The following is a summary of “Factors Predicting Long-term Outcome and the Need for Surgery in Graves Orbitopathy: Extended Follow-up From the CIRTED Trial,” published in the October 2023 issue of Endocrinology by Taylor, et al.
For a study, researchers sought to conduct a three-year follow-up on a subset of the CIRTED trial participants, investigating the efficacy of medical interventions in Graves orbitopathy beyond the typical 18-month follow-up period.
The study involved a subset of the CIRTED trial, comprising 68 participants out of the original 126. The trial randomized patients to receive high-dose oral steroids with azathioprine/placebo and radiotherapy/sham radiotherapy. Assessments included a binary clinical composite outcome measure (BCCOM), modified European Group on Graves’ Orbitopathy score, Ophthalmopathy Index, and Clinical Activity Score (CAS). Quality of life and the need for surgical intervention were also evaluated.
At the three-year mark, data were available for 68 participants (54% of the original sample). No additional benefits were observed for patients randomized to azathioprine or radiotherapy concerning BCCOM, modified European Group on Graves’ Orbitopathy score, or Ophthalmopathy Index. While CAS, Ophthalmopathy Index, and Total Eye Score improved over three years (P < .001), quality of life remained poor. Surgical intervention was required for 37.5% of individuals with available data, with disease duration exceeding 6 months before treatment correlating with an increased likelihood of surgery (odds ratio 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 an elevated requirement for surgery.
Long-term outcomes from this clinical trial’s follow-up indicate ongoing suboptimal results, with persistently poor quality of life and a notable proportion requiring surgical intervention. Notably, the reduction in CAS during the first year, often considered a surrogate outcome, did not correlate with improved long-term outcomes.