Immunomodulators in Lepra Reaction “Transfer Factor”: Randomized Controlled Clinical Trial on the Effectiveness and Safety of Transfer Factor vs Prednisone in Lepra Reaction among Leprosy Patients in Jose R. Reyes Memorial Medical Center
Abelaine Venida Tablizo, Ma. Luisa Abad Venida, Ma. Luisa Ticzon-Puyat, Marilyn CrisostomoAbstract
Background:
Lepra reactions (LRs) are acute inflammatory complications of leprosy that contribute substantially to nerve damage, disability, and long-term morbidity. Systemic corticosteroids are the mainstay of therapy but are often associated with significant adverse effects, particularly with prolonged use. Transfer factor (TF), an immunomodulatory agent that enhances cell-mediated immunity, has been proposed as a potential alternative for managing LRs by modulating host immune responses to
Aims:
This study evaluated the efficacy and safety of TF versus prednisone in managing LRs. Outcomes included reaction signs and symptoms, sensory and voluntary muscle function, ocular scores, World Health Organization (WHO) disability scores, bacillary index, and adverse events.
Methodology:
In a randomized, double-blind trial at the Leprosy Unit of Jose R. Reyes Memorial Medical Center, patients aged ≥15 years with LR were assigned to receive either prednisone or oral TF for 12 weeks. Outcomes were assessed at baseline and week 12. Statistical analyses included Chi-square tests,
Results:
Sixty-six patients were randomized (25 prednisone, 41 TF). Both groups showed significant improvements in reaction signs, sensory nerve function, and WHO disability grade, with no significant differences in efficacy. TF was associated with significantly fewer adverse effects (
Conclusion:
TF demonstrated comparable efficacy to prednisone in managing LRs, with fewer adverse effects and beneficial effects on laboratory parameters, suggesting it may serve as a safe alternative or adjunctive therapy for LRs.