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Research summary · 2 d ago

AI summary · not yet reviewedHuman studyPhase 4Published in a peer-reviewed journal

Real-World Safety and Effectiveness of Cladribine Tablets in Older Patients with Relapsing Multiple Sclerosis

This observational study involving 115 patients (PwRMS) assessed the safety and effectiveness of cladribine tablets over 24 months. The mean annual relapse rate (ARR) was low at 0.07, with 73% of participants under 65 years and 27% aged 65 or older. 69.6% experienced at least one adverse event, predominantly mild-to-moderate, with lower incidences in older patients compared to younger ones.

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Source: Read original source (PMID 42905248)

This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.

Human efficacy: Not established from this source
Mechanism: Not reported
Evidence strength: Limited
Outcome: Not reported

Why it matters

The study provides insights into cladribine's safety profile across age groups in a real-world setting, particularly for older patients who are often underrepresented in clinical trials.

What this does not prove

The findings may not generalize to the broader MS population due to the underrepresentation of older patients in clinical trials, limiting the applicability of results.

Next milestone

No next milestone was established from the available source.

Study facts

Study design: Observational
Participants / samples: 115 · basis not reported
Randomised: No
Controlled: Not reported
Primary endpoint met: Yes
Relevant MS type: Not reported
Publication date: 2026-10-21
Evidence reviewed: Abstract only
Regulatory approval: Not reported
Research areas: Not classified
Biological target: Not reported
Pathway: Not reported
Population: Not reported
Size of effect: Not reported
Secondary endpoints: Not reported
MRI endpoints: Not reported
Biomarkers: Not reported
Safety: Not reported

Original sources

Primary evidenceReal-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. ↗DOI: 10.1007/s40120-026-01041-8

Supporting passages (12)

study phasePhase 4 Observational Study.

study designThis study characterized the safety and effectiveness of short-course treatment with cladribine tablets (CladT) over 24 months in PwRMS aged ≥ 50 years.

subjectsRESULTS: Of 115 PwRMS included, 84 (73.0%) were aged < 65 years and 31 (27.0%) ≥ 65 years.

sample sizeOf 115 PwRMS included

randomizedMETHODS: "Aging" was a 24-month observational, single-arm, real-world, phase 4 study conducted at 14 centers in the USA.

peer reviewedJournal Article

primary endpoint metAt 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).

publication date2026-10-21

interventionThis study characterized the safety and effectiveness of short-course treatment with cladribine tablets (CladT) over 24 months in PwRMS aged ≥ 50 years.

findingsRESULTS: 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.

limitationsTitle: 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.

peer reviewedPublication types: Journal Article

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