SFEBES2021 Oral Communications Thyroid (6 abstracts)
Adjuvant Rituximab – exploratory trial in young people with Graves’ disease
Tim Cheetham 1 , Michael Cole 1 , Mario Abinun 1 , Amit Alalhabadia 2 , Tim Barratt 3 , Justin Davies 4 , Paul Dimitri 5 , Amanda Drake 6 , Zainaba Mohamed 3 , Robert Murray 7 , Caroline Steele 8 , Nicola Zammitt 6 , Sonya Carnell 1 , Jonathan Prichard 1 , Gillian Watson 1 , Sophie Hambleton 1 , John Matthews 1 & Simon Pearce 1
1Newcastle University, Newcastle upon Tyne, United Kingdom; 2Royal Hallamshire Hospital, Sheffield, United Kingdom; 3Birmingham University, Birmingham, United Kingdom; 4University of Southampton, Southampton, United Kingdom; 5Sheffield Children’s Hospital NHS Trust, Sheffield, United Kingdom; 6Edinburgh University, Edinburgh, United Kingdom; 7Leeds Teaching Hospitals, Leeds, United Kingdom; 8Children and Adolescent Services, Leeds Teaching Hospitals, Leeds, United Kingdom
Objective: Remission rates in young people with Graves’ hyperthyroidism are <25% after a 2-yr course of thionamide antithyroid drug (ATD). Immunomodulatory agents might improve outcome by facilitating immune tolerance. We explored whether rituximab (RTX) would increase remission rates when administered with a short course of ATD.
Design: This was an open label multi-centre single arm phase 2 trial in newly presenting young people (12-20y) with Graves’ hyperthyroidism. The trial used an A’Hern design to distinguish an encouraging remission rate of 40% from an unacceptable rate of 20%, with power of 80% and Type I error of 10%. Participants received 500 mg dose of RTX followed by up to 12 months of ATD. The primary endpoint was relapse at 24 months (suppressed serum TSH and raised FT3), needing to restart ATD or to undergo thyroidectomy/radioiodine therapy.
Results: Twenty-seven participants were recruited (6 UK centres). All completed the trial and there were no serious side effects linked to treatment. The daily Carbimazole dose at 12 months was 5 mg or less in 20/27 participants (1/27 on 50 mg propylthiouracil). 13 of 27 participants were in remission at 24 months (48%, 90% one-sided confidence interval 35%, 100%); this number exceeded the critical value (9) for the A’Hern design, providing evidence that the remission rate exceeded 40%. B lymphocyte count at 28 weeks (percentage of baseline value) was 18.0 in the remission group versus 46.5 in the relapse group (95% CI for difference; 8.1,48.0). There was no significant difference between remission/relapse groups in terms of total ATD dose or time to non-suppressed TSH.
Conclusions: Adjuvant RTX, administered with a 12 month course of ATD, may increase the likelihood of remission in young people with Graves’ hyperthyroidism. A formal randomised trial of adjuvant rituximab in young people with Graves’ hyperthyroidism is warranted.
Volume 77
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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