27. T. Shimizu, M. Ichihara, Y. Yoshioka, T. Ishida, S. Nakagawa, H. Kiwada, Intravenous
administration of polyethylene glycol-coated (PEGylated) proteins and PEGylated adenovirus
elicits an anti-PEG immunoglobulin M response. Biol. Pharm. Bull. 35(8), 1336–1342 (2012)
28. A.W. Richter, E. Akerblom, Polyethylene glycol reactive antibodies in man: titer distribution
in allergic patients treated with monomethoxy polyethylene glycol modified allergens or
placebo, and in healthy blood donors. Int. Arch. Allergy Appl. Immunol. 74(1), 36–39 (1984)
29. P. Caliceti, O. Schiavon, F.M. Veronese, Immunological properties of uricase conjugated to
neutral soluble polymers. Bioconjug. Chem. 12(4), 515–522 (2001)
30. P.E. Lipsky, L.H. Calabrese, A. Kavanaugh, J.S. Sundy, D. Wright, M. Wolfson et al.,
Pegloticase immunogenicity: the relationship between efficacy and antibody development in
patients treated for refractory chronic gout. Arthritis Res. Ther. 16(2), R60 (2014)
31. M.S. Hershfield, N.J. Ganson, S.J. Kelly, E.L. Scarlett, D.A. Jaggers, J.S. Sundy, Induced and
pre-existing anti-polyethylene glycol antibody in a trial of every 3-week dosing of pegloticase
for refractory gout, including in organ transplant recipients. Arthritis Res. Ther. 16(2), R63
(2014)
32. J.T. White, S.D. Newsome, B.C. Kieseier, R.A. Bermel, Y. Cui, A. Seddighzadeh et al.,
Incidence, characterization, and clinical impact analysis of peginterferon beta1a immunogenicity in patients with multiple sclerosis in the ADVANCE trial. Ther. Adv. Neurol. Disord.
9(4), 239–249 (2016)
33. A. Tocoian, P. Buchan, H. Kirby, J. Soranson, M. Zamacona, R. Walley et al., First-in-human
trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L
antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus
erythematosus. Lupus 24(10), 1045–1056 (2015)
34. S.K. Nune, P. Gunda, P.K. Thallapally, Y.Y. Lin, M.L. Forrest, C.J. Berkland, Nanoparticles
for biomedical imaging. Expert Opin. Drug Deliv. 6(11), 1175–1194 (2009)
35. A. Makino, S. Kimura, Solid tumor-targeting theranostic polymer nanoparticle in nuclear
medicinal fields. Sci. World J. 2014, 424513 (2014)
36. L. Yildirimer, N.T. Thanh, M. Loizidou, A.M. Seifalian, Toxicology and clinical potential of
nanoparticles. Nano Today 6(6), 585–607 (2011)
37. Y. Barenholz, Doxil(R)–the first FDA-approved nano-drug: lessons learned. J. Control
Release 160(2), 117–134 (2012)
38. T.M. Allen, P.R. Cullis, Liposomal drug delivery systems: from concept to clinical
applications. Adv. Drug Deliv. Rev. 65(1), 36–48 (2013)
39. J. Szebeni, Complement activation-related pseudoallergy: a stress reaction in blood triggered
by nanomedicines and biologicals. Mol. Immunol. 61(2), 163–173 (2014)
40. T. Ishida, M. Harada, X.Y. Wang, M. Ichihara, K. Irimura, H. Kiwada, Accelerated blood
clearance of PEGylated liposomes following preceding liposome injection: effects of lipid
dose and PEG surface-density and chain length of the first-dose liposomes. J. Control Release
105(3), 305–317 (2005)
41. S.M. Moghimi, T. Gray, A single dose of intravenously injected poloxamine-coated
long-circulating particles triggers macrophage clearance of subsequent doses in rats. Clin. Sci.
