Hospital Ferrol

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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Observational Studies Poster Presentation

P0901 - Real life efficacy and tolerability of Teriflunomide: 3 years of following in a multicentre study in Galicia (TERIGAL 2019). (ID 110)

Abstract

Background

Teriflunomide is an oral formulation which was approved as first line option for the treatment of Relapsing-Remitent Multiple Sclerosis. Its efficacy and adverse events have been described in randomized controlled trials. Data for regular clinical practice are need. We have been using teriflunomide since july 2015.

Objectives

Our objetive is to describe our initial experience with Teriflunomide in terms of tolerance and clinical effectiveness after 3 years of treatment.

Methods

All patients from 10 Clinical Hospitals in Galicia, Spain, who were prescribed Teriflunomide were included, regardless of time on treatment. Basics demographic, clinical data, disability (EDSS scale), number of relapses, number of GD enhancing lesions on craneal MRI, adverse events and reasons for discontinuation under teriflunomide were reported.

Results

378 patients (70.6% woman) were reviewed, 41.5% naive, average age 44.9 years old (±9.7), average anual relapse 0.64 (±0.7), average EDSS 1.8 (±1.5), average number Gd enhancing lesions 0.58 (±1.3). 295, 182 and 90 patients complied 1, 2, 3 years of treatment, respectively. Teriflunomide decrease average anual relapse 0.41(±0.0), 0.43(±0.0) and 0.47(±0.0) p<0,05 at 1, 2, 3 year, disability was worst 1.9 (±1.6), 2.0 (±1.8) and 2.6 (±1.8) p<0.05 at 1, 2, 3 year, average number Gd enhanging lesions was 0.23 (±0,6), 0.20 (±0,8) and 0.15 (±0.5) p<0,05, at 1, 2, 3 year. 135 (45.7%), 50 (27.4%) and 21 (23.3%) experience adverse events at 1, 2, 3 year, most common hair thinning (15.5%), gastrointestinal (13.8%), elevation ALT (8.1%) and headache (5.7%). 3 severe adverse event (elevation ALT, myocardial infarction, breast carcinoma). 33, 26 and 22 patients stopped the treatment in the 1, 2, 3 year, 50% inneficacy.

Conclusions

The efficacy of teriflunomide in real-life setting was demostrate by the stability in reduce the number of relapses, although dissability was mild worsten. Teriflunomide has been well tolerated by the majority of patients.

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