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 * Corresponding author. 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.

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Allergic rhinitis (AR) has considerable impact on the general health of individuals. Therefore, treatment trials should include an evaluation of quality of life. We aimed to determine changes in the quality of life of moderate/severe AR patients treated with standard treatment in addition to dialyzable leukocyte extract (DLE), a peptide-based immunomodulator. In a prospective, non-controlled trial, DLE was added to the standard treatment regimen for patients with moderate/severe AR. DLE was administered orally at 2 mg per day for 5 days, followed by 4 mg per week for 5 weeks, and then 2 mg per week for 5 weeks. The primary endpoints were overall improved Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores, domain scores, and individual item scores of 0.5 points or higher. Statistical significance was defined as P < .05. Thirty patients (50% female) aged 14 to 60 years old (33.4 ± 11.9) were enrolled in this study. The mean overall basal quality of life score was 3.41 ± 1.22. After 11 weeks, the mean RQLQ score was 1.74 ± 1.09 (P < .0001; 95% confidence interval [CI], 1.05-2.33), and all the domain scores improved (daily activities P < .001, 95% CI 0.91–2.15, sleep P < .001, 95% CI 0.9–2.26, non-hay fever symptoms P = .001, 95% CI 0.51–1.82, practical problems P < .001, 95% CI 1.55–2.85, nasal symptoms P < .001, 95% CI 1.36–2.67, ocular symptoms P < .001, 95% CI 1.05–2.17, emotional P < .001, 95% CI 1.23–2.55). Each of the 28 individual item scores on the RQLQ showed clinical (minimal important difference [MID] ≥ 0.5) and statistical (P < .05) improvements. DLE might be a beneficial adjuvant treatment for AR. Our results provide preliminary data for future research. Clinical trials registration ID: NCT02506998