Long-Term Ravulizumab Efficacy and Safety in AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder: Final CHAMPION-NMOSD Results.

What was studied

This was the final report of CHAMPION-NMOSD. It tested ravulizumab in adults with AQP4 antibody-positive neuromyelitis optica spectrum disorder. It was a phase 3, open-label trial. There was no placebo group in the trial itself. Instead, an outside placebo group from an eculizumab trial was used. 58 patients were enrolled. The report covers the main period and a long extension.

What they found

Of 58 patients, 56 entered and 55 finished the extension. Median follow-up was 170.3 weeks. No patient on ravulizumab had a relapse judged on the trial. Compared with an outside placebo group of 47, the risk of relapse was lower. Nearly all patients had a side effect. Some were serious. Most were mild and not linked to the drug. One patient stopped the drug because of side effects. Cases of meningococcal infection occurred in the main period, and none in the extension. One death from heart disease was not linked to ravulizumab.

What it means for patients

The authors say long-term ravulizumab kept lowering relapse risk. They say median follow-up passed 3 years. They say the safety profile was consistent with what is known for ravulizumab.

Why it is not certain yet

There was no concurrent placebo group. An outside group from another trial was used for comparison. The trial was open-label. Cases of meningococcal infection occurred.

Source

Long-Term Ravulizumab Efficacy and Safety in AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder: Final CHAMPION-NMOSD Results.

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