Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy

Treatment tested

• Cladribine

  DNA inhibitor

• Rituximab

  B-lymphocyte antigen CD20 binding agent

• Ocrelizumab

  B-lymphocyte antigen CD20 binding agent

Other measures (11)

Inclusion Criteria: * Relapsing MS according to Lublin; * Treatment with ocrelizumab or rituximab for ≥18 months and having received 1.8 / 3.0 gr, respectively; * CLAD_GROUP: Planning to switch to cladribine because of concerns about increased risks of infections related to hypogammaglobulinemia developing during long term anti CD20 therapies or a documented decrease of ≥10% IgG and/or IgM compared to pre- anti CD20 therapy; * or CD20_GROUP: no need to stop CD20 therapy due decrease of ≥10% IgG and/or IgM, or increased risk of infections related to hypogammaglobulinemia or other reasons, continued anti CD20 therapies clinically indicated; * EDSS ≤7.0; * Age >18 years. Exclusion Criteria: * Non relapsing MS; * Pregnancy - breastfeeding; * Contraindications to perform MRI; * Contraindication to receive cladribine or to continue anti CD therapies

Prolonged anti CD20 therapy for the treatment of active multiple sclerosis leading to continuous B cell depletion is associated with hypogammaglobulinemia predisposing to a potentially increased risk of serious infections, particularly in the more disabled and aged patients. No data have been published on the sequential use of anti CD20 therapies and cladribine, that is thought to act as an immune reconstitution agent. his study aims at investigating IgG and IgM serum concentration changes at 6 and 12 months after switching to cladribine in patients previously treated with anti CD20 therapies (ie, ocrelizumab ≥1.8 gr or rituximab 3.0 gr) for ≥18 months, as compared to continued anti CD20 therapies.