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Aging: cladribine tablets in people 50 and older

Published by MyelinWatch:

Organisation
Neurology and Therapy
Study sponsor
EMD Serono Research & Development Institute, Inc.
Funder
EMD Serono Research & Development Institute, Inc.

Aging (cladribine tablets) · The US Aging study observed people aged 50 or older with relapsing multiple sclerosis (MS) after starting cladribine tablets, which reduce selected immune-cell populations. It was a 24-month Phase 4 observational study without a comparator.

What is being studied

The US Aging study observed people aged 50 or older with relapsing multiple sclerosis (MS) after starting cladribine tablets, which reduce selected immune-cell populations. It was a 24-month Phase 4 observational study without a comparator.

Research stage

Completed human study

Follow-up completed; results published

What we know so far

Among 115 participants, the observed annualised relapse rate was 0.07 over 24 months. Adverse events occurred in 69.6%, serious adverse events in 7.0%, and lymphopenia in 44.3%. Only 31 participants were 65 or older. These are descriptive observations.

What this means for patients today

The findings may inform clinical discussion but cannot prove effectiveness or comparative safety. Patient selection, retention and incomplete imaging limit interpretation. The US paper does not establish Greek access or reimbursement.

Treatment or approach
Cladribine tablets in relapsing MS after age 50
How it is intended to work
Cladribine tablets reduce selected immune-cell populations
Where the study is running
United States; Greek access unverified
Source: Neurology and Therapy — peer-reviewed research article ↗Source: PubMed — Aging original article, PMID 42905248 ↗
Published by MyelinWatch
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  1. Peer-reviewed Phase 4 single-arm observational study in 115 US patients with relapsing MSResearch event/source date:

    Cladribine tablets after age 50: 24-month Aging study published

    The Aging study followed 115 US patients aged 50 or older with relapsing multiple sclerosis (MS) who received cladribine tablets. Over 24 months the observed annualised relapse rate was 0.07. At least one adverse event occurred in 80/115 (69.6%), a serious adverse event in 8/115 (7.0%), and lymphopenia in 51/115 (44.3%). Only 31 participants were aged 65 or older.

    Source: Neurology and Therapy — peer-reviewed research article ↗Source: PubMed — Aging original article, PMID 42905248 ↗