Author Of 3 Presentations
P0018 - Variability of the response to immunotherapy among sub-groups of patients with multiple sclerosis (ID 1239)
- I. Diouf
- C. Malpas
- D. Horakova
- E. Kubala Havrdová
- F. Patti
- V. Shaygannejad
- S. Ozakbas
- G. Izquierdo
- S. Eichau
- M. Zakaria
- M. Onofrj
- A. Lugaresi
- R. Alroughani
- A. Prat
- M. Girard
- P. Duquette
- M. Terzi
- C. Boz
- F. Grand'Maison
- S. Hamdy
- P. Sola
- D. Ferraro
- P. Grammond
- R. Turkoglu
- H. Butzkueven
- B. Yamout
- A. Altintas
- V. Van Pesch
- D. Maimone
- J. Lechner-Scott
- R. Bergamaschi
- R. Karabudak
- F. Giuliano
- C. McGuigan
- E. Cartechini
- M. Barnett
- S. Hughes
- M. Sa
- L. Kappos
- C. Ramo-Tello
- E. Cristiano
- S. Hodgkinson
- D. Spitaleri
- A. Soysal
- T. Petersen
- M. Slee
- E. Butler
- F. Granella
- F. Verheul
- P. McCombe
- R. Ampapa
- O. Skibina
- J. Prevost
- L. Sinnige
- J. Sánchez-Menoyo
- S. Vucic
- G. Laureys
- L. Van Hijfte
- D. Khurana
- R. Macdonell
- T. Castillo-Trivino
- O. Gray
- E. Agüera
- I. Kister
- C. Shaw
- N. Deri
- T. Al-Harbi
- Y. Fragoso
- T. Csepany
- A. Sempere
- T. Kalincik
Abstract
Background
Our current understanding of demographic and clinical modifiers of the effectiveness of multiple sclerosis (MS) therapies is limited.
Objectives
To assess whether patients’ response to disease modifying therapies (DMT) in MS varies by disease activity (annualised relapse rate, presence of new MRI lesions), disability, age, MS duration or disease phenotype.
Methods
Using the international MSBase registry, we selected patients with MS followed for ≥1 year, with ≥3 visits, ≥1 visit per year. Marginal structural models (MSMs) were used to compare the hazard ratios (HR) of 6-month confirmed worsening and improvement of disability (EDSS), and the incidence of relapses between treated and untreated periods. MSMs were continuously re-adjusted for patient age, sex, pregnancy, date, time from first symptom, prior relapse history, disability and MRI activity.
Results
Among 23 687 patients with relapsing MS, those on DMT experienced 20% greater chance of disability improvement [HR 1.20 (95% CI 1.0-1.5)], 47% lower risk of disability worsening [HR 0.53 (0.39-0.71)] and 51% reduction in relapses [HR 0.49 (0.43-0.55)]. The effect of DMT on relapses and EDSS worsening was attenuated with longer MS duration and higher prior relapse rate. The effect of DMT on EDSS improvement and relapses was more evident in low EDSS categories. DMT was associated with 51% EDSS improvement in patients without new MRI lesions [HR 1.51 (1.00-2.28)] compared to 4% in those with MRI activity [HR 1.04 (0.88-1.24)]. Among 26329 participants with relapsing or progressive MS, DMT was associated with 25% reduction in EDSS worsening and 42% reduction in relapses in patients with relapsing MS [HR 0.75 (0.65-0.86) and HR 0.58 (CI 0.54-62), respectively], while evidence for such beneficial effects of treatment in patients with progressive MS was not found [HR 1.11 (0.91-1.46) and HR 1.16 (0.91-1.46), respectively].
Conclusions
DMTs are associated with reduction in relapse frequency, progression of disability, and increased chance of recovery from disability. In general, the effectiveness of DMTs was most pronounced in subgroups with shorter MS duration, lower EDSS, lower relapse rate and relapsing MS phenotype.
P0915 - Safety and effectiveness of ocrelizumab in multiple sclerosis: a real-world study from Spain (ID 1026)
Abstract
Background
Although phase 3 clinical trials have demonstrated the efficacy and safety of ocrelizumab in patients with multiple sclerosis, real-world data are scarce.
Objectives
The aim of this study was to describe the effectiveness and safety of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting.
Methods
In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. The main inclusion criteria was a history of initiation of ocrelizumab. Patients involved in any ocrelizumab trial were excluded. No evidence of disease activity (NEDA) outcome was assessed in RMS patients who were followed for at least one year.
Results
The cohort included 71 patients (43 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients’ mean age was 47.1 years in the PPMS group and 39.4 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 12.6 months (range 2 to 32). The median number of treatment cycles was 3. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 58% of the patients; by the first MRI control at 4-6 months, all patients except one were free of T1 Gd-enhancing lesions (63/64, 98.4% P<0.001). The proportion of patients with NEDA was 93.3% in the group of RMS patients who were followed for at least one year. Only two patients (2.8%) discontinued ocrelizumab; one due to pregnancy and the other one because of lack of efficacy, but none did so due to safety issues. Ocrelizumab was generally well tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious.
Conclusions
Our data confirm the short-term effectiveness, tolerability, and safety of ocrelizumab in real-world clinical practice. Further studies are needed to assess patient outcomes with longer follow-up periods.
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.
Presenter Of 1 Presentation
P0915 - Safety and effectiveness of ocrelizumab in multiple sclerosis: a real-world study from Spain (ID 1026)
Abstract
Background
Although phase 3 clinical trials have demonstrated the efficacy and safety of ocrelizumab in patients with multiple sclerosis, real-world data are scarce.
Objectives
The aim of this study was to describe the effectiveness and safety of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting.
Methods
In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. The main inclusion criteria was a history of initiation of ocrelizumab. Patients involved in any ocrelizumab trial were excluded. No evidence of disease activity (NEDA) outcome was assessed in RMS patients who were followed for at least one year.
Results
The cohort included 71 patients (43 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients’ mean age was 47.1 years in the PPMS group and 39.4 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 12.6 months (range 2 to 32). The median number of treatment cycles was 3. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 58% of the patients; by the first MRI control at 4-6 months, all patients except one were free of T1 Gd-enhancing lesions (63/64, 98.4% P<0.001). The proportion of patients with NEDA was 93.3% in the group of RMS patients who were followed for at least one year. Only two patients (2.8%) discontinued ocrelizumab; one due to pregnancy and the other one because of lack of efficacy, but none did so due to safety issues. Ocrelizumab was generally well tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious.
Conclusions
Our data confirm the short-term effectiveness, tolerability, and safety of ocrelizumab in real-world clinical practice. Further studies are needed to assess patient outcomes with longer follow-up periods.