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Stefan Wietek
AIM: To present data from three studies of a Post-Authorization Safety Surveillance (PASS) program for the subset of patients receiving octagam® 5% or 10% for chronic inflammatory demyelinating polyneuropathy (CIDP). METHODS: Data on patients with CIDP treated with octagam were analyzed to assess its safety and tolerability. RESULTS: Of 2314 patients included in the studies, 58 patients (mean age: 64.6 years) received octagam for CIDP, mean dose of which was 0...
March 8, 2018: Neurodegenerative Disease Management
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
Stefan Wietek, Daniel Svorc, Anette Debes, Tor-Einar Svae
OBJECTIVES: To provide detailed data on the tolerability and safety of octagam(®) 10%, a ready-to-use intravenous immunoglobulin, in a subgroup of patients with immune thrombocytopenia (ITP) involved in an integrated analysis of post-authorisation safety surveillance (PASS) studies. METHODS: A subgroup analysis was conducted using data collected from two non-interventional studies that included patients with ITP treated with octagam(®) 10%. Patients were observed and monitored for possible adverse drug reactions (ADRs) during or after administration of octagam(®) 10%, with a particular focus on thromboembolic events (TEEs)...
October 11, 2017: Hematology (Amsterdam, Netherlands)
Nathaniel Washburn, Robin Meccariello, Shaohui Hu, Maurice Hains, Naveen Bhatnagar, Hetal Sarvaiya, Bulbul Kapoor, John Schaeck, Ignacio Pino, Anthony Manning, Jonathan C Lansing, Carlos J Bosques
Intravenous immunoglobulin (IVIg) is a complex mixture drug comprising diverse immunoglobulins and non-IgG proteins purified from the plasma of thousands of healthy donors. Approved IVIg products on the market differ regarding source of plasma, isolation process, and formulation. These products are used widely, and often interchangeably, for the treatment of immunodeficiency and autoimmune and inflammatory diseases, but their mechanisms of action in different indications are not well understood. A primary limitation to understanding the therapeutic relevance of specific components within IVIg has been the limited resolution of analytics historically implemented to characterize its complex mixture...
2017: PloS One
Matthias Stefan Schampera, Katrin Schweinzer, Harald Abele, Karl Oliver Kagan, Reinhild Klein, Ingo Rettig, Gerhard Jahn, Klaus Hamprecht
BACKGROUND: Based on a non-randomized study of Nigro et al. (2005) the intravenous administration of hyperimmunoglobulins (HIGs) is applied frequently to women with primary CMV-infection as "off-label use" in Germany. OBJECTIVES: In order to describe their CMV-specific neutralization-capacity in vitro, we analyzed the HIG preparations Cytotect® , and Cytogam® as well as the standard intravenous immunoglobulins (IVIG) Octagam® , Gamunex® , Kiovig® ...
May 2017: Journal of Clinical Virology: the Official Publication of the Pan American Society for Clinical Virology
Shengliang Ye, Renyong Zeng, Peng Jiang, Mingxia Hou, Fengjuan Liu, Zongkui Wang, Xi Du, Jing Yuan, Yunhua Chen, Haijun Cao, Li Ma, Changqing Li
Intravenous immunoglobulin (IVIg) preparations are being investigated as a potential agent for treatment or prevention of Alzheimer's disease (AD). Antibodies towards soluble β-amyloid (Aβ) contained in IVIg were considered to be the major component contributing to the beneficial effect of the preparations in pilot studies. This study compared the antibody concentrations against Aβ in Octagam(®) IVIg (Octapharma) and 9 IVIg preparations from different Chinese manufacturers by ELISA, using Aβ40 monomer, Aβ40 soluble oligomers, Aβ42 monomer and Aβ42 soluble oligomers as the antigens...
May 10, 2017: Journal of Pharmaceutical and Biomedical Analysis
Denis Kühnel, Sebastian Müller, Alexander Pichotta, Kai Uwe Radomski, Andreas Volk, Torben Schmidt
BACKGROUND: In 2016 the World Health Organization declared the mosquito-borne Zika virus (ZIKV) a "public health emergency of international concern." ZIKV is a blood-borne pathogen, which therefore causes concerns regarding the safety of human plasma-derived products due to potential contamination of the blood supply. This study investigated the effectiveness of viral inactivation steps used during the routine manufacturing of various plasma-derived products to reduce ZIKV infectivity...
