Assessing Ciclosporin in the Treatment of Leprosy Reactions: Evidence from a Randomized Controlled Trial and Other Studies.

Leprosy patients present with a spectrum of skin lesions and neuropathy. Despite multi-drug therapy (MDT), which cures the infection, immunological reactions continue to occur, leading to disability and deformity secondary to neuropathy. Reactions are a major cause of morbidity and long term disability. The treatment of reactions is currently inadequate, with prednisolone being the main drug used with partial success and a high rate of side effects. Identifying better agents for treating leprosy reactions is an important clinical need with major service implications. This work investigated the safety and efficacy of ciclosporin to treat reactions in leprosy patients in Ethiopia. A double-blind randomized controlled clinical trial comparing the efficacy and adverse event profiles of ciclosporin and prednisolone was conducted in patients presenting with Type 1 Reaction. Two similar pilot studies were conducted in patients with Erythema Nodosum Leprosum. Validating the Type 1 Reaction Severity Scale in Ethiopian patients, assessing features of ENL severity and validating a quality of life questionnaire in Amharic were important preliminary projects to produce valid tools for measuring treatment outcomes. Patients on ciclosporin and prednisolone had similar clinical outcomes in the treatment of new and chronic Type 1 Reaction. There was a high rate of Type 1 Reaction recurrence in both groups but the patients on ciclosporin required greater amounts of additional prednisolone to control these recurrences. Patients with acute ENL on ciclosporin had a significant 16-week delay in the onset of ENL recurrence. This important difference was not observed in patients with chronic ENL. Prednisolone related adverse events were much more frequent than those related to ciclosporin in all four studies.