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Massimo Mangiola, Marilyn Marrari, Christopher Ensor, Martin O Spycher, Mel Berger, Adriana Zeevi
BACKGROUND: Human immunoglobulins (H-Ig) are widely used in solid organ transplantation for IgG replacement and for desensitization and treatment of antibody mediated rejection. They are obtained from plasma pools and may contain HLA antibodies that can be detrimental to transplant recipients. The goal of this study was to evaluate HLA antibodies in multiple lots of 2 commercial H-Ig preparations by. Luminex single antigen bead (SAB) and cell-based crossmatch assays. METHODS: Thirty lots of 2 commercial H-Ig products (CSL Behring, King of Prussia, PA...
June 6, 2018: Transplantation
Melvin Berger, Thomas Harbo, David R Cornblath, Orell Mielke
Subcutaneous IgG (SCIG) administration may be preferred over the intravenous route (IVIG) in chronic inflammatory demyelinating polyneuropathy (CIDP) because it minimizes 'end of cycle' treatment-related fluctuations, reduces systemic adverse effects, improves convenience/quality of life and potentially lowers overall costs. Early reports of the use of highly concentrated SCIG preparations suggested they were effective and well-tolerated in chronic inflammatory demyelinating polyneuropathy. This was confirmed in the Polyneuropathy and Treatment with Hizentra® study of 172 subjects randomized to receive maintenance therapy with placebo or one of two doses of IgPro20 (20% IgG stabilized with L-Proline) for 6 months...
May 16, 2018: Immunotherapy
Gayathri Sridhar, Bola F Ekezue, Hector S Izurieta, Richard A Forshee, Nandini Selvam, Paul D Mintz, Steven A Anderson, Mikhail D Menis
BACKGROUND: Hemolytic reactions (HRs) are rare serious adverse events after immune globulin (IG) use. Our large claims-based study evaluated occurrence of same-day hemolysis after administration of different IG products and potential risk factors, during the 2008 to 2014 study period. STUDY DESIGN AND METHODS: We conducted a retrospective cohort study using a large commercial administrative database. The study included individuals exposed to IG products as identified by procedure codes...
January 2018: Transfusion
Bola F Ekezue, Gayathri Sridhar, Richard A Forshee, Hector S Izurieta, Nandini Selvam, Paul D Mintz, Steven A Anderson, Mikhail D Menis
BACKGROUND: Acute renal failure (ARF) is a rare serious adverse event after immune globulin (IG) use. Our large claims-based study evaluated occurrence of same-day ARF after administration of different IGs and ascertained potential risk factors, during the 2008 to 2014 study period. STUDY DESIGN AND METHODS: A retrospective cohort study was conducted using a large commercial administrative database. The cohort included individuals exposed to IG products as identified by procedure codes...
December 2017: Transfusion
I N van Schaik, V Bril, N van Geloven, H P Hartung, R A Lewis, G Sobue, J P Lawo, O Mielke, B L Durn, D R Cornblath, I S J Merkies, M M Dimachkie
INTRODUCTION: Patients with chronic inflammatory demyelinating polyneuropathy (CIDP) often require long-term intravenous immunoglobulin (IVIG) maintenance therapy. Subcutaneous immunoglobulin (SCIG) offers an alternative administration option with anticipated improvements in patient quality of life, convenience, and flexibility. OBJECTIVES: To evaluate IgPro20 (SCIG) as a maintenance treatment in CIDP. METHODS: A randomized, double-blind trial in CIDP patients (n=172) investigated 0...
August 22, 2017: Muscle & Nerve
Girishanthy Krishnarajah, Jee-Yeon K Lehmann, Brian Ellman, Rachel H Bhak, Maral DerSarkissian, Deane Leader, Ann L Bullinger, Mei Sheng Duh
BACKGROUND: Current prescribing information recommends that physicians apply a dose ratio of 1.37:1 (1.53:1 prior to January 2015) in the United States (US) when switching patients with primary immunodeficiency disease (PI) from intravenous (IVIG) therapy to most subcutaneous therapy ([SCIG], except the 10% SCIG human hyaluronidase and immune globulin). However, a dose ratio of 1:1 was studied and approved for the European Union (EU). The dose-adjustment ratio used by prescribers in real-world US clinical practice is unknown...
October 2016: American Journal of Managed Care
Mats Clarsund, Ulf Blom, Ann Gardulf
BACKGROUND: Primary immunodeficiencies include a variety of disorders that render patients more susceptible to infections. If left untreated, these infections may be fatal. Patients with primary antibody deficiencies are therefore given prophylactic immunoglobulin G replacement therapy. ColdZyme® Mouth Spray is a medical device intended to reduce the probability of catching a cold and/or can help shorten the duration of a cold, if used at an early stage of the infection, by forming a thin protective barrier on the pharyngeal mucous membrane...
