Aging Study Reveals Cladribine Tablets as a Potent Option for Older Patients With MS

At the Consortium for Multiple Sclerosis Centers (CMSC) 2026 Annual Meeting, new data were released that could shift the treatment paradigm for an often-overlooked demographic: older adults living with relapsing multiple sclerosis (MS). The findings, presented from a subgroup analysis of the Aging study, suggest that cladribine tablets (Mavenclad; EMD Serono) remain highly effective and remarkably safe for patients aged 50 and older, with some of the most striking results seen in those over age 65.¹

Bridging the Data Gap

For years, a significant gap has existed in MS clinical research. Older adults with MS are frequently underrepresented in clinical trials, leaving clinicians with limited evidence regarding how disease-modifying therapies perform in an aging immune system.² This lack of data is particularly concerning given the unique challenges of aging with MS, including immunosenescence, a higher prevalence of comorbidities, and the complexities of polypharmacy.^1,2

The Aging study sought to address this evidence void. It was designed as a 24-month, observational, phase 4 study across 14 sites in the US, following 115 older adults with relapsing MS who were at least 50 years old when they initiated cladribine treatment.¹

Striking Effectiveness in the Over-65 Cohort

The study’s results highlighted impressive stabilization of the disease. Across the entire 115-patient cohort, the unadjusted annualized relapse rate (ARR) over 24 months was a low 0.10.¹

However, the data for the oldest participants—those aged 65 and older—was even more noteworthy. In this subgroup, the ARR was 0.00, meaning this group remained entirely relapse-free throughout the study period. Furthermore, a higher proportion of patients in the 65 years and older group remained relapse-free at every time point compared to their younger counterparts in the 50- to 64-year age bracket.¹

The clinical stability was further evidenced by MRI activity and disability scores. At the 24-month mark, 100% of patients with available MRI data were free from new T1 gadolinium-enhancing (T1 Gd+) lesions and new T2 lesions. Additionally, the median Expanded Disability Status Scale (EDSS) scores remained stable throughout the 2-year period, with most patients maintaining a score of less than 5.¹

A Favorable Safety Profile

Safety is a primary concern for older patients, whose immune systems may respond differently to potent disease-modifying therapies. The Aging study found that cladribine tablets demonstrated a favorable and comparable safety profile across all age groups.¹

Although approximately 70% of patients experienced at least 1 adverse event (AE), the rate of serious AEs remained low at 7%. The most common AEs reported were lymphopenia (44.3%), COVID-19 (13%), and urinary tract infections (6.1%). Interestingly, patients aged 65 and older actually showed a lower incidence of these common AEs compared to those under 65.¹

Crucially, the study reported no cases of progressive multifocal leukoencephalopathy, no opportunistic infections, no malignancies, and no deaths. Lymphopenia, a known AE of cladribine tablets, was mostly mild-to-moderate (grade 1 or 2) at the 24-month mark, with no cases of grade 4 severity observed.¹

Conclusion: Age is Not a Barrier

The investigators concluded that cladribine tablets maintain a favorable benefit-risk profile regardless of a patient’s age at the time of treatment initiation. These findings support the use of cladribine as a viable therapeutic option for older adults with relapsing MS, providing sustained effectiveness with a manageable safety profile in a population that has historically lacked clear treatment guidelines.¹

As the Aging study provides these crucial insights, it offers hope to older patients that they can effectively manage their MS without compromising their safety as they age.

REFERENCES

1. Gutierrez A. Real-world effectiveness and safety of cladribine tablets in older patients with relapsing MS: insights from the ‘aging’ study subgroup analysis. Presented at: Consortium for Multiple Sclerosis Centers (CMSC) 2026 Annual Meeting. May 28, 2026. Charlotte, NC.

2. van der Walt A, Strijbis EMM. Advancing multiple sclerosis management in older adults. Nat Rev Neurol. 2025;21(432-448). doi:10.1038/s41582-025-01115-5