Tolerability and safety of Octagam® (IVIG): a post-authorization safety analysis of four non-interventional phase IV trials

Abstract

Objective: To evaluate the tolerability and safety of Octagam® 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. Results: Altogether 21,780 infusions of Octagam in 2,397 patients were included in our analysis. The most frequent indication for Octagam was secondary immunodeficiencies (SID; n = 1,368, 11,348 infusions), followed by primary immunodeficiencies (PID; n = 363; 3,923 infusions). During the individual patient observation, 83% of SID and 67% of PID patients were free of any infection. In up to 85% of all investigator assessments, Octagam was rated to have a favorable effect. In autoimmune diseases, investigators assessed Octagam as being beneficial in 70% (immune thrombocytopenia) up to 100% (Guillain-Barré syndrome), depending on the indication. The majority of patients (92%) tolerated Octagam treatment without any ADR. The overall incidence of reported ADRs was 1.0% for all infusions. The majority of ADRs were considered non-serious (93%) and mild or moderate (87%) in severity. No unexpected ADR signal was detected. Conclusions: This analysis demonstrates that the changes in the preparation of raw material used to manufacture Octagam did not affect the safety profile of Octagam® 5% and 10%.

Meta-analysis of intravenous immunoglobulin preparation Octagam 10%® clinical e ectiveness and safety

“…Эффект заместительной терапии препаратом Октагам 10% ® у пациентов с вторичными иммунодефицитами: влияние на частоту развития, тяжесть и продолжительность инфекций и потребность в антибактериальной терапии [14] /л. В исследование были включены пациенты как с хронической, так и с острой ИТП.…”

“…В исследовании W. Frenzel и соавт. [14] ® при различных заболеваниях Исследование А. Debes [12] на примере 11762 инфу-зий у 1043 пациентов с ПИД и ВИД показало высокий уровень безопасности препарата: реакции на введе-ние возникли в 1,45% случаев, у 93% пациентов они не носили серьезного характера; в 87% случаев были легкой степени выраженности (в основном повыше-ние температуры и боли различной локализации -голова, спина и др.). В 2016 году W. Frenzel и соавт.…”

“…В 2016 году W. Frenzel и соавт. [14] проанализировали данные двух неинтервенцион-ных постмаркетинговых многоцентровых исследова-ний с применением Октагам 10% ® -9556 введений у 961 пациента с медианой возраста 60 лет (от 3 до 94 лет). Большинство пациентов получало заместитель-ную терапию в связи с ПИД или ВИД в дозе 0,2-0,4 г/ кг в среднем один раз в 4 недели, однако в исследо-вание были включены и пациенты с ИТП, рассеянным склерозом и другими аутоиммунными/воспалитель-ными состояниями, при которых наивысшая доза со-ставляла 1,6 г/кг.…”

Tolerability and safety of the intravenous immunoglobulin octagam®10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials

“…Octagam® 10% was originally approved in 2008 in Germany and other European countries. In 2011, octagam® 10% and a less concentrated preparation of octagam® 5% became available on the market with an amended manufacturing process [7].…”

“…In March 2014, an integrated safety analysis from four non-interventional post-authorisation safety surveillance (PASS) studies was conducted to evaluate the tolerability and safety of octagam® 10% and 5% in various indications, most commonly secondary immunodeficiency, followed by primary immunodeficiency, ITP and other autoimmune disorders [7]. Here, we provide more detailed data on the tolerability and safety of octagam® 10% in the subgroup of patients with ITP identified from the overall integrated safety analysis.…”