Prior studies carried out by our laboratory have employed rhu IL-2 in patients with lepromatous leprosy who are under chemotherapy but still have many bacilli in their tissues. Injection of the lymphokine intradermally, resulted in the local accumulation of the cellular elements of a delayed type cell mediated immune reaction. CD4 and CD8 positive T cells, monocytes and Langerhans cells accumulated in the dermis and resulted in areas of induration dependent on the dose of rIL-2. The bacillary indices (BI) of M. leprae of the cutaneous sites were reduced by one or more log units. The administration of up to 25 5g x 3 did not result in any untoward local or systemic symptoms. A subsequent study with 14 LL/BL patients was conducted in Nepal (Anandaban Hospital) in November of 1989. It employed low doses (10 5g) of IL-2 administered twice a day for a period of 8 days. In total 160 5g of IL-2 was given to the patients. Patients receiving the cytokine had brief episodes of low grade fever (1 0.5 C) and five days after therapy, they developed nontender axillary lymphadenopathy. The injections were given intradermally into sites over the upper back affecting the draining nodes. The following conclusions can be reached from these studies: a) No significant systemic symptoms occurred. No evidence of reactive states or nerve damage. b) Lymphocyte counts in the peripheral blood increased transiently as did the number of CD4+ cells. NK cells increased by 8 folds. c) Reduction in induration of both macular and histoid type skin lesions occurred. d) Induration following IL-2 injection was dose dependent. e) Evidence for a generalized, systemic effect was achieved in the majority of patients. This included the increase in the number of dermal T cells, the presence of epithelioid and giant cell granulomas, a 6-fold reduction in BI, and upgrading of the lesion according to the Ridley Jopling classification of leprosy. We plan to evaluate the effects of repeated cycles of 2 injections per day for 8 days of rIL-2 on the bacillary load of multibacillary leprosy patients.
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