La Princesa Hospital
MS UNIT. Neurology Service

Author Of 3 Presentations

Clinical Outcome Measures Poster Presentation

P0025 - Analysis fo the results of the establishment of a SARS-CoV-2 safety protocol for Multiple Sclerosis patients  (ID 1512)

Speakers
Presentation Number
P0025
Presentation Topic
Clinical Outcome Measures

Abstract

Background

The SARS-CoV-2 infection has spread worlwide becoming a pandemic never before seen. Immunosuppressive (IS) treatments used in Multiple Sclerosis (MS) patients could activate the infection in asymptomatic carriers or reactivate COVID-19 in apparently recovered cases. Our similar experience in some MS patients during the pandemic lead us to design a safety protocol at our MS Unit. It was based on epidemiological data and testing for PCR in nasopharyngeal swabs and serology before administration of monoclonal antibodies, doses of pulsed disease modifying therapies (DMTs), new starts of oral DMTs and methylprednisolone pulses.

Objectives

To describe our experience in the establishment of a SARS-CoV-2 safety protocol in MS patients. We analyze its utility to prevent COVID-19 complications

Methods

Observational, prospective and clinical practice study in the establishment of a multidisciplinary safety protocol (MS Unit – Neurology/Microbiology/Preventive Medicine). Sequential protocol over time adapted to the different pandemic phases and levels of available resources.

Results

152 PCR and 140 serology tests were performed in 90 patients over 3 months. They were performed preceding the treatment with Natalizumab (96 tests), Ocrelizumab (36 tests), Rituximab (3 tests), Methylprednisolone (7 tests), Cladribine (4 tests) and Dimethyl Fumarate (3 tests). 7 asymptomatic carriers were diagnosed (7,8%), 5 of them with positive IgM+IgG serology (5,6%). 5 patients with positive IgM+IgG serology post-infection were confirmed. No COVID-19 reactivation was detected after the establishment of the protocol.

Conclusions

The combined analysis of PCR and serology increased the sensitivity of the SARS-CoV-2 infection diagnosis during the pandemic peak of cases phase. However, this does not happen at pandemic phases with less daily cases, when testing PCR alone detected the same number of cases than testing combined PCR and serology. The safety protocol reaches its objective of avoiding disease reactivation and clinical activation in asymptomatic carriers.

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Clinical Outcome Measures Poster Presentation

P0043 - Clinical practice experience with Cladribine in Multiple Sclerosis (ID 1499)

Speakers
Presentation Number
P0043
Presentation Topic
Clinical Outcome Measures

Abstract

Background

There are different disease-modifying therapies (DMTs) for treating patients with Relapsing-Remitting Multiple Sclerosis (RRMS). Oral Cladribine was commercialized in 2018.

Objectives

To analyze the first year of treatment with Cladribine in RRMS patients: tolerability, security and initial approach to its effectiveness.

Methods

Retrospective, longitudinal and unicenter study in RRMS patients treated with Cladribine. We analyzed its security measuring overall lymphocyte count by Friedman Test and time to appearance of lymphopenia by Kaplan-Meier. We studied its effectiveness by comparing the following variables with the Wilcoxon Test: relapses, Expanded Disability Status Scale (EDSS) score and gadolinium enhancing lesions before and one year after starting Cladribine (statistically significant p<0’05).

Results

53 patients were studied. 88,7% were women with a mean age of 44,8 years old (DS10,25). 56,6% of the patients had a RRMS evolution of less than 10 years, 32,1% between 10 and 20 years, and 9,4% between 20 and 30 years. 64,1% had been previously treated with one or two DMTs. Patients were exposed to Cladribine for 8 months as a median (percentiles P15=2 months, P85=15 months): 36,4% patients for 6 months, 34,1% between 6-12 months and 29,5% for more than 12 months. The overall lymphocyte count reduction regarding the basal level after starting the drug was statistically significant (p<0’05). The lymphocyte count reduction rate was 52,89% during the first year of treatment and 58,99% during the second one. Tolerability was good in 93,02% of the patients. We observed significant reduction of the relapses rate after one year of treatment.

Conclusions

Cladribine seems to be a secure treatment. The most common adverse effect was lymphopenia (81,8%) but it was severe only in 9,09% of the patients and not associated with severe infections. Its tolerability was very good. Effectiveness results are positive, but, to date, they are preliminary.

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Clinical Outcome Measures Poster Presentation

P0079 - Experience in Multiple Sclerosis Patients with SARS CoV-2 Infection (ID 1508)

Speakers
Presentation Number
P0079
Presentation Topic
Clinical Outcome Measures

Abstract

Background

The new coronavirus SARS-CoV-2 infection has spread worlwide becoming a pandemic never before seen. Multiple Sclerosis (MS) patients in a state of immunosuppression (IS) may be exposed to a greater risk of COVID-19 complications, although there is increasing evidence postulating a possible protective role of selective IS.

Objectives

To describe the real-world experience in MS patients with SARS-CoV-2 infection at a MS Unit of a hospital in Madrid, Spain. We describe clinical evolution and MS treatment actions

Methods

Observational, prospective and usual clinical practice study in MS patients affected by SARS-CoV-2 infection with clinical diagnosis (at least three of the following: fever, anosmia, cough, diarrhea, myalgia) and/or microbiological diagnosis (PCR in nasopharyngeal swabs and/or serology).

Results

41 SARS-CoV-2 infection cases were registered. 21 were women with a mean age of 39,4 years old (DS10,3). 38 were relapsing-remitting MS patients and 3 had a progressive MS. The mean MS time course was nine years (DS1,4). 39 patients were treated with disease-modifying therapies (DMTs): 46,3% with oral agents, 39% with monoclonal antibodies and 10% with injectable agents. 27 patients were previously treated with other DMTs. The median Expanded Disability Status Scale (EDSS) was 2,5 (DS0,7). 11 patients had clinical activity the previous year. 18 cases were confirmed by PCR and/or serology and 23 were clinically diagnosed. 17% of the patients were admitted to hospital (6 were diagnosed with pneumonia) and none required admission to the intensive care unit. There were no deaths.Three patients had other comorbidities. Admitted patients were older and had higher EDSS score without statistical significance. MS got worse in 7 patients. DMTs were stopped or delayed in 10 patients due to the SARS-CoV-2 infection.

Conclusions

All the MS patients studied had a good outcome of the SARS-CoV-2 infection. Only 17% of them required admission to hospital and 14,6% of the cases were asymptomatic. 95% of the patients were treated with DMTs. From our experience, the SARS-CoV-2 infection does not seem to entail a more aggressive form of the disease in this group of patients. Selective IS may favor the good evolution. Larger clinical registers are needed to establish solid conclusions.

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