Centro de esclerosis múltiple de Buenos Aires, Buenos Aires, Argentina
Neurology

Author Of 1 Presentation

COVID-19 Late Breaking Abstracts

SS02.04 - First results of the COVID-19 in MS Global Data Sharing Initiative suggest anti-CD20 DMTs are associated with worse COVID-19 outcomes

Abstract

Background

As the COVID-19 pandemic amplifies, efforts to minimise the risk on vulnerable people are essential. People with multiple sclerosis (MS) may be a vulnerable group due to the high proportion taking long-term immunosuppressive disease-modifying therapies (DMTs). Studies from Italy and France suggest older age, higher disability and progressive MS are associated with severe COVID-19, yet there remains uncertainty around the influence of DMTs.

Objectives

Given the many approved MS DMTs and the relatively low frequency of COVID-19 in MS patients per country, international data sharing is desirable to examine the impact of DMTs on COVID-19 severity. Here, we present the first results of the COVID-19 in MS global data sharing initiative of the MS International Federation and MS Data Alliance and many other data partners to inform MS clinical management during the COVID-19 pandemic.

Methods

Clinician-reported data from 21 countries were aggregated into a dataset of 1540 patients. Characteristics of admission to hospital, admission to intensive care unit (ICU), need for artificial ventilation, and death, were assessed in patients with confirmed or suspected COVID-19 infection using log-binomial regression. Adjusted prevalence ratios (aPR) were calculated adjusting for age, sex, MS type, and Expanded Disability Status Scale (EDSS).

Results

Of 1540 patients, 476 (30.9%) with suspected and 776 (50.4%) with confirmed COVID-19 were included in the analysis. Older age, progressive MS and higher EDSS were associated with higher frequencies of severe outcomes. Anti-CD20 DMTs, ocrelizumab and rituximab, were positively associated with hospital admission (aPRs=1.19 & 1.58), ICU admission (aPRs=3.53 & 4.12), and the need for artificial ventilation (aPRs=3.17 & 7.27) compared to dimethyl fumarate. Higher frequencies of all three outcomes were associated with combined anti-CD20 DMT use compared to all other DMTs (hospitalisation aPR=1.49; ICU aPR=2.55; ventilation aPR=3.05) and compared to natalizumab (hospitalisation aPR=1.99; ICU aPR=2.39; ventilation aPR=2.84). Importantly, associations persisted on restriction to confirmed COVID-19 cases and upon exclusion of each contributing data source in turn. No associations were observed between DMTs and death.

Conclusions

This study used the largest federated international cohort of people with MS and COVID19 currently available. We demonstrate a consistent association of anti-CD20 DMTs with hospitalisation, ICU admission and use of artificial ventilation suggesting their use among MS patients at risk for COVID-19 exposure may be a risk factor for more severe COVID-19 disease. To address study limitations, further research incorporating comorbidities, smoking and body mass index is required. Alternative study designs are needed to address questions on COVID-19 susceptibility among people with MS.

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Author Of 19 Presentations

Diagnostic Criteria and Differential Diagnosis Poster Presentation

P0255 - Improvement during the last decades in the time of diagnosis but not in the time of starting DMD in MS patients in Argentina (ID 1297)

Speakers
Presentation Number
P0255
Presentation Topic
Diagnostic Criteria and Differential Diagnosis

Abstract

Background

There has been a significant shortening of time from multiple sclerosis (MS) onset to diagnosis in parallel with the adoption of new diagnostic criteria. However, it is not clear whether that time has been accompanied by a shortening in the time since diagnosis to the initiation of disease modifying treatment (DMD).

Objectives

The objective of the study was described and compare the interval from first symptom of MS to the date of diagnosis and the interval between date of diagnosis and DMD initiation regarding the introduction of upgraded MS diagnosis criteria.

Methods

retrospective cohort study that included relapsing remitting MS patients between January 2005 and January 2018. To be included, date of disease onset (first relapse), date of diagnosis (confirmed disease) and date of DMD initiation must be available. Kaplan-Meier estimator and plots were applied. Survival probabilities were evaluated for the 2 diagnosis epoch groups according to the diagnostic criteria advised at the time: group 1, for diagnosis performed between 2005-2009 (2005 revised McDonald criteria) and group 2, for diagnosis performed between 2010-2017 (2010 revised McDonald criteria). Survival curves were compared by log-rank method. P-value less than 0.05 was considered statistically significant

Results

654 patients were revised, 586 included (278 in group 1 and 308 in group 2) and 68 excluded due to missing data. Most of patients in group 1 were treated with beta interferons (82%), while in group 2, 32% were on beta interferons, 45% on oral treatments (fingolimod, teriflunomide and dymethil-fumarate), 15% on natalizumab and 8 % on alemtuzumab. There were no differences in mean age at disease onset between group 1 and 2 (33 ± 5 and 31 ± 6 years, p=0.45). The mean time since disease onset to diagnosis in group 1 was 1.35 ± 0.32 vs. 1.11 ± 0.22 years (p 0.001). Mean time since disease diagnosis to first DMD was 4.6 ± 2.1 months in group 1 vs. 5.8 ± 1.5 months in group 2 (p=0.07).

Conclusions

despite a shorten in time of diagnosis was described a trend to increase the time to initiate a DMD was noted in group 2. An improvement in access to treatments must follow the improvement in diagnosis if it is intended to treat patients earlier to prevent disease progression.

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Diagnostic Criteria and Differential Diagnosis Poster Presentation

P0268 - Time interval between disease onset and MS diagnosis during the last decades in Latin America (ID 1201)

Speakers
Presentation Number
P0268
Presentation Topic
Diagnostic Criteria and Differential Diagnosis

Abstract

Background

Previous studies have shown a significant shortening of time from multiple sclerosis (MS) onset (first relapse) to diagnosis in parallel with the adoption of new diagnostic criteria. However, the observation was not evaluated in Latin America.

Objectives

The objective of the study was to study the interval from first symptom of MS to the date of diagnosis in relation to the introduction of upgraded MS diagnostic criteria in a Latin American population.

Methods

Cross-sectional study based on a self-reported survey. Patients with MS completed a regional survey in 12 Latin American countries. To be included, date of disease onset (first relapse) and date of diagnosis (confirmed disease) should be completed. Survival probabilities were evaluated for 5 diagnosis epoch groups according to the diagnostic criteria advised at the time: group 1- 1983-2000 Poser; group 2- 2001-2004 McDonald's first version; group 3- 2005-2009 revisions of 2005; group 4- 2010-2016 revisions of 2010; and group 5 -2017-2019 revisions of 2017.

Results

1434 patients were included. 1108 (75%) females, mean age at study entry 39 ± 11 years. The mean time since disease onset to diagnosis in group 1 was 21 ± 8 months; in group 2, 19 ± 7 months; in group 3, 16 ± 10 months; in group 4, 9.6 ± 8.5 months and in group 5, 8.2 ± 10 months. Significant differences were observed between groups 1, 2, 3 vs. 4 and 5 (p<0.001) while no differences were observed between group 4 and 5 (p=0.08).

Conclusions

This study showed a significant shortening of time from MS onset to diagnosis in parallel with the adoption of new diagnostic criteria in Latin America in recent decades.

