Rituximab is not a reasonable alternative in MS treatment
ECTRIMS Online Library. Wallin M. 09/12/19; 279477; 186
Mitchell Wallin
Mitchell Wallin
Contributions
Abstract

Abstract: 186

Type: Hot Topic

Abstract Category: Hot Topic 6: B-cells in the pathogenesis of MS

M. Wallin1,2

1Neurology, George Washington University & Univeristy of Maryland, Washington, DC, 2Neurology, Dept of Veterans Affairs-MS Center of Excellence, Baltimore, MD, United States

The success of B cell-directed therapy in patients with multiple sclerosis (MS) has been highlighted and demonstrates the essential role these cells have in the pathogenesis of the disease. The chimeric anti-CD20 monoclonal antibody (mAb) rituximab (RTX) was the first anti-CD20 to be licensed for use in humans. RTX has shown promise in clinical trials in relapsing remitting multiple sclerosis (RRMS) as well as observational MS trials. More recently, the humanized anti-CD20 mAb ocrelizumab (OCR) was tested in phase III trials for relapsing MS and primary progressive multiple sclerosis (PPMS). These pivotal trials provided the support for the United States (US) Food and Drug Administration (FDA) to license OCR for both PPMS and relapsing forms of MS in 2017. Controversy has arisen as to whether RTX should be an acceptable replacement for OCR. While there is an FDA indication for RTX in the US for specific malignancies and rheumatoid arthritis, the use of RTX as an MS therapy would be considered 'off-label.' Arguments have been made regarding equivalent efficacy and convenience between RTX and OCR. However, there is a significant difference in cost, which is substantially lower for RTX. Long term safety data in patients with MS for both medications is scarce. In the near future, biosimilar development and follow-on product release for RTX and OCR will influence market share among CD-20 mAbs. The author contrasts the use of RTX and OCR for MS within these topical areas to show the unique niche for OCR at the present time in the US health care system.
Disclosure: Research funding from the US National MS Society, US Department of Defense and Veterans Affairs. I have participated in data safety monitoring boards at the US National Institutes of Health.

Abstract: 186

Type: Hot Topic

Abstract Category: Hot Topic 6: B-cells in the pathogenesis of MS

M. Wallin1,2

1Neurology, George Washington University & Univeristy of Maryland, Washington, DC, 2Neurology, Dept of Veterans Affairs-MS Center of Excellence, Baltimore, MD, United States

The success of B cell-directed therapy in patients with multiple sclerosis (MS) has been highlighted and demonstrates the essential role these cells have in the pathogenesis of the disease. The chimeric anti-CD20 monoclonal antibody (mAb) rituximab (RTX) was the first anti-CD20 to be licensed for use in humans. RTX has shown promise in clinical trials in relapsing remitting multiple sclerosis (RRMS) as well as observational MS trials. More recently, the humanized anti-CD20 mAb ocrelizumab (OCR) was tested in phase III trials for relapsing MS and primary progressive multiple sclerosis (PPMS). These pivotal trials provided the support for the United States (US) Food and Drug Administration (FDA) to license OCR for both PPMS and relapsing forms of MS in 2017. Controversy has arisen as to whether RTX should be an acceptable replacement for OCR. While there is an FDA indication for RTX in the US for specific malignancies and rheumatoid arthritis, the use of RTX as an MS therapy would be considered 'off-label.' Arguments have been made regarding equivalent efficacy and convenience between RTX and OCR. However, there is a significant difference in cost, which is substantially lower for RTX. Long term safety data in patients with MS for both medications is scarce. In the near future, biosimilar development and follow-on product release for RTX and OCR will influence market share among CD-20 mAbs. The author contrasts the use of RTX and OCR for MS within these topical areas to show the unique niche for OCR at the present time in the US health care system.
Disclosure: Research funding from the US National MS Society, US Department of Defense and Veterans Affairs. I have participated in data safety monitoring boards at the US National Institutes of Health.

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