March 2017: Transfusion
Wolfgang Frenzel, Stefan Wietek, Tor-Einar Svae, Anette Debes, Daniel Svorc
OBJECTIVE: To evaluate the tolerability and safety of Octagam<sup>®</sup> 5% and 10% across all indications, ages, and treatment regimens, using data from four non-interventional post-authorization safety studies (PASS); this analysis was performed following changes in the preparation of raw material used to manufacture Octagam. METHODS: All four studies included in- and out-patients prescribed Octagam for treatment of their medical condition. Physicians used case report forms to document baseline demographics, Octagam treatment details, and data on the efficacy of Octagam, and recorded all adverse drug reactions (ADRs) and other safety data...
November 2016: International Journal of Clinical Pharmacology and Therapeutics
Stephen D Betschel, Richard J Warrington, Robert Schellenberg
In Canada, intravenous immune globulin (IVIg) products are licensed for six disease indications, however it has been demonstrated that patients with a number of other conditions also benefit from IVIg. Here we report the routine clinical use of Octagam(®) 10 % across three Canadian institutions. A total of 135 patients were treated with Octagam(®), for conditions represented by five distinct indication groups. The results of this review indicate that Octagam(®) has been well adopted and is prescribed to Canadian patients similar to other IVIg products...
2016: Allergy, Asthma, and Clinical Immunology
Hyewon Kwon, Amanda C Crisostomo, Hayley Marie Smalls, John M Finke
The fraction of IgG antibodies with anti-oligomeric Aβ affinity and surface sialic acid was compared between Octagam and Gammagard intravenous immunoglobulin (IVIG) using two complementary surface plasmon resonance methods. These comparisons were performed to identify if an elevated fraction existed in Gammagard, which reported small putative benefits in a recent Phase III clinical trial for Alzheimer's Disease. The fraction of anti-oligomeric Aβ IgG was found to be higher in Octagam, for which no cognitive benefits were reported...
2015: PloS One
Danielli C Bichuetti-Silva, Fernanda P Furlan, Fernanda A Nobre, Camila T M Pereira, Tessa R T Gonçalves, Mariana Gouveia-Pereira, Rafael Rota, Lusinete Tavares, Juliana T L Mazzucchelli, Beatriz T Costa-Carvalho
Intravenous immunoglobulin (IVIG) is increasingly recommended for many diseases apart from primary immunodeficiency diseases (PID). Although effective and safe, adverse reactions may occur. We conducted a 2-year prospective observational study in 117 patients with PID who received regular IVIG replacement therapy at a median dose of 600 mg/kg every 3 to 4 weeks to examine IVIG's adverse effects; 1765 infusions were performed (mean=15/patient) in 75 males and 42 females (aged 3 months to 77 years) in 3 groups: ≤ 9 years (34...
December 2014: International Immunopharmacology
Gayathri Sridhar, Bola F Ekezue, Hector S Izurieta, Nandini Selvam, Mikhail V Ovanesov, Hozefa A Divan, Yideng Liang, Basil Golding, Richard A Forshee, Steven A Anderson, Mikhail Menis
BACKGROUND: Thrombotic events (TEs) are rare and serious adverse events after administration of immune globulin (IG) products. Our study evaluated the occurrence of same-day TEs for different IG products and ascertained potential risk factors. STUDY DESIGN AND METHODS: This retrospective cohort study utilized HealthCore's Integrated Research Database (HIRD) to assess individuals exposed to IGs during 2008 to 2012. IG products were identified using recorded procedure codes and TEs were ascertained using ICD-9-CM diagnosis codes...
October 2014: Transfusion
David A Loeffler
Intravenous immunoglobulin (IVIG) products are prepared from purified plasma immunoglobulins from large numbers of healthy donors. Pilot studies with the IVIG preparations Octagam and Gammagard in individuals with mild-to-moderate Alzheimer's disease (AD) suggested stabilization of cognitive functioning in these patients, and a phase II trial with Gammagard reported similar findings. However, subsequent reports from Octagam's phase II trial and Gammagard's phase III trial found no evidence for slowing of AD progression...
2013: Journal of Neuroinflammation
F Dhainaut, P-O Guillaumat, H Dib, G Perret, A Sauger, C de Coupade, M Beaudet, M Elzaabi, L Mouthon
OBJECTIVE: To compare in vitro and in vivo biological and biochemical properties of five liquid intravenous immunoglobulin (IVIg) preparations licensed for therapeutic use in Europe. METHODS: ClairYg(®) was compared in a blinded manner to four other liquid IVIg preparations licensed in Europe (Octagam(®) , Kiovig(®) , Gamunex(®) , Privigen(®) ). Three batches of each preparation were tested, except for the IgG repertoires and the animal model. RESULTS: Levels of anti-A and anti-B antibodies were lower in ClairYg(®) (0·11/0·11) relative to a positive EDQM standard and Octagam(®) (0·11/0·08) than in other preparations (0·33-0·69/0·42-0·46)...
