Oral cladribine has been proven effective in clinical trials of active relapsing-remitting multiple sclerosis (aRRMS). Few studies report real world data. This study assessed efficacy and safety of oral cladribine with an average follow-up of 41.6 months in a large neuroscience centre in London, UK.
Data were retrospectively collected on relapses, new MRI lesions, EDSS change, annualised relapse rates (ARR), lymphocyte counts, and infections.
83 patients were included in our study: 71 had cladribine years 1+2; 12 had only year 1; median follow-up 41.6 months. Of 83 patients, 7 (8.4%) had a relapse, 18 (21.7%) developed new MRI lesions, 16 (19.3%) had EDSS progression, and 16 (19.3%) had EDSS improvement. NEDA-3 was seen in 54/83 (65.1%). PIRA (progression independent of relapse activity) was seen in 13/83 (15.7%) and PIA (progression independent of any inflammatory activity) in 8/83 (9.6%). Lymphopenia was seen in 65.1% patients (grade 3 = 12/83; grade 4 = 0).
The number of patients who had relapses, and rates of NEDA-3, PIRA and PIA were similar to other reported studies with similar or shorter follow-up. Our data confirms that cladribine is an effective treatment for aRRMS.