Comparison of Relapse Rate and Disease Severity among patients with Type 2 Lepra Reaction receiving Tofacitinib and Thalidomide separately as an adjuvant to systemic steroids: A Longitudinal Analytical Study

Read the full article See related articles

Discuss this preprint

Start a discussion What are Sciety discussions?

Listed in

This article is not in any list yet, why not save it to one of your lists.
Log in to save this article

Abstract

Background Erythema nodosum leprosum (ENL) is a severe immune-mediated complication of multibacillary leprosy requiring prolonged immunosuppression. Steroid-sparing agents are essential to reduce relapse and treatment-related morbidity. Methods This longitudinal analytical observational study compared outcomes in patients with ENL treated with prednisolone plus thalidomide (Group A; n=30) and prednisolone plus tofacitinib (Group B; n=31). Patients were followed for 6 months. Primary outcomes included relapse rate and ENLIST ENL Severity Score (EESS). Secondary outcomes were neutrophil–lymphocyte ratio (NLR), Dermatology Life Quality Index (DLQI), steroid dependency, and adverse events. Inter-group comparisons and longitudinal analyses were performed using non-parametric tests. Correlations between NLR, EESS, and DLQI were assessed using Spearman’s rank correlation. Results Relapse occurred in 36.7% of patients in Group A and 71.0% in Group B (p=0.007). The mean number of relapses was significantly lower in Group A (0.70±1.06 vs 1.84±1.51, p=0.002). At 3 and 6 months, Group A demonstrated significantly lower NLR values (p=0.017 and p<0.001, respectively). DLQI and EESS scores improved in both groups; however, sustained improvement was more consistent in Group A. Steroid-free status at 6 months was achieved in 93.3% of Group A compared with 58.1% of Group B (p<0.001). NLR showed a positive correlation with EESS (ρ=0.269, p=0.018) and DLQI (ρ=0.604, p<0.001) at 6 months. On multivariable logistic regression analysis adjusting for baseline confounders, patients receiving tofacitinib had significantly higher odds of relapse compared with those receiving thalidomide (adjusted OR 9.87, 95% CI 1.73–27.12; p = 0.006).Adverse events were predominantly mild to moderate, with differing safety profiles between groups. Conclusion Thalidomide demonstrated superior relapse prevention and steroid-sparing efficacy compared with tofacitinib in ENL. NLR correlated with disease severity and quality of life, supporting its role as a useful biomarker for monitoring disease activity during follow-up.

Article activity feed