The clinical course of thyroid eye disease (TED) was improved with the treatment of teprotumumab in all patient subgroups, according to a study examining short-term and long-term aggregate response from 2 trials.
In this study, the integrated outcomes and follow-up data from 2 trials including adult patients with Graves’ disease and active TED were analyzed. Patients were treated with 8 intravenous infusions of either teprotumumab (n =84) or placebo (n = 87) every 3 weeks.
At week 24, a reduction of at least 2 mm in proptosis was achieved in more patients in the treatment group than in the placebo group (77% vs 15%). The stratified treatment difference was 63%.
Numbers-needed-to-treat (NNT) were as follows:
-1.6 for proptosis response
-2.5 for diplopia response
-1.7 for overall response
-2·5 for disease inactivation
An ophthalmic composite outcome of “improvement in ≥1 eye from baseline without deterioration in either eye in ≥2 of the following: absence of eyelid swelling; CAS ≥2; proptosis ≥2 mm; lid aperture ≥2 mm; diplopia disappearance or grade change; or improvement of 8 degrees of globe motilit” was reached in 81% of patients in the treatment group and 44% of patients in the placebo group, according to a post-hoc assessment.
In all subgroups at week 24, there were significantly more proptosis responders treated with teprotumumab. For all subgroups except tobacco users and patients with thyrotropin binding inhibiting immunoglobulin <10 IU/L at baseline, diplopia responders were significantly higher with teprotumumab.
Integrated treatment differences for proptosis and diplopia ranged from 47% in tobacco users to 83% in patients aged 65 years and older and from 29% in tobacco users to 47% in those with baseline CAS of 6 or 7, respectively.
In 87% of patients (n = 71), integrated responses were observed at 7 weeks after final dose for proptosis, and 67% (n = 57) at 51 weeks after final dose.
Reference
Kahaly PGJ, Douglas RS, Holt RJ, et al. Teprotumumab for patients with active thyroid eye disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomised, double-masked, placebo-controlled, multicentre trials. Lancet Diabetes Endocrinol. 2021; DOI: https://doi.org/10.1016/S2213-8587(21)00056-5
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