| Presentation preference | Oral presentation |
| Title | Interleukin-6 receptor (IL-6R) signaling inhibition with satralizumab in thyroid eye disease (TED): phase 3 SatraGO-1 and SatraGO-2 trial design |
| Accept poster if oral is not possible ? | Yes |
| Purpose | TED is an inflammatory orbitopathy that can cause facial disfigurement and vision loss. Disease-modifying treatments are needed as current therapies for active TED may be ineffective, cause relapses, or lead to side-effects, while inactive TED is largely treated surgically. Interleukin-6 (IL-6) and its receptor (IL-6R) are implicated in TED pathogenesis. Satralizumab, a humanized monoclonal anti–IL-6R antibody with recycling technology, enhances IL-6 suppression to address inflammation, with subcutaneous (SC) dosing every 4 weeks (Q4W). We describe the SatraGO-1 and SatraGO-2 trials evaluating satralizumab in TED. |
| Methods | SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828) are identical, global, phase 3, randomized, double-masked, placebo-controlled, 72-week trials to recruit ~120 participants (pts) across ~70 sites in 20 countries. Pts ≥18 years with moderate-to-severe active or stable inactive TED are eligible if the systemic disease is controlled (euthyroid or mild hyper-/hypothyroidism). Pts will be randomized 1:1 to SC satralizumab or placebo at weeks (W) 0, 2, and 4 (loading doses), then Q4W through W20. From W24, nonresponders continue satralizumab Q4W; proptosis responders re-randomized to satralizumab or placebo Q4W through W44. |
| Results | Primary endpoint: proportion of active TED pts achieving a proptosis response (≥2 mm proptosis improvement from baseline) at W24. Safety outcomes include incidence, seriousness, and severity of adverse events. |
| Conclusion | SatraGO-1 and SatraGO-2 are investigating IL-6R inhibition via satralizumab as a potential disease-modifying treatment in TED with reduced safety risks vs current options. |
| Conflict of interest | No |
1
| Last name | CORONEL |
| Initials of first name(s) | M |
| Department | Charles Research Center Paraguay 1896, Piso 2 C1121ABB |
| City | Buenos Aires |
| Country | Argentina |
2
| Last name | Ezra |
| Initials of first name(s) | D |
| Department | Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London |
| City | London |
| Country | United Kingdom |
3
| Last name | Collins |
| Initials of first name(s) | A |
| Department | Ophthalmology, Oculoplastic Surgery, Kaiser Permanente |
| City | Fresno, CA |
| Country | United States |
4
| Last name | Stan |
| Initials of first name(s) | M |
| Department | Endocrinology, Chair Thyroid Core Group, Mayo Clinic |
| City | Rochester, MN |
| Country | United States |
5
| Last name | Haskova |
| Initials of first name(s) | Z |
| Department | Genentech, Inc. |
| City | South San Francisco, CA |
| Country | United States |
6
| Last name | Kuenzel |
| Initials of first name(s) | T |
| Department | F. Hoffmann-La Roche Ltd. |
| City | Basel |
| Country | Switzerland |
7
| Last name | Triyatni |
| Initials of first name(s) | M |
| Department | F. Hoffmann-La Roche Ltd. |
| City | Basel |
| Country | Switzerland |
8
| Last name | Idowu |
| Initials of first name(s) | O |
| Department | Genentech, Inc. |
| City | South San Francisco, CA |
| Country | United States |
