Adjuvant rituximab – exploratory trial in young people with Graves’ disease
Journal of Clinical Endocrinology and Metabolism Oct 28, 2021
Cheetham T, Cole M, Abinun M, et al. - Young people suffering from Graves’ hyperthyroidism may achieve increased likelihood of remission in relation to adjuvant rituximab given with a 12 month course of antithyroid drug (ATD).
In this open label multicenter single arm phase 2 trial, 27 young people (12-20y) with Graves’ hyperthyroidism were treated with 500mg rituximab and 12 months of ATD titrated according to thyroid function.
No treatment-associated serious side effects occurred.
At 24 months, remission was achieved by 13/27 participants (48%, 90% one-sided confidence interval 35%, 100%); this was more than the critical value (9) for the A’Hern design and offered evidence of a promising remission rate.
An association was found between B lymphocyte count at 28 weeks (expressed as a percentage of baseline) and likelihood of remission.
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