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????? ????????? ?? ?"? Lee, Deborah A, ???? ???? ????"? ??????????? ?????, ??????? ???? 2010 ??????, ???? ???????? ???? ??-???? ?? ????????????????. ?????? ??????? ???????? ?? ????? CIDP ??????? ??????. (???: ??????)

Deborah A. Lee
Westlake Village, CA

Biography / Profile:
Learning Objectives:

Concurrent Symposium
06/05/2010 - 11:00
Peripheral Neuropathies

Abstract:

Subcutaneous Immunoglobulin Administration Using Recombinant Human Hyaluronidase: A Novel Approach for the Treatment of Peripheral Neuropathies in Children

Deborah A. Lee, MD, PhD1, Samuel S. Dychter, MD2, and Richard I Schiff, MD, PhD1

1Baxter Healthcare Corp., One Baxter Way, Westlake Village, CA, 91362, USA

2Halozyme Therapeutics, Inc., 11388 Sorrento Valley Road, San Diego, CA 92121, USA

Subcutaneous administration of immunoglobulin has major advantages over intravenous, including improved safety profile, the convenience of self administration at home, improved quality of life, and better resource utilization. It has also been successful in treating multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating neuropathy (CIDP) in adults. However, the disadvantages of current subcutaneous treatment include the small volumes that can be infused at a single site, slow infusion rates using standard available equipment, and the large volumes required for neurological indications.

Recombinant human hyaluronidase (rHUPH20) has been approved in the United States as an adjuvant to increase absorption and dispersion of other injected drugs. It breaks down the hyaluronan in subcutaneous tissue to allow faster and more widespread dispersion. In a Phase I/2 tolerability study in patients with primary immune deficiencies, patients tolerated subcutaneous flow rates of 300mL/h and volumes up to 612 mL (61 g) infused at a single site. This allowed for the total 4-week dose to be given as a single infusion at a single site. Based on the area under the curve (AUC), bioavailability was 92% of intravenous immunoglobulin compared to 63% when gammaglobulin is given without rHuPH20.

If approved, this new technology may allow pediatric patients to receive their immunoglobulin at home with for fewer side effects and at the same infusion rate and frequency as intravenous immunoglobulin, with the  potential of improving the quality of life for children on chronic immunoglobulin therapy. Baxter plans to study this combination in children with CIDP.

 

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