Low Dose Vs Conventional Rituximab Regimen in Pemphigus Vulgaris - A Retrospective Single Centre Comparative Analysis to Assess the Clinical Efficacy and Cost-Effectiveness.

BACKGROUND

Rituximab (RTX) is considered the first-line treatment for pemphigus vulgaris (PV), a B-cell-mediated autoimmune bullous disease. However, no clear consensus on the optimum dosage has been achieved yet.

OBJECTIVES

To compare the clinical efficiency and cost-effectiveness of a low-dose (RTX 2×500mg) vs conventional (RTX 2×1g) RTX regimen.

MATERIALS AND

METHODS

It is a retrospective study of PV patients who received two doses of RTX during the study period of January 2021 to December 2022 at a tertiary care hospital in South India. The study population was divided into Group A (low-dose RTX 2×500 mg) and Group B (conventional dose RTX 2×1g). Clinical response was assessed according to Murrell et al. response criteria, at 6 and 9 months, as RTX-induced B cell depletion is expected to last till 6 to 9 months.

RESULTS

A total of 57 patients with PV were enrolled in this study (43 in Group A and 14 in Group B). At the end of 6 months, 97.5% achieved remission in Group A and 100% of patients in Group B. At the end of 9 months, 91.66% of patients remained in remission in Group A, whereas all patients maintained remission in Group B. At the end of the 6 months and 9 months, one (2.5%) and three (8.3%) patients had relapse in Group A, whereas in Group B there were no relapses till the completion of 9 months follow-up period. The difference in clinical outcome and relapse rate at the end of the 6 and 9 months was not statistically significant in the two groups of patients.

LIMITATIONS: Retrospective study with limited sample size; serological assay and immunological assay were not performed.

CONCLUSION

This study indicated that low-dose RTX is equally efficacious, safe, and cost-effective compared to conventional regimens, over a 9-month study period.