2 NMOSD drugs show equal power at preventing disease relapses
Uplizna causes fewer side effects than rituximab, real-word study finds
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For adults with neuromyelitis optica spectrum disorder (NMOSD), rituximab and Uplizna (inebilizumab) work equally well to prevent disease relapses, but Uplizna appears to be safer because it causes fewer infusion-related side effects.
Those are the main findings of a real-world study analyzing data from more than 250 NMOSD patients who tested positive for self-reactive antibodies against the AQP4 protein and were treated with either therapy at two hospitals in China.
“Given the complexities of real-world management, clinical decision-making should weigh factors such as tolerability, accessibility, and convenience to optimize patient-tailored strategies,” the researchers wrote.
The study, “Efficacy and Safety of Rituximab Versus Inebilizumab in Patients With Neuromyelitis Optica Spectrum Disorder: A Dual-Center, Real-World Cohort Study,” was published in the European Journal of Neurology.
Comparisons lacking for common treatments
In NMOSD, self-reactive antibodies, most commonly those targeting AQP4, cause damaging inflammation in the eye nerves and spinal cord. Some treatments commonly used in NMOSD work by killing B-cells, the immune cells that produce antibodies, including self-reactive ones.
These include rituximab — used off label in NMOSD, except in Japan, where it is approved — and Uplizna, which is cleared for use in most regions, including China, to treat NMOSD patients positive for anti-AQP4 antibodies. Rituximab is sold as Rituxan and MabThera, with biosimilars available.
Although insurance can make Uplizna more accessible, rituximab is a practical option for patients with limited coverage because it costs less. Rituximab requires more monitoring, while Uplizna is simpler to use, with a fixed dosing schedule.
Still, it is unclear which treatment is safer and more effective for NMOSD. “Currently, direct comparative evidence remains limited,” the researchers wrote.
To learn more, they reviewed medical records from 211 NMOSD patients treated with rituximab and 65 NMOSD patients treated with Uplizna at two hospitals in China.
The main goal was to watch for differences in time to first confirmed relapse, defined as new or worsening NMOSD symptoms for longer than 24 hours, with new or enlarging lesions on MRI scans that corresponded to symptoms.
Secondary outcomes included changes in the annualized relapse rate (the number of relapses adjusted to a one-year time window), Expanded Disability Status Scale (EDSS) scores, and levels of circulating antibodies.
Statistical analyses adjusted for potential influencing factors, such as age and EDSS score at treatment start, showed that the two drugs performed similarly, with no significant difference in the time to first confirmed relapse. The annualized relapse rate decreased in both groups, by a median of 1.36 with rituximab and 2.86 with Uplizna, without significant differences between them.
There were also no significant group differences in how much EDSS scores changed over six and 12 months. The levels of anti-AQP4 antibodies were reduced in both groups, with no significant group differences at six or 12 months. However, Uplizna caused a significantly greater reduction in IgG antibodies, including those against AQP4, at six months.
Overall, adverse events were more commonly reported in the rituximab group (22.7% vs. 10.8%. Participants treated with Uplizna had 60% lower odds of experiencing adverse events compared with those on rituximab.
The higher rate of adverse events with rituximab was mainly driven by infusion-related reactions such as rash, fever, or tight throat. Uplizna reduced the odds of these specific reactions by 94%. Rates of other adverse events, such as infections, were similar between the two groups.
“Although most [infusion-related reactions] are mild and [temporary], effective management is crucial for optimizing patient adherence and confidence, particularly with rituximab,” the researchers wrote. “Thus, rigorous pre-medication and close monitoring are essential.”
Because the two treatment groups differed in some demographic and clinical features at the start of treatment, the team used propensity score matching, a statistical method that creates comparable groups. This resulted in 61 matched pairs with similar clinical characteristics.
All findings in the whole patient population remained consistent after propensity score matching, showing that both treatments “share comparable efficacy in the medium term in preventing relapses and reducing disability in [AQP4-related] NMOSD patients,” the researchers wrote. “For patients unable to tolerate rituximab, [Uplizna] may offer a favorable alternative.”
