A recent study has demonstrated that neuromyelitis optica spectrum disorder (NMSOD) patients treated with eculizumab have a lower risk of adjudicated relapse compared to those treated with placebo.
This study specifically examined this treatment in patients who had been treated with rituximab in the past.
PREVENT
A past trial, called PREVENT, demonstrated that NMSOD patients who were given eculizumab instead of a placebo had a lower risk of relapse.
In this investigation, 46 of the patients had been given rituximab in the past. However, this trial did not specifically investigate the safety or efficacy of eculizumab treatment in this patient population.
The new study aimed to evaluate this group of patients specifically.
The New Study
This study was a post-hoc analysis of the 46 aquaporin-4 immunoglobulin G-positive NMOSD patients who had participated in the PREVENT trial. This subgroup of patients had similar characteristics to the rest of the trial participants at baseline except that the subgroup had a smaller percentage of Asian patients and a larger proportion of individuals from North and South America.
All of the patients had been given rituximab within the past year. All of them had received the therapy more than 3 months before the PREVENT trial began.
Of the 46 individuals, 26 were a part of the eculizumab group and 20 were a part of the placebo group. The treatment group was given 1200mg of eculizumab every 2 weeks. The placebo group was also given placebo every 2 weeks.
Results
Eculizumab group
- One of the 26 individuals faced adjudicated relapse
- The AE rates in this group were 1025.8/100 patient-years
- The rate of serious AEs was 46.9/100 patient-years
- 11.1% of patients faced serious infections
Placebo group
- Seven of 20 individuals faced adjudicated relapse
- The AE rates in this group were 1029.1/100 patient-years
- The rate of serious AEs was 66.0/100 patient-years
- 11.8% of patients faced serious infections
Ultimately this trial showed that among those patients treated with rituximab in the past, the risk of relapsing was less with eculizumab treatment than treatment with the placebo. However, the rate of severe infections was similar among the groups.
You can read more about this new study here.
Reference
Levy M, Berthele A, Kim HJ, et al. Efficacy and safety of eculizumab in patients with neuromyelitis optica spectrum disorder previously treated with rituximab: findings from PREVENT. Presented at: CMSC 2021 Annual Meeting; October 25-28, 2021; Orlando, Florida. Abstract DMT48.