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Disease Modifying Therapies – Risk Management Poster Presentation

P0301 - Beyond pivotal trials inclusion criteria: real world clinical profile of multiple sclerosis patients under disease modifying treatment in Argentina. (ID 851)

Abstract

Background

Background: In multiple sclerosis (MS), randomized controlled trials (RCT) have provided relevant information about the efficacy and safety in ideal scenarios. While RCT are powerful tools for developing scientific evidence based on their high internal validity, there is always uncertainty about the generalizability, especially since the populations enrolled in such studies may differ in significant ways from those seen in clinical practice.

Objectives

Objective: to describe the frequency and clinical profile of MS patients under disease modifying treatment in Argentina that would have not fulfilled inclusion criteria in RCT.

Methods

Methods: MS patients included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177) were analyzed. RelevarEM is a longitudinal, strictly observational MS and NMOSD registry in Argentina. From May 2018 to March 2020, the centers and principal investigators were contacted and incorporated into the Registry. All patients with definite MS and receiving DMT at 31 December 2019 were screened, those with EDSS >6, phenotypes secondary progressive (SP) and primary progressive (PP)(with other DMT than ocrelizumab) and age <18 and >55 years old were included in the analysis.

Results

Results: A total of 1782 patients with MS receiving DMT were screened, of whom 465 (26%)would not have been included in a pivotal trial. From the 465,218 had and EDSS >6, 67 had phenotype SP and 19 PP; 292 were patients with <18 and >55 years of age (2 under 18 years old). Most prescribed DMT among patients with EDSS >6 was fingolimod (31%), among age >55 was beta interferon (35%), phenotype SP fingolimod (30%) and PP fingolimod and glatiramer acetate (each 26%).

Conclusions

Conclusion: in our registry, we found a significant number of MS patients who would have not been included in pivotal trials, receiving DMT. Real life evidence is highly relevant to assess effectiveness as well as safety of DMT in this subset of patients.

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Epidemiology Poster Presentation

P0427 - Absence of latitudinal gradient in oligoclonal bands prevalence in Argentina (ID 858)

Abstract

Background

Similarly, to what occurs with MS prevalence, it has been previously described that oligoclonal bands (OCB) prevalence follows a latitudinal gradient being more frequent farther away from the equator. Argentina has the particularity of being longitudinally extensive (21°46’S to 66°13’S). Previous epidemiological studies from Argentina have not found an MS prevalence latitudinal gradient.

Objectives

The aim of the present study is to describe the prevalence of OCB in CSF in patients with MS, CIS and RIS included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177) and to investigate if the prevalence follows a latitudinal gradient.

Methods

RelevarEM is a longitudinal, observational MS and NMOSD registry in Argentina. For each province, an average latitude was calculated using extreme N and S latitudes obtained from Google Maps. Regarding OCB, pattern II or III where considered as positive. The frequency of OCB was calculated for each diagnostic category (MS, CIS, RIS) and for each province. Statistical analysis was carried out using SPSS v22. Multivariate logistical regression analysis was performed considering OCB as a dichotomic dependent variable and latitude as an ordinal independent variable, adjusted by clinically relevant variables. Also, the percentage of patients OCB positive for each province was calculated and linear correlation was tested.

Results

We included 2866 patients from different locations in Argentina (92.4% MS, 5.8% CIS and 1.8% RIS). The mean age at diagnosis (SD) was 32.7 (11.2), 35.2 (10.7) and 40.7 (11.2) for MS, CIS and RIS patients, respectively. Lumbar puncture was performed in 54.6%, 63.9%, and 43.4% of MS, CIS and RIS patients, respectively. OCB where positive in 75.4%, 55.7% and 60.9% of MS, CIS and RIS patients, respectively. No association was found between OCB positivity and latitude, adjusted by gender, age at diagnosis and diagnostic category. No linear correlation was found between the percentage of OCB positive patients and latitude.

Conclusions

Similarly, to what has been described regarding MS prevalence, OCB positivity does not seem to follow a latitudinal gradient in Argentina. Also, OCB positivity in our study is lower that described in previous reports from other world regions.

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Comorbidities Poster Presentation

P0483 - Prevalence of cancer in multiple sclerosis patients in Argentina: cross sectional study from RelevarEM (ID 1043)

Abstract

Background

Multiple Sclerosis (MS) is an autoimmune demyelinating and neurodegenerative disease of the central nervous system of multifactorial origin. Studies about the prevalence of cancer in MS population are scarce and results are conflicting. Previous studies described a higher prevalence as well as an increased risk of cancer in MS patients while there are others that found no differences regarding general population.

Objectives

The aim of our study was to estimate the prevalence of cancer in a large sample of multiple sclerosis patients in Argentina.

Methods

the eligible study population and cohort selection included all patients with definite MS included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177) at 31 December 2019. History of current or past cancer diagnosis, was collected. Prevalence rates and 95% CI were calculated.

Results

We analyzed 2647 MS patients. 14 malignancies were identified. Overall prevalence of cancer was 0.53% (CI95% 0.02-0.08%). 78.6% were female, 85.8% relapsing remitting MS, median (IQR) disease duration: 10.5 (6-13) years; median (IQR) age at diagnosis: 42.5 (37-49); median (IQR) age at study date: 52.5, median (IQR); current EDSS: 2 (1.5-4.5); 42% patients were untreated and 58% under DMT (beta interferon 1a: 14.3%, 1b: 7.1%, glatiramer acetate: 7.1% and fingolimod: 28.6%). Most frequent malignancy was breast cancer (28.6%).

Conclusions

The prevalence of cancer in MS population identified in Argentina was 0.53% (CI 95% 0.02-0.08), being females more affected than males and breast cancer the most frequent one.

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Epidemiology Poster Presentation

P0493 - Severe infections in patients with multiple sclerosis: a nationwide registry study in Argentina (ID 929)

Abstract

Background

Data on the rates of infections among patients with multiple sclerosis (MS) are sparse and even more from Latin American countries.

Objectives

The objective of this study was to quantify the incidence of severe infections (SI) in patients with MS included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177).

Methods

RelevarEM is a longitudinal, strictly observational MS and NMOSD registry in Argentina. From May 2018 to March 2020, the centers and principal investigators were contacted and incorporated into the Registry. SI were defined as those that required intravenous treatment or that led to hospitalization or death. Patients contributed person-years of follow-up for the study period. Incidence rates and 95% CI were calculated.

Results

A total of 2158 patients with MS were included, mean age 42 (IIQ 34-52), 65,5% (1576) were female, 82,3% were RRMS. During the period (May 2018-March 2020), 28 SI were reported (IR 1.16, 95%CI 0.77-1.68). In patients with SI, the mean age was 54 (min 43- max 63, p<0.01) years, 11 (39%) were secondary progressive MS (p<0.01), the mean EDSS was 6.5 (range 5-8)(p<0.01), mean disease duration 12 years (p<0.01). 42% of patients were free of MS treatment while 17% were on injectables, 25% on orals and 10% on monoclonal antibodies (p=0.24). The most common sites of severe infection were the lower respiratory tract (39%)

Conclusions

IR of severe infection during the study period was 1.16 (95%CI 0.77-1.68). Most frequent SI were in SPMS and older patients while no relation was observed regarding MS treatment.

