S. Tizio
Hospital Español de La Plata
Neurología

Author Of 7 Presentations

 On-Demand Program
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)

Speakers
Authors
Presentation Number
P0301
Presentation Topic
Disease Modifying Therapies – Risk Management

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)

Speakers
Authors
Presentation Number
P0427
Presentation Topic
Epidemiology

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)

Speakers
Authors
Presentation Number
P0483
Presentation Topic
Comorbidities

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)

Speakers
Authors
Presentation Number
P0493
Presentation Topic
Epidemiology

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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Observational Studies Poster Presentation

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

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Authors
Presentation Number
P0836
Presentation Topic
Observational Studies

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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Patient-Reported Outcomes and Quality of Life Poster Presentation

P1033 - Health-related quality of life in relapsing multiple sclerosis patients from Argentina: impact of clinical features and coping strategies (ID 1032)

Speakers
Authors
Presentation Number
P1033
Presentation Topic
Patient-Reported Outcomes and Quality of Life

Abstract

Background

Multiple sclerosis (MS) patients have reported decreased health-related quality of life (HRQoL). Identifying factors that contribute to a worse HRQoL is needing in order to improve the HRQoL of these patients.

Objectives

We aimed to investigate the HRQoLin an Argentinean population of MS patients and their correlation with clinical variables and coping strategies.

Methods

Nationwide cross-sectional study. Screening instruments: Demographics and clinical data, HRQoL (MS Impact Scale, [MSIS-29]), Fatigue Severity Scale and physical disability (self-administrated Expanded Disability Status Scale, [EDSS]) and coping strategies (Brief Coping Orientation to Problems Experienced, [COPE-28]).

Results

We included 249 (74.7% women) MS patients with a mean age at survey of 38.6 (±10.7), a MS duration of 7.3 years (range: 1-43 years) and a mean EDSS of 1.9 (±1.8). The multivariate analysis via linear regression showed: lower fatigue scores and higher EDSS score, perception of severity of MS score and dysfunctional (maladaptive) coping strategies score significantly correlated with both higher (worse) HRQoL total (from p=0.009 to p<0.0001) and MSIS-physical scores (from p=0.04 to p<0.0001). Additionally, higher age and lower fatigue, dysfunctional coping strategies and perception of severity of MS scores were significantly correlated with worse MSIS-psychological (from p=0.006 to p<0.0001). An inverse correlation between live alone (p=0.04) and emotion-focused strategies (p=0.02) was significantly associated with a better MSIS-psychological.

Conclusions

This study showed a negative impact of physical disability and maladaptive coping strategies on HRQoL in MS patients from Argentina. Therefore, it would be necessary to increase interdisciplinary interventions and based on adaptive coping strategies to improve the HRQoL of these patients.

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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)

Speakers
Authors
Presentation Number
P1120
Presentation Topic
Gender Differences, Hormones and Sex Chromosomes

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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