Disease Modifying Therapies – Risk Management Poster Presentation

P0364 - Ocrelizumab real-world safety and effectiveness in the two years of treatment in multiple sclerosis. (ID 1855)

Speakers
  • B. Vollmer
Authors
  • B. Vollmer
  • A. Declusin
  • K. Nair
  • S. Sillau
  • J. Corboy
  • T. Vollmer
  • E. Alvarez
Presentation Number
P0364
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Ocrelizumab (OCR), used in the treatment of multiple sclerosis (MS), is a monoclonal antibody targeting CD20, resulting in B-cell depletion.

Objectives

To describe the patient two-year experience of MS patients treated with OCR at the Rocky Mountain MS Center at the University of Colorado.

Methods

94 randomly selected MS patients prescribed OCR prior to May 2018 at the Rocky Mountain MS Center at the University of Colorado were retrospectively followed for up to two years from OCR start date. Lab data, relapse history, adverse events, MRI outcomes, disease history and patient characteristics were collected. Descriptive statistics were used to describe the sample group.

Results

Patients had a mean age of 44.2 years at date of first infusion; were predominantly female (75.5%); and had a mean MS disease duration of 10.4 years. Of the sample group, 76 (80.9%), 16 (17.0%), and 2 (2.1%) were relapsing-remitting, secondary progressive, and primary progressive MS, respectively. Two (2.1%), 1 (1.2%), and 6 (7.4%) patients experienced a clinical relapse, enhancing lesion and new T2 lesion, respectively. Of 48 patients with available MRI data for re-baselining after initiation of OCR, 1 (2.1%) patient had a new T2 lesion. Twenty (21.3%) patients discontinued OCR at our center at <24 months. Nine patients were lost to follow-up or relocated care, 7 patients discontinued due to issues with insurance, 1 patient discontinued due to adverse events, specifically hypogammaglobulinemia, and 3 patients discontinued due to other reasons, such as family planning and concern for cancer. During the first and second infusion course, 19 (20.2%) and 7 (7.4%) experienced an infusion reaction that interrupted the OCR infusion, respectively, and none experienced a life-threatening reaction or were hospitalized. After initiating OCR, 3 patients were diagnosed with basal cell carcinoma. Infections resulting in an emergency department visit or hospitalization occurred in 11 (11.7%) and 1 (1.1%) patients, respectively. Eleven (11.7%) patients experienced lymphopenia ≤500/mm3, and 2 (2.1%) experienced neutropenia ≤1000/mm3. Seven (7.4%) patients experienced IgG levels ≤500, 25 (26.6%) experienced IgM levels ≤40.

Conclusions

Our data suggests OCR is safe and effective in the treatment of MS. Additional data on an increased sample size will be presented.

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