Efficacy and tolerability of 16% subcutaneous immunoglobulin compared with 20% subcutaneous immunoglobulin in primary antibody deficiency

Summary Multiple subcutaneous immunoglobulin (SCIG) products are available to treat primary antibody deficiency (PAD). The efficacy and tolerability of 16% SCIG (Vivaglobin®) was compared with 20% SCIG (Hizentra®) in PAD subjects. The study was a prospective, single‐centre, open‐label study of PAD s...

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Veröffentlicht in:Clinical and experimental immunology 2015-09, Vol.181 (3), p.441-450
Hauptverfasser: Niebur, H. B., Duff, C. M., Shear, G. F., Nguyen, D., Alberdi, T. K., Dorsey, M. J., Sleasman, J. W.
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container_issue 3
container_start_page 441
container_title Clinical and experimental immunology
container_volume 181
creator Niebur, H. B.
Duff, C. M.
Shear, G. F.
Nguyen, D.
Alberdi, T. K.
Dorsey, M. J.
Sleasman, J. W.
description Summary Multiple subcutaneous immunoglobulin (SCIG) products are available to treat primary antibody deficiency (PAD). The efficacy and tolerability of 16% SCIG (Vivaglobin®) was compared with 20% SCIG (Hizentra®) in PAD subjects. The study was a prospective, single‐centre, open‐label study of PAD subjects transitioning Vivaglobin to equivalent Hizentra doses, rounded to the nearest vial size. Comparisons included immunoglobulin (Ig)G levels; tetanus, varicella and Streptococcus pneumoniae titres; adverse events (AEs), annual infection rate and quality of life during 8 weeks of Vivaglobin and 24 weeks of Hizentra. Thirty‐two subjects (aged 2–75 years) participated. Rounding to the nearest Hizentra vial size resulted in a 12·8% (± 2·9%) increase in SCIG dose. Median immunoglobulin (Ig)G level following 8 weeks of Vivaglobin was similar to 24 weeks of Hizentra (1050 versus 1035 mg/dl, respectively; P = 0·77). Both products had similar protective titres to tetanus, varicella and serotypes of S. pneumoniae, which were variable but well above protective levels. After 12 weeks of Hizentra, subjects reported fewer local site reactions compared with Vivaglobin. Switching products resulted in increased systemic AEs in some subjects but, overall, not significantly higher than during Vivaglobin treatment. Average infusion time decreased from 104·7 min (3·3 sites) with Vivaglobin to 70·7 min (2·2 sites) with Hizentra (P = 0·0005). Acute serious bacterial infections were similar. Treatment satisfaction was superior with Hizentra. Hizentra and Vivaglobin have similar pharmacokinetics and efficacy. Although transition to a different SCIG product initially increased AEs, Hizentra is well tolerated and can be infused more rapidly and with fewer sites compared to Vivaglobin.
doi_str_mv 10.1111/cei.12623
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B. ; Duff, C. M. ; Shear, G. F. ; Nguyen, D. ; Alberdi, T. K. ; Dorsey, M. J. ; Sleasman, J. W.</creator><creatorcontrib>Niebur, H. B. ; Duff, C. M. ; Shear, G. F. ; Nguyen, D. ; Alberdi, T. K. ; Dorsey, M. J. ; Sleasman, J. W.</creatorcontrib><description>Summary Multiple subcutaneous immunoglobulin (SCIG) products are available to treat primary antibody deficiency (PAD). The efficacy and tolerability of 16% SCIG (Vivaglobin®) was compared with 20% SCIG (Hizentra®) in PAD subjects. The study was a prospective, single‐centre, open‐label study of PAD subjects transitioning Vivaglobin to equivalent Hizentra doses, rounded to the nearest vial size. Comparisons included immunoglobulin (Ig)G levels; tetanus, varicella and Streptococcus pneumoniae titres; adverse events (AEs), annual infection rate and quality of life during 8 weeks of Vivaglobin and 24 weeks of Hizentra. Thirty‐two subjects (aged 2–75 years) participated. Rounding to the nearest Hizentra vial size resulted in a 12·8% (± 2·9%) increase in SCIG dose. Median immunoglobulin (Ig)G level following 8 weeks of Vivaglobin was similar to 24 weeks of Hizentra (1050 versus 1035 mg/dl, respectively; P = 0·77). Both products had similar protective titres to tetanus, varicella and serotypes of S. pneumoniae, which were variable but well above protective levels. After 12 weeks of Hizentra, subjects reported fewer local site reactions compared with Vivaglobin. Switching products resulted in increased systemic AEs in some subjects but, overall, not significantly higher than during Vivaglobin treatment. Average infusion time decreased from 104·7 min (3·3 sites) with Vivaglobin to 70·7 min (2·2 sites) with Hizentra (P = 0·0005). Acute serious bacterial infections were similar. Treatment satisfaction was superior with Hizentra. Hizentra and Vivaglobin have similar pharmacokinetics and efficacy. 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B.</creatorcontrib><creatorcontrib>Duff, C. M.</creatorcontrib><creatorcontrib>Shear, G. F.</creatorcontrib><creatorcontrib>Nguyen, D.</creatorcontrib><creatorcontrib>Alberdi, T. K.</creatorcontrib><creatorcontrib>Dorsey, M. J.</creatorcontrib><creatorcontrib>Sleasman, J. W.