Validation of the Leprosy Type 1 Reaction Severity Scale in Ethiopia.
Leprosy Type 1 Reactions (T1R) are immune-mediated events leading to nerve damage and preventable disabilities. They manifest clinically with erythema and oedema of skin lesions and tender peripheral nerves with loss of function. Up to 30% of patients with borderline leprosy are affected by T1R. Although T1R can occur at any time, the frequency is higher in the first six months of MDT treatment. T1R are treated with corticosteroids. Clinical trials are needed to assess not only efficacious and safe second line drugs but also to assess the best regimens of prednisolone in terms of dosage, length of treatment and rate of decrease. A tool which enables clinicians to assess the severity of T1R is useful in defining outcomes in clinical trials. The lack of uniformity surrounding interpretation of data has hindered development of internationally accepted treatment protocols and guidelines, while also making trialling of new therapeutic agents difficult. Using a validated clinical severity scale for leprosy reactions improves research quality and provides a tool to promote uniformity and comparability of research. A Severity Scale for T1R, based on the INFIR clinical severity scoring system, was developed and prospectively validated in Bangladesh and Brazil. The scale consists of 21 items to assesses three components of T1R. The first section looks at skin involvement using number of affected lesions, the degree of inflammation and the presence of peripheral oedema (Score A). The second section is a measurement of sensory function of the nerves by using graded Semmes-Weinstein monofilaments (SWM) to assess sensation in the hands and feet, and cotton wool for corneal sensation (Score B). The third section uses a standard measure of muscle power (MRC grading) to assess the motor function of the nerves of the face, hands and feet (Score C). The sum of the total for each section (A, B, and C) gives the overall severity scale score with a range of 0–63 (Appendix 1).