- Phase III METEOROID (Genentech) showed satralizumab (IL-6 receptor mAb) reduced time-to-first MOGAD relapse by 68% versus placebo (p=0.0025), with response onset by ~8 weeks.
- At 48 weeks 87% on satralizumab were relapse-free vs 67% on placebo; annualized relapse rate fell 66% (p=0.0030) and annualized MRI-active lesion rate dropped 79%.
- Randomized double-blind placebo-controlled trial in patients >=12 used SC satralizumab 60/120/180 mg at weeks 0, 2, 4 then every 4 weeks; double-blind period ended after 28 adjudicated relapses and data will be submitted to regulators.
Phase III METEOROID: primary outcome
METEOROID met its primary endpoint: satralizumab reduced risk of a new MOGAD relapse by 68% versus placebo (time-to-first-relapse; p=0.0025), with response onset around 8 weeks; 87% of patients on satralizumab were relapse-free versus 67% on placebo at 48 weeks.
Efficacy secondary outcomes
Annualized relapse rate decreased 66% (p=0.0030); annualized rate of active MRI lesions across optic nerves, brain and spinal cord fell 79% (p=0.0026); proportion receiving rescue therapy declined 73% (p=0.0024); inpatient hospitalizations were 17% lower versus placebo (p=0.7528, not significant).
Safety
No new safety signals were reported and the safety profile was consistent with prior data; adverse events ≥5% more common with satralizumab included injection-related reactions (16%), influenza (9%), arthralgia (9%), back pain (9%), sinusitis (7%) and diarrhea (6%); treatment interruptions were low (6% satralizumab, 5% placebo); one fatality was reported as not related to treatment and serious AEs were not considered treatment-related.
Study design and next steps
The randomized, double-blind, placebo-controlled METEOROID trial enrolled patients aged ≥12 and used subcutaneous satralizumab (60/120/180 mg by weight) at weeks 0, 2 and 4 then every 4 weeks; the double-blind period was event-driven and ended after 28 adjudicated relapses, with an open-label extension available; data will be submitted to regulatory authorities.
