Safety and Efficacy of Intrathecal Rituximab in Patients With Multiple Sclerosis

Treatment tested

• Rituximab

  B-lymphocyte antigen CD20 binding agent

Other measures (10)

Inclusion Criteria: * Age 18-65; * 1.0-7.5 points on the EDSS scale (for MS); * Length of illness - any; * Disease progression during the last 6 months while taking drugs of 1st and 2nd lines; * An established and confirmed diagnosis of an autoimmune disease in the previous stages of treatment; * Ineffectiveness, inaccessibility or intolerance of Disease-Modifying Therapies; * Relapse after AHSCT. * Absence of severe concomitant somatic pathology; * Left ventricular injection fraction > 50%; * Karnofsky Performance Score (KPS) > 30%; * The ability to take oral medications; * Life expectancy is more than 1 month; * Signed informed consent of the patient or legal representatives. Exclusion Criteria: * Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50% * Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted * Respiratory distress >grade I * Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits * Creatinine clearance \< 60 mL/min * Uncontrolled bacterial or fungal infection at the time of enrollment * Requirement for vasopressor support at the time of enrollment * Karnofsky performans status \<30% * Pregnancy * Somatic or psychiatric disorder making the patient unable to sign informed consent

Considering the accumulated data on the pathogenesis of multiple sclerosis, indicating a significant role of B cells in the progression of the disease, the use of monoclonal antibodies to CD20 antigen, administered intrathecally to achieve adequate B-lymphodepletion in the barrier tissues can increase the duration of the recurrence-free course of autoimmune diseases, suspend their progression, and also prevent clinical relapse when memory B cells are detected.