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Factors predicting long-term outcome and the need for surgery in Graves orbitopathy: Extended follow-up from the CIRTED trial

Taylor, Peter ORCID:, Rajendram, Rathie, Hanna, Stephanie, Wilson, Victoria, Pell, Julie, Li, Chunhei, Cook, Anne, Gattamaneni, Rao, Plowman, Nicholas, Jackson, Sue, Hills, Robert, French, Robert ORCID:, Uddin, Jimmy M., Lee, Richard W. J. and Dayan, Colin M. ORCID: 2023. Factors predicting long-term outcome and the need for surgery in Graves orbitopathy: Extended follow-up from the CIRTED trial. The Journal of Clinical Endocrinology & Metabolism 108 (10) , pp. 2615-2625. 10.1210/clinem/dgad084

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Graves orbitopathy is both disabling and disfiguring. Medical therapies to reduce inflammation are widely used, but there is limited trial data beyond 18 months of follow-up. Methods: Three-year follow-up of a subset of the CIRTED trial (N = 68), which randomized patients to receive high-dose oral steroid with azathioprine/placebo and radiotherapy/sham radiotherapy. Results: Data were available at 3 years from 68 of 126 randomized subjects (54%). No additional benefit was seen at 3 years for patients randomized to azathioprine or radiotherapy with regard to a binary clinical composite outcome measure (BCCOM), modified European Group on Graves’ Orbitopathy score, or Ophthalmopathy Index. Clinical Activity Score (CAS), Ophthalmopathy Index, and Total Eye Score improved over 3 years (P < .001). However, quality of life at 3 years remained poor. Of 64 individuals with available surgical outcome data, 24 of 64 (37.5%) required surgical intervention. Disease duration of greater than 6 months before treatment was associated with increased need for surgery [odds ratio (OR) 16.8; 95% CI 2.95, 95.0; P = .001]. Higher baseline levels of CAS, Ophthalmopathy Index, and Total Eye Score but not early improvement in CAS were associated with increased requirement for surgery. Conclusion: In this long-term follow-up from a clinical trial, 3-year outcomes remained suboptimal with ongoing poor quality of life and high numbers requiring surgery. Importantly, reduction in CAS in the first year, a commonly used surrogate outcome measure, was not associated with improved long-term outcomes.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: Oxford University Press
ISSN: 0021-972X
Funders: None
Date of First Compliant Deposit: 24 April 2023
Date of Acceptance: 8 February 2023
Last Modified: 11 Oct 2023 17:25

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