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Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency

医学 耐受性 生物利用度 药代动力学 生物等效性 不利影响 加药 抗体 分配量 胃肠病学 内科学 药理学 麻醉 免疫学
作者
Richard L. Wasserman,Isaac Melamed,Mark R. Stein,Sudhir Gupta,Jennifer M. Puck,Werner Engl,Heinz Leibl,Barbara McCoy,Victoria G. Empson,David Gelmont,Richard I. Schiff
出处
期刊:The Journal of Allergy and Clinical Immunology [Elsevier]
卷期号:130 (4): 951-957.e11 被引量:97
标识
DOI:10.1016/j.jaci.2012.06.021
摘要

Background

Subcutaneous immunoglobulin (IGSC) replacement therapy for primary immunodeficiency (PI) is equally efficacious to intravenous immunoglobulin (IGIV), induces fewer systemic reactions, and may be self-infused. Limited SC infusion volumes and reduced bioavailability, however, necessitate multiple infusion sites, more frequent treatment, and dose adjustment to achieve pharmacokinetic equivalence. Recombinant human hyaluronidase (rHuPH20) increases SC tissue permeability and facilitates dispersion and absorption, enabling administration of monthly doses in one site.

Objective

This study investigated the efficacy and tolerability of rHuPH20-facilitated IGSC (IGHy) in patients with PI.

Methods

In this open-label, multicenter phase III study, 87 patients with PI aged ≥2 years received 10% IGIV for 3 months, then IGHy (n = 83) for approximately 14 to 18 months at 108% of the IGIV dose. IGHy infusions began weekly, increasing to 3- or 4-week intervals.

Results

The majority (94.0%) of IGHy infusions were administered every 3 or 4 weeks, using one site (median, 1.09/month), with a mean volume of 292.2 mL. The bioavailability of IGHy measured by area under the concentration versus time curve was 93.3% of IGIV, which is pharmacokinetically equivalent. Systemic reactions were less frequent with IGHy than with IGIV (8.3% vs 25.0% of infusions). Local reactions to IGHy were generally mild to moderate, with a rate of 0.203 per infusion. The acute serious bacterial infection rate per subject-year for IGHy was low (0.025; upper 99% CI limit, 0.046). Overall infection rates per subject-year were 2.97 for IGHy and 4.51 for IGIV.

Conclusion

IGHy was effective, safe, and pharmacokinetically equivalent to IGIV at the same administration intervals, but it caused fewer systemic reactions. Tolerability was good despite high infusion volumes and rates.
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