Cladribine is an immune reconstitution therapy for multiple sclerosis (MS) that selectively produces long-term reductions in highly pathological memory B cells, with temporary reductions in other B- and T-cell subsets, thereby restoring immune function close to baseline levels in the short term (1):
- is an immune reconstitution therapy that selectively and transiently reduces CD19+ B- and T-cell levels, leading to the reconstitution of adaptive immune function
- in patients with MS, cladribine tablets (10 mg) are given as a cumulative oral dose of 3.5 mg/kg over two years (i.e., 1.75 mg/kg/year, separated by 12 months)
- each treatment course comprises two weeks per year (five days of treatment weekly), one at the beginning of the first month and another at the beginning of the second month
- if medically necessary (such as for recovery of lymphocytes), the treatment course in year 2 can be delayed for up to six months
- typically, after two years of cladribine therapy, no further treatment is required in years 3 and 4
NICE state (2)
- cladribine is recommended as an option for treating active relapsing forms of multiple sclerosis in adults, only:
- if they have active relapsing–remitting multiple sclerosis, and
- when high-efficacy disease-modifying therapies would be offered
The NICE committee stated that "..Clinical trial evidence shows that cladribine reduces relapses and increases the time until disability progresses compared with placebo. Indirect comparisons suggest that the relapse rate with cladribine is similar to that of ocrelizumab and ofatumumab..."
Reference:
- Hernandez MA, Abreu Rodriguez R, Contreras Martin Y. Cladribine Use in Relapsing Multiple Sclerosis After 8-10 Years: Two Case Reports of Patients From the ORACLE-MS Study. Cureus. 2024 Nov 28;16(11):e74671.
- NICE (April 2025). Cladribine for treating active relapsing forms of multiple sclerosis