Neurology. 2018 Oct 10. pii: 10.1212/WNL.0000000000006500. doi: 10.1212/WNL.0000000000006500. [Epub ahead of print]
OBJECTIVES:
To perform a phase 1b assessment of the safety and feasibility of intrathecally delivered rituximab as a treatment for progressive multiple sclerosis (PMS) and to evaluate the effect of treatment on disability and CSF biomarkers during a 1-year follow-up period.
METHODS:
Three doses of rituximab (25 mg with a 1-week interval) were administered in 23 patients with PMS via a ventricular catheter inserted into the right frontal horn and connected to a subcutaneous Ommaya reservoir. Follow-ups were performed at 1, 3, 6, 9, and 12 months.
RESULTS:
Mild to moderate vertigo and nausea were common but temporary adverse events associated with intrathecal rituximab infusion, which was otherwise well tolerated. The only severe adverse event was a case of low-virulent bacterial meningitis that was treated effectively. Of 7 clinical assessments, only 1 showed statistically significant improvement 1 year after treatment. No treatment effect was observed during the follow-up period among 6 CSF biomarkers.
CONCLUSIONS:
Intrathecal administration of rituximab was well tolerated. However, it may involve a risk for injection-related infections. The lack of a control group precludes conclusions being drawn regarding treatment efficacy.
There have been a number of rituximab trials in progressive MS and there have been a failures. There have been at least four intra thecal trials and they show that the antbody rapidly enters the blood and doesnt do much to the B cells in the brain. The plasma cells do not express CD 20 and so they are not touched. So why do yet another trial. In the past intrathecal studies, they delivered the the drug into the spinal space. IThe flow is down and out. So in this stud,y they injected into the brain. Will it show anthing?