February 2013: Vox Sanguinis
Takeshi Tabira, Shin-Ei Matsumoto, Haifeng Jin
In order to avoid Abeta-induced autoimmune encephalitis, several monoclonal and polyclonal antibodies are in clinical trials. These are bapineuzumab, solanezumab, ponezumab, gantenerumab, BAN2401, gammaguard and octagam. Since each antibody has a different antigen epitope of Abeta, anti-amyloid activities are different. It is unknown which antibody is effective for Alzheimer disease, and we must wait for the result of clinical trials. Some patients who developed tissue amyloid plaque immuno-reactive (TAPIR) antibody showed slower decline after AN-1792 vaccination...
November 2011: Rinshō Shinkeigaku, Clinical Neurology
F C Renner, S Wienzek-Lischka, A Feustel, G Bein, W A Stertmann, W Padberg, R Weimer
BACKGROUND: From March 2007 to July 2010, we performed 14 AB0-incompatible (AB0i) living kidney transplantations using donor blood group-specific immunoadsorption (IA), anti-CD20 monoclonal antibody, and intravenous immunoglobulin (IVIG) pretreatment. METHODS: To analyze the effect of a presumed anti-donor blood group-specific antibody transfer by IVIG administration (0.5 g/kg; 5.4 ± 0.9 days pretransplant), we assessed AB0i antibody titers in different IVIG preparations and evaluated their impact on patient AB0i antibody titers...
December 2010: Transplantation Proceedings
Tadeusz Robak, Claudia Mainau, Barbara Pyringer, Krzysztof Chojnowski, Krzysztof Warzocha, Anna Dmoszynska, Jan Straub, Paul Imbach
Intravenous immunoglobulin (IVIg) has an established role in the treatment of immune thrombocytopenia (ITP). The safety and efficacy of a new ready-to-use IVIg 10% formulation (octagam(®) 10%) were investigated in a prospective phase III study in 116 adult patients with ITP (platelet count ≤20×10(9)/l). Sixty-six patients had chronic ITP and 49 were newly diagnosed. Patients received octagam 10% 1 g/kg/day on two consecutive days; infusion rate was adjusted according to tolerability to a maximum of 0·12 ml/kg/minute...
October 2010: Hematology (Amsterdam, Netherlands)
Anette Debes, Maria Bauer, Sybille Kremer
PURPOSE: Following the approval of Octagam in 1995, an open prospective observational cohort study has been initiated to observe the tolerability of the intravenous immunoglobulin Octagam. This study aimed to evaluate the long-term safety profile of Octagam in daily use in the treatment of various primary (PID) and secondary (SID) immunodeficiencies and autoimmune diseases (AID). METHODS: Within a time period of 10 years, data were collected in 310 study sites. The treating physicians documented patient characteristics, treatment parameters and the occurrence of an adverse drug reaction (ADR) by using detailed case record forms (CRF)...
September 2007: Pharmacoepidemiology and Drug Safety
A Chrissafidou, M Malek, E Musch
INTRODUCTION: Treatment of Crohn's disease is based on anti-inflammatory and immunosuppressive therapy. Over time, however, approx. 20 % of patients develop steroid resistance. In these cases, alternative treatment methods are required. Short-term application of intravenous immunoglobulin (IVIg) may serve as an additional alternative. PATIENTS AND METHODS: In 19 steroid-resistant patients (case collection over 15 years) suffering from Crohn's disease (mean CDAI 284...
July 2007: Zeitschrift Für Gastroenterologie
H F Rabenau, L Biesert, T Schmidt, G Bauer, J Cinatl, H W Doerr
SARS-coronavirus (SARS-CoV) is a newly emerged, highly pathogenic agent that caused over 8000 human infections with nearly 800 deaths between November 2002 and September 2003. While direct person-to-person transmission via respiratory droplets accounted for most cases, other modes have not been ruled out. SARS-CoV viraemia does not seem to reach high titres, however, it has to be excluded that virus transmission may occur via blood transfusion or application of therapeutic plasma products, e.g. fresh-frozen plasma or single components derived thereof...
June 2005: Biologicals: Journal of the International Association of Biological Standardization
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