Tocilizumab in Active, Moderate-to-Severe, Glucocorticoid-Resistant Thyroid Eye Disease: An Open-Label Prospective Study in Two Independent Cohorts - PubMed

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Tocilizumab (TCZ) was studied as a second-line therapy for glucocorticoid-resistant, active, moderate-to-severe thyroid eye disease (TED).
In an open-label prospective study across two cohorts (Warsaw, Poland and Belgrade, Serbia), patients received TCZ intravenously for four cycles.
Primary endpoints included improvement in composite ophthalmic score and Graves' ophthalmopathy quality of life (GO-QoL).
In Warsaw, 62.5% of patients met primary endpoints; in Belgrade, 100% met them.
Clinical activity score (CAS) reduction by ≥2 points occurred in 75% (Warsaw) and 100% (Belgrade) of patients.
Proptosis reduction by ≥2 mm was observed in 59.4% (Warsaw) and 58.3% (Belgrade) of patients.
Diplopia improved in 21.9% (Warsaw) and 50% (Belgrade) of patients.
Eyelid aperture decreased by ≥2 mm in 34.4% (Warsaw) and 66.7% (Belgrade) of patients.
Thyrotropin receptor antibody (TRAb) levels decreased significantly in both cohorts.
No TED deterioration was reported, and adverse events were generally acceptable, with only one severe event.
The study supports TCZ as an effective and safe second-line option for glucocorticoid-resistant TED.

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