Disease Modifying Therapies – Risk Management Poster Presentation

P0417 - Utilization, safety, and tolerability of ocrelizumab: year 3 data from the Providence Ocrelizumab Registry (ID 475)

Speakers
  • K. Smoot
Authors
  • K. Smoot
  • T. Stuchiner
  • C. Chen
  • L. Grote
  • S. Cohan
Presentation Number
P0417
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody, was approved in the US in 2017 for the treatment of relapsing MS (RMS) and primary progressive MS (PPMS). The Providence OCR Registry (POR) was established to monitor long-term treatment and safety outcomes.

Objectives

To evaluate OCR treatment outcomes including clinical and radiographic changes as well as safety issues using real-world data from a diverse, community-based MS population.

Methods

Adult MS patients who have been prescribed OCR were eligible. Chart reviews at OCR start date and every 6 months thereafter were done by a trained RN. Expanded Disability Status Scale (EDSS) scores were determined by the treating provider on the start date and then yearly. Descriptive statistics and paired t-tests were used.

Results

Of the 355 patients enrolled from March 2017 to March 2020, 71.9% were female; mean (SD) age was 51.8 (12.5) years; 78.3% had RMS, 13.2% had SPMS, and 8.5% had PPMS. Median baseline EDSS [interquartile range (IQR)] was 3.0 [2.0, 4.0], 6.5 [6.0, 7.5], and 6.5 [6.0, 7.0] respectively. The RMS cohort had an annualized relapse rate (ARR) of 0.34 prior to starting OCR. Among all patients who had > 1 dose of OCR (n=332), ARR was 0.09 with 4 patients having 2 relapses and 1 patient having 3 relapses. Median EDSS scores at 12 months were 3.0 [2.0, 5.5] (n=151) for RMS patients, 6.5 [6.5, 7.5] (n=31) for SPMS, and 6.5 [5.6, 7.5] (n=16) for PPMS. Infusion reactions occurred in 32.9% of patients during dose one, becoming less frequent with subsequent doses. Respiratory infections occurred in 40.1% of patients followed by urinary tract infections (UTI) (33.1%). Of 34 patients hospitalized, 11 patients had multiple hospitalizations. 25 hospitalizations were due to infections, 14 (56%) of which were due to UTIs. Sixty-five percent of these patients were 55 years or older. Forty-three (12.0%) patients have stopped OCR with a median time to discontinuation [IQR] of 10.8 [6.1,18.9] months; 24 patients stopped due to side effects, 15 patients stopped due to a relapse or clinical progression, and four patients died one each due to septic shock from pneumonia, urosepsis, suicide, and respiratory distress. There were no significant changes in Beck Depression Inventory (BDI), but 87 patients who had baseline and 12 month Modified Fatigue Inventory (MFIS), had significant improvement at 12 months (mean difference -3.7 (±14.1), (p=0.02).

Conclusions

Our study showed that OCR was effective in controlling relapse and disability worsening and reported similar rates of infusion reactions compared to earlier phase III clinical trials. Although only a small percentage of patients have stopped OCR, infections resulting in hospitalization are a concern, especially in older patients.

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