Consolidation Therapy with Immune Reconstitution Therapy (cladribine) in Relapsing Multiple Sclerosis Patients Following a Treatment with Anti-CD20 Compounds: a Pivotal Study
To investigate the impact on IgG and IgM concentration, infection risk and effectiveness of switching from anti-CD20 to cladribine compared to continued anti-CD20 treatment over 2 years in relapsing MS patients.
• Relapsing MS according to Lublin \[23\]
⁃ EDSS ≤7.0 - Male and female patients with age \>18 years - Treatment with ocrelizumab or rituximab for ≥12 months and/or having received ≥ 1.2 / 1.0 gr, respectively - For CLAD\_GROUP: Planning to switch to cladribine because of concerns about increased risk of infections related to long term anti-CD20 therapies, defined as at least 3 infectious events/year or a serious infection under anti-CD20 and/or a documented decrease of ≥ 5% IgG and/or a level of IgG below 7 gr/L compared to pre- anti-CD20 therapy (will be considered as CLAD\_GROUP)
⁃ \- For OCR\_GROUP and RTX\_GROUP: continuing anti-CD20 therapies (considered as OCR\_GROUP and RTX\_GROUP with ocrelizumab with rituximab treatment, respectively)
⁃ \- Anti-CD20 and Cladribine are prescribed according to Swiss and European SmPC.