Hospital de Santa Maria

Author Of 3 Presentations

Disease Modifying Therapies – Mechanism of Action Poster Presentation

P0328 - Effectiveness of cladribine in multiple sclerosis – clinical experience of two tertiary centers (ID 1498)

Speakers
Presentation Number
P0328
Presentation Topic
Disease Modifying Therapies – Mechanism of Action

Abstract

Background

Cladribine is a selective and oral immunological reconstitution treatment, approved in Europe in 2017 and in Portugal in 2018 for very active multiple sclerosis (MS) with relapses. Its safety and efficacy profile were assessed in phase III CLARITY (2005-2009) trial. Post-commercialization studies in real life conditions, are essential to confirm this profile.

Objectives

To assess the efectiveness of cladribine in multiple sclerosis patients a real-world clinical setting, during treatment follow-up.

Methods

Observational, multicentric, prospective study. Consecutive MS patients treated with cladribine were included in two tertiary hospitals in Lisbon and followed during treatment. Demographic and clinical aspects, EDSS, previous disease-modifying drugs (DMD) and annual relapse rate (ARR) were recorded, as well as laboratory and imaging monitoring during treatment

Results

Eighty-five included patients, 54 (63.5%) female, mean age 42±12 years old, mean disease duration 9±7 years. Seventy-seven (90.6%) had relapsing-remitting MS, and the remaining had secondary progressive MS. Median pre-treatment EDSS was 2,0 (1,5-4,0), and 40 (47.1%) patients had at least one relapse in previous year. Most (65.9%) patients had been submitted to more than one DMD before, 43 (51.2%) with first-line therapies and 9 (10.7%) were naïve. Cladribine was started in 57 (68.7%) patients due to inefficacy of previous drug. Mean follow-up time was 13±6 months, and 54 (63.5%) completed first year of treatment. Second year of treatment was delayed in some patients due to global COVID-19 pandemic. Fifteen relapses were registered in 12 patients. Five (5.9%) stopped treatment because of disease activity in the first year. After 12 months of follow-up (n=54), no difference was found between previous and 12-month EDSS medians (2 (IQR 1,5-4,0) vs 2 (IQR 1,25-4) p=0.606). Mean 12-month ARR (0,1±0,4) was significantly inferior to previous year ARR (0,6±1,0), p<0.001.

Conclusions

At pivot trial, the efficacy of cladribine was proved after two annual treatment cycles. In this population, short follow-up period is a limitation, but after mean follow-up of one year, clinical estabilization was found in MS patients treated with cladribine.

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Disease Modifying Therapies – Risk Management Poster Presentation

P0387 - Safety and tolerability of cladribine in multiple sclerosis – clinical experience of two tertiary centers (ID 1491)

Speakers
Presentation Number
P0387
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Cladribine is a selective and oral immunological reconstitution treatment, approved in Europe in 2017 and in Portugal in 2018 for very active multiple sclerosis (MS) with relapses. Its safety and efficacy profile were assessed in phase III CLARITY (2005-2009) trial. Post-commercialization studies in real life conditions, are essential to confirm this profile.

Objectives

To assess the safety and tolerability of cladribine in MS patients a real-world clinical setting, during treatment follow-up.

Methods

Observational, multicentric, prospective study. Consecutive MS patients treated with cladribine were included in two tertiary hospitals in Lisbon and followed during treatment. Demographic and clinical aspects, EDSS, previous disease-modifying drugs (DMD) and annual relapse rate (ARR) were recorded, as well as laboratory, imaging monitoring and adverse reactions during treatment.

Results

Eighty-five included patients, 54 (63.5%) female, mean age 42±12 years old, mean disease duration 9±7 years. Seventy-seven (90.6%) had relapsing-remitting MS, and the remaining had secondary progressive MS. Median pre-treatment EDSS was 2,0 (1,5-4,0). Most (65.9%) patients had been submitted to more than one DMD before, 43 (51.2%) with first-line therapies and 9 (10.7%) were naïve. Cladribine was started in 57 (68.7%) patients due to inefficacy of previous drug. Mean follow-up time was 13±6 months, and 54 (63.5%) completed first year of treatment. Second year of treatment was delayed in some patients due to global COVID-19 pandemic. Most frequent adverse reactions were lymphocytopenia (43,5%), infections (20,8%) and fatigue (18,1%). After two months of first dose, CD19+ lymphocyte count showed greater reduction compared with CD4+ and CD8+. There were no grade 4 lymphocytopenia cases registered. Four (5.5%) serious adverse reactions were recorded. There were no cases of cladribine withdrawal because of adverse reactions.

Conclusions

This cohort has similar characteristics to the CLARITY trial study population. Registered adverse reactions were comparable to previously described, showing higher incidence of fatigue and lower incidence of infections. This study confirms the short-term tolerability and safety profile of cladribine in real life scenarios.