(Lond.) 93(4), 371–379 (1997)
42. T. Ishida, X. Wang, T. Shimizu, K. Nawata, H. Kiwada, PEGylated liposomes elicit an
anti-PEG IgM response in a T cell-independent manner. J. Control Release 122(3), 349–355
(2007)
43. M. Ichihara, T. Shimizu, A. Imoto, Y. Hashiguchi, Y. Uehara Y, T. Ishida et al., Anti-PEG
IgM Response against PEGylated liposomes in mice and rats. Pharmaceutics 3(1), 1–11
(2010)
44. T. Ishida, K. Masuda, T. Ichikawa, M. Ichihara, K. Irimura, H. Kiwada, Accelerated clearance
of a second injection of PEGylated liposomes in mice. Int. J. Pharm. 255(1–2), 167–174
(2003)
45. T. Ishida, R. Maeda, M. Ichihara, K. Irimura, H. Kiwada, Accelerated clearance of PEGylated
liposomes in rats after repeated injections. J. Control Release 88(1), 35–42 (2003)
20 Immune Response to PEGylated Nanomedicines …
385
administration of polyethylene glycol-coated (PEGylated) proteins and PEGylated adenovirus
elicits an anti-PEG immunoglobulin M response. Biol. Pharm. Bull. 35(8), 1336–1342 (2012)
28. A.W. Richter, E. Akerblom, Polyethylene glycol reactive antibodies in man: titer distribution
in allergic patients treated with monomethoxy polyethylene glycol modified allergens or
placebo, and in healthy blood donors. Int. Arch. Allergy Appl. Immunol. 74(1), 36–39 (1984)
29. P. Caliceti, O. Schiavon, F.M. Veronese, Immunological properties of uricase conjugated to
neutral soluble polymers. Bioconjug. Chem. 12(4), 515–522 (2001)
30. P.E. Lipsky, L.H. Calabrese, A. Kavanaugh, J.S. Sundy, D. Wright, M. Wolfson et al.,
Pegloticase immunogenicity: the relationship between efficacy and antibody development in
patients treated for refractory chronic gout. Arthritis Res. Ther. 16(2), R60 (2014)
31. M.S. Hershfield, N.J. Ganson, S.J. Kelly, E.L. Scarlett, D.A. Jaggers, J.S. Sundy, Induced and
pre-existing anti-polyethylene glycol antibody in a trial of every 3-week dosing of pegloticase
for refractory gout, including in organ transplant recipients. Arthritis Res. Ther. 16(2), R63
(2014)
32. J.T. White, S.D. Newsome, B.C. Kieseier, R.A. Bermel, Y. Cui, A. Seddighzadeh et al.,
Incidence, characterization, and clinical impact analysis of peginterferon beta1a immunogenicity in patients with multiple sclerosis in the ADVANCE trial. Ther. Adv. Neurol. Disord.
9(4), 239–249 (2016)
33. A. Tocoian, P. Buchan, H. Kirby, J. Soranson, M. Zamacona, R. Walley et al., First-in-human
trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L
antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus
erythematosus. Lupus 24(10), 1045–1056 (2015)
34. S.K. Nune, P. Gunda, P.K. Thallapally, Y.Y. Lin, M.L. Forrest, C.J. Berkland, Nanoparticles
for biomedical imaging. Expert Opin. Drug Deliv. 6(11), 1175–1194 (2009)
35. A. Makino, S. Kimura, Solid tumor-targeting theranostic polymer nanoparticle in nuclear
medicinal fields. Sci. World J. 2014, 424513 (2014)
36. L. Yildirimer, N.T. Thanh, M. Loizidou, A.M. Seifalian, Toxicology and clinical potential of
nanoparticles. Nano Today 6(6), 585–607 (2011)
37. Y. Barenholz, Doxil(R)–the first FDA-approved nano-drug: lessons learned. J. Control
Release 160(2), 117–134 (2012)
38. T.M. Allen, P.R. Cullis, Liposomal drug delivery systems: from concept to clinical
applications. Adv. Drug Deliv. Rev. 65(1), 36–48 (2013)
39. J. Szebeni, Complement activation-related pseudoallergy: a stress reaction in blood triggered
by nanomedicines and biologicals. Mol. Immunol. 61(2), 163–173 (2014)
40. T. Ishida, M. Harada, X.Y. Wang, M. Ichihara, K. Irimura, H. Kiwada, Accelerated blood
clearance of PEGylated liposomes following preceding liposome injection: effects of lipid
dose and PEG surface-density and chain length of the first-dose liposomes. J. Control Release
105(3), 305–317 (2005)
41. S.M. Moghimi, T. Gray, A single dose of intravenously injected poloxamine-coated
long-circulating particles triggers macrophage clearance of subsequent doses in rats. Clin. Sci.
(Lond.) 93(4), 371–379 (1997)
42. T. Ishida, X. Wang, T. Shimizu, K. Nawata, H. Kiwada, PEGylated liposomes elicit an
anti-PEG IgM response in a T cell-independent manner. J. Control Release 122(3), 349–355
(2007)
43. M. Ichihara, T. Shimizu, A. Imoto, Y. Hashiguchi, Y. Uehara Y, T. Ishida et al., Anti-PEG
IgM Response against PEGylated liposomes in mice and rats. Pharmaceutics 3(1), 1–11
(2010)
44. T. Ishida, K. Masuda, T. Ichikawa, M. Ichihara, K. Irimura, H. Kiwada, Accelerated clearance
of a second injection of PEGylated liposomes in mice. Int. J. Pharm. 255(1–2), 167–174
(2003)
45. T. Ishida, R. Maeda, M. Ichihara, K. Irimura, H. Kiwada, Accelerated clearance of PEGylated
liposomes in rats after repeated injections. J. Control Release 88(1), 35–42 (2003)
20 Immune Response to PEGylated Nanomedicines …
385