ramp-up schedules. For patients with AEs, slower infusion rates and the use of two sites may improve medication tolerability. Four of five pediatric patients reported no AEs, and only one discontinued, stating a fear of needles. HyQvia may be tailored to adults requiring alternative rates, ramp-up, and/ or dosing regimens and may be especially wellsuited to children.

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Real-World Use of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Immunoglobulin G (IG) (IGHy) in Patients with Primary Immunodeficiency Disorders (PIDD)

Cited by 2 publications

References 0 publications

Recombinant Human Hyaluronidase-Facilitated Subcutaneous Immunoglobulin Infusion in Primary Immunodeficiency Diseases

Recombinant Human Hyaluronidase-Facilitated Subcutaneous Immunoglobulin Infusion in Primary Immunodeficiency Diseases

Clinical Practice Experience with HyQvia in Adults Using Alternative Dosing Regimens and Pediatric Patients: A Retrospective Study

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