London School of Hygiene Tropical Medicine
Erythema nodosum leprosum (ENL) is a severe and extremely painful complication of leprosy which can occur before, during or after completion of antibacterial treatment. This study conducts two randomised controlled trials in several countries to test the effectiveness of methotrexate, which might provide a better option than current treatment methods.
Two randomised controlled trials in ENL - ENLIST MTX
November 2016 - October 2022
Erythema nodosum leprosum (ENL) is a severe and extremely painful complication of leprosy which can occur before, during or after completion of antibacterial treatment. ENL is often chronic and causes severe morbidity affecting not only the skin but also bones, joints, eyes, nerves, testes and kidneys. ENL may be fatal and it has been shown that the adverse effects of long term corticosteroid treatment also contribute to mortality. An effective treatment for ENL is thalidomide but this is not available in many leprosy endemic countries or severely constrained by availability, cost, adverse effects and justified concerns about teratogenicity. Thalidomide despite its effectiveness is rarely used as a first line agent. Other effective and preferably cheaper drugs need to be identified to reduce the burden of this condition. There is some evidence that methotrexate may be useful in helping to control the debilitating symptoms of ENL and reduce the amount of corticosteroid treatment needed. Methotrexate has been available since the 1950s and is used throughout the world to treat common conditions such as psoriasis. It is also inexpensive. This study tests whether methotrexate is effective in ENL by comparing it with prednisolone (the corticosteroid most commonly used to treat ENL). Individuals with ENL are invited to participate in this study but neither they nor their doctors know which medication they are taking. At the end of the study the two groups of patients will be compared to see which have had the best response as measured against pre-determined outcomes. The participants in the study are drawn from Bangladesh, Brazil, Ethiopia, India, Indonesia, Nepal and the Philippines from centres who together form the ENL International STudy Group which is coordinated from the London School of Hygiene and Tropical Medicine. The Group will ensure that the results of the study are disseminated to the participants, other leprosy affected people and national and international agencies involved in policymaking about the best way to deal with ENL.
Turing Foundation and Plan:G