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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, P. ; Rajendram, R. ; Hanna, S. ; Wilson, V. ; Pell, J. ; Li, C. ; Cook, A. ; Gattamaneni, Rao ; Plowman, N. ; Jackson, S. ... show 5 more
Taylor, P.
Rajendram, R.
Hanna, S.
Wilson, V.
Pell, J.
Li, C.
Cook, A.
Gattamaneni, Rao
Plowman, N.
Jackson, S.
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Abstract
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: 3 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 randomised 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, modified EUGOGO score or Ophthalmopathy Index.Clinical Activity Score (CAS), Ophthalmopathy Index and Total Eye Score improved over 3 years (p<0.001). However, quality of life at 3 years remained poor. Of 64 individuals with available surgical outcome data, 24/64 (37.5%) required surgical intervention. Disease duration of greater than 6 months before treatment was associated with increased need for surgery OR=16.8 (95%CI 2.95, 95.0) p=0.001. 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.
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2023
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Taylor P, Rajendram R, Hanna S, Wilson V, Pell J, Li C, et al. 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 and metabolism. 2023 Mar 27. PubMed PMID: 36971324. Epub 2023/03/28. eng.