• Research priorities: Disability
• Country: Bangladesh, India
• Budget: € 197,213 | Project number: 707.19.21
• Duration: January 2020 – April 2026
• Status: Ongoing

This study aims to assess the effectiveness of additional doses of Clofazimine in reducing frequency and severity of ENL.

Does additional clofazimine for MB cases at high risk of ENL improve their prognosis/outcome over 2 years?

Project coordination

• Bombay Leprosy Project

Project summary

Erythema nodosum leprosum (ENL) is an unpleasant complication of leprosy which can lead to considerable suffering, impaired quality of life, and long term disability. Clofazimine has long been used to reduce severity and recurrence of ENL, however, there is limited published evidence for its effectiveness.

This study intends to test the effectiveness of additional Clofazimine in reducing the incidence and severity of ENL. One group of patients who are suffering from ENL reactions will receive extra doses of Clofazimine for 6 to 12 months. The other group of patients suffering from ENL reactions will be given placebo vitamin tablets to compare the difference in well-being between the two groups. Both groups will also receive standard treatment with steroids, the same as given to people who are not in the trial.

Research question: Does 6- 12months additional administration of Clofazimine medicine to patients under the leprosy treatment or within 12 months of the completion of the treatment and once suffered from ENL reactions, reduce the frequency and severity of the reaction and its consequences in them and possibly have a beneficial effect on their nerve function during the observation period of 24 months.

The research group will assess the results in each group by using standard scales for ENL severity. This will also be done for quality of life as well as nerve damage, and the amount of steroid medication needed. The results will help doctors decide best treatments for ENL patients in future.

Co-financer: Turing Foundation

• Grant: LRI Regular Grant
• Budget round: 2019
• Research priorities: Disability
• Country: Indonesia, Nepal
• Project no.: 707.19.20
• Budget: € 153,321
• Duration: September 2020 – December 2025
• Status: Completed
• Co-funding partners: Turing Foundation

Project coordination
Universitas Gadjah Mada

Partners
National University of Singapore
NLR Indonesia

Aim: This study aimed to reduce the incidence of dapsone allergy on leprosy patients, by testing the patients’ blood for a genetic markerbefore they receive dapsone as part of their treatment.

Full project title:
Implementation of Dapsone Hypersensitivity Syndrome (DHS) Biomolecular Predictive Test to reduce the incidence of DHS among Leprosy Patients in Papua and Nepal

Final project summary:
Dapsone is one of the key medicines used in the treatment of leprosy and has helped millions of people successfully complete multidrug therapy. However, a small number of patients experience a rare but potentially life-threatening adverse reaction known as Dapsone Hypersensitivity Syndrome (DHS). DHS can cause severe skin reactions, fever, liver damage, and other serious complications, and may lead to hospitalization or death if not identified and managed early.

Research over the past decade has shown that DHS is strongly associated with a specific genetic marker known as HLA-B*13:01. Individuals who carry this genetic variant have a significantly higher risk of developing the syndrome when treated with dapsone. This discovery created an opportunity to prevent DHS through simple genetic screening before treatment begins.

This project aimed to implement and evaluate a biomolecular predictive test for DHS among people affected by leprosy in Papua and Nepal. The goal was to determine whether genetic testing could be integrated into routine leprosy services to identify individuals at risk and prevent severe adverse drug reactions.

The project introduced screening for the HLA-B*13:01 genetic marker before starting multidrug therapy. Patients found to carry the risk variant could be offered alternative treatment options, avoiding exposure to dapsone and reducing their likelihood of developing DHS. At the same time, healthcare workers were trained in the use of the test and in the management of patients identified as being at higher risk.

By incorporating genetic screening into leprosy programmes, the project demonstrated the potential of personalized medicine in the management of neglected tropical diseases. The approach enabled safer treatment decisions, improved patient confidence in therapy, and reduced the risk of serious treatment-related complications.

The implementation of DHS predictive testing also strengthened local healthcare capacity by introducing molecular diagnostic tools into routine practice. In settings where access to specialized care may be limited, preventing severe adverse drug reactions before they occur can significantly reduce healthcare costs, improve treatment adherence, and enhance patient outcomes.

This initiative highlights how advances in genetic medicine can be translated into practical public health solutions. By identifying patients at risk before treatment begins, DHS predictive testing offers a powerful strategy to make leprosy treatment safer and more effective while supporting the global goal of improving quality of care for people affected by the disease.

The experience from Papua and Nepal demonstrates that integrating genetic screening into leprosy programmes is both feasible and impactful, providing a model that could be expanded to other endemic countries seeking to improve treatment safety and patient care.

Impact

Krismawati, H., Ferdiana, A., Irwanto, A., Budiawan, T., Imaniar, C., Wahyuni, T., ... & Pongtiku, A. (2022). Implementation of genetic screening test to reduce the incidence of dapsone hypersensitivity syndrome among patients with leprosy in Papua, Indonesia: a study protocol. BMJ open, 12(5), e057173.