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Imaging Poster Presentation

P0636 - Relationship of real-world brain atrophy to MS disability using icobrain: 4 centre pilot study (ID 716)

Abstract

Background

To date, no studies have explored the relationship between brain atrophy and MS disability using differing MRI protocols and scanners at multiple sites.

Objectives

To assess the association between brain atrophy and MS disability, as measured by EDSS and 6-month confirmed disability progression (CDP).

Methods

In this retrospective study at 4 MS centres, a total of 1300 patients had brain MRI imaging assessed by icobrain. Relapse-onset MS patients were included if they had two clinical MRIs 12 (±3) months apart and ≥2 EDSS scores post MRI-2, the first ≤3 months from MRI-2, with ≥6 months between first and last EDSS. Volumetric data were analysed if the alignment similarity between two images was as good as that of same-scanner scan-rescan images (normalised mutual information ≥0.2). The percentage brain volume change (PBVC), percentage grey matter change (PGMC), FLAIR lesion volume change, whole brain volume, grey matter volume, FLAIR lesion volume and T1 hypointense lesion volume at MRI-2 were calculated. Ordinal mixed effect models were used to determine the association between these volumetric MRI measures and all EDSS scores post MRI-2. Cox proportional hazards models were used for the 6-month CDP outcome, using a subset of patients with ≥3 EDSS. Models were adjusted for proportion of time spent on disease-modifying therapy during MRIs ± whole brain/grey matter volume at baseline MRI.

Results

Of the 260 relapse-onset MS patients included, 204 (78%) MRI pairs were performed in the same scanner and 56 (22%) pairs were from different scanners. During the follow-up period (median 3.8 years, range 1.3-8.9), 29 of 244 (12%) patients experienced 6-month CDP. There was no evidence for association between annualised PBVC or PGMC and CDP or EDSS (p>0.05). Cross-sectional whole brain and grey matter volume (at MRI-2) tended to associate with CDP (HR 0.99, 95% CI 0.98-1.00, p=0.06). Every 1ml of whole brain or grey matter volume lost represented a 1% higher chance of reaching 6-month CDP. Only whole brain volume (at MRI-2) was associated with EDSS score (β -0.03, SE 0.01, p<0.001) and the slope of EDSS change over time (β -0.001, SE 0.0003, p=0.02). On average, every 33ml reduction of brain volume was associated with a 1 step increase in EDSS.

Conclusions

In this real-world clinical setting where a fifth of the brain atrophy analysis were performed on different scanners, we found no association between individual brain atrophy and MS disability. However, there was an association between cross-sectional whole brain volume with EDSS and slope of EDSS change.

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Neuromyelitis Optica and Anti-MOG Disease Poster Presentation

P0720 - Incidence of relapses in NMOSD patients under immunosupressive therapies in Argentina: observational study from RelevarEM. (ID 1684)

Abstract

Background

Several retrospective studies have demonstrated the clinical benefits of immunosuppressive therapies (IST) such as azathioprine (AZA), mycophenolate mofetil (MMF) and rituximab (RTX) for reducing relapse rates in neuromyelitis optica spectrum disorders (NMOSD) patients. However, there is considerable uncertainty regarding the relative benefits and harms associated with each of these IST in real world clinical practice and current data describing the strategies are limited

Objectives

The objective of this study was to describe the incidence of relapses in patients with NMOSD under IST included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177).

Methods

We conducted a retrospective cohort study from RelevarEM. RelevarEM is a longitudinal, strictly observational MS and NMOSD registry in Argentina. From May 2018 to June 2020, the centers and principal investigators were contacted, and patients were incorporated into the Registry. NMOSD patients were defined based on the 2015 International Consensus Diagnostic Criteria for NMOSD. Relapses during the study period, demographics and radiological (e.g. new/enlarging and/or enhancing-contrast MRI lesions) data were collected. Only patients under IST were included in the analysis. Patients contributed person-years of follow-up for the study period. Incidence rates and 95% CI were calculated. Thus, global and associated with each IST incidence density rate of relapses was estimated.

Results

We included a total of 132 (77% women) NMOSD patients with a median age at diagnosis of 36 years (27-47) and a disease duration of 6 years (4-10). Aquaporin-4 antibody was positive in 54.8%. At the time of entering the registry, 39.4% were treated with RTX, 33.3% with AZA, 3.6% MMF. The global incidence density rate of relapse was 0.032/person-year (CI95% 0,021-0,048), for RTX 0.051 (CI95% 0,024-0,1) and for AZA 0,031 (CI95% 0,016-0,06). There were no relapses in the group of MMF during this period of time.

Conclusions

This study showed a low incidence density rate of relapses in NMOSD patients under IST during this study period. Further studies will help expand our initial findings, hopefully leading to improve treatment options for NMOSD patients.

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Neuromyelitis Optica and Anti-MOG Disease Poster Presentation

P0731 - Multiple sclerosis and NMOSD testing and treatment availability in Latin America (ID 1311)

Speakers
Presentation Number
P0731
Presentation Topic
Neuromyelitis Optica and Anti-MOG Disease

Abstract

Background

To be aware of the availability of multiple sclerosis (MS) and neuromyelitis optica spectrum disorders diseases (NMOSD) diagnosis and treatment is a highly relevant point to better understand how to treat affected patients in our region.

Objectives

The objective of the study was to describe the availability of diagnosis tests and treatment for MS and NMOSD in Latin America (LATAM).

Methods

a survey instrument designed and piloted by the authors was used in a sample of physicians from all LATAM countries. The goal of the survey was to understand 1) imaging tests available for diagnosing MS and NMOSD and barriers in its acquisition; 2) diagnostic laboratory tests available for diagnosing MS and NMOSD and barriers; 3) treatments available for MS and NMOSD in the acute and chronic phases of diseases

Results

Responses were received from 80 physicians from all LATAM countries. AQP4-ab test was available in 54% of the countries and MOG-ab test in 42%. MRI was available in 93% of the countries. 100% of countries had the availability to use high doses of intravenous methilprednisolone, oral steroids, plasmapheresis as well as intravenous immunoglbulins for relapses. For NMOSD, 93% of the countries had the possibility to use azathioprine and mycophenolate mofetil and 87 % rituximab. Eculizumab and satralizumab was not available in any country. In MS, 93 % of countries had the availability of IFN beta, 69% glatiramer acetate, 75% teriflunomide, 93% fingolimod, 69% dimetyl-fumarate, 75% cladribine, 69% Natalizumab, 93% ocrelizumab and 81% alemtuzumab. Siponimod was not available in any conutry of the region. The most common challenge and barrier identified was the cost of medications to the health sector followed by the inability to consistently obtain medicine supplies for affected patients. MS treatments was completely covered by the health care system in most of the surveyed countries.

Conclusions

the present study allows an understanding of the delivery of care for MS and NMOSD in the region. This information will allow us to make health care policies in affected patients that will improve the care in LATAM.

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Neuromyelitis Optica and Anti-MOG Disease Poster Presentation

P0757 - The neutrophil-to-lymphocyte ratio in aquaporin-4-positive NMOSD patients: A Latin American multicenter study (ID 1034)

Abstract

Background

Neutrophil-to-lymphocyte ratio (NLR) has been investigated in many autoimmune diseases as a marker of both inflammation and disease activity. So far, the role of NLR in aquaporin-4(AQP4)-ab-positive neuromyelitis optica spectrum disorders (NMOSD) is uncertain due to a lack of data.

