To report our early experience using cladribine tablets in a real-world US cohort of MS patients and of a subgroup who were Black/Hispanic. Outcomes presented include patient characteristics, previous DMT use, safety, and lymphocyte counts of both groups.

The efficacy and safety of cladribine tablets 3.5 mg/kg was demonstrated in clinical trials; however, the real-world clinical experience is still emerging.  An area of growing interest is the use of disease-modifying therapies (DMTs) in racial minorities with multiple sclerosis (MS) as they have distinct disease characteristics but historically low participation in clinical trials. Understanding the risk/benefit profile of this therapy in these populations are of extreme importance.

Prospective and retrospective chart review of 72 patients with RMS who were treated with ≥1 course of cladribine tablets. A subgroup analysis was also performed for patients who were Black /Hispanic (n=26)

We report on 72 patients who have initiated therapy with cladribine tablets by data cut-off (June 2021). Median age at cladribine tablets initiation was 46 years (range 24-71) and 36% of patients were Black/Hispanic.  Median disease duration was 13 years (range 2-34) and median baseline EDSS was 3.5 (range 0-7.5). The mean number of prior DMTs was 2.5 and 31% of patients completed both treatment courses by data cut-off. Overall, cladribine tablets were well tolerated. 57% of patients experienced lymphopenia with no grade 4 reported. No serious adverse events occurred. Updated data including preliminary efficacy data will be presented.

In this cohort of patients initiating cladribine tablets in the real-world, the initial treatment was well-tolerated, even among those who are Black/Hispanic. The side effect profile was consistent with that seen in the clinical trial program.  Ongoing follow-up will further expand on these results as more patients complete their full treatment course.