The Phase 4 OCTAGON Study Investigating Oral Corticosteroid Tapering in Adult Patients with Generalized Myasthenia Gravis Treated with Ravulizumab: Trial in Progress
Benjamin Yungher1, Emma Weiskopf2, Rasha Aguzzi1, Guido Sabatella1
1Alexion, AstraZeneca Rare Disease, Boston, MA, 2Alexion Pharmaceuticals
Objective:
To describe OCTAGON, a phase 4, prospective, multicenter, single-arm study (NCT07221838) evaluating the effectiveness and safety of a rapid, predefined oral corticosteroid (OCS)-tapering schedule in adult patients with generalized myasthenia gravis (gMG) receiving ravulizumab.
Background:

OCS are used to treat patients with anti‑acetylcholine receptor antibody-positive (AChR-Ab+) gMG. However, high-dose therapy and long-term use—even at lower doses—are associated with substantial systemic adverse effects (AEs). Ravulizumab, a terminal complement component 5 inhibitor approved for AChR-Ab+ gMG, enables reduction and discontinuation of OCS, while maintaining symptom control. Treatment guidelines recommend steroid-sparing strategies, yet clinical practice trends employ prolonged OCS-tapering regimens with higher steroid exposure and risk of associated AEs compared with faster tapering. 

Design/Methods:

Planned enrollment: ~75 adults with gMG, receiving ravulizumab Q8W and a stable OCS regimen equivalent to a daily average of ≥7.5 mg/day for ≥4 weeks. A tapering schedule based on baseline OCS dose will be assessed. Patients with baseline OCS 7.5-10 mg/day will reduce by 2.5 mg/day Q4W to 2.5 mg/day, then by 1.25 mg/day Q4W until completion. Patients with baseline OCS >10 mg/day will reduce by 5 mg/day Q2W to 10 mg/day, then follow the schedule for those with baseline OCS 7.5-10 mg/day. Primary endpoint is the proportion of patients who discontinue OCS or reduce to ≤5 mg/day (if the reason for no further OCS reduction is suspected adrenal insufficiency) and maintain for ≥4 weeks without gMG clinical deterioration.

Results:
OCTAGON is currently recruiting.
Conclusions:
OCTAGON addresses a critical unmet need for an evidence-based rapid OCS tapering schedule in patients with gMG. Results will provide a framework for effective and safe OCS management in the targeted immunotherapy era, minimizing risks associated with prolonged corticosteroid exposure, while optimizing outcomes for patients with gMG receiving ravulizumab.
Generative AI Usage
No, did not use generative AI in the drafting or editing in this abstract.
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