TITLE:
The Adverse Event Profile in Patients Treated with TransferonTM (Dialyzable Leukocyte Extracts): A Preliminary Report
AUTHORS:
Toni Homberg, Violeta Sáenz, Jorge Galicia-Carreón, Iván Lara, Edgar Cervantes-Trujano, Maria C. Andaluz, Erika Vera, Oscar Pineda, Julio Ayala-Balboa, Alejandro Estrada-García, Sergio Estrada-Parra, Mayra Pérez-Tapia, Maria C. Jiménez-Martínez
KEYWORDS:
Dialyzable Leukocyte Extracts, Adverse Events, Monitoring, Drug Safety, Adjuvant Therapy, Immunoregulation, Guidelines, Transfer Factor, Pharmacovigilance
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.6 No.2,
February
10,
2015
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.