University Hospital of Schleswig-Holstein
Department of Neurology

Author Of 1 Presentation

Disease Modifying Therapies – Risk Management Poster Presentation

P0366 - Ocrelizumab-Therapy associated Lymphopenia is linked to age in patients with Multiple Sclerosis in a Single-Centre Retrospective Cohort Study. (ID 1413)

Speakers
Presentation Number
P0366
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Ocrelizumab is a humanised monoclonal anti-CD20 antibody approved for intravenous treatment of both relapsing-remitting Multiple Sclerosis (RRMS) and primary progressive Multiple Sclerosis (PPMS) since 2018. The OPERA I, II and ORATORIO trials have shown evidence of efficacy and safety of B-cell depletion with Ocrelizumab but also detected newly occurring lymphopenia in 20% to 26% of patients. Although Ocrelizumab is increasingly clinically established, treatment associated lymphopenia in patients with Multiple Sclerosis (pwMS) has barely been studied.

Objectives

Our aim was to objectify and analyse incidence, course, and severity of lymphopenia in pwMS and to investigate risk factors in a real-life setting.

Methods

We performed a single centre retrospective cohort study in n=72 Ocrelizumab-treated patients with RRMS and PPMS. Patients were followed-up from 2016 to 2020. Age, sex, and Expanded Disability Status Scale (EDSS) at initiation of Ocrelizumab treatment (baseline) were investigated as well as number, drugs, and duration of prior treatments. Absolute numbers of lymphocytes (cells/microliters) at baseline and during treatment were collected. Lymphopenia was defined by <1000 cells/microliters. Odds ratios (OR) were calculated for lymphopenia and age, duration, and previous treatments.

Results

Patients were medium aged 41 years (range 21 to 60 years) with a median EDSS of 4.0. The cohort was 75% female. Of all patients 82% had received prior treatments with Dimethyl Fumarate (40.28%), Fingolimod (23.61%) and Natalizumab (23.61%) being the most relevant drugs. Mean lymphocyte counts were 1745 ±702 at baseline, 1318 ±523 after three months and 1488 ±478 after fifteen months follow-up. We observed lymphopenia in n=15 (20.83%) patients after three months of Ocrelizumab but only in 10.55% after 15 months follow-up (OR 1.46 versus 1.0 for lymphopenia and therapy duration at three and fifteen months). While 73.33% of patients with lymphopenia were aged >40, only 54.39% with normal lymphocyte count were over 40 (OR 2.31 for lymphopenia and age >40). Number and type of prior treatments did not differ significantly between patients with and without lymphopenia (OR 0.95 for lymphopenia and prior treatment).

Conclusions

We observed Lymphopenia in 20.83% of patients after three months of treatment with Ocrelizumab. Analyses of possible risk factors indicate patients’ age to be the major risk factor for development of lymphopenia during ocrelizumab therapy.

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Presenter Of 1 Presentation

Disease Modifying Therapies – Risk Management Poster Presentation

P0366 - Ocrelizumab-Therapy associated Lymphopenia is linked to age in patients with Multiple Sclerosis in a Single-Centre Retrospective Cohort Study. (ID 1413)

Speakers
Presentation Number
P0366
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Ocrelizumab is a humanised monoclonal anti-CD20 antibody approved for intravenous treatment of both relapsing-remitting Multiple Sclerosis (RRMS) and primary progressive Multiple Sclerosis (PPMS) since 2018. The OPERA I, II and ORATORIO trials have shown evidence of efficacy and safety of B-cell depletion with Ocrelizumab but also detected newly occurring lymphopenia in 20% to 26% of patients. Although Ocrelizumab is increasingly clinically established, treatment associated lymphopenia in patients with Multiple Sclerosis (pwMS) has barely been studied.

Objectives

Our aim was to objectify and analyse incidence, course, and severity of lymphopenia in pwMS and to investigate risk factors in a real-life setting.

Methods

We performed a single centre retrospective cohort study in n=72 Ocrelizumab-treated patients with RRMS and PPMS. Patients were followed-up from 2016 to 2020. Age, sex, and Expanded Disability Status Scale (EDSS) at initiation of Ocrelizumab treatment (baseline) were investigated as well as number, drugs, and duration of prior treatments. Absolute numbers of lymphocytes (cells/microliters) at baseline and during treatment were collected. Lymphopenia was defined by <1000 cells/microliters. Odds ratios (OR) were calculated for lymphopenia and age, duration, and previous treatments.

Results

Patients were medium aged 41 years (range 21 to 60 years) with a median EDSS of 4.0. The cohort was 75% female. Of all patients 82% had received prior treatments with Dimethyl Fumarate (40.28%), Fingolimod (23.61%) and Natalizumab (23.61%) being the most relevant drugs. Mean lymphocyte counts were 1745 ±702 at baseline, 1318 ±523 after three months and 1488 ±478 after fifteen months follow-up. We observed lymphopenia in n=15 (20.83%) patients after three months of Ocrelizumab but only in 10.55% after 15 months follow-up (OR 1.46 versus 1.0 for lymphopenia and therapy duration at three and fifteen months). While 73.33% of patients with lymphopenia were aged >40, only 54.39% with normal lymphocyte count were over 40 (OR 2.31 for lymphopenia and age >40). Number and type of prior treatments did not differ significantly between patients with and without lymphopenia (OR 0.95 for lymphopenia and prior treatment).

Conclusions

We observed Lymphopenia in 20.83% of patients after three months of treatment with Ocrelizumab. Analyses of possible risk factors indicate patients’ age to be the major risk factor for development of lymphopenia during ocrelizumab therapy.

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