Safety and efficacy of cladribine tablets in patients with relapsing–remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study

Abstract

Cladribine tablets treatment for 2 years followed by 2 years' placebo treatment produced durable clinical benefits similar to 4 years of cladribine treatment with a low risk of severe lymphopenia or clinical worsening. No clinical improvement in efficacy was apparent following further treatment with cladribine tablets after the initial 2-year treatment period in this trial setting.

Cladribine for highly active relapsing multiple sclerosis

“…5 About 75% of patients switched from cladribine to placebo remained relapse-free during the extension period; continuous treatment for four years was not superior to two years' treatment with follow-up.…”

“…5 This phase 3 trial randomised patients to receive treatment with cladribine 3.5mg/kg (n=433) or placebo (n=437), given as two courses in the first 48 weeks followed by two courses starting at week 48 and week 52. Some patients received a higher, unlicensed dose; their data are not reported here.…”

Cladribine for multiple sclerosis

“…15 Those who had received placebo received cladribine 3.5mg/kg and those who had received cladribine were randomised to cladribine 3.5mg/kg or placebo. As patient numbers in the extension study were limited, it was not powered for efficacy analyses.…”

First Oral Short-course Treatment for Adults with Highly Active Relapsing Multiple Sclerosis Now Approved in Europe

“…In the CLARITY phase III study, NEDA was 47%, which places cladribine among the DMTs with the highest efficacy. [7][8][9][10][11][12] Q: Which patients are likely to benefit most from treatment with cladribine?…”