Proof-of-concept and Randomized, Placebo-controlled Trials of an FcRn Inhibitor, Batoclimab, for Thyroid Eye Disease
- randomized trial terminated early
Authors' conclusion
These results provide insight into the efficacy and safety of batoclimab and support its further investigation as a potential therapy for TED.
Study context
- Population
- Patients with moderate-to-severe, active thyroid eye disease (TED); multicentre65 of planned 77 analyzed
- Comparison
- Weekly SC batoclimab vs placebo
- Primary endpoint
- Change from baseline in serum anti-TSH-R-Ab and total IgG (POC); proptosis response (randomized trial)
- Follow-up
- 12 weeks (randomized trial)
Methodological detailsdouble-blind, placebo-controlled, multicentre, randomized 2:2:1:2, Randomized trial terminated because of an unanticipated increase in serum cholesterol
- Double-blind
- Placebo-controlled
- Multicentre
- Randomized 2:2:1:2
- Randomized trial terminated because of an unanticipated increase in serum cholesterol
Primary result
As reported in the abstract
12 weeks
- Marked decreases in pathogenic anti-TSH-R-Ab and total IgG serum levels with batoclimab, both trials
- P < .001
Further findings
Orbital muscle volume (680 mg) · 12 weeks
- Orbital muscle volume decreased with batoclimab 680 mg
- P < 0.03
Quality of life, appearance subscale (680 mg) · 19 weeks
- Quality of life (appearance subscale) improved with batoclimab 680 mg
- P < 0.03
Safety
- Generally well tolerated; albumin reductions and lipid increases that reversed upon discontinuation
- Randomized trial terminated because of unanticipated increase in serum cholesterol
Original publication
Proof-of-concept and Randomized, Placebo-controlled Trials of an FcRn Inhibitor, Batoclimab, for Thyroid Eye Disease. J Clin Endocrinol Metab. Published 30 June 2023. doi:10.
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