Hospital Universitario Virgen Macarena
Multiple Sclerosis Department

Author Of 3 Presentations

Disease Modifying Therapies – Risk Management Poster Presentation

P0294 - Autoinmunity secondary to alemtuzumab in clinical practice: 5 years of RWE (ID 1424)

Presentation Number
P0294
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Aletuzumab(ALZ) is an approved drug for the treatment of active recurrent-remitting multiple sclerosis (RRMS), with proved efficacy and safety in clinical trials. Among its most frequent adverse effects are autoinmune disorders related to secondary autoinmunity (SA) phenomena.

Objectives

We analyze and characterize secondary autoinmunity in our multiple sclerosis unit after more than five years of clinical experience.

Methods

Retrospective observational descriptive study of RRMS patients treated with ALZ in our center, characterizing SA phenomena after more than 5 years of experience

Results

n=131(77% women), with a mean age of 40,2 years (SD±9,1) and a mean time of disease of 13.8 years (SD±7,1). The mean pre-treatment EDSS was 4,5 (DS±1,6) with an prior annualized relapse rate of 1.48 (SD±0,83). SA was found in 42 patients (32%), most of them with thyroid disease (81% with 73,5% hyperthyroidism, asymptomatic majority) with aggresive treatment (surgical, radiotherapy) in 20%. Hematological SA was found in 0.01% (autoinmune thrombopenia, with monophasic course and excellent response to pharmacological treatment) and cutaneous SA in 0.05% (most of them vitiligo and well-controlled alopecia areata and one patient with chronic urticaria). Currently one patient is under study for nephropathy (0.01%). Like the available evidence, we detected an increase in SA around third year.

Conclusions

In our experience ALZ is emerging as a drug with a safety profile similar to available evidence regarding SA, although some complications have been described in other body systems, and it requires an adequate patient selection and close clinical control.

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Disease Modifying Therapies – Mechanism of Action Poster Presentation

P0377 - Real world experience with cladribine: patient profile, efficacy and safety. (ID 1430)

Presentation Number
P0377
Presentation Topic
Disease Modifying Therapies – Mechanism of Action

Abstract

Background

Cladribine is a nucleoside analog of deoxyadenosine, recently approved for treatment of active multiple sclerosis (RMS) defined by neuroimaging or clinical features.

Objectives

We analyze our treated patients profile, efficacy and safety in real clinical practice after two years of experience.

Methods

Two-year retrospective observational study of our RMS patients treated with oral cladribine, analyzing demographic, clinical, efficacy and safety data.

Results

n=81 (78% women), mean age 37.7 years (21-65) and a previous mean EDSS of 2.67(1-6). The mean time of evolution of RMS prior to treatment was 6.7 years and the mean annualized relapse rate 1,2. 50% of patients had at least 10 lesions in T2 with a mean of ehanced lesions of 0.9 (0-4). The mean of previous treatments was 1.25 and the mean time with last treatment was 2.44. Drug tolerance was good, with less than 15% adverse effects (Aes), all mild and self-limiting. Lymphocyte counts reached a mínimum mean value of 1.03x103/mm3 in month 3, with subsequent recovery and only 3 patients reaching asymptomatic grade 3 (0.04%). Currently 24 patients have received second year according to protocol, haveing detected previos radiological activity in four of them (0.05%) and clinical activity in two (0.02%), being reason for discontinuation in one patient without completing complete course of treatment.

Conclusions

In our experience, and after its first two years in clinical practice, oral cladribine is emerging as a treatment with a good efficacy and safety profile in active MS, in parallel with the available evidence.

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Disease Modifying Therapies – Risk Management Poster Presentation

P0378 - Real World Experience with Ocrelizumab in patiens with Relapsing-Remitting Multiple Sclerosis (ID 380)

Speakers
Presentation Number
P0378
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Ocrelizumab is an anti-CD20 humanized monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis

Objectives

To describe baseline characteristics of patients with RRMS treated with OCR. Analyze previous disease modifying treatments(DMT), reasons to change, safety and laboratory parameters

Methods

Retrospective observational study in patients with RRMS treated with OCR from November 2016 to May 2020 at Virgen Macarena Hospital, Seville, Spain.

Demographic/disease characteristics, ARR, previous DMTs, reasons to change DMT, adverse events changes in disability, and cerebral MRI findings were collected at enrolment.

Results

38 RRMS patients were treated with OCR (65,8%females) Mean follow-up after OCR initiation:11,4 months (1-40) 47,4% have received two or more cycles of treatment.

Average age was 39.8 years (21-58) Mean time since RRMS diagnosis was 9,9 years (0,3-26,2) The patients had been treated with a mean of 1,5DMT prior to OCR. 3 of them were treatment naïve. DMT previous OCR was IFN-b 2pax, glatiramer acetate 2pax, teriflunomide 4pax, dimethyl fumarate 3pax, rituximab 1pax, fingolimod 16pax, natalizumab 3pax, alemtuzumab 3pax. The reason to DMT change were: lack of efficacy:32 pax; security:6 pax (vJC seroconversion or alemtuzumab contraindications)

After 11,4 months of OCR initiation, annualized relapse rate (ARR) decreased from 1,2 to 0, and the EDSS score remained unchanged: mean 3,8 (1,5-6,5). None of the patients had relapses after OCR initiation.

