Author(s)

Toni Homberg¹, Violeta Sáenz², Jorge Galicia-Carreón², Iván Lara², Edgar Cervantes-Trujano^1,2, Maria C. Andaluz^1,2, Erika Vera¹, Oscar Pineda¹, Julio Ayala-Balboa¹, Alejandro Estrada-García³, Sergio Estrada-Parra³, Mayra Pérez-Tapia⁴, Maria C. Jiménez-Martínez^5*

¹Clinical Trials Branch and Clinical Immunology Service, Unit of External Services and Clinical Research (USEIC), National School of Biological Sciences, National Polytechnic Institute, Mexico City, Mexico.
²Unit of Pharmacovigilance, Unit of External Services and Clinical Research (USEIC), National School of Biological Sciences, National Polytechnic Institute, Mexico City, Mexico.
³Department of Immunology, National School of Biological Sciences, National Polytechnic Institute, Mexico City, Mexico.
⁴Unit of R&D in Bioprocesses (UDIBI), National School of Biological Sciences, National Poly-technic Institute, Mexico City, Mexico.
⁵Department of Biochemistry, Faculty of Medicine, National Autonomous University of Mexico, Mexico City, Mexico.

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. Transferon^TM 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 Transferon^TM 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 Transferon^TM. Objective: To assess the safety of Transferon^TM 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 Transferon^TM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with Transferon^TM (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 Transferon^TM, 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: Transferon^TM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.

Dialyzable Leukocyte Extracts, Adverse Events, Monitoring, Drug Safety, Adjuvant Therapy, Immunoregulation, Guidelines, Transfer Factor, Pharmacovigilance

Homberg, T. , Sáenz, V. , Galicia-Carreón, J. , Lara, I. , Cervantes-Trujano, E. , Andaluz, M. , Vera, E. , Pineda, O. , Ayala-Balboa, J. , Estrada-García, A. , Estrada-Parra, S. , Pérez-Tapia, M. and Jiménez-Martínez, M. (2015) The Adverse Event Profile in Patients Treated with Transferon^TM (Dialyzable Leukocyte Extracts): A Preliminary Report. Pharmacology & Pharmacy, 6, 65-74. doi: 10.4236/pp.2015.62009.