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Lookup NU author(s): Professor Timothy Cheetham, Mike Cole, Dr Mario Abinun, Dr Sonya Carnell, Jon Prichard, Gillian WatsonORCiD, Professor Sophie Hambleton, Professor John MatthewsORCiD, Professor Simon PearceORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. CONTEXT: Remission rates in young people with Graves hyperthyroidism are less than 25% after 2 years of thionamide antithyroid drug (ATD). OBJECTIVE: We explored whether rituximab (RTX), a B-lymphocyte-depleting agent, would increase remission rates when administered with a short course of ATD. METHODS: This was an open-label, multicenter, single-arm, phase 2 trial in young people (ages, 12-20 years) with Graves hyperthyroidism. An A'Hern design was used to distinguish an encouraging remission rate (40%) from an unacceptable rate (20%). Participants presenting with Graves hyperthyroidism received 500 mg RTX and 12 months of ATD titrated according to thyroid function. ATDs were stopped after 12 months and primary outcome assessed at 24 months. Participants had relapsed at 24 months if thyrotropin was suppressed and free 3,5,3'-triiodothyronine was raised; they had received ATD between months 12 and 24; or they had thyroid surgery/radioiodine. RESULTS: A total of 27 participants were recruited and completed the trial with no serious side effects linked to treatment. Daily carbimazole dose at 12 months was less than 5 mg in 21 of 27 participants. Thirteen of 27 participants were in remission at 24 months (48%, 90% one-sided CI, 35%-100%); this exceeded the critical value (9) for the A'Hern design and provided evidence of a promising remission rate. B-lymphocyte count at 28 weeks, expressed as a percentage of baseline, was related to likelihood of remission. CONCLUSION: Adjuvant RTX, administered with a 12-month course of ATD, may increase the likelihood of remission in young people with Graves hyperthyroidism. A randomized trial of adjuvant RTX in young people with Graves hyperthyroidism is warranted.
Author(s): Cheetham TD, Cole M, Abinun M, Allahabadia A, Barratt T, Davies JH, Dimitri P, Drake A, Mohamed Z, Murray RD, Steele CA, Zammitt N, Carnell S, Prichard J, Watson G, Hambleton S, Matthews JNS, Pearce SHS
Publication type: Article
Publication status: Published
Journal: Journal of Clinical Endocrinology and Metabolism
Year: 2022
Volume: 107
Issue: 3
Pages: 743-754
Print publication date: 01/03/2022
Online publication date: 23/10/2021
Acceptance date: 18/10/2021
Date deposited: 14/03/2022
ISSN (print): 0021-972X
ISSN (electronic): 1945-7197
Publisher: Oxford University Press
URL: https://doi.org/10.1210/clinem/dgab763
DOI: 10.1210/clinem/dgab763
PubMed id: 34687316
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