What this means
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.
A plain-English summary is on its way. Until then, this is the start of the authors' own summary.
- Who it was tested in
- Not stated
- Kind of research
- A study
The science
- Original title
- 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.
- Authors
- Katz J, Gutierrez A, Goldstick L et al.
- Journal
- Neurology and therapy
- Published
- Oct 22, 2026
- Study type
- Study
- PMID
- 42905248 ↗
Abstract
Background
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.
What they did
"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.
What they found
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. 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.
The authors' abstract, grouped under plain headings from its own section labels.
Katz J, Gutierrez A, Goldstick L et al. 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. Neurology and therapy. 2026. doi:10.1007/s40120-026-01041-8. PMID: 42905248. https://pubmed.ncbi.nlm.nih.gov/42905248/