Objectives

The aim of this study was to evaluate NLR in AQP4-ab-positive NMOSD patients at disease onset and determine their clinical significance during follow-up.

Methods

We retrospectively included and reviewed the medical records of all recent/newly diagnosed treatment-naïve AQP4-ab-positive NMOSD patients (n=90) according to the 2015 international diagnostic criteria. Additionally, demographic, clinical, paraclinical (e.g. new/enlarging or contrast-enhancing lesions) and prognostic (via EDSS) data at 12 and 24 months were also evaluated. NRL was calculated as the absolute count of neutrophils divided by the absolute count of lymphocytes from peripheral blood samples. Three-hundred and sixty-five healthy subjects who underwent routine physical exam were included as controls. Multivariate regression analysis was used to describe and identified independent association between log-transformed NLR and clinical (relapses and EDSS change) as well as MRI activity (new/enlarging and/or contrast-enhancing MRI lesions). P<0.05 was considered as significant.

Results

NLR was higher in NMOSD patients during the first relapse compared with controls (2.9 ±1.6vs. 1.8 ±0.6;p<0.0001). Regardless of immunosuppressants’ initiation at disease onset, NLR continued to be higher in NMOSD patients at 12 (2.8 ±1.3;p<0.0001) and 24 (3.1 ±1.6;p<0.0001) months compared with controls. No association was observed at 12 and 24 months between log-transformed NLR and the presence of relapses ([OR=0.66, CI95%0.28-1.58, p=0.36] and [OR=0.76, CI95%0.30-1.93, p=0.57], respectively), new/enlarging and/or contrast-enhancing MRI lesions ([OR=1.72, CI95%0.58-5.04, p=0.32] and [OR=0.42, CI95%0.47-2.52, p=0.82], respectively) and physical disability ([OR=-0.21, CI95%-1.04-0.61, p=0.60] and [OR=-0.15, CI95%-1.01-0.69, p=0.71], respectively).

Conclusions

This study suggested that NLR may be a marker of inflammation in AQP4-ab-positive NMOSD patients. However, a higher NLR was not an independent predictor of clinical or radiological disease activity in our model.

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Neuromyelitis Optica and Anti-MOG Disease Poster Presentation

P0762 - What percentage of AQP4-Ab-negative NMOSD patients are MOG-Ab positive? A study from the Argentinean multiple sclerosis registry (RelevarEM) (ID 1033)

Abstract

Background

Myelin oligodendrocyte glycoprotein antibodies (MOG-Ab) have been described in aquaporin-4-antibodies(AQP4-Ab)-negative neuromyelitis optica spectrum disorders (NMOSD) patients.

Objectives

We aimed to investigate the percentage of AQP4-Ab-negative NMOSD patients who are positive for MOG-Ab included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177).

Methods

RelevarEM is a longitudinal, strictly observational multiple sclerosis (MS) and NMOSD registry in Argentina. Epidemiological, serological test and neuroimaging (MRI) data from NMOSD were described.

Results

A total of 165 patients (79 AQP4-Ab positive, 67 AQP4-Ab negative and 19 unknown) were included. Of these, 155 patients fulfilled the 2015 NMOSD diagnostic criteria. Of 67 AQP4-Ab-negative patients, 36 were tested for MOG-Ab and 10 of them (31.8%) tested positive. Presence of relapses during the previous 6 months (40% vs. 12.9%), shorter disease duration (3.9 vs. 7.5 years), lower disability (2.3 vs. 3.4) and treatment duration (1.5 vs. 3.4 years) and both optic neuritis (90% vs. 44.5%) and optic nerve lesion on MRI (80% vs. 25.1%) were significantly associated with MOG-Ab-positive compared with NMOSD respectively

Conclusions

This is the first study of the longitudinal Argentinean registry of MS and NMOSD describing and comparing diseases that contributes to provide reliable real-world data in the country. We observed that 31.8% (10/36) of the AQP4-ab-negative patients tested for MOG-Ab were positive for this antibody, in line with results from other world regions.

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Observational Studies Poster Presentation

P0836 - Aggressive multiple sclerosis in Argentina: data from the nationwide registry RelevarEM (ID 1632)

Abstract

Background

Aggressive MS (AMS) describes a form of the disease with a rapid progressive course leading to significant disability in multiple neurologic systems or even death in a relatively short time after onset. Despite there being no consensus on the exact definition of AMS, several studies performed during the last years have tried to better identify and understand the frequency and distribution as well as the progression and treatment response in order to determine more accurately which patients with AMS would most benefit from higher-efficacy, higher-risk treatments

Objectives

The objectives of the present study were to describe the frequency of aggressive multiple sclerosis (AMS) as well as to compare clinical and radiological characteristics in AMS and non-AMS patients included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177).

Methods

The eligible study population and cohort selection included adult-onset patients (≥18 years) with definite MS. AMS were defined as those reaching confirmed EDSS ≥6 within 5 years from symptom onset. Confirmation was achieved when a subsequent EDSS ≥6 was recorded at least six months later but within 5 years of the first clinical presentation. AMS and non-AMS were compared using the χ2 test for categorical and the Mann-Whitney for continuous variables at MS onset and multivariable analysis was performed using forward stepwise logistic regression with baseline characteristics at disease onset.

Results

A total of 2158 patients with MS were included: 74 AMS and 2084 non-AMS. The prevalence of AMS in our cohort was 3.4% (95%CI 2.7-4.2). AMS were more likely to be male (p=0.003), older at MS onset (p<0.001), have primary progressive MS (PPMS) phenotype (p=0.03), multifocal presentation (p<0.001), and spinal cord as well as infratentorial lesions at MRI during disease onset (p=0.004 and p=0.002, respectively).

Conclusions

3.4% of our patient population could be considered AMS. Men, patients older at symptom onset, multifocal presentation, PPMS phenotype, and spinal cord as well as brainstem lesion on MRI at clinical presentation all had higher odds of having AMS.

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Observational Studies Poster Presentation

P0841 - Brain volume loss during the first year and physical and cognitive impairment over 3 years in naïve multiple sclerosis patients under fingolimod (ID 1301)

Speakers
Presentation Number
P0841
Presentation Topic
Observational Studies

Abstract

Background

The loss of brain volume (BVL), or brain atrophy, has been classically considered as a marker present in severe or advanced stages of the disease

Objectives

The objective of this study was analyze the percentage of brain volume loss (PBVL) during the first year and physical and cognitive impairment over 3 years multiple sclerosis (MS) patients

Methods

prospective cohort study that include naïve patients who initiated fingolimod. Patients were followed longitudinally for at least 36 months evaluating relapses and EDSS progression (defined as worsening of 1 point on the EDSS). Magnetic resonance image (MRI) evaluation was done at 6 months (range 4-7 months) after fingolimod initiation (baseline MRI), and then at 12, 24 and 36 months after. PBVL loss between the baseline MRI and the first year MRI after treatment initiation was done by SIENA. Cognitive evaluation was done at study entry to exclude patients with cognitive impairment (CI) (defined as patients who scored at least 2 SDs below controls on at least 2 domains) and then at month 24 and 36. At 36 months patients with CI and EDSS progression were identified. Logistic regression analysis between the first year BVL and CI and EDSS progression was done adjusted by co-variables

Results

A total of 71 patients were included, mean age 35.4 ± 3 years, mean follow up time 43 ± 5 months. At month 36, 12% patients were classified as CI and 5.6% had EDSS progression. In the CI group, first year PBVL was -0.52 (± 0.07) vs. -0.42 (± 0.04) in no CI (p 0.003, OR=2.13, 95% CI 1.63-2.31). In the group that showed EDSS progression the PBVL was 0.59 (± 0.05) vs. 0.42 (± 0.03) (p 0.008, OR=2.13, 95% CI 1.63-2.31).