Regarding cerebral MRI parameters, Gd+ lesions diminished from 1,3 previous to 0 after OCR. T2 lesion burden showed no changes on cerebral MRI.

The more frequent adverse events were infusion reactions (26,32% of patients: 4 fatigue; 3 headache; 3 redness skin; 2 allergic reaction) All of them were mild but in two patients lead to treatment discontinuation (allergic reaction). Infections occurred in 3 patients (2 urinary tract infection, 1 zoster reactivation)

Five patients (13,2%) showed decrease in total lymphocyte count (3 grade 1; 2 grade 2) 18,9% patients showed IgM index under lower limit of the normal range. All patients showed normal levels IgG index before and after OCR. Percentage of CD19+Cells diminished in all patients: median of 14%(previous) to 1%(after OCR) No clear associations between lymphopenia/immunoglobulines and infections was detected.

Conclusions

This data shows that RRMS patients treated with OCR in a real world clinical setting show significant decreases in ARR and the majority maintain EDSS score unchanged. The most common adverse event were mild infusion reactions and mild infectious diseases. Some patients showed lymphopenia and IgM below lower limit of normal. No clear associations between lymphopenia/immunoglobulines and infections was detected.

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Presenter Of 2 Presentations

Disease Modifying Therapies – Risk Management Poster Presentation

P0294 - Autoinmunity secondary to alemtuzumab in clinical practice: 5 years of RWE (ID 1424)

Presentation Number
P0294
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Aletuzumab(ALZ) is an approved drug for the treatment of active recurrent-remitting multiple sclerosis (RRMS), with proved efficacy and safety in clinical trials. Among its most frequent adverse effects are autoinmune disorders related to secondary autoinmunity (SA) phenomena.

Objectives

We analyze and characterize secondary autoinmunity in our multiple sclerosis unit after more than five years of clinical experience.

Methods

Retrospective observational descriptive study of RRMS patients treated with ALZ in our center, characterizing SA phenomena after more than 5 years of experience

Results

n=131(77% women), with a mean age of 40,2 years (SD±9,1) and a mean time of disease of 13.8 years (SD±7,1). The mean pre-treatment EDSS was 4,5 (DS±1,6) with an prior annualized relapse rate of 1.48 (SD±0,83). SA was found in 42 patients (32%), most of them with thyroid disease (81% with 73,5% hyperthyroidism, asymptomatic majority) with aggresive treatment (surgical, radiotherapy) in 20%. Hematological SA was found in 0.01% (autoinmune thrombopenia, with monophasic course and excellent response to pharmacological treatment) and cutaneous SA in 0.05% (most of them vitiligo and well-controlled alopecia areata and one patient with chronic urticaria). Currently one patient is under study for nephropathy (0.01%). Like the available evidence, we detected an increase in SA around third year.

Conclusions

In our experience ALZ is emerging as a drug with a safety profile similar to available evidence regarding SA, although some complications have been described in other body systems, and it requires an adequate patient selection and close clinical control.

Collapse
Disease Modifying Therapies – Mechanism of Action Poster Presentation

P0377 - Real world experience with cladribine: patient profile, efficacy and safety. (ID 1430)

Presentation Number
P0377
Presentation Topic
Disease Modifying Therapies – Mechanism of Action

Abstract

Background

Cladribine is a nucleoside analog of deoxyadenosine, recently approved for treatment of active multiple sclerosis (RMS) defined by neuroimaging or clinical features.

Objectives

We analyze our treated patients profile, efficacy and safety in real clinical practice after two years of experience.

Methods

Two-year retrospective observational study of our RMS patients treated with oral cladribine, analyzing demographic, clinical, efficacy and safety data.

Results

n=81 (78% women), mean age 37.7 years (21-65) and a previous mean EDSS of 2.67(1-6). The mean time of evolution of RMS prior to treatment was 6.7 years and the mean annualized relapse rate 1,2. 50% of patients had at least 10 lesions in T2 with a mean of ehanced lesions of 0.9 (0-4). The mean of previous treatments was 1.25 and the mean time with last treatment was 2.44. Drug tolerance was good, with less than 15% adverse effects (Aes), all mild and self-limiting. Lymphocyte counts reached a mínimum mean value of 1.03x103/mm3 in month 3, with subsequent recovery and only 3 patients reaching asymptomatic grade 3 (0.04%). Currently 24 patients have received second year according to protocol, haveing detected previos radiological activity in four of them (0.05%) and clinical activity in two (0.02%), being reason for discontinuation in one patient without completing complete course of treatment.

Conclusions

In our experience, and after its first two years in clinical practice, oral cladribine is emerging as a treatment with a good efficacy and safety profile in active MS, in parallel with the available evidence.

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