Pharma Update
Satralizumab in thyroid eye disease
Potential disease-modifying treatment option with a well-established safety profile
Thyroid eye disease
Disease process of TED usually follows the
trajectory of Rundle's curve*
IL-6 as a potential target for treating TED
Roche
IL-6 in TED²
Ph III (SatraGo-1/SatraGo-2) trial design
Orbital volume (CT) in TED patients with or without
detectable IL-6 mRNA expression in OF (RT-PCR)
W24
W48
W72
D1 W2 W4-Q4W until W20
W24 W26 W28-Q4W until W44
Clinical Manifestations
Inflammation
Fibrosis
Active Phase
1-3 Years
Inactive Phase
3+ Years
Complex orbital inflammatory autoimmune disease¹
Retroorbital volume (mm²)
2500
P<0.05
P<0.05
P<0.05
2000
1500
1000
500
TU
0
IL-4
+
IL-6
+
IL-10
Cytokine gene expression
in orbital fat tissue
R
satralizumab n=60
1:1 placebo n=60
Primary
endpoint
Final in
Final
person
phone
visit
call
satralizumab
placebo
satralizumab / placebo
phone call follow-up
•
•
Most common orbital disease in adults, with symptoms
such as redness, dry eye, double vision, protrusion of
the eye with periorbital swelling and vision loss¹
Treatment options limited; faster and durable disease
modification needed to prevent downstream fibrosis
•
.
IL-6 is a pleiotropic cytokine produced by orbital fibroblasts, macrophages and adipocytes of TED
patients, mediating inflammation and fibrosis
Satra binds to the IL-6R, preventing IL-6 from binding, inhibiting inflammatory signalling pathways3,4
Two identical Ph III studies investigating Satra in TED (SatraGo-1/SatraGo-2) initiated Q3 2023
* Rundle's curve depicts schematically the typical course of thyroid eye disease severity with time; 1. https://eandv.biomedcentral.com/counter/pdf/10.1186/s40662-014-0009-8.pdf; 2. Hiromatsu et al. J Clin
Endocrinol Metab. 2000 Mar;85(3):1194-9; 3. Traboulsee A, et al. Lancet Neurol 2020;19:402–412; 4. Yamamura T, et al. N Engl J Med 2019;381:2114-2124; TED-Thyroid eye disease; CT-Computed tomography;
OF-Orbital fat; IL-6=interleukin-6; IL-6R-Interleukin-6 receptor; RT-PCR-Reverse transcriptase polymerase chain reaction; Satra-Satralizumab; W=week; IL-4(10)=Interleukin 4(10)
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