Conclusions

In patients that progressed in terms of CI and physical disability, the rate of PBVL during the first year of treatment was significantly high than in patients that did not. This is the first study that shows this association in our region.

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Observational Studies Poster Presentation

P0867 - Dynamics of brain volume loss during 3 years in multiple sclerosis patients with cognitive impairment: prospective cohort study (ID 1306)

Speakers
Presentation Number
P0867
Presentation Topic
Observational Studies

Abstract

Background

Cognitive impairment may reflect damages to brain structures, pathophysiological impairment, [BK1] or both and are usually detected too late to implement an effective preventive therapy

Objectives

The objective of this study was describe and compare the annual percentage of brain volume loss (PBVL) during 3 years in patients with multiple sclerosis (MS) who developed cognitive impairment (CI) vs. patients that did not (noCI)

Methods

prospective cohort study that included recently diagnosed (less than 6 months since first relapse) and naïve relapsing remitting MS patients. Patients were followed for at least 36 months evaluating relapses and EDSS. Magnetic resonance image (MRI) evaluation was done at study entry and then at 12, 24 and 36 months. PBVL was done by SIENA. Cognitive evaluation was done at study entry to exclude patients with cognitive impairment (CI) (defined as patients who scored at least 2 SDs below controls on at least 2 domains) and then at month 36. Annual PBVL between CI and noCI were described and compare. Linear model with generalized estimating equations (GEE) was used

Results

A total of 71 patients were included, mean age 35.4 ± 3 years, mean follow up time 43 ± 5 months. All patients received fingolimod after diagnosis. At month 36, 12% patients were classified as CI. PBVL at year 1 in CI and noCI group was -0.52 (± 0.07) vs. -0.42 (± 0.04), at year 2 was -0.41 (± 0.03) vs. -0.71 (± 0.07) and at year 3 was -0.43 (± 0.05) vs. -0.81 (± 0.05) respectively. PBVL for the entire period (0 to 3 year) in CI and no CI was -1.25 (± 0.11) vs. -2.05 (± 0.12) respectively.

Conclusions

In patients with CI, since the first year a significant difference in BVL was observed that increased almost 2-fold during the 2 and 3 year of follow up. Early differences in BVL were identified in patients that progressed CI vs. patients that did not progressed.

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Observational Studies Poster Presentation

P0899 - Prevalence of late-onset Multiple Sclerosis in Argentina: cross sectional study from RelevarEM (ID 1020)

Abstract

Background

Multiple Sclerosis (MS) tipically affects young adults; however, the first symptoms can occur after age 50 and is classified as late-onset MS (LOMS). Previous population-based studies described a frequency that ranged from 2 to 10% of LOMS, however scarce information exists in our region regarding this aspect.

Objectives

The objective of the present study was to describe the frecuency and clinical aspects of LOMS patients included in the Argentinean MS and NMOSD registry (Relevar EM, NCT 03375177).

Methods

Relevar EM is a longitudinal, strictly observational MS and NMOSD registry in Argentina. The eligible study population and cohort selection included all patients with definite MS included in the registry at 31 December 2019. LOMS was defined in MS patients in which the first symptom of disease was identified after the age of 50 years. Clinical and demographic aspects of the disease was described. Prevalence rate of LOMS and 95% CI was calculated.

Results

We included 2408 MS patients, mean age 42 (SD 8) years, 65.5% female. LOMS was identified 191 patients, prevalence rate 7.9%, 95% CI 6.85-9.01. In LOMS patients, 141 (68.5%) were female, mean age at disease onset 55 (SD 3.5) years. The mean EDSS was 3.5 (range 2-6). The most frequent first symptoms were motors deficits (33%) and multisystem deficits (33%). Most frequent clinical course (in all the cases with a minimal disease follow up of 3 years after the onset) was the relapsing remitting-MS (54.5%) fenotype. Primary progressive-MS in LOMS was observed in 20.9%. Oligoclonal IgG bands were positive in the 72 % of patients in the CSF study.

Conclusions

In our study we found a prevalence of LOMS of almost 8%. Most patients were RRMS. The frequency found in our cohort is like other population- based studies performed in Europe

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Observational Studies Poster Presentation

P0905 - Real-world experience of ocrelizumab in multiple sclerosis patients in Latin America (ID 1307)

Speakers
Presentation Number
P0905
Presentation Topic
Observational Studies

Abstract

Background

Ocrelizumab was approved in March 2017 for the treatment of relapsing or primary progressive MS. Despite the abundance of information concerning the efficacy and safety of ocrelizumab in phase III clinical trials, there is scarce evidence regarding real world patient profiles

Objectives

The aim of this study was to evaluate patient profiles, effectiveness and persistence to treatment in patients who used ocrelizumab for the treatment of multiple sclerosis (MS) in Latin America (LATAM)

Methods

retrospective multicenter study in Argentina, Chile and Mexico. Medical record databases of patients who received ocrelizumab and were followed for at least 1 year before and after treatment initiation were analyzed. Demographic and clinical variables were described as well as the effectiveness outcomes that included the proportion of patients free from clinical relapses, from disability progression, from new or enlarging T2 or T1 gadolinium-enhancing lesions on annual MRI. The proportion of patients discontinuing the treatment and the reason were registered.

Results

A total of 81 patients were included. The most frequent phenotype was relapsing remitting MS in 64.2% of patients. The mean age at study entry was 41.3 ± 12 years and 51.8 % were women. A total of 38% had relapse activity during the previous 12 months of ocrelizumab initiation, with a mean relapse rate of 1.3 ±0.6 during that period. 75 % were free from clinical relapses and 91% were free from gadolinium enhancing lesions in RRMS. Ocrelizumab discontinuation during the first 12 months was observed in 3 patients (3.7%). The mean persistence observed during the first year follow up was 338 ± 24 days.

Conclusions

Our study is in line with previous randomized clinical trials and recent real-world studies describing patient profiles effectiveness and persistence to ocrelizumab treatment in MS patients in LATAM.

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Observational Studies Poster Presentation

P0930 - Usage trend of oral drugs for multiple sclerosis in Argentina (ID 1183)

Abstract

Background

Over the past decade, numerous disease modifying drugs (DMDs) for relapsing multiple sclerosis (RMS) have been approved in Argentina. It is believed that the use of oral DMDs (oDMDs) i.e. fingolimod, teriflunomide and dimetil fumarate has increased in recent years, although the real-life data in our country is limited.

Objectives

Our aim was to describe the tendency of the use of oDMDs (as first treatment option or after switch) regarding its approval in Argentina.

