1356. A randomized controlled trial of prednisolone vs. TNF-α inhibitor infliximab in the management of type 1 lepra reaction in leprosy patients
Background
Leprosy is a chronic granulomatous infectious disease caused by Mycobacterium leprae. Type 1 lepra reactions (T1R) are an acute inflammatory response during the chronic course of the disease. If it is not treated promptly with immune suppression, it can lead to a permanent disability affecting hands, feet and eyes. tumor necrosis factor-alpha (TNF-a) which is produced mainly by inflammatory T cells is up-regulated in patients of Type I Lepra reaction. Conventionally oral corticosteroids steroids have been the mainstay in the management of Type 1 Lepra reactions. This novel biologic drug is a targeted therapy which blocks the offending interleukin molecule without any serious adverse effects. We report the results of this randomized control study wherein an immuno-modulator biologic molecule has been safely used to treat an inflammatory reaction in a chronic infectious disease. Outcomes were measured using recurrence rate, a clinical severity score, quality of life and adverse events.
Methods
62 patients with new Type 1 Lepra reactions were randomized to receive Infliximab (a chimeric monoclonal antibody biologic drug that works against tumor necrosis factor-alpha (TNF-α) or Prednisolone for 20 weeks. TNF-α levels were correlated before and after the intervention.
Results
Recovery rates in skin signs were similar in both groups (91% vs. 86%). Improvements in nerve function both, new and old, sensory (68% vs. 49%) and motor (72% vs. 77%) loss were higher (but not significantly so) in the patients on Infliximab. Recurrences rates of lepra reaction (24%) were high in both groups, and recurrences occurred significantly earlier (8 weeks) in patients on Infliximab, who needed 10% more additional prednisolone. Serious major and minor adverse events rates were much lesser with Infliximab as compared with Prednisolone alone. Both groups had a significant improvement in their quality of life after the study, measured by the short-form survey SF-36.
Conclusion
This is the first double-blind randomized control trial assessing Infliximab, in the management of lepra reaction. It could be a safe alternative second-line drug for patients with leprosy reactions who are not improving with prednisolone or are experiencing adverse events related to prednisolone.