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). RESULTS: A total of 6357 patients of all ages received 92 958 infusions of Octagam. ADR occurred in 4.2% of the patients and in 0.35% of all infusions. Most of them (94.8%) were classified as nonserious, the majority (90.2%) were of mild or moderate intensity. The ADR frequency differed slightly between the indication groups, for example in PID patients ADR occurred in 8.3% of patients and 0.5% of infusions, in SID patients in 5.0% of patients and 0.62% of infusions. Rigors were reported most frequently, followed by fever, headache, nausea and flush. The ADR symptoms differed between the indication groups, rigors were predominantly described in SID patients, headache in PID and AID patients including idiopathic thrombocytopenic purpura (ITP). A relation between the ADR frequency and elevated infusion rates or high dosages was not detected. CONCLUSIONS: This unique 10-year observational study demonstrates that Octagam is well tolerated in routine clinical use with an overall ADR frequency of 0.35%. Copyright (c) 2007 John Wiley & Sons, Ltd.
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). RESULTS: A total of 6357 patients of all ages received 92 958 infusions of Octagam. ADR occurred in 4.2% of the patients and in 0.35% of all infusions. Most of them (94.8%) were classified as nonserious, the majority (90.2%) were of mild or moderate intensity. The ADR frequency differed slightly between the indication groups, for example in PIDpatients ADR occurred in 8.3% of patients and 0.5% of infusions, in SIDpatients in 5.0% of patients and 0.62% of infusions. Rigors were reported most frequently, followed by fever, headache, nausea and flush. The ADR symptoms differed between the indication groups, rigors were predominantly described in SIDpatients, headache in PID and AID patients including idiopathic thrombocytopenic purpura (ITP). A relation between the ADR frequency and elevated infusion rates or high dosages was not detected. CONCLUSIONS: This unique 10-year observational study demonstrates that Octagam is well tolerated in routine clinical use with an overall ADR frequency of 0.35%. Copyright (c) 2007 John Wiley & Sons, Ltd.
Authors: Roger H Kobayashi; Sudhir Gupta; Isaac Melamed; J Fernando Mandujano; Ai Lan Kobayashi; Bruce Ritchie; Bob Geng; Thomas Prescott Atkinson; Syed Rehman; Eva Turpel-Kantor; Jiří Litzman Journal: Front Immunol Date: 2019-02-04 Impact factor: 7.561
Authors: Nathan J Roth; Herbert O Dichtelmüller; Fabrizio Fabbrizzi; Eckhard Flechsig; Albrecht Gröner; Mary Gustafson; Juan I Jorquera; Thomas R Kreil; Dominika Misztela; Elisa Moretti; Mila Moscardini; Gerhard Poelsler; John More; Peter Roberts; Andreas Wieser; Rodrigo Gajardo Journal: Transfusion Date: 2020-08-19 Impact factor: 3.157