October 31, 2016: Journal of Medical Case Reports
Megan K Young, Joseph Bertolini, Pushpa Kotharu, Darryl Maher, Allan W Cripps
The effectiveness of passive immunisation post-exposure to measles appears subject to a dose-response effect. New Zealand and the United Kingdom have increased the recommended dose of polyclonal human immunoglobulin for post-exposure prophylaxis within the last decade in response to concerns about decreasing levels of measles antibodies in these products. This study used the plaque-reduction neutralization test (PRNT) to measure the titer of measles-specific antibodies in Australian immunoglobulin products for post-exposure prophylaxis and compared the utility of an enzyme-linked immunosorbent assay (ELISA) to the PRNT in available Australian and international samples: Australian intramuscular (n = 10), Australian intravenous (n = 28), New Zealand intramuscular (n = 2), Hizentra (subcutaneous)(USA) (n = 3), and Privigen (intravenous)(USA) (n = 2)...
March 4, 2017: Human Vaccines & Immunotherapeutics
J F Viallard, P Agape, V Barlogis, G Cozon, C Faure, F Fouyssac, C Gaud, M P Gourin, M Hamidou, C Hoarau, F Husseini, M Ojeda-Uribe, M Pavic, I Pellier, A Perlat, N Schleinitz, B Slama
BACKGROUND: Although Hizentra is indicated for immunoglobulin replacement therapy in patients with primary and secondary immunodeficiencies, phase III trials have focused on patients with primary immunodeficiencies. In this 9-month, real-life, prospective, non-interventional, longitudinal, multicenter study of patients with primary and secondary immunodeficiencies in France, treatment modalities (primary endpoint), efficacy, safety, tolerability, quality of life, and treatment satisfaction were evaluated using descriptive statistics...
September 29, 2016: BMC Immunology
Ivo N van Schaik, Nan van Geloven, Vera Bril, Hans-Peter Hartung, Richard A Lewis, Gen Sobue, John-Philip Lawo, Orell Mielke, David R Cornblath, Ingemar S J Merkies
BACKGROUND: Subcutaneous administration of Ig (SCIg) has gained popularity as an alternative route of administration but has never been rigorously examined in chronic inflammatory demyelinating polyneuropathy (CIDP). METHODS/DESIGN: The primary objective of the PATH study (Polyneuropathy and Treatment with Hizentra) is to determine the efficacy of two different doses of SCIg IgPro20 (0.2 g/kg bw or 0.4 g/kg bw) in a 24-week maintenance treatment of CIDP in comparison to placebo...
July 25, 2016: Trials
Niraj C Patel, Joel L Gallagher, Hans D Ochs, Thomas Prescott Atkinson, Justin Wahlstrom, Morna Dorsey, Francisco A Bonilla, Jennifer Heimall, Lisa Kobrynski, David Morris, Elie Haddad
BACKGROUND: Hizentra® (IGSC 20%) is a 20% liquid IgG product approved for subcutaneous administration in adults and children 2 years of age and older who have primary immunodeficiency disease (PIDD). There is limited information about the use of IGSC 20 % in very young children including those less than 5 years of age. METHODS: A retrospective chart review involved 88 PIDD infants and children less than 5 years of age who received Hizentra®. RESULTS: The mean age at the start of Hizentra® was 34 months (range 2 to 59 months)...
August 2015: Journal of Clinical Immunology
Andrew C Issekutz, Derek Rowter, Sylvia Miescher, Fabian Käsermann
IVIG modulates T cell activation in vitro and inflammatory-autoimmune conditions in vivo. Sialylation of IgG, Fc receptor interactions, modulation of monocyte/macrophage/B cell functions have been implicated in IVIG effects. Subcutaneous IgG (SCIG) therapy is increasingly used for IgG replacement but whether these preparations share the effects of IVIG on T cell modulation is not documented. We compared the potency of SCIG-Hizentra™ (20% IgG preparation) with IVIG-Privigen® (10% IgG) for T cell inhibition, and assessed the involvement of IgG sialylation, monocytes and B cells in this process...
October 2015: Clinical Immunology: the Official Journal of the Clinical Immunology Society
H B Niebur, C M Duff, G F Shear, D Nguyen, T K Alberdi, M J Dorsey, J W Sleasman
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...
September 2015: Clinical and Experimental Immunology
Alan P Koterba, Mark R Stein
BACKGROUND: Patients with immunodeficiency diseases require lifelong treatment with immunoglobulin (Ig), yet few studies have vetted dosing strategies and effectiveness of Ig in older patient populations. Patients requiring subcutaneous (SC) Ig (SCIG) typically start with intravenous dosing before transitioning to SCIG weekly maintenance. In this retrospective review, we investigated an alternate strategy with higher initial SC doses among an older patient population with antibody deficiency syndromes...
