1345. randomized control trial to evaluate the clinical and cytokine response profile to oral Thalidomide in leprosy patients with erythema nodosum leprosum
Leprosy is a chronic granulomatous disease caused by Mycobacterium leprae. Erythema Nodosum Leprosum is an acute inflammatory Type III hypersensitivity response during the chronic course of the disease process. This immune response manifests clinically as painful red nodules and systemic symptoms similar to sepsis with neutrophilic leukocytosis. Capsule Thalidomide is the drug of choice for treating this condition.
A randomized control study to study the immunological markers involved in the pathogenesis of erythema nododsum leprosum and its successful suppression by Thalidomide should provide newer insight into the pathogenesis of this disease process, provide better diagnostic and therapeutic options and better markers to predict prognosis. Based on the previous studies our aim was to find a correlation with tumor necrosis factor-a, interferon-gamma, and Cd-64 expression on activated circulating neutrophils during Type II lepra reaction and the successful response to capsule Thalidomide. Venous blood samples were collected from all the samples and after 7 days post thalidomide therapy, only in the treated population. All the patients with type II lepra reaction responded to Capsule Thalidomide clinically and all the skin lesions resolved in 7–14 days. Blood samples and skin biopsy was subjected to histopathology, immunofluorescence assay, immunohistochemical staining, quantitative RT–PCR (reverse transcriptase-polymerase chain reaction) and flow cytometry.
Study found out that Interferon Γand Tumor necrosis factor-Α are sensitive markers in diagnosing erythema nodosum leprosum and Cd-64 expression on activated circulating neutrophils is both a specific and sensitive marker. Cd-64 expression also had a positive correlation with Thalidomide treatment and clinical response.
Cd-64 expression on circulating neutrophils is a potential early biophysical marker for diagnosing erythema nodosum leprosum and can be used as a tool to assess thalidomide response. InterferonΓ and Tumor necrosis factorΑ are sensitive markers to screen for lepra reactions and this study showed no significant correlation with Thalidomide therapy.