Hospital Clínico Santiago de Compostela

Author Of 2 Presentations

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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Patient-Reported Outcomes and Quality of Life Poster Presentation

P1050 - Quantifying the patient´s perspective in neuromyelitis optica spectrum disorders: Design of a multicenter, non-interventional study (ID 222)

Abstract

Background

Patients with neuromyelitis optica spectrum disorders (NMOSD) experience a spectrum of symptoms negatively impacting on daily living and quality of life. The systematic assessment of patient perspectives has the capacity to provide crucial clinical information that could otherwise be lost when relying on clinical evaluation alone. However, the patient experience living with NMOSD is limited, in particular implementing standardized patient-reported outcomes (PROs).

Objectives

The primary objective of this study protocol is to assess the health-related quality of life and well-being of NMOSD patients.

Methods

A multicenter, non-interventional, cross-sectional study will be conducted with patients diagnosed with NMOSD (2015 Wingerchuk criteria) (PERSPECTIVES-NMO Study). Primary outcomes measures will be the 29-item Multiple Sclerosis Impact Scale and the Satisfaction with Life Scale. Demographic characteristics, clinical and imaging outcomes will be collected, including the number and type of attacks, antibody status, Expanded Disability Status Scale score, Nine-Hole Peg Test, Timed 25-Foot Walk, and Magnetic Resonance Imaging findings. Cognition will be evaluated using the Rao Brief Repeatable Neuropsychological Battery. Additional outcomes from the patient´s perspective (PROs) will be collected, including symptoms severity (SymptoMScreen questionnaire), fatigue (Fatigue Impact Scale for Daily Use), pain (MOS Pain Effects Scale), mood (Beck Depression Inventory-Fast Screen), perception of stigma (8-item Stigma Scale for Chronic Illness), and work-related difficulties (23-item Multiple Sclerosis Work Difficulties Questionnaire).

Results

Patient recruitment began in December 2019 with a planned total sample of 70 patients. The study is currently ongoing.

Conclusions

The study results are expected to provide meaningful insights into the clinical burden of disease. A better understanding of patient experiences may foster the development of patient-centered specific plans and more targeted rehabilitation in clinical practice.

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