Abstract
Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Objective: To assess the safety of TransferonTM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with TransferonTM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with TransferonTM (MD 1.9, IQR 1.7 - 2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with TransferonTM, and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: TransferonTM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.
Highlights
Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides under 10 kDa, released after disruption of peripheral blood leukocytes from healthy donors [1]
TransferonTM is a human dialyzable leukocyte extract manufactured by National Polytechnic Institute (IPN), Mexico, at Good Manufacturing Practice (GMP) facilities
From a total of 42 patients that developed an adverse events (AE), 41.4% were observed in patients with diagnosis of allergic diseases, 24.3% were observed in patients with diagnosis of autoimmune diseases, and 34.3% were observed in patients with diagnosis of infectious disease
Summary
Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides under 10 kDa, released after disruption of peripheral blood leukocytes from healthy donors [1]. TransferonTM is a human dialyzable leukocyte extract manufactured by National Polytechnic Institute (IPN), Mexico, at Good Manufacturing Practice (GMP) facilities. Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with
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