Methods

A retrospective study was conducted in a cohort of MS patients follow-up in five Argentinian MS centers incorporated in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177). Patients who started their treatment since 2012 were included. Regarding to the availability of different oDMDs in Argentina, we define three period (P1-3): P1: 2012 – 2014; P2: 2015 - 2017 and P3: 2018 - 2020. An analysis was performed comparing between these three periods to assess the tendency of oDMDs use over time. Three scenarios were defined: initial treatment, first switch and second switch. For the switch scenarios, only P1 and P2 were analyzed considering that the patients belonging P3 have a short evolution time and a scarce patient’s number required treatment changes.

Results

Out of 202 patients, 58% were female, mean age 32.4 ±11.0 years, mean disease evolution 8.0 ±5.5 years, 46 % started with oDMDs and 64% was the first choice after a switch. Injectable therapies were the most frequently withdrawn in relation to oDMDs and monoclonal antibodies (p<0.01). The main cause of switching treatment was treatment failture (39%). We found an increase in the use of oDMDs as initial treatment over time (P1: 17.7%, P2: 63.9% and P3: 65.0%; p <0.01). We found a tendency in increasing use of oDMDs after a first switch (P1: 59.6%, P2: 73.1%) or second switch (P1: 59.6%, P2: 73.1%). Multivariate analysis showed that disease evolution (OR=1.06, p=0.04), and year of starting treatment (OR=0.66, p<0.01) were independently associated with choice of oDMDs.

Conclusions

We have identified an increasing tendency in the use of oDMDs as initial treatment of RMS regarding its approval in Argentina.

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Gender Differences, Hormones and Sex Chromosomes Poster Presentation

P1120 - Disparities in access to health care for women with multiple sclerosis in Argentina (ID 1509)

Abstract

Background

Disparities about health care access in females were previously reported. In Argentina, previous studies have shown the unequal access to health care in MS patients stratified by health coverage, but no information were obtained regarding disparities in the access by gender

Objectives

The objective of the study was to evaluate whether disparities in the access to healthcare was identified in women with multiple sclerosis (MS) in Argentina.

Methods

A cross-sectional study based on a self-administered survey was carried in 13 provinces from Argentina. We asked about demographic and clinical aspects of the disease as well as the access and barriers to MS care through self-report measures on waiting time for both neurological visits and MRI test, disease modifying treatment (DMTs) access and waiting time for delivery of DMTs. We applied multivariate analysis via both logistic and lineal regression to evaluate the impact of different factors on health care resources utilization

Results

We included 219 patients, mean age 39 (± 16) years and a female predominance 149 (68%). There were no differences between females and males in RRMS phenotype (92% vs. 89%), mean EDSS (2.5 ± 1 vs. 2.2 ± 1.3), mean age at disease onset (38±4 vs. 36 ±5 years) and working status (currently full time employed 63% vs. 68%) respectively. 97% of males vs. 89% of females received DMDs (p=0.02). No differences in neurological visits between females and males (at least 2 visits during the last year) (98% vs. 95%) neither MRI test (93% vs. 97%) was identified, respectively. Females reported longer waiting time for delivery of first DMDs (7.1 ±2 vs. 5.1 ±1.1 weeks, p=0.02) and longer waiting time for delivery of DMDs at follow-up DMDs (4.1 ±0.6 vs. 3.1 ±1 weeks, p=0.03). No differences in legal actions were identified between gender (22 % females vs. 19 % males).

Conclusions

despite no differences between demographic and clinical aspects, we identified an increased time for delivery of DMTs in female MS patients compared to males in our region.

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Reproductive Aspects and Pregnancy Poster Presentation

P1122 - Family planning in women with multiple sclerosis: an important yet seldom approached issue (ID 1174)

Abstract

Background

There are scarce data from Argentina or Latin America that evaluate family planning (FP) in women with multiple sclerosis (WwMS).

Objectives

The purpose of this study was to assess family planning experience and knowledge among Argentinian women with multiple sclerosis

Methods

604 WwMS from 10 MS Argentinian centers were invited to answer an online survey. Demographics, disease characteristics, disease modifying treatment (DMDs), knowledge and influences on FP, parenthood desire, occurrence of unplanned pregnancies were collected.

Results

A total of 433 (71.68%) WwMS completed the survey, mean age 32.4 ±11.0 years, mean EDSS 1.88 ±1.99, disease evolution ≤ 3 years 29.9%, motherhood before MS diagnosis 42.1%. A total of 82 WwMS became pregnant after MS diagnosis and regarding last pregnancy, 63.41% were planned and 36.58% unplanned. 53% of unplanned did not received information on FP. 55.8% stopped DMDs after pregnancy confirmation. In WwMS of reproductive age, 230 ≤ 40 years were identified. 49,6% considered FP an important factor in choice of treatment. Out of 230, 88.69% experienced concerns regarding maternity and MS, 32.2% changed maternity longing after MS diagnosis and 48.69% have future motherhood desire. Age 32.37 ±5.56, MS evolution ≤5 years, EDSS<3, no pregnancy before MS diagnosis and neurologist discussed FP planning, were significantly associated with future desire for motherhood (p<0.05).

Conclusions

The research highlights that pregnancy remains an important concern among WwMS. More than half of unplanned pregnancies did not receive FP. FP should be discussed not only out of a desire for motherhood, but also as part of the treatment decision process.

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Presenter Of 8 Presentations

Diagnostic Criteria and Differential Diagnosis Poster Presentation

P0255 - Improvement during the last decades in the time of diagnosis but not in the time of starting DMD in MS patients in Argentina (ID 1297)

Speakers
Presentation Number
P0255
Presentation Topic
Diagnostic Criteria and Differential Diagnosis

Abstract

Background

There has been a significant shortening of time from multiple sclerosis (MS) onset to diagnosis in parallel with the adoption of new diagnostic criteria. However, it is not clear whether that time has been accompanied by a shortening in the time since diagnosis to the initiation of disease modifying treatment (DMD).

Objectives

The objective of the study was described and compare the interval from first symptom of MS to the date of diagnosis and the interval between date of diagnosis and DMD initiation regarding the introduction of upgraded MS diagnosis criteria.

Methods

retrospective cohort study that included relapsing remitting MS patients between January 2005 and January 2018. To be included, date of disease onset (first relapse), date of diagnosis (confirmed disease) and date of DMD initiation must be available. Kaplan-Meier estimator and plots were applied. Survival probabilities were evaluated for the 2 diagnosis epoch groups according to the diagnostic criteria advised at the time: group 1, for diagnosis performed between 2005-2009 (2005 revised McDonald criteria) and group 2, for diagnosis performed between 2010-2017 (2010 revised McDonald criteria). Survival curves were compared by log-rank method. P-value less than 0.05 was considered statistically significant

Results

654 patients were revised, 586 included (278 in group 1 and 308 in group 2) and 68 excluded due to missing data. Most of patients in group 1 were treated with beta interferons (82%), while in group 2, 32% were on beta interferons, 45% on oral treatments (fingolimod, teriflunomide and dymethil-fumarate), 15% on natalizumab and 8 % on alemtuzumab. There were no differences in mean age at disease onset between group 1 and 2 (33 ± 5 and 31 ± 6 years, p=0.45). The mean time since disease onset to diagnosis in group 1 was 1.35 ± 0.32 vs. 1.11 ± 0.22 years (p 0.001). Mean time since disease diagnosis to first DMD was 4.6 ± 2.1 months in group 1 vs. 5.8 ± 1.5 months in group 2 (p=0.07).

