Abstract
Rituximab is a promising therapy in pemphigus. However, there is no consensus on optimum dose. To compare the efficacy, in terms of clinical and immunological outcomes in patients with pemphigus, of a high (2×1000mg) vs. a low dose (2×500mg) of rituximab. This was a randomized, observer-blinded trial wherein 22 patients with pemphigus were randomized into two treatment groups. Patients received either two doses (day 0 and day 15) of 1000mg rituximab or 500mg rituximab, and were followed up for 48weeks. Clinical activity was assessed by a blinded investigator. Indices of enzyme-linked immunosorbent assays (ELISAs) for desmoglein (Dsg)1 and Dsg3, and CD19 cell count were examined at regular intervals. There was no statistically significant difference in early and late clinical end points, and total cumulative dose of corticosteroids between the two groups. At week 40, the fall in Ikeda severity score was significantly more in the 2×1000mg group than in 2×500mg group (P=0·049). Patients in the 2×500mg group received a significantly higher cumulative dose of azathioprine (P=0·018). The ELISA indices of Dsg1 and Dsg3 showed a statistically significant decline in the 2×1000mg group only. B cell repopulation occurred earlier in the 2×500mg group by 8weeks. A few clinical and immunological study parameters have suggested improved outcomes in patients receiving high-dose (2×1000mg) rituximab.
Published Version
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