Observational Study of Cladribine in Humans with Relapsing Multiple Sclerosis
In a cohort of 204 relapsing MS patients treated with cladribine, 39.7% lost NEDA-3 (no evidence of disease activity) during follow-up. NEDA-3 survival rates were 82.8% at 12 months, 69.6% at 24 months, and 56.4% at 48 months. The overall annual relapse rate was low at 0.06, and relapses decreased over time. MRI activity was noted in 29.9% of patients, and 6-month confirmed disability progression occurred in 7.4%.
- Tags
- #MSResearch
- Most relevant to
- —
- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- Limited
- Outcome
- Not reported
Why it matters
These findings provide insights into the long-term effectiveness and relapse patterns following cladribine treatment in a real-world setting for MS patients. Understanding NEDA-3 loss helps gauge disease control post-treatment.
What this does not prove
The study indicates that long-term disease control after cladribine is not well-characterized with notable variability in outcomes. Not all patients achieved prolonged treatment-free remission.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- 204 · basis not reported
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- 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 evidenceLong-Term Disease Control Following Completion of Cladribine Treatment in Multiple Sclerosis: Extended Follow-Up of the CladStop Cohort. ↗DOI: 10.1111/ene.70763
Supporting passages (10)
study designPublication types: Journal Article; Multicenter Study
subjectsMeSH terms: Humans; Cladribine; Female; Immunosuppressive Agents; Follow-Up Studies; Multiple Sclerosis, Relapsing-Remitting; Male; Adult; Middle Aged; Cohort Studies; Treatment Outcome
sample sizeMETHODS: We included 204 patients with relapsing MS who completed the approved two-year cladribine regimen and had ≥ 6 months of follow-up after treatment completion.
primary endpointCo-primary endpoints were time to loss of no evidence of disease activity (NEDA-3) and annualized relapse rate (ARR) after CladStop.
findingsOverall, 81/204 patients (39.7%) lost NEDA-3.
findingsNEDA-3 survival was 82.8% (95% CI 77.8-88.2) at 12 months, 69.6% (95% CI 63.6-76.2) at 24 months, and 56.4% (95% CI 49.2-64.8) at 48 months.
findingsForty-two patients (20.6%) relapsed, with an overall ARR of 0.06 (95% CI 0.04-0.08).
limitationsTitle: Long-Term Disease Control Following Completion of Cladribine Treatment in Multiple Sclerosis: Extended Follow-Up of the CladStop Cohort.
peer reviewedPublication types: Journal Article; Multicenter Study
study designMeSH terms: Humans; Cladribine; Female; Immunosuppressive Agents; Follow-Up Studies; Multiple Sclerosis, Relapsing-Remitting; Male; Adult; Middle Aged; Cohort Studies; Treatment Outcome
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