Merck Serono GmbH
Neurolgie

Author Of 2 Presentations

Observational Studies Poster Presentation

P0849 - CLADQoL (CLADribine Tablets – evaluation of Quality of Life) study: evaluating Qol 12 months after treatment initiation with cladribine tablets (ID 771)

Speakers
Presentation Number
P0849
Presentation Topic
Observational Studies

Abstract

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 31st 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.

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Observational Studies Poster Presentation

P0884 - MS disease modifying therapy sequencing – natalizumab to cladribine tablets – experience in 46 patients (ID 566)

Speakers
Presentation Number
P0884
Presentation Topic
Observational Studies

Abstract

Background

Natalizumab proved to be very effective in patients with active relapsing-remitting multiple sclerosis but harbors the risk of progressive multifocal leukoencephalopathy (PML), especially in combination with specific risk factors. Accordingly, a safe and an equally effective therapeutic alternative is warranted in this patient group. A high efficacy therapy for Relapsing Multiple Sclerosis are cladribine tablets, representing a short course oral therapy. It has been approved in Europe since 2017 and in the USA since April 2019.

Objectives

Safety of switching from natalizumab to cladribine tablets has been investigated in a limited number of patients and with limited observational time. We therefore analyzed this safety issue with a longer follow-up time in the subgroups of post-natalizumab patients in 2 non-interventional studies (NIS).

Methods

46 patients who switched from natalizumab to oral cladribine were reviewed. They originated from 2 cohorts analyzed separately: 23 patients each from the still ongoing NIS CLEVER (in Germany, 24 weeks follow-up as per study duration) and CLADQoL (in Germany and Austria, mean follow-up 11 months). Different study designs accounted for different timings in data collection. Patients were closely monitored, and data was collected regarding MS relapses, disease progression, or possible adverse events.

Results

The NIS CLEVER provides data from 23 patients (mean age 41.6 years; 78% female; 87% RRMS). The most frequent reason for therapy switch was increased JCV antibody titer/risk of PML or lack of efficacy. Median time on natalizumab was 26.6 months and median gap between therapies 3.2 months. 1 out of 15 evaluable patients at week 24 experienced relapses. For 7 patients at least one AE was reported and no SAE.

The NIS CLADQoL provides data from 23 patients (mean age 38.8 years; 70% female; 91% RRMS). The most frequent reason for therapy switch was increased JCV antibody titer/risk of PML. Median time on natalizumab was 40.1 months and median gap between therapies 3.4 months. 2 out of 10 evaluable patients at month 12 experienced relapses. 6 patients experienced at least one AE and 3 patients one SAE (Anterior Myocardial Infarction (among underlying risk factors), Multiple sclerosis relapse, Dyspnoea).

Conclusions

Based on data from 46 patients, switching from natalizumab to cladribine tablets continued to be safe in a larger patient population and after a longer follow-up. Especially no cases of PML were observed.

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