Neurology and therapy · 2026
Real-World Safety and Effectiveness of Cladribine Tablets in Older (≥ 50 Years) Patients with Relapsing Multiple Sclerosis: Results from the "Aging" Study-A Multicenter, Single-Arm, Phase 4 Observational Study.
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Katz Joshua, Gutierrez Amy, Goldstick Lawrence, Koelbach Ralf, Aldridge Julie, Caon Christina, Chandler Angela, Hughes Bruce
Аннотация
INTRODUCTION: Older patients with relapsing multiple sclerosis (PwRMS) are often underrepresented in clinical trials, limiting evidence on the safety and effectiveness of disease-modifying therapies. This study characterized the safety and effectiveness of short-course treatment with cladribine tablets (CladT) over 24 months in PwRMS aged ≥ 50 years.
METHODS: "Aging" was a 24-month observational, single-arm, real-world, phase 4 study conducted at 14 centers in the USA. PwRMS aged ≥ 50 years who initiated CladT (cumulative dose 3.5 mg/kg over 2 years) on/before January 31, 2022 were included. The primary endpoint was annualized relapse rate (ARR) at 24 months after CladT initiation. Additional clinical, imaging, disability, and safety endpoints were assessed. Post hoc subgroup analyses were conducted by age.
RESULTS: Of 115 PwRMS included, 84 (73.0%) were aged < 65 years and 31 (27.0%) ≥ 65 years. At 24 months, mean ARR was low overall and in both subgroups-total: 0.07 (95% confidence interval [CI] 0.03-0.12), < 65 years: 0.10 (95% CI 0.03-0.16), ≥ 65 years: 0.02 (95% CI - 0.02 to 0.05). Safety profiles were comparable across age groups: ≥ 1 adverse event (AE) occurred in 80/115, 69.6% of PwRMS (< 65 years: 60/84, 71.4%; ≥ 65 years: 20/31, 64.5%), and serious AEs in 8/115, 7.0% (< 65 years: 6/84, 7.1%; ≥ 65 years: 2/31, 6.5%). Lymphopenia (51/115, 44.3%), COVID-19 (15/115, 13.0%), and urinary tract infections (7/115, 6.1%) were the most frequent AEs and predominantly mild-to-moderate; PwRMS aged ≥ 65 years had lower incidences than those < 65 years. Median lymphocyte counts were stable; most lymphopenia events were grade 1-2; no grade 4 lymphopenia occurred. AE-related treatment discontinuation rates were low and similar across age groups. No unexpected safety concerns, malignancies, opportunistic infections, or deaths occurred.
CONCLUSION: In older PwRMS, CladT was found to be effective with a favorable safety profile at 2 years, including in PwRMS aged ≥ 65 years. These findings support the therapeutic value of CladT in older PwRMS. Infographic available for this article. INFOGRAPHIC.
METHODS: "Aging" was a 24-month observational, single-arm, real-world, phase 4 study conducted at 14 centers in the USA. PwRMS aged ≥ 50 years who initiated CladT (cumulative dose 3.5 mg/kg over 2 years) on/before January 31, 2022 were included. The primary endpoint was annualized relapse rate (ARR) at 24 months after CladT initiation. Additional clinical, imaging, disability, and safety endpoints were assessed. Post hoc subgroup analyses were conducted by age.
RESULTS: Of 115 PwRMS included, 84 (73.0%) were aged < 65 years and 31 (27.0%) ≥ 65 years. At 24 months, mean ARR was low overall and in both subgroups-total: 0.07 (95% confidence interval [CI] 0.03-0.12), < 65 years: 0.10 (95% CI 0.03-0.16), ≥ 65 years: 0.02 (95% CI - 0.02 to 0.05). Safety profiles were comparable across age groups: ≥ 1 adverse event (AE) occurred in 80/115, 69.6% of PwRMS (< 65 years: 60/84, 71.4%; ≥ 65 years: 20/31, 64.5%), and serious AEs in 8/115, 7.0% (< 65 years: 6/84, 7.1%; ≥ 65 years: 2/31, 6.5%). Lymphopenia (51/115, 44.3%), COVID-19 (15/115, 13.0%), and urinary tract infections (7/115, 6.1%) were the most frequent AEs and predominantly mild-to-moderate; PwRMS aged ≥ 65 years had lower incidences than those < 65 years. Median lymphocyte counts were stable; most lymphopenia events were grade 1-2; no grade 4 lymphopenia occurred. AE-related treatment discontinuation rates were low and similar across age groups. No unexpected safety concerns, malignancies, opportunistic infections, or deaths occurred.
CONCLUSION: In older PwRMS, CladT was found to be effective with a favorable safety profile at 2 years, including in PwRMS aged ≥ 65 years. These findings support the therapeutic value of CladT in older PwRMS. Infographic available for this article. INFOGRAPHIC.