Hospital Universitario de Burgos

Author Of 2 Presentations

Disease Modifying Therapies – Risk Management Poster Presentation

P0349 - Long term effectiveness and safety of teriflunomide in Relapsing Remitting Multiple Sclerosis, and improvement in quality of life: Tericare study (ID 1654)

Presentation Number
P0349
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of multiple sclerosis (MS) or relapsing remitting MS (RRMS) depending on the local label. Teri-CARE is a real-world study investigating quality of life and clinical outcomes in patients with RRMS treated with teriflunomide 14 mg in Spain.

Objectives

To evaluate effectiveness of teriflunomide in Relapsing Remitting Multiple Sclerosis (RRMS) and its impact on quality of life, fatigue and depression.

Methods

Prospective multicenter study in RRMS patients treated with teriflunomide for ≤4 weeks. Clinical data and questionnaires were completed during the inclusion visit and every 6 months for 2 years: MSIS-29 (MS-Impact Scale), MFIS (Modified Fatigue-Impact Scale), BDI (Beck Depression Inventory).

Results

325 patients with RRMS (36% naive, 71% female) were included. Median±SD age was 43,2±10,4, MS duration was 7,2±7,3 years, EDSS was 1,75±1,52, annualized relapse rate (ARR) was 0,4. 30% of patients presented T1Gd+ lesions (2,1±1,8). 49% reduction on ARR was observed on year 1 (0,22) and 60% on year 2 (0,17). EDSS was maintained stable after 2 years (1,83±1,66; p=0,081) and 80% of the patients did not show disability progression. T1Gd+ median lesion decreased at year 1 (1,5±0,7) and at year 2 (1,2±0,6). Nineteen patients reported 20 serious adverse events and no death was reported. After 2 years of treatment, a significant reduction in the psychological impact of MS was observed in the MSIS-29 (32,4±25,4 vs 28,8±24,5; p=0,001), but not in the physical component. At baseline, patients presented a mild grade of fatigue (MFIS: 26,4±21,1) and depression (BDI: 12,3±10,0), which were maintained at year 2 without significant changes.

Conclusions

Long term treatment with teriflunomide significantly reduces relapses and maintains disability progression stable. Teriflunomide improves aspects of quality of life and seems to delay the MS impact on fatigue and emotional well-being.

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Patient-Reported Outcomes and Quality of Life Poster Presentation

P1024 - Economic impact of the Secondary Progressive Multiple Sclerosis in Spain: Interim analysis of the DISCOVER study (ID 1595)

Abstract

Background

Multiple Sclerosis (MS) is a chronic, inflammatory, autoimmune, neurodegenerative disease. Around 19% of treated patients with relapsing-remitting MS progress to Secondary Progressive MS (SPMS) 15 years after disease onset, representing the most severe stage of the disease. MS symptoms lead to a general disability, impacting the quality of life of patients and also being related with an important economic burden on the National Health System, the patients, their caregivers and the whole society.

Objectives

There are limited published data on the economic impact of SPMS. The main objective of the study was to estimate the economic impact of SPMS in Spain.

Methods

DISCOVER (CBAF312AES01) is an observational, non-interventional, cross-sectional, retrospective and multicenter study, including 297 SPMS patients ≥18 years treated and monitored according to routine clinical practice in Spain in 34 public hospitals. All data was collected in one single visit. Primary endpoint: total annual cost per patient, including direct healthcare and non-healthcare costs and indirect costs. Interim results from 99 patients are presented.

Results

62.6% females; mean (SD) age 53.1 (9.3) years; 40.4% with higher education; 86.9% living with a relative. Mean (SD) time since first MS diagnosis was 17.5 (8.9) years and since progression to SPMS 5.2 (4.3) years. At diagnosis, mean (SD) EDSS was 2.0 (1.1), being 5.0 (1.1) at the time of progression and 5.9 (0.8) at the study visit, 47.5% patients reaching EDSS>6. 12.8% of patients presented relapses between 12-24 months before the study. According to EQ-5D-5L, mean (SD) utility (<1) was 0.48 (0.27) for patients with Gd+ lesions and/or relapses 2 years before. According to EQ-5D-5L, mean (SD) utility (<1) for patients with cognitive impairment was 0.45 (0.29) vs 0.51 (0.21) for those without it. Mean (SD) utility for Spanish general population was 0.897 (0.21). EDSS score showed a significative effect (P=0.0074) on the economic burden of the disease, with total costs increasing from 14,546€ (EDSS 4-4.5) to 21,918€ (EDSS 5-5.5) and 26,832€ (EDSS=6). Costs related to patients with EDSS=6 from the societal, patient and healthcare system were 6,441€, 8,450€ and 11,941€, respectively.

Conclusions

Interim results of the DISCOVER study revealed a significant economic impact of MS progression, highlighting the importance of implementing therapeutic strategies specific to the SPMS patient within the early stages of progression.

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