Teprotumumab for thyroid eye disease: early response is not required for benefit.

Abstract

PURPOSE:

In recent trials, 50% of patients treated with teprotumumab for thyroid eye disease had significant improvements in proptosis at 6 weeks. However, a small subgroup of patients did not have a significant response by week 12. We examine the outcomes at week 24 in patients from both trials who had little or no proptosis response at week 12.

DESIGN:

In this post hoc analysis, data from teprotumumab-treated patients in the placebo-controlled randomized phases 2 and 3 trials were reviewed.

METHODS:

Patients treated with teprotumumab or placebo with a ≤2 mm reduction from baseline in proptosis at week 12 and completed assessments at both the weeks 12 and 24 visits were included. The main outcome measures were a change in proptosis, clinical activity score (CAS) and diplopia in response to teprotumumab therapy at baseline and weeks 6, 12, 18, and 24.

RESULTS:

From the phases 2 and 3 studies, 24 patients from the treated and placebo groups were included for analysis (48 total). In the teprotumumab group, of the 24 who had no improvement in proptosis (≥2 mm from baseline) at 12 weeks, 15 (63%) demonstrated a clinically significant improvement at week 24. No patients from the 24 placebo patients had a clinically significant improvement in proptosis at 12 weeks, and 24 weeks. At week 12, 22 patients (92%) in the teprotumumab group had a significant reduction in the CAS (≥2 points) and at 24 weeks all patients achieved this reduction. At week 12, 11 (46%) patients from the placebo group had a significant improvement, while 10 (42%) had a significant improvement at 24 weeks. 22 of the 24 patients (92%) in the teprotumumab group had a diplopia grade > 0 at baseline. At week 12, 12 of the 22 (55%) had improvement in diplopia ≥ 1 grade. By week 24, 16 patients (73%) had an improvement in diplopia ≥ 1 grade. In the placebo group, 15 (63%) had significant diplopia. At week 12, 3 (20%) from this group had improvement in diplopia ≥ 1 grade, while at 24 weeks this number rose to 4 (27%).

CONCLUSIONS:

There is variability in the time taken to manifest a clinically significant response to teprotumumab, some patients my need a longer time to respond.

• Authors: Shoaib Ugradar, Yao Wang, Tunde Mester, George J Kahaly, Raymond S Douglas
• Journal: Eye (London, England) (Eye (Lond)) Vol. 36 Issue 7 Pg. 1403-1408 (07 2022) ISSN: 1476-5454 [Electronic] England
• PMID: 34183792 (Publication Type: Journal Article)
• Copyright: © 2021. The Author(s).

Chemical References

• Antibodies, Monoclonal, Humanized
• teprotumumab

Topics

• Antibodies, Monoclonal, Humanized (therapeutic use)
• Clinical Trials, Phase II as Topic
• Clinical Trials, Phase III as Topic
• Diplopia (drug therapy)
• Exophthalmos (drug therapy)
• Graves Ophthalmopathy (drug therapy)
• Humans
• Randomized Controlled Trials as Topic