Real-world experience with cladribine tablets in people with multiple sclerosis: effectiveness data from a...

Area of Science:

• Neurology
• Immunology
• Pharmacology

Background:

• Cladribine (CLAD) is an oral disease-modifying treatment (DMT) for multiple sclerosis (MS).
• Real-world data on CLAD effectiveness beyond the initial 2-year schedule are limited.
• Understanding long-term management and outcomes is crucial for MS patient care.

Purpose of the Study:

• To evaluate the real-world effectiveness of CLAD in MS patients.
• To determine the proportion of patients achieving No Evidence of Disease Activity (NEDA-3).
• To identify factors associated with successful NEDA-3 status.

Main Methods:

• Retrospective study analyzing data from 10 Italian MS Clinics (2018-2023).
• Inclusion of 1094 MS patients treated with CLAD.
• Assessment of annualized relapse rate (ARR), radiological activity, disability progression, and NEDA-3 status.

Main Results:

• Significant reduction in ARR from 0.91 to 0.04 (p < 0.01).
• 70.2% of patients achieved NEDA-3 status.
• Younger age and lower EDSS scores were associated with higher NEDA-3 achievement; 8.9% relapsed, 22.0% had radiological activity, 7.9% disability progression.

Conclusions:

• CLAD demonstrates significant effectiveness in reducing MS disease activity.
• A substantial proportion of patients maintain NEDA-3 status.
• Treatment escalation, often with anti-CD20 therapies, is necessary for some patients with persistent disease activity.