Teprotumumab improves clinical course of TED

Posted on June 1, 2021

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.

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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