Recombinant Human PH20: Baseline Analysis of the Reactive Antibody Prevalence in the General Population Using Healthy Subjects

BioDrugs

Volumn 32, Issue 1, 2018, Pages 83-89

  Rosengren, Sanna ^a   Souratha, Jennifer ^a   Conway, Dave ^a   Muchmore, Douglas B ^a   Sugarman, Barry J ^a  

^a Halozyme Therapeutics Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT ANTIBODY; RECOMBINANT HUMAN PH20 REACTIVE ANTIBODY; UNCLASSIFIED DRUG; ANTIBODY; CELL ADHESION MOLECULE; HYALURONIDASE PH-20; HYALURONOGLUCOSAMINIDASE; RECOMBINANT PROTEIN;

ADOLESCENT; ADULT; AGE; ANTIBODY TITER; ARTICLE; ASTHMA; AUTOIMMUNE DISEASE; BLOOD SAMPLING; CELIAC DISEASE; CHILD; CYANOCOBALAMIN DEFICIENCY; FEMALE; FEMALE FERTILITY; HUMAN; IMMUNOASSAY; INFERTILITY; INFLAMMATORY BOWEL DISEASE; MALE; MALE FERTILITY; NORMAL HUMAN; PREGNANCY; PRIORITY JOURNAL; PSORIASIS; SEX DIFFERENCE; SYSTEMIC LUPUS ERYTHEMATOSUS; URTICARIA; AGED; BLOOD; FATHER; IMMUNOLOGY; MIDDLE AGED; PREVALENCE; SEX FACTOR; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGE FACTORS; AGED; AGED, 80 AND OVER; ANTIBODIES; CELL ADHESION MOLECULES; CHILD; FATHERS; FEMALE; HEALTHY VOLUNTEERS; HUMANS; HYALURONOGLUCOSAMINIDASE; MALE; MIDDLE AGED; PREVALENCE; RECOMBINANT PROTEINS; SEX FACTORS; YOUNG ADULT;

EID: 85041928281     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-018-0260-y     Document Type: Article

References (24)

1. ® (recombinant [hyaluronidase human injection]). Prescribing Information. Halozyme Therapeutics, Inc. 2017.
2. Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007;4(4):427–40.
3. Bookbinder LH, Hofer A, Haller MF, Zepeda ML, Keller GA, Lim JE, et al. A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006;114(2):230–41.
4. Thomas JR, Yocum RC, Haller MF, von Gunten CF. Assessing the role of human recombinant hyaluronidase in gravity-driven subcutaneous hydration: the INFUSE-LR study. J Palliat Med. 2007;10(6):1312–20.
5. Kang DW, Jadin L, Nekoroski T, Drake FH, Zepeda ML. Recombinant human hyaluronidase PH20 (rHuPH20) facilitates subcutaneous infusions of large volumes of immunoglobulin in a swine model. Drug Deliv Transl Res. 2012;2(4):254–64.
6. Dychter SS, Harrigan R, Bahn JD, Printz MA, Sugarman BJ, DeNoia E, et al. Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers. Clin Ther. 2014;36(2):211–24.
7. Chamley LW, Clarke GN. Antisperm antibodies and conception. Semin Immunopathol. 2007;29(2):169–84.
8. Mazumdar S, Levine AS. Antisperm antibodies: etiology, pathogenesis, diagnosis, and treatment. Fertil Steril. 1998;70(5):799–810.
9. Rosengren S, Dychter SS, Printz MA, Huang L, Schiff RI, Schwarz HP, et al. Clinical immunogenicity of rHuPH20, a hyaluronidase enabling subcutaneous drug administration. AAPS. 2015;17(5):1144–56.
10. Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal. 2008;48(5):1267–81.
11. Dychter SS, Ebel D, Mead TR, Yocum RC. Comparison of the tolerability of recombinant human hyaluronidase + normal saline and recombinant human hyaluronidase + lactated ringer’s solution administered subcutaneously: a phase IV, double-blind, randomized pilot study in healthy volunteers. Curr Ther Res Clin Exp. 2009;70(6):421–38.
12. Hompesch M, Muchmore DB, Morrow L, Vaughn DE. Accelerated insulin pharmacokinetics and improved postprandial glycemic control in patients with type 1 diabetes after coadministration of prandial insulins with hyaluronidase. Diabetes Care. 2011;34(3):666–8.
13. Morrow L, Muchmore DB, Hompesch M, Ludington EA, Vaughn DE. Comparative pharmacokinetics and insulin action for three rapid-acting insulin analogs injected subcutaneously with and without hyaluronidase. Diabetes Care. 2013;36(2):273–5.
14. Morrow L, Muchmore DB, Ludington EA, Vaughn DE, Hompesch M. Reduction in intrasubject variability in the pharmacokinetic response to insulin after subcutaneous co-administration with recombinant human hyaluronidase in healthy volunteers. Diabetes Technol Ther. 2011;13(10):1039–45.
15. Muchmore DB, Vaughn DE. Accelerating and improving the consistency of rapid-acting analog insulin absorption and action for both subcutaneous injection and continuous subcutaneous infusion using recombinant human hyaluronidase. J Diabetes Sci Technol. 2012;6(4):764–72.
16. Vaughn DE, Muchmore DB. Use of recombinant human hyaluronidase to accelerate rapid insulin analogue absorption: experience with subcutaneous injection and continuous infusion. Endocr Pract. 2011;17(6):914–21.
17. Wasserman RL. Progress in gammaglobulin therapy for immunodeficiency: from subcutaneous to intravenous infusions and back again. J Clin Immunol. 2012;32(6):1153–64.
18. Wasserman RL, Melamed I, Stein MR, Gupta S, Puck J, Engl W, et al. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol. 2012;130(4):951–7.e11.
19. ® [immune globulin infusion 10% (human) with recombinant human hyaluronidase] Solution SC. Westlake Village, CA: Baxalta US, Inc.
20. ® (trastuzumab) for injection or IV use. Prescribing Information. San Francisco, CA: Genentech, Inc.
21. ® (rituximab) SC. Prescribing Information. San Francisco, CA: Genentech, Inc.
22. ® (rituximab/hyaluronidase human SC injection). Prescribing Information. San Francisco, CA: Genentech, Inc.
23. Xue L, Fiscella M, Rajadhyaksha M, Goyal J, Holland C, Gorovits B, et al. Pre-existing biotherapeutic-reactive antibodies: survey results within the American Association of Pharmaceutical Scientists. AAPS. 2013;15(3):852–5.
24. Xue L, Rup B. Evaluation of pre-existing antibody presence as a risk factor for posttreatment anti-drug antibody induction: analysis of human clinical study data for multiple biotherapeutics. AAPS. 2013;15(3):893–6.