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Comorbidities Poster Presentation

P0476 - Multiple sclerosis and acute stroke: are we missing something?  (ID 1490)

Speakers
Presentation Number
P0476
Presentation Topic
Comorbidities

Abstract

Background

Multiple sclerosis (MS) is a chronic disease characterized by inflammation and demyelination of the central nervous system (CNS) with variable degrees of axonal and neuronal damage. Although it is primarily a parenchymal disorder, endothelial function and platelet activation is altered in MS. People with MS have a higher prevalence of cardiovascular risk factors, such as smoking, hypertension and hyperlipidemia. Furthermore, people with MS have an increased risk of cardiovascular and cerebrovascular disease not completely accounted by traditional risk factors. All-cause mortality and cardiovascular disease mortality is also increased in people with MS. Nevertheless, stroke in people with MS in clinical practice is probably underdiagnosed and may be frequently missed, and there are no studies evaluating MS prevalence in stroke cohorts.

Objectives

To identify patients with stroke and MS and to estimate the prevalence of MS patients with stroke in a stroke unit cohort.

Methods

We conducted a retrospective closed cohort study, including all non-elective patients who were admitted and discharged over a ten year period from a stroke unit of an University Hospital (2010-2019). Demographic variables including previous diagnosis of MS, cerebrovascular disease diagnosis, stroke mimics diagnosis, imaging studies information and de novo diagnosis of MS or other inflammatory disorders of the CNS were retrieved and analyzed.

Results

Our cohort included 4440 patients with suspected acute cerebrovascular disorders admitted to the Stroke Unit over the last 10 years. Mean age was 63.8 years (SD=15.9 years), and 46.3% (n=2057) of patients were female. As part of the normal clinical investigation, brain magnetic resonance imaging (MRI) was done in 54.9% (n=2436) of patients. We identified 7 patients with a diagnosis of MS and 4 with a diagnosis of other (specified or unspecified) inflammatory disorders of the CNS, most of them admitted to the Stroke Unit as stroke mimics. Only two patients (0.045%) with acute stroke had a previous or de novo diagnosis of MS, one with a high-risk cardioembolic cause (exuberant right-left cardiac shunt), and one with a recurrent internal carotid artery dissection.

Conclusions

Although patients in MS cohorts have an increased risk of stroke, in a real-life setting of an acute stroke unit patients with MS and stroke are very rare. This may be a result of a failure to identify stroke in a previously diagnosed MS patient or a bias towards diagnosis of a MS relapse. Clinicians should be aware of stroke as a differential diagnosis for atypical or more sudden than expected onset attacks, in order to properly offer acute stroke treatment instead of MS relapse treatment.

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Presenter Of 3 Presentations

Disease Modifying Therapies – Mechanism of Action Poster Presentation

P0328 - Effectiveness of cladribine in multiple sclerosis – clinical experience of two tertiary centers (ID 1498)

Speakers
Presentation Number
P0328
Presentation Topic
Disease Modifying Therapies – Mechanism of Action

Abstract

Background

Cladribine is a selective and oral immunological reconstitution treatment, approved in Europe in 2017 and in Portugal in 2018 for very active multiple sclerosis (MS) with relapses. Its safety and efficacy profile were assessed in phase III CLARITY (2005-2009) trial. Post-commercialization studies in real life conditions, are essential to confirm this profile.

Objectives

To assess the efectiveness of cladribine in multiple sclerosis patients a real-world clinical setting, during treatment follow-up.

Methods

Observational, multicentric, prospective study. Consecutive MS patients treated with cladribine were included in two tertiary hospitals in Lisbon and followed during treatment. Demographic and clinical aspects, EDSS, previous disease-modifying drugs (DMD) and annual relapse rate (ARR) were recorded, as well as laboratory and imaging monitoring during treatment

Results

Eighty-five included patients, 54 (63.5%) female, mean age 42±12 years old, mean disease duration 9±7 years. Seventy-seven (90.6%) had relapsing-remitting MS, and the remaining had secondary progressive MS. Median pre-treatment EDSS was 2,0 (1,5-4,0), and 40 (47.1%) patients had at least one relapse in previous year. Most (65.9%) patients had been submitted to more than one DMD before, 43 (51.2%) with first-line therapies and 9 (10.7%) were naïve. Cladribine was started in 57 (68.7%) patients due to inefficacy of previous drug. Mean follow-up time was 13±6 months, and 54 (63.5%) completed first year of treatment. Second year of treatment was delayed in some patients due to global COVID-19 pandemic. Fifteen relapses were registered in 12 patients. Five (5.9%) stopped treatment because of disease activity in the first year. After 12 months of follow-up (n=54), no difference was found between previous and 12-month EDSS medians (2 (IQR 1,5-4,0) vs 2 (IQR 1,25-4) p=0.606). Mean 12-month ARR (0,1±0,4) was significantly inferior to previous year ARR (0,6±1,0), p<0.001.

Conclusions

At pivot trial, the efficacy of cladribine was proved after two annual treatment cycles. In this population, short follow-up period is a limitation, but after mean follow-up of one year, clinical estabilization was found in MS patients treated with cladribine.

