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Abstract Details

Early clinical experience with cladribine tablets in a Black/Hispanic patient population
Multiple Sclerosis
P9 - Poster Session 9 (5:30 PM-6:30 PM)

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.

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.

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.

Christine Ochoa, MD (Orlando Health)
Dr. Ochoa has nothing to disclose.
Amparo Gutierrez, MD, FAAN (Orlando Health) Dr. Gutierrez has nothing to disclose.