Rituximab in Graves’ disease 2

Graves’ disease (GD) is one of the more common disorders of the thyroid gland, affecting 700 young people in the UK each year. In GD, the immune system mistakenly makes antibodies that stimulate the thyroid, causing it to produce too much thyroid hormone. This can have a profound impact on physical health, quality of life, attention span and education or work performance. Treating GD is more difficult in the young because standard antithyroid drug therapy (ATD), typically using carbimazole (CBZ), is more likely to result in side-effects and less likely to result in cure when treatment is stopped. Only 1 in 4 patients will require no further treatment after 2 years of CBZ. Other treatment options if the GD recurs are surgery (total thyroidectomy) or radioactive iodine. These are associated with additional risks and greater costs in the young, necessitate life-long thyroid hormone replacement and reduced quality of life. Rituximab (RTX) medication is used to treat many immune disorders. It works by targeting blood cells that make antibodies responsible for attacking body tissues including the thyroid. A recent exploratory study in young patients with GD suggested that giving one dose of RTX in addition to standard ATD is well tolerated and may increase the likelihood of remission. We are carrying out a clinical trial throughout the UK, where 124 young people with GD, aged between 12-24 years, will be randomly allocated to one of two different groups: 1) A 2-year course of ATD 2) 1 dose of RTX as well as 2 years of ATD. Participants will not know which group they are in. They will have bloods taken to check thyroid function at 4 weeks and then every 8 weeks in the first year and 3- monthly thereafter. The visit frequency is similar to standard care. The primary outcome will be a comparison of young people in each group with normal thyroid function and who have had no further treatment 12 months after stopping ATD.