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.
The study population will include patients with remitting relapsing multiple sclerosis consulting the Multiple Sclerosis Center of Neurocenter of Southern Switzerland. Enrolled patients will have 5 Study Visits, one every 3 months according to clinical practice. At visits at 3 and 6 months only adverse events will be collected for study purposes. Clinical assessments will be performed at baseline, Month 6 and Month 12. Clinical assessments correspond to medical exams performed routinely in MS patients treated with anti CD20 or cladribine therapy: clinical assessments, monitoring haemoglobin parameters, serum immunoglobulins, liver and renal function.(6, 12 months), radiological disability progression and biomarker of ongoing neurodegeneration (12 months).
Study Type
OBSERVATIONAL
Enrollment
45
Treatment according to the label and medical prescription
Treatment according to the label and medical prescription
Treatment according to the label and medical prescription
Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano
Lugano, Canton Ticino, Switzerland
Changes in IgG serum concentrations in Cald-Group
Standard laboratory test
Time frame: 6 months
Changes in IgM serum concentrations in Cald-Group
Standard laboratory test
Time frame: 6 months
Changes in IgG serum concentrations in Clad-Group
Standard laboratory test
Time frame: 12 months
Changes in IgM serum concentrations in Clad-Group
Standard laboratory test
Time frame: 12 months
Changes in IgG serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies
Standard laboratory test
Time frame: 6 months
Changes in IgM serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies
Standard laboratory test
Time frame: 6 months
Changes in IgG serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies
Standard laboratory test
Time frame: 12 months
Changes in IgM serum concentrations after switching to cladribine, as compared to continued anti CD20 therapies
Standard laboratory test
Time frame: 12 months
Proportion of patients reaching NEDA -3
NEDA -3: no relapses, no disability progression, no new/enlarging or Gd enhancing brain or spinal MR lesions
Time frame: 12 months
Annualized relapse rate (ARR) over 12 months after switching to cladribine as compared to patients continuing anti CD20 therapies
ARR will be calculated based on recorded number of relapses
Time frame: 12 months
Proportion of patients with disability progression
Expanded disability scale 0-6 (6 worst outcome)
Time frame: 6 months
Proportion of patients with disability progression
Expanded disability scale 0-6 (6 worst outcome)
Time frame: 12 months
Number/volume of cumulative new T2/ enlarging lesions at brain and spinal MRI over 12 months after switching to cladribine, as compared to patients continuing anti CD20 therapies
Evaluation of MRI
Time frame: 12 months
Number/volume of cumulative Gd enhancing lesions at brain and spinal MRI over 12 months after switching to cladribine, as compared to patients continuing anti CD20 therapies
Evaluation of MRI
Time frame: 12 months
Changes in serum neurofilament light chain concentration
single-molecule array (Simoa) assay
Time frame: 12 months
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