Conclusions

despite a shorten in time of diagnosis was described a trend to increase the time to initiate a DMD was noted in group 2. An improvement in access to treatments must follow the improvement in diagnosis if it is intended to treat patients earlier to prevent disease progression.

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Diagnostic Criteria and Differential Diagnosis Poster Presentation

P0268 - Time interval between disease onset and MS diagnosis during the last decades in Latin America (ID 1201)

Speakers
Presentation Number
P0268
Presentation Topic
Diagnostic Criteria and Differential Diagnosis

Abstract

Background

Previous studies have shown a significant shortening of time from multiple sclerosis (MS) onset (first relapse) to diagnosis in parallel with the adoption of new diagnostic criteria. However, the observation was not evaluated in Latin America.

Objectives

The objective of the study was to study the interval from first symptom of MS to the date of diagnosis in relation to the introduction of upgraded MS diagnostic criteria in a Latin American population.

Methods

Cross-sectional study based on a self-reported survey. Patients with MS completed a regional survey in 12 Latin American countries. To be included, date of disease onset (first relapse) and date of diagnosis (confirmed disease) should be completed. Survival probabilities were evaluated for 5 diagnosis epoch groups according to the diagnostic criteria advised at the time: group 1- 1983-2000 Poser; group 2- 2001-2004 McDonald's first version; group 3- 2005-2009 revisions of 2005; group 4- 2010-2016 revisions of 2010; and group 5 -2017-2019 revisions of 2017.

Results

1434 patients were included. 1108 (75%) females, mean age at study entry 39 ± 11 years. The mean time since disease onset to diagnosis in group 1 was 21 ± 8 months; in group 2, 19 ± 7 months; in group 3, 16 ± 10 months; in group 4, 9.6 ± 8.5 months and in group 5, 8.2 ± 10 months. Significant differences were observed between groups 1, 2, 3 vs. 4 and 5 (p<0.001) while no differences were observed between group 4 and 5 (p=0.08).

Conclusions

This study showed a significant shortening of time from MS onset to diagnosis in parallel with the adoption of new diagnostic criteria in Latin America in recent decades.

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Neuromyelitis Optica and Anti-MOG Disease Poster Presentation

P0731 - Multiple sclerosis and NMOSD testing and treatment availability in Latin America (ID 1311)

Speakers
Presentation Number
P0731
Presentation Topic
Neuromyelitis Optica and Anti-MOG Disease

Abstract

Background

To be aware of the availability of multiple sclerosis (MS) and neuromyelitis optica spectrum disorders diseases (NMOSD) diagnosis and treatment is a highly relevant point to better understand how to treat affected patients in our region.

Objectives

The objective of the study was to describe the availability of diagnosis tests and treatment for MS and NMOSD in Latin America (LATAM).

Methods

a survey instrument designed and piloted by the authors was used in a sample of physicians from all LATAM countries. The goal of the survey was to understand 1) imaging tests available for diagnosing MS and NMOSD and barriers in its acquisition; 2) diagnostic laboratory tests available for diagnosing MS and NMOSD and barriers; 3) treatments available for MS and NMOSD in the acute and chronic phases of diseases

Results

Responses were received from 80 physicians from all LATAM countries. AQP4-ab test was available in 54% of the countries and MOG-ab test in 42%. MRI was available in 93% of the countries. 100% of countries had the availability to use high doses of intravenous methilprednisolone, oral steroids, plasmapheresis as well as intravenous immunoglbulins for relapses. For NMOSD, 93% of the countries had the possibility to use azathioprine and mycophenolate mofetil and 87 % rituximab. Eculizumab and satralizumab was not available in any country. In MS, 93 % of countries had the availability of IFN beta, 69% glatiramer acetate, 75% teriflunomide, 93% fingolimod, 69% dimetyl-fumarate, 75% cladribine, 69% Natalizumab, 93% ocrelizumab and 81% alemtuzumab. Siponimod was not available in any conutry of the region. The most common challenge and barrier identified was the cost of medications to the health sector followed by the inability to consistently obtain medicine supplies for affected patients. MS treatments was completely covered by the health care system in most of the surveyed countries.

Conclusions

the present study allows an understanding of the delivery of care for MS and NMOSD in the region. This information will allow us to make health care policies in affected patients that will improve the care in LATAM.

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Observational Studies Poster Presentation

P0836 - Aggressive multiple sclerosis in Argentina: data from the nationwide registry RelevarEM (ID 1632)

Abstract

Background

Aggressive MS (AMS) describes a form of the disease with a rapid progressive course leading to significant disability in multiple neurologic systems or even death in a relatively short time after onset. Despite there being no consensus on the exact definition of AMS, several studies performed during the last years have tried to better identify and understand the frequency and distribution as well as the progression and treatment response in order to determine more accurately which patients with AMS would most benefit from higher-efficacy, higher-risk treatments

Objectives

The objectives of the present study were to describe the frequency of aggressive multiple sclerosis (AMS) as well as to compare clinical and radiological characteristics in AMS and non-AMS patients included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177).

Methods

The eligible study population and cohort selection included adult-onset patients (≥18 years) with definite MS. AMS were defined as those reaching confirmed EDSS ≥6 within 5 years from symptom onset. Confirmation was achieved when a subsequent EDSS ≥6 was recorded at least six months later but within 5 years of the first clinical presentation. AMS and non-AMS were compared using the χ2 test for categorical and the Mann-Whitney for continuous variables at MS onset and multivariable analysis was performed using forward stepwise logistic regression with baseline characteristics at disease onset.

Results

A total of 2158 patients with MS were included: 74 AMS and 2084 non-AMS. The prevalence of AMS in our cohort was 3.4% (95%CI 2.7-4.2). AMS were more likely to be male (p=0.003), older at MS onset (p<0.001), have primary progressive MS (PPMS) phenotype (p=0.03), multifocal presentation (p<0.001), and spinal cord as well as infratentorial lesions at MRI during disease onset (p=0.004 and p=0.002, respectively).

Conclusions

3.4% of our patient population could be considered AMS. Men, patients older at symptom onset, multifocal presentation, PPMS phenotype, and spinal cord as well as brainstem lesion on MRI at clinical presentation all had higher odds of having AMS.