2015: Allergy, Asthma, and Clinical Immunology
Ataru Igarashi, Hirokazu Kanegane, Midori Kobayashi, Toshio Miyawaki, Kiichiro Tsutani
PURPOSE: IgPro20, Hizentra(®) an L-proline-stabilized 20% human subcutaneous immunoglobulin (SCIG), has been shown in a Phase III pivotal study to be well tolerated and efficacious in adult and pediatric Japanese patients with primary immunodeficiency. Economic aspects of SCIG treatment in comparison with previous intravenous immunoglobulin (IVIG) therapy were analyzed in this Phase III study in Japan. METHODS: Twenty-four Japanese patients with primary immunodeficiency on IVIG treatment were switched to IgPro20 at an equivalent dose (full analysis set)...
November 1, 2014: Clinical Therapeutics
Richard L Wasserman
Immunoglobulin (IgG) replacement therapy has been the cornerstone of treatment for primary immunodeficiency disease for nearly 60 years. During this time, research has continually refined the target IgG trough level and IgG replacement dosages to allow patients with primary immunodeficiency disease to achieve effective protection from infection. Manufacturers have also improved IgG formulations to allow patients to receive clinically beneficial dosages of IgG replacement with improved safety and tolerability...
October 2014: Expert Review of Clinical Immunology
Hirokazu Kanegane, Kohsuke Imai, Masafumi Yamada, Hidetoshi Takada, Tadashi Ariga, Martin Bexon, Mikhail Rojavin, Wilson Hu, Midori Kobayashi, John-Philip Lawo, Shigeaki Nonoyama, Toshiro Hara, Toshio Miyawaki
PURPOSE: Intravenous (IVIG) and subcutaneous (SCIG) immunoglobulin infusions are widely used for the treatment of patients with primary immunodeficiency (PID) worldwide. This prospective, multicenter, open-label, single-arm Phase III study evaluated the efficacy, tolerability, and safety of IgPro20 (Hizentra®; L-proline-stabilized 20 % human SCIG) in adult and pediatric Japanese patients with PID. METHODS: Patients received three IVIG infusions at 3-4-week intervals followed by a dose-equivalent switch to weekly SCIG infusions...
February 2014: Journal of Clinical Immunology
Stephen Jolles, Michael Borte, Robert P Nelson, Mikhail Rojavin, Martin Bexon, John-Philip Lawo, Richard L Wasserman
Hizentra(®) (20% subcutaneous immunoglobulin [SCIG]) was administered to subjects with primary immunodeficiency disease in two extension studies in the EU and US to assess long-term efficacy and tolerability. Subjects (aged 4-69 years) were treated for 148 weeks in the EU (N = 40; 5405 infusions) and 87 weeks in the US (N = 21; 1735 infusions). Weekly doses were 116.0 mg/kg (EU) and 193.2 mg/kg (US); IgG levels were 7.97 g/L (EU) and 11.98 g/L (US). Annualized rates of serious bacterial infections were 0.05 infections/subject/year (EU) and 0...
February 2014: Clinical Immunology: the Official Journal of the Clinical Immunology Society
Maria Giovanna Danieli, Romina Moretti, Simona Gambini, Luca Paolini, Armando Gabrielli
UNLABELLED: The objective of this study is to describe the benefit of 20 % subcutaneous infusions of immunoglobulin (SCIg) in patients with dermatomyositis (DM) or polymyositis (PM) after a switch from previous 16 % SCIg treatment. Eight patients with DM or PM, who met the Bohan and Peter's criteria, previously treated with 16 % SCIg, were switched to weekly 20 % SCIg infusions (Hizentra®; CSL Behring) at doses equivalent to their previous subcutaneous treatment. A standardised protocol was used to evaluate patients, disease activity and treatment response...
April 2014: Clinical Rheumatology
Carla Duff, Patty Riley, Annette Zampelli, Elyse Murphy
Increased use of specialized infusion therapies has necessitated training of health care providers and patients. The Starting Hizentra Administration with Resources and Education (SHARE) program provided 709 US participants with information to educate patients with primary immunodeficiency disease (PIDD) on self-administration of 20% subcutaneous immunoglobulin (SCIG). Postprogram surveys assessed participants' experience and opinion of 20% SCIG. The most frequent questions about 20% SCIG regarded subcutaneous challenges (29%)...
January 2014: Journal of Infusion Nursing: the Official Publication of the Infusion Nurses Society
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