Background

CLADQoL is a non-interventional study (NIS) in patients with RMS treated with cladribine tablets, focusing on quality of life. This is the first publication on the change in quality of life (examined by MSQoL-54) of patients treated with cladribine tablets in real world conditions at baseline and after 12 months. The recruitment period has ended in April 2020. Patient follow-up will continue and is planned for four years.

Objectives

Describing the patient population including pre-treatment and relapse rate and evaluating changes in patients’ quality of life (MSQoL-54 physical health and mental health composite scores) under therapy with cladribine tablets 12 months after treatment initiation.

Methods

Quality of life (QoL) was evaluated from the patient subset where MSQoL-54 was available both at baseline and month 12. Cut-Off date for analysis was January 31^st 2020.

Results

87 of 254 recruited patients were evaluated so far (mean age 37 years; 78.2% female; 93.1% RRMS). Most frequent last previous therapy for treated patients was fingolimod, dimethyl fumarate, glatiramer acetate and daclizumab.

For the subsets with valid MSQoL-54 at baseline and month 12 the physical health composite score showed a decrease -0.942 ±14.08 whereas the mental health composite score revealed an increase 0.711 ±17.33 (Change 12 months vs. baseline). None of the differences reached significance.

The number of relapses decreased from 1.0 ±1.09 (Mean ±SD) at baseline to 0.2 ±0.58 (Mean ±SD) at month 12.

Regarding safety, evaluation was performed for the overall study population (N=254). 82 patients experienced at least one AE and 15 patients at least one SAE.

Conclusions

Within the first year of treatment with cladribine tablets in patients with RRMS or SPMS with superimposed relapses there were minimal changes in QoL scores.

We observed a decrease in relapses and the safety results were in line with known safety profile of cladribine tablets.

The NIS is ongoing and patient subset is being followed up.