Collapse
Disease Modifying Therapies – Risk Management Poster Presentation

P0387 - Safety and tolerability of cladribine in multiple sclerosis – clinical experience of two tertiary centers (ID 1491)

Speakers
Presentation Number
P0387
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Cladribine is a selective and oral immunological reconstitution treatment, approved in Europe in 2017 and in Portugal in 2018 for very active multiple sclerosis (MS) with relapses. Its safety and efficacy profile were assessed in phase III CLARITY (2005-2009) trial. Post-commercialization studies in real life conditions, are essential to confirm this profile.

Objectives

To assess the safety and tolerability of cladribine in MS patients a real-world clinical setting, during treatment follow-up.

Methods

Observational, multicentric, prospective study. Consecutive MS patients treated with cladribine were included in two tertiary hospitals in Lisbon and followed during treatment. Demographic and clinical aspects, EDSS, previous disease-modifying drugs (DMD) and annual relapse rate (ARR) were recorded, as well as laboratory, imaging monitoring and adverse reactions during treatment.

Results

Eighty-five included patients, 54 (63.5%) female, mean age 42±12 years old, mean disease duration 9±7 years. Seventy-seven (90.6%) had relapsing-remitting MS, and the remaining had secondary progressive MS. Median pre-treatment EDSS was 2,0 (1,5-4,0). Most (65.9%) patients had been submitted to more than one DMD before, 43 (51.2%) with first-line therapies and 9 (10.7%) were naïve. Cladribine was started in 57 (68.7%) patients due to inefficacy of previous drug. Mean follow-up time was 13±6 months, and 54 (63.5%) completed first year of treatment. Second year of treatment was delayed in some patients due to global COVID-19 pandemic. Most frequent adverse reactions were lymphocytopenia (43,5%), infections (20,8%) and fatigue (18,1%). After two months of first dose, CD19+ lymphocyte count showed greater reduction compared with CD4+ and CD8+. There were no grade 4 lymphocytopenia cases registered. Four (5.5%) serious adverse reactions were recorded. There were no cases of cladribine withdrawal because of adverse reactions.

Conclusions

This cohort has similar characteristics to the CLARITY trial study population. Registered adverse reactions were comparable to previously described, showing higher incidence of fatigue and lower incidence of infections. This study confirms the short-term tolerability and safety profile of cladribine in real life scenarios.

Collapse
Comorbidities Poster Presentation

P0476 - Multiple sclerosis and acute stroke: are we missing something?  (ID 1490)

Speakers
Presentation Number
P0476
Presentation Topic
Comorbidities

Abstract

Background

Multiple sclerosis (MS) is a chronic disease characterized by inflammation and demyelination of the central nervous system (CNS) with variable degrees of axonal and neuronal damage. Although it is primarily a parenchymal disorder, endothelial function and platelet activation is altered in MS. People with MS have a higher prevalence of cardiovascular risk factors, such as smoking, hypertension and hyperlipidemia. Furthermore, people with MS have an increased risk of cardiovascular and cerebrovascular disease not completely accounted by traditional risk factors. All-cause mortality and cardiovascular disease mortality is also increased in people with MS. Nevertheless, stroke in people with MS in clinical practice is probably underdiagnosed and may be frequently missed, and there are no studies evaluating MS prevalence in stroke cohorts.

Objectives

To identify patients with stroke and MS and to estimate the prevalence of MS patients with stroke in a stroke unit cohort.

Methods

We conducted a retrospective closed cohort study, including all non-elective patients who were admitted and discharged over a ten year period from a stroke unit of an University Hospital (2010-2019). Demographic variables including previous diagnosis of MS, cerebrovascular disease diagnosis, stroke mimics diagnosis, imaging studies information and de novo diagnosis of MS or other inflammatory disorders of the CNS were retrieved and analyzed.

Results

Our cohort included 4440 patients with suspected acute cerebrovascular disorders admitted to the Stroke Unit over the last 10 years. Mean age was 63.8 years (SD=15.9 years), and 46.3% (n=2057) of patients were female. As part of the normal clinical investigation, brain magnetic resonance imaging (MRI) was done in 54.9% (n=2436) of patients. We identified 7 patients with a diagnosis of MS and 4 with a diagnosis of other (specified or unspecified) inflammatory disorders of the CNS, most of them admitted to the Stroke Unit as stroke mimics. Only two patients (0.045%) with acute stroke had a previous or de novo diagnosis of MS, one with a high-risk cardioembolic cause (exuberant right-left cardiac shunt), and one with a recurrent internal carotid artery dissection.

Conclusions

Although patients in MS cohorts have an increased risk of stroke, in a real-life setting of an acute stroke unit patients with MS and stroke are very rare. This may be a result of a failure to identify stroke in a previously diagnosed MS patient or a bias towards diagnosis of a MS relapse. Clinicians should be aware of stroke as a differential diagnosis for atypical or more sudden than expected onset attacks, in order to properly offer acute stroke treatment instead of MS relapse treatment.

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