MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study

  title={MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study},
  author={Giancarlo Comi and Stuart D. Cook and Gavin Giovannoni and Kottil Rammohan and Peter Rieckmann and Per Soelberg S{\o}rensen and Patrick Vermersch and Anthony Hamlett and Vissia Viglietta and Steven J. Greenberg},
  journal={Journal of Neurology},
We herein provide a comprehensive assessment of magnetic resonance imaging (MRI) outcomes from CLARITY, a 96-week, double-blind study demonstrating significant clinical and MRI improvements in patients with relapsing–remitting multiple sclerosis (RRMS) treated with cladribine tablets. Patients with RRMS were randomized 1:1:1 to annual short-course therapy with cladribine tablets cumulative dose 3.5 or 5.25 mg/kg or placebo. MRI endpoints included mean number of T1 gadolinium-enhancing (Gd… 

Long-term effects of cladribine tablets on MRI activity outcomes in patients with relapsing–remitting multiple sclerosis: the CLARITY Extension study

A 2-year treatment with CT 3.5 mg/kg has a durable effect on MRI outcomes in the majority of patients, an effect that was sustained in patients who were not retreated in the subsequent 2 years after initial treatment.

Efficacy of Cladribine Tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: A post hoc analysis of the CLARITY study

Patients with HDA showed clinical and MRI responses to Cladribine Tablets 3.5 mg/kg that were generally better than, or at least comparable with, the outcomes seen in the overall CLARITY population.

Early MRI outcomes in participants with a first clinical demyelinating event at risk of multiple sclerosis in the ORACLE-MS study

  • M. FreedmanP. Coyle T. Leist
  • Medicine, Psychology
    Multiple sclerosis journal - experimental, translational and clinical
  • 2021
In participants with an FCDE, cladribine tablets appeared to reduce lesion numbers within 13 weeks (time of first evaluation) in participants with a first clinical demyelinating event.

Early Reduction of MRI Activity During 6 Months of Treatment With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis

Class IV evidence is provided that, in patients with highly active relapsing MS, treatment with cladribine tablets is associated with an early onset of action with reductions in active MRI lesion counts from month 2 (day 60) onward, with an increasing reduction in such lesions over time.

Predictors of Cladribine Effectiveness and Safety in Multiple Sclerosis: A Real-World, Multicenter, 2-Year Follow-Up Study

Previous data about cladribine effectiveness on disease activity and disability worsening and information on response predictors that might inform therapeutic choices are confirmed and provided.

Effects of delayed-release dimethyl fumarate on MRI measures in the phase 3 CONFIRM study

The robust effects on MRI active lesion counts and total lesion volume in patients with RRMS demonstrate the ability of DMF to exert beneficial effects on inflammatory lesion activity in multiple sclerosis, and support DMF therapy as a valuable new treatment option in RRMS.

Cladribine Tablets: A Review in Relapsing MS

  • E. Deeks
  • Medicine, Psychology
    CNS Drugs
  • 2018
Active comparisons and longer-term follow-up are beneficial, although current data indicate that for adults with highly active relapsing MS, cladribine tablets are an effective treatment option with the convenience of low-burden, short-course, oral administration.

The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study

Despite of the criteria used to define CIS or MS, 3.5 mg/kg cladribine tablets are effective in patients with a first clinical demyelinating attack, and the risk of conversion to clinically definite multiple sclerosis (CDMS) is reduced.

Effects of delayed-release dimethyl fumarate on MRI measures in the Phase 3 DEFINE study

The results suggest that delayed-release DMF favorably affects multiple aspects of MS pathophysiology, including brain atrophy and lesion counts.



MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS

Natalizumab has a sustained effect in preventing the formation of new lesions in patients with relapsing multiple sclerosis.

Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study

The safety and tolerability profile observed in the CLARITY study together with the reported efficacy support the potential for cladribine tablets as an MS therapy.

Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.

Interferon beta-1b treatment had a robust effect on MRI measures, supporting its value as an early intervention in this patient group, and this effect was maintained despite including patients who switched from placebo to interferonBeta1b in the active treatment group.

Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis.

In patients with relapsing-remitting multiple sclerosis, both BG-12 regimens, as compared with placebo, significantly reduced the proportion of patients who had a relapse, the annualized relapse rate, the rate of disability progression, and the number of lesions on MRI.

Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.

This trial showed the superior efficacy of oral fingolimod with respect to relapse rates and MRI outcomes in patients with multiple sclerosis, as compared with intramuscular interferon beta-1a.

A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.

Both doses of oral fingolimod improved the relapse rate, the risk of disability progression, and end points on MRI and were superior to placebo with regard to MRI-related measures.

GLANCE: Results of a phase 2, randomized, double-blind, placebo-controlled study

The combination of natalizumab and glatiramer acetate seemed safe and well tolerated during 6 months of therapy, with the exception of an increase in anti-natalizumAB antibodies with combination therapy.

A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis.

Treatment with cladribine tablets significantly reduced relapse rates, the risk of disability progression, and MRI measures of disease activity at 96 weeks, and the benefits need to be weighed against the risks.