Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2025 Oct;12(10):2152-2157.
doi: 10.1002/acn3.70160. Epub 2025 Aug 22.

Real World Effectiveness and Tolerability of Novel Monoclonal Antibodies and Rituximab for NMOSD

Zarmina Javed  1 , Mengke Du  2 , Mary Rensel  1 , Le H Hua  3 , Carrie M Hersh  3 , Justin R Abbatemarco  1 , Devon S Conway  1 , Daniel Ontaneda  1 , Jeffrey A Cohen  1 , Amy Kunchok  1
Affiliations
Multicenter Study

Real World Effectiveness and Tolerability of Novel Monoclonal Antibodies and Rituximab for NMOSD

Zarmina Javed et al. Ann Clin Transl Neurol. 2025 Oct.

Abstract

In this multicenter retrospective cohort study of 135 people with aquaporin-4 IgG+ neuromyelitis optica spectrum disorder (NMOSD), some of whom were exposed to multiple therapies, we evaluated the effectiveness and tolerability of rituximab (n = 111) and novel monoclonal antibodies (nMAbs): eculizumab (n = 9), inebilizumab (n = 23), and satralizumab (n = 14). Over a median follow-up of 3.92 years, 21/111 rituximab-treated patients relapsed. In contrast, relapse occurred in only 1/23 inebilizumab-treated patients (median follow-up 1.27 years), with no relapses observed in those receiving eculizumab or satralizumab. Twelve-month relapse-free probabilities were 92% (rituximab), 94% (inebilizumab), and 100% (eculizumab and satralizumab). Among those with available MRI data, 10/73 rituximab and 1/14 inebilizumab developed new lesions. There were no serious adverse events. These findings support nMAbs as effective and well-tolerated first-line therapies for NMOSD.

Keywords: NMOSD; effectiveness; monoclonal antibodies; rituximab; tolerability.

PubMed Disclaimer

Conflict of interest statement

Z.J./M.D.: No disclosures, M.R.: received research funding (Roche, Novartis, Biogen, Genentech, Connor B Judge (CBJ) Foundation and National Multiple Sclerosis), patient education funds (Genzyme, CBJ Foundation) also served on the Data Safety Monitoring Committee (DSMC) for Biogen, speaker or consultant for (Serono, Novartis, Genentech, Genzyme, Horizon, TG Therapeutics, Bristol Myers Squibb [BMS]), Cycle and Sanofi and is Founder of Brain Fresh LLC and Co‐Founder of Brain Ops Group. L.H.H. serves/ed as a consultant to Genentech, Novartis, EMD Serono, Genzyme, TG Therapeutics, Horizon, and Alexion; on scientific advisory boards for Novartis; and has received non‐promotional speaker honoraria for TG Therapeutics. She has received research funding paid directly to her institution from Genentech. C.M.H. received speaker, consulting, and/or advisory board fees from Biogen, Novartis, Bristol‐Myers Squibb, EMD Serono, Genentech, Genzyme, TG Therapeutics, Alexion Pharmaceuticals, and Horizon Therapeutics; she also receives research funding paid directly to her institution from Biogen, Novartis, Bristol Myers Squibb, NIH‐NINDS 1U01NS111678‐01A1 sub‐award, and Patient Centered Outcomes Research Institute. J.R.A.: served on scientific advisory boards for EMD Serono, Genentech, Horizon Therapeutics, and TG Therapeutics; has received research support from Horizon Therapeutics. D.S.C.: received grants/contracts from Bristol Myers Squibb, Biogen, Novartis, EMD Serono, Amgen. Received consulting fees from Biogen, Novartis, TG Therapeutics, and Genentech. D.O.: received research support from the National Institutes of Health, National Multiple Sclerosis Society, Patient Centered Outcomes Research Institute, Race to Erase MS Foundation, Agency for Healthcare Research and Quality, Genentech, Genzyme, and Novartis. Received consulting fees from Biogen Idec, Bristol Myers Squibb, Genentech/Roche, Genzyme, Novartis, Merck, Sanofi, and Pipeline Therapeutics. J.A.C.: received personal compensation for consulting for Astoria, Bristol‐Myers Squibb, Convelo, and Viatris, and chairing a DSMB for Celltrion. A.K.: received compensation from Genentech, Alexion, and Horizon Therapeutics.

Figures

FIGURE 1
FIGURE 1
Disease course of patients initiating novel MAbs: Prior treatments and relapse activity. Acute therapies: Intravenous methylprednisolone, intravenous immunoglobulins and plasmapheresis, AZA = azathioprine, ECU = eculizumab, INEB = inebilizumab, MMF = mycophenolate mofetil, other therapies: Cyclophosphamide, methotrexate, hydroxychloroquine, mitoxantrone, glatiramer acetate, interferon beta, teriflunomide, and prednisone. RTX = rituximab, SAT = satralizumab.
FIGURE 2
FIGURE 2
Relapse free survival in nMAbs and Rituximab. Figure is truncated at 7 years but RTX and INEB data extends to 13 and 8.5 years, respectively. 1 clinical relapse on INEB and none on ECU and SAT for median 1.27, 2.04 and 1.34 years follow‐up, respectively. Probability of relapse freedom at 1 year for RTX and INEB is 92% and 94%, respectively. ECU = eculizumab, INEB = inebilizumab, RTX = rituximab, SAT = satralizumab.
See this image and copyright information in PMC

References

    1. Pittock S. J., Berthele A., Fujihara K., et al., “Eculizumab in Aquaporin‐4‐Positive Neuromyelitis Optica Spectrum Disorder,” New England Journal of Medicine 381, no. 7 (2019): 614–625, 10.1056/NEJMoa1900866. - DOI - PubMed
    1. Wingerchuk D. M., Fujihara K., Palace J., et al., “Long‐Term Safety and Efficacy of Eculizumab in Aquaporin‐4 IgG‐Positive NMOSD,” Annals of Neurology 89, no. 6 (2021): 1088–1098, 10.1002/ana.26049. - DOI - PMC - PubMed
    1. Singh P., Gao X., Kleijn H. J., Bellanti F., and Pelto R., “Eculizumab Pharmacokinetics and Pharmacodynamics in Patients With Neuromyelitis Optica Spectrum Disorder,” Frontiers in Neurology 12 (2021): 696387, 10.3389/fneur.2021.696387. - DOI - PMC - PubMed
    1. Cree B. A. C., Bennett J. L., Kim H. J., et al., “Inebilizumab for the Treatment of Neuromyelitis Optica Spectrum Disorder (N‐MOmentum): A Double‐Blind, Randomised Placebo‐Controlled Phase 2/3 Trial,” Lancet 394, no. 10194 (2019): 1352–1363, 10.1016/S0140-6736(19)31817-3. - DOI - PubMed
    1. Traboulsee A., Greenberg B. M., Bennett J. L., et al., “Safety and Efficacy of Satralizumab Monotherapy in Neuromyelitis Optica Spectrum Disorder: A Randomised, Double‐Blind, Multicentre, Placebo‐Controlled Phase 3 Trial,” Lancet Neurology 19, no. 5 (2020): 402–412, 10.1016/S1474-4422(20)30078-8. - DOI - PMC - PubMed

Publication types

MeSH terms

LinkOut - more resources