Hospital Pontevedra

Author Of 2 Presentations

Disease Modifying Therapies – Risk Management Poster Presentation

P0416 - Use of Dimethyl fumarate in real clinical practice and strategy to minimize adverse effects and health resources (ID 937)

Speakers
Presentation Number
P0416
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Background: Dimethyl fumarate (DMF) has shown efficacy in reducing relapse rates in patients with multiple sclerosis (MS). However, associated adverse effects (AE) (mainly gastrointestinal [GI] and flushing) are the main cause of treatment discontinuation.

Objectives

Objective: The aim of this study was to evaluate the efficacy of DMF, and to explore how to reduce treatment discontinuation rates in routine clinical practice.

Methods

Methods: Ninety patients initiated DMF treatment between August 2015 and February 2020. Prior to DMF therapy, patients received written information including guidelines for DMF administration, dose administration schedule and description of treatment-associated AE along with medical prescriptions for proper AE management. Clinical and analytical data were collected at least at every 6-monthly clinical visit, and disease progression was evaluated by brain magnetic resonance imaging (MRI).

Results

Results: At final follow-up of DMF treatment, both annual relapse rate (ARR) and median Expanded Disability Status Scale (EDSS) score were significantly reduced: ARR = 0.09 (p < 0.001); median EDSS = 0 (interquartile range: 0-1.625; p < 0.001) and 26.7% of patients with baseline brain MRI showed improvement. 53 patients reported incidence of DMF-associated EA during follow-up, 96.2% of them did it already during the first clinical visit. Most frequent EA were flushing (n = 39 patients; 43.3%) and GI EA (n = 34; 37.7%). Twelve patients (13.5%) abandoned DMF treatment but none because of GI AE or flushing.

Conclusions

Conclusions: In our series, DMF showed high efficacy at clinical and radiological levels. More important, we found that providing patients with complete information prior to treatment on the management of associated AE helped them to better understand what to expect, improved tolerance and reduced discontinuation rate and clinical and telephone consultations. The use of this strategy in real world clinical practice may allow to maximize the benefits of DMF treatment and diminish the use and cost of healthcare resources.

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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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