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Rituximab Trial Involving People with Secondary-Progressive MS Terminated Early

March 2, 2016

Summary
  • A small clinical trial was underway to determine whether rituximab (an antibody that depletes immune B cells) could reduce brain atrophy in people with secondary-progressive MS
  • An interim analysis of the trial revealed that the treatment did not sufficiently remove immune cells from the spinal fluid, leading investigators to terminate the study early.
  • B cell-depleting therapies remain under study for the treatment of MS. Positive results were reported in 2015 on ocrelizumab – an antibody that also depletes B cells – in people with primary-progressive MS.
  • The team (Drs. Mika Komori, Bibiana Bielekova, and others at the National Institutes of Health, Bethesda, MD) has published results in Annals of Clinical and Translational Neurology (published online, February 1, 2016).
Background: Currently available disease-modifying therapies for relapsing forms of MS generally are not effective in people with progressive forms of MS who do not experience relapses or show other signs of active inflammation. Recent research suggests that inflammation may be occurring within compartments of the brain and spinal cord in progressive MS, where current therapies do not reach because the blood-brain barrier limits what can gain access to the brain from the bloodstream.

Researchers at the National Institutes of Health launched a small, controlled clinical trial to understand whether the medication rituximab, which is used to treat rheumatoid arthritis and some types of cancer, is able to slow down or stop the progression of secondary-progressive MS. Rituximab depletes immune B cells, which are thought to play a role in immune-system-mediated damage to nervous system tissues in MS. This study investigated whether rituximab would reach the brain and spinal cord if participants received it by both intravenous (by vein) and intrathecal infusion (through a lumbar puncture into the cerebrospinal fluid, or “spinal tap”). The dynamics of how B cells are reduced, whether in spinal fluid, or from the central nervous system, remain unclear.

The Study:  Investigators recruited 27 people with secondary-progressive MS, and randomly assigned them to receive either rituximab or placebo through both intravenous (2 infusions) and intrathecal infusion (2 infusions). The primary outcome measure was to determine whether rituximab could decrease brain atrophy – loss of brain tissue volume – significantly more than placebo. However, the investigators planned an interim analysis to determine if B cells were being depleted in the spinal fluid as an indirect way of measuring whether the rituximab was getting into the central nervous system.
 
The interim analysis revealed that B cells in the spinal fluid were not depleted sufficiently, suggesting that rituximab would not be able to achieve the desired endpoint. The team also found that a biochemical indicator of nerve damage, called neurofilament light chain, did not change as a result of the treatment. Therefore, the study was terminated.
 
The team (Drs. Mika Komori, Bibiana Bielekova, and others, National Institutes of Health, Bethesda, MD) has published results in Annals of Clinical and Translational Neurology
(published online, February 1, 2016).
 
Next Steps: B cell-depleting therapies remain under study for the treatment of MS, including progressive MS. Recently, positive results were reported in 2015 on ocrelizumab – an antibody that also depletes B cells – in people with primary-progressive MS and relapsing MS.
 
Read more about current research in progressive MS

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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