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Observational Studies Poster Presentation

P0841 - Brain volume loss during the first year and physical and cognitive impairment over 3 years in naïve multiple sclerosis patients under fingolimod (ID 1301)

Speakers
Presentation Number
P0841
Presentation Topic
Observational Studies

Abstract

Background

The loss of brain volume (BVL), or brain atrophy, has been classically considered as a marker present in severe or advanced stages of the disease

Objectives

The objective of this study was analyze the percentage of brain volume loss (PBVL) during the first year and physical and cognitive impairment over 3 years multiple sclerosis (MS) patients

Methods

prospective cohort study that include naïve patients who initiated fingolimod. Patients were followed longitudinally for at least 36 months evaluating relapses and EDSS progression (defined as worsening of 1 point on the EDSS). Magnetic resonance image (MRI) evaluation was done at 6 months (range 4-7 months) after fingolimod initiation (baseline MRI), and then at 12, 24 and 36 months after. PBVL loss between the baseline MRI and the first year MRI after treatment initiation was done by SIENA. Cognitive evaluation was done at study entry to exclude patients with cognitive impairment (CI) (defined as patients who scored at least 2 SDs below controls on at least 2 domains) and then at month 24 and 36. At 36 months patients with CI and EDSS progression were identified. Logistic regression analysis between the first year BVL and CI and EDSS progression was done adjusted by co-variables

Results

A total of 71 patients were included, mean age 35.4 ± 3 years, mean follow up time 43 ± 5 months. At month 36, 12% patients were classified as CI and 5.6% had EDSS progression. In the CI group, first year PBVL was -0.52 (± 0.07) vs. -0.42 (± 0.04) in no CI (p 0.003, OR=2.13, 95% CI 1.63-2.31). In the group that showed EDSS progression the PBVL was 0.59 (± 0.05) vs. 0.42 (± 0.03) (p 0.008, OR=2.13, 95% CI 1.63-2.31).

Conclusions

In patients that progressed in terms of CI and physical disability, the rate of PBVL during the first year of treatment was significantly high than in patients that did not. This is the first study that shows this association in our region.

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Observational Studies Poster Presentation

P0867 - Dynamics of brain volume loss during 3 years in multiple sclerosis patients with cognitive impairment: prospective cohort study (ID 1306)

Speakers
Presentation Number
P0867
Presentation Topic
Observational Studies

Abstract

Background

Cognitive impairment may reflect damages to brain structures, pathophysiological impairment, [BK1] or both and are usually detected too late to implement an effective preventive therapy

Objectives

The objective of this study was describe and compare the annual percentage of brain volume loss (PBVL) during 3 years in patients with multiple sclerosis (MS) who developed cognitive impairment (CI) vs. patients that did not (noCI)

Methods

prospective cohort study that included recently diagnosed (less than 6 months since first relapse) and naïve relapsing remitting MS patients. Patients were followed for at least 36 months evaluating relapses and EDSS. Magnetic resonance image (MRI) evaluation was done at study entry and then at 12, 24 and 36 months. PBVL was done by SIENA. Cognitive evaluation was done at study entry to exclude patients with cognitive impairment (CI) (defined as patients who scored at least 2 SDs below controls on at least 2 domains) and then at month 36. Annual PBVL between CI and noCI were described and compare. Linear model with generalized estimating equations (GEE) was used

Results

A total of 71 patients were included, mean age 35.4 ± 3 years, mean follow up time 43 ± 5 months. All patients received fingolimod after diagnosis. At month 36, 12% patients were classified as CI. PBVL at year 1 in CI and noCI group was -0.52 (± 0.07) vs. -0.42 (± 0.04), at year 2 was -0.41 (± 0.03) vs. -0.71 (± 0.07) and at year 3 was -0.43 (± 0.05) vs. -0.81 (± 0.05) respectively. PBVL for the entire period (0 to 3 year) in CI and no CI was -1.25 (± 0.11) vs. -2.05 (± 0.12) respectively.

Conclusions

In patients with CI, since the first year a significant difference in BVL was observed that increased almost 2-fold during the 2 and 3 year of follow up. Early differences in BVL were identified in patients that progressed CI vs. patients that did not progressed.

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Observational Studies Poster Presentation

P0905 - Real-world experience of ocrelizumab in multiple sclerosis patients in Latin America (ID 1307)

Speakers
Presentation Number
P0905
Presentation Topic
Observational Studies

Abstract

Background

Ocrelizumab was approved in March 2017 for the treatment of relapsing or primary progressive MS. Despite the abundance of information concerning the efficacy and safety of ocrelizumab in phase III clinical trials, there is scarce evidence regarding real world patient profiles

Objectives

The aim of this study was to evaluate patient profiles, effectiveness and persistence to treatment in patients who used ocrelizumab for the treatment of multiple sclerosis (MS) in Latin America (LATAM)

Methods

retrospective multicenter study in Argentina, Chile and Mexico. Medical record databases of patients who received ocrelizumab and were followed for at least 1 year before and after treatment initiation were analyzed. Demographic and clinical variables were described as well as the effectiveness outcomes that included the proportion of patients free from clinical relapses, from disability progression, from new or enlarging T2 or T1 gadolinium-enhancing lesions on annual MRI. The proportion of patients discontinuing the treatment and the reason were registered.

Results

A total of 81 patients were included. The most frequent phenotype was relapsing remitting MS in 64.2% of patients. The mean age at study entry was 41.3 ± 12 years and 51.8 % were women. A total of 38% had relapse activity during the previous 12 months of ocrelizumab initiation, with a mean relapse rate of 1.3 ±0.6 during that period. 75 % were free from clinical relapses and 91% were free from gadolinium enhancing lesions in RRMS. Ocrelizumab discontinuation during the first 12 months was observed in 3 patients (3.7%). The mean persistence observed during the first year follow up was 338 ± 24 days.

Conclusions

Our study is in line with previous randomized clinical trials and recent real-world studies describing patient profiles effectiveness and persistence to ocrelizumab treatment in MS patients in LATAM.

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Gender Differences, Hormones and Sex Chromosomes Poster Presentation

P1120 - Disparities in access to health care for women with multiple sclerosis in Argentina (ID 1509)

Abstract

Background

Disparities about health care access in females were previously reported. In Argentina, previous studies have shown the unequal access to health care in MS patients stratified by health coverage, but no information were obtained regarding disparities in the access by gender

Objectives

The objective of the study was to evaluate whether disparities in the access to healthcare was identified in women with multiple sclerosis (MS) in Argentina.

Methods

A cross-sectional study based on a self-administered survey was carried in 13 provinces from Argentina. We asked about demographic and clinical aspects of the disease as well as the access and barriers to MS care through self-report measures on waiting time for both neurological visits and MRI test, disease modifying treatment (DMTs) access and waiting time for delivery of DMTs. We applied multivariate analysis via both logistic and lineal regression to evaluate the impact of different factors on health care resources utilization

Results

We included 219 patients, mean age 39 (± 16) years and a female predominance 149 (68%). There were no differences between females and males in RRMS phenotype (92% vs. 89%), mean EDSS (2.5 ± 1 vs. 2.2 ± 1.3), mean age at disease onset (38±4 vs. 36 ±5 years) and working status (currently full time employed 63% vs. 68%) respectively. 97% of males vs. 89% of females received DMDs (p=0.02). No differences in neurological visits between females and males (at least 2 visits during the last year) (98% vs. 95%) neither MRI test (93% vs. 97%) was identified, respectively. Females reported longer waiting time for delivery of first DMDs (7.1 ±2 vs. 5.1 ±1.1 weeks, p=0.02) and longer waiting time for delivery of DMDs at follow-up DMDs (4.1 ±0.6 vs. 3.1 ±1 weeks, p=0.03). No differences in legal actions were identified between gender (22 % females vs. 19 % males).

Conclusions

despite no differences between demographic and clinical aspects, we identified an increased time for delivery of DMTs in female MS patients compared to males in our region.

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