</creatorcontrib><title>Efficacy and tolerability of 16% subcutaneous immunoglobulin compared with 20% subcutaneous immunoglobulin in primary antibody deficiency</title><title>Clinical and experimental immunology</title><addtitle>Clin Exp Immunol</addtitle><description>Summary Multiple subcutaneous immunoglobulin (SCIG) products are available to treat primary antibody deficiency (PAD). The efficacy and tolerability of 16% SCIG (Vivaglobin®) was compared with 20% SCIG (Hizentra®) in PAD subjects. The study was a prospective, single‐centre, open‐label study of PAD subjects transitioning Vivaglobin to equivalent Hizentra doses, rounded to the nearest vial size. Comparisons included immunoglobulin (Ig)G levels; tetanus, varicella and Streptococcus pneumoniae titres; adverse events (AEs), annual infection rate and quality of life during 8 weeks of Vivaglobin and 24 weeks of Hizentra. Thirty‐two subjects (aged 2–75 years) participated. Rounding to the nearest Hizentra vial size resulted in a 12·8% (± 2·9%) increase in SCIG dose. Median immunoglobulin (Ig)G level following 8 weeks of Vivaglobin was similar to 24 weeks of Hizentra (1050 versus 1035 mg/dl, respectively; P = 0·77). Both products had similar protective titres to tetanus, varicella and serotypes of S. pneumoniae, which were variable but well above protective levels. After 12 weeks of Hizentra, subjects reported fewer local site reactions compared with Vivaglobin. Switching products resulted in increased systemic AEs in some subjects but, overall, not significantly higher than during Vivaglobin treatment. Average infusion time decreased from 104·7 min (3·3 sites) with Vivaglobin to 70·7 min (2·2 sites) with Hizentra (P = 0·0005). Acute serious bacterial infections were similar. Treatment satisfaction was superior with Hizentra. Hizentra and Vivaglobin have similar pharmacokinetics and efficacy. 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B.</creatorcontrib><creatorcontrib>Duff, C. M.</creatorcontrib><creatorcontrib>Shear, G. F.</creatorcontrib><creatorcontrib>Nguyen, D.</creatorcontrib><creatorcontrib>Alberdi, T. K.</creatorcontrib><creatorcontrib>Dorsey, M. J.</creatorcontrib><creatorcontrib>Sleasman, J. W.</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical and experimental immunology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Niebur, H. B.</au><au>Duff, C. M.</au><au>Shear, G. F.</au><au>Nguyen, D.</au><au>Alberdi, T. K.</au><au>Dorsey, M. J.</au><au>Sleasman, J. W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and tolerability of 16% subcutaneous immunoglobulin compared with 20% subcutaneous immunoglobulin in primary antibody deficiency</atitle><jtitle>Clinical and experimental immunology</jtitle><addtitle>Clin Exp Immunol</addtitle><date>2015-09</date><risdate>2015</risdate><volume>181</volume><issue>3</issue><spage>441</spage><epage>450</epage><pages>441-450</pages><issn>0009-9104</issn><eissn>1365-2249</eissn><abstract>Summary Multiple subcutaneous immunoglobulin (SCIG) products are available to treat primary antibody deficiency (PAD). The efficacy and tolerability of 16% SCIG (Vivaglobin®) was compared with 20% SCIG (Hizentra®) in PAD subjects. The study was a prospective, single‐centre, open‐label study of PAD subjects transitioning Vivaglobin to equivalent Hizentra doses, rounded to the nearest vial size. Comparisons included immunoglobulin (Ig)G levels; tetanus, varicella and Streptococcus pneumoniae titres; adverse events (AEs), annual infection rate and quality of life during 8 weeks of Vivaglobin and 24 weeks of Hizentra. Thirty‐two subjects (aged 2–75 years) participated. Rounding to the nearest Hizentra vial size resulted in a 12·8% (± 2·9%) increase in SCIG dose. Median immunoglobulin (Ig)G level following 8 weeks of Vivaglobin was similar to 24 weeks of Hizentra (1050 versus 1035 mg/dl, respectively; P = 0·77). Both products had similar protective titres to tetanus, varicella and serotypes of S. pneumoniae, which were variable but well above protective levels. After 12 weeks of Hizentra, subjects reported fewer local site reactions compared with Vivaglobin. Switching products resulted in increased systemic AEs in some subjects but, overall, not significantly higher than during Vivaglobin treatment. Average infusion time decreased from 104·7 min (3·3 sites) with Vivaglobin to 70·7 min (2·2 sites) with Hizentra (P = 0·0005). Acute serious bacterial infections were similar. Treatment satisfaction was superior with Hizentra. Hizentra and Vivaglobin have similar pharmacokinetics and efficacy. Although transition to a different SCIG product initially increased AEs, Hizentra is well tolerated and can be infused more rapidly and with fewer sites compared to Vivaglobin.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>25761372</pmid><doi>10.1111/cei.12623</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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source MEDLINE; Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals; PubMed Central; Alma/SFX Local Collection
subjects Adolescent
Adult
Aged
antibody deficiency
Bacterial Infections - immunology
Bacterial Infections - prevention & control
Child
Child, Preschool
Dose-Response Relationship, Drug
Edema - chemically induced
Female
Fever - chemically induced
Headache - chemically induced
Hizentra
Humans
IgG
immunodeficiency
Immunoglobulin G - administration & dosage
Immunoglobulin G - adverse effects
Immunoglobulin G - immunology
Immunoglobulin G - metabolism
Immunoglobulin G - therapeutic use
Immunoglobulins - administration & dosage
Immunoglobulins - adverse effects
Immunoglobulins - therapeutic use
Immunologic Deficiency Syndromes - drug therapy
Immunologic Deficiency Syndromes - immunology
Infusions, Subcutaneous
IVIG
Male
Middle Aged
pneumococcal titres
Prospective Studies
Quality of Life
Streptococcus pneumoniae
subcutaneous immunoglobulin
Surveys and Questionnaires
Translational
Treatment Outcome
varicella
Vivaglobin
Young Adult
title Efficacy and tolerability of 16% subcutaneous immunoglobulin compared with 20% subcutaneous immunoglobulin in primary antibody deficiency
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