Expanded Access Protocol of Teprotumumab (HZN-001) for Patients With Active Thyroid Eye Disease

Inclusion criteria

• . Written informed consent.
• . Male or female patient at least 18 years old.
• . Clinical diagnosis active TED with a CAS ≥ 4 (on the 7-item scale).
• . Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
• . Onset of Active TED symptoms (as determined by patient records) within approximately 12 months prior to eligibility review.
• . Patients must be euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \[FT4\] and free triiodothyronine \[FT3\] levels \< 50% above or below the normal limits) at Eligibility review. Every effort should be made to correct the mild hypo- or hyperthyroidism promptly and to maintain the euthyroid state for the full duration of participation.
• . Does not require immediate surgical ophthalmological intervention.
• . Diabetic patients must have well-controlled stable disease (defined as HbA1c \< 9.0%).

Exclusion criteria