NMOSD treatment
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Batoclimab, a neonatal Fc receptor (FcRn) antagonist, has shown neurological benefits in neuromyelitis optica spectrum disorder (NMOSD) when combined with intravenous methylprednisolone pulse (IVMP), according to a recently published study.

Although IVMP remains the most commonly used therapy for acute NMOSD attacks, only a minority of patients that receive it experience complete remission. Over 15% of patients experience no improvement at all with IVMP. Therefore, there is currently high interest in research regarding possible adjuvants to IVMP, reported Wei Qiu, MD, of the Third Affiliated Hospital of Sun Yat-Sen University in Guangzhou, China, and colleagues.

According to 2 clinical trials performed on healthy volunteers in both Western and Asian populations, batoclimab is capable of significantly reducing serum IgG levels. The authors hypothesize that batoclimab should significantly reduce pathogenic aquaporin-4 antibodies (AQP4-IgG) in patients with acute NMOSD attacks.


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The results were published online in the European Journal of Neurology.

Read more about NMOSD therapies

The researchers assessed the safety, tolerability, and efficacy of batoclimab in a population of 9 patients with NMOSD. All patients included in the study had 1 dose of subcutaneous batoclimab per week for 4 weeks. The doses varied between 340 mg and 680 mg. IVMP was also administered. The study team performed the key efficacy assessment at week 4. 

The primary study endpoint was the presence of adverse effects; secondary endpoints included changes in baseline AQP4-IgG levels and changes in baseline Expanded Disability Status Scale (EDSS).

Of the 9 patients enrolled in the study, 1 withdrew from the study voluntarily after 1 dose; treatment was discontinued in 2 patients due to hypoalbuminemia. There were no deaths or severe adverse effects during the study; however, a moderate cholesterol increase from baseline was noted.

From a pharmacodynamic standpoint, IgG levels decreased over 50% from baseline after week 1 of treatment and more than 70% by week 3, recovering 80% of baseline 9 weeks after ending treatment. At week 3 of treatment, AQP4-IgG levels were undetectable in all patients. All patients had significant EDSS improvement.

“As a conclusion, 4 consecutive weekly subcutaneous injections of batoclimab at 680 mg as add-on to IVMP are safe and tolerable in NMOSD patients. It could rapidly and deeply reduce total IgG and AQP4-IgG. Preliminary evidence suggests a beneficial neurological effect,” the study authors wrote.

Reference

Wang Y, Zhong X, Wang H, et al. Batoclimab as an add‐on therapy in neuromyelitis optica spectrum disorder patients with acute attacks. Eur Neurol. Published online September 10, 2022. doi:10.1111/ene.15561