F. Hoffmann-La Roche Ltd

Author Of 1 Presentation

Patient-Reported Outcomes and Quality of Life Poster Presentation

P1039 - Improvements in patient-reported SymptoMScreen scores among ocrelizumab-treated patients with RRMS: 2-year results from the CASTING clinical trial (ID 977)

Speakers
Presentation Number
P1039
Presentation Topic
Patient-Reported Outcomes and Quality of Life

Abstract

Background

SymptoMScreen is a patient-reported outcome tool designed to rapidly assess symptom limitations across 12 symptoms commonly affected in people with multiple sclerosis (MS). Each domain is scored on a 7-point Likert scale (0 [not affected] to