Two-Year Extension Study of Cladribine for Multiple Sclerosis

Results from a randomized extension of the CLARITY study show sustained efficacy at 4 years with low risk for severe adverse events.

The original CLARITY study demonstrated an improvement in clinical and radiological outcomes in patients with relapsing–remitting multiple sclerosis (RRMS) treated with cladribine compared with placebo for 2 years. This extension was aimed at assessing the safety and continued efficacy of cladribine. In this manufacturer-funded extension trial, researchers enrolled 806 eligible participants of the 1184 who had completed the CLARITY trial. Participants previously on placebo received cladribine 3.5 mg/kg (PC arm) and participants previously treated with cladribine (3.5 mg/kg or 5.25 mg/kg) were rerandomized in a 1:2 fashion to placebo (CP arms) or cladribine 3.5 mg/kg (CC arms) for 2 years.

The PC group demonstrated a reduction in annualized r…

Reviewing Author

Pavan Bhargava, MD

Two-Year Extension Study of Cladribine for Multiple Sclerosis

Topics

Reviewing Author