Early clinical experience with cladribine tablets in a Black/Hispanic patient population (P9-3.001)

Abstract

<h3>Objective:</h3> 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. <h3>Background:</h3> 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. <h3>Design/Methods:</h3> 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) <h3>Results:</h3> 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. <h3>Conclusions:</h3> 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. <b>Disclosure:</b> Dr. Gutierrez has nothing to disclose. Dr. Ochoa has nothing to disclose.