Obinutuzumab β for aquaporin-4-positive neuromyelitis optica spectrum disorder: a phase 3 randomized controlled trial.

What was studied

This was a phase 3 trial in neuromyelitis optica spectrum disorder (NMOSD). The patients tested positive for AQP4-IgG. It was multicenter, randomized and double-blind. Obinutuzumab β is a new anti-CD20 antibody. Adults aged 18-70 years were randomized 1:1. 45 got obinutuzumab β 1,000 mg by vein and 46 got placebo.

What they found

The main goal was time to first relapse by week 52. It was met. 21 of 46 placebo patients had a relapse. Far fewer treated patients had one. The hazard ratio was 0.069, with a range of 0.016-0.296. Grade 3 or higher treatment-related adverse events were similar in both groups.

What it means for patients

The authors said these findings support obinutuzumab β as a treatment option for AQP4-IgG-positive NMOSD. They described it as a glycoengineered anti-CD20 therapy.

Why it is not certain yet

The abstract notes that large randomized trials of B cell depletion had been limited before. The groups had 45 and 46 people. The main goal was checked up to week 52. A trial of this size may miss rare side effects.

Source

Obinutuzumab β for aquaporin-4-positive neuromyelitis optica spectrum disorder: a phase 3 randomized controlled trial.

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