Study to Compare the Efficacy and Cost-Effectiveness of Various Disease Modifying Drugs in the Management of Multiple Sclerosis in India- An Observational Study.

ABSTRACT

Background: Real-world data on the efficacy and cost-effectiveness of multiple sclerosis (MS) disease-modifying drugs (DMTs) is lacking in the Indian setting. The primary objective of this study was to evaluate the efficacy of DMTs, and the secondary objective was to evaluate cost-effectiveness and the quality of life (QoL) in these patients. Method: Seventy-four patients fulfilling study criteria were recruited in the retrospective observational study, of which 69 completed the study. Primary outcome was measured by annualized relapse rate (ARR), and secondary outcome was measured by WHOQOL-BREF scale, modified Kuppuswamy scale, and rating of DMT scale through a subjective questionnaire. Results: Patients on natalizumab, rituximab, and glatiramer acetate showed the highest reduction in ARR. The highest reduction of ARR (2.5) was produced by natalizumab and least by Peg-IFNß1a (0.5). In QoL analysis, teriflunomide group had the highest average score for both physical health (22.7, SD 4.7) and psychological (21.3, SD 4.0) domains, whereas natalizumab group had the lowest average score. Socio-economic status analysis showed DMF, IFNß 1a, peg-IFNß 1a, rituximab, and glatiramer acetate are affordable to the upper middle class and above, whereas natalizumab could be afforded only by high-class strata. Teriflunomide was most affordable annually. Study of adverse drug reactions showed natalizumab was very well tolerated by the study participants. Conclusion: Natalizumab, an infusion DMT, was highly effective in terms of reducing the ARR. Rituximab, an off-label DMT, was found to be very effective. Teriflunomide was overall an effective DMT in terms of affordability, QoL balance, and an acceptable ARR reduction.