Ravulizumab Prevents Neuromyelitis Optica Spectrum Disorder Relapse Over 73 Weeks

In the phase 3 CHAMPION-NMOSD trial (NCT04201262), ravulizumab (Ultomiris; Alexion, Wilmington, DE) prevented neuromyelitis optica spectrum disorder (NMOSD) relapses in 58 people with antiaquaporin 4 positivity (antiAQP4+). Ravulizumab was administered as an intrvenous infusion every 8 weeks over the 73-week trial. 

The relapse rate in the CHAMPION-NMOSD trial was a statistically significant improvement when compared with the 45% relapse rate seen in participants with NMOSD/antiAQP4+ treated with placebo for 144 weeks in the PREVENT trial (NCT02003144) of eculizumab (Soliris, Alexion).

Ravulizumab is a long-acting C5 complement inhibitor, recently approved to treat generalized myasthenia gravis (gMG). The successful treatment of NMOSD thus suggests ravulizumab may be effective for multiple autoimmune diseases mediated by IgG antibodies. 

Marc Dunoyer, chief executive officer, Alexion, said: “Soliris established the role of complement inhibition in preventing relapses in NMOSD, and with ravulizumab, we continue to innovate for patients with a more convenient every 8-week dosing schedule. These trial results show that Ultomiris may help patients move towards eliminating relapses, which is an important advancement in the treatment of NMOSD.”

A majority (56/58) of participants in CHAMPION-NMOSD are continuing to receive treatment in a long-term extension period. 

Adverse events that may occur with ravulizumab is an infusion reaction. The reaction may cause lower back pain, tiredness, feeling faint, discomfort in your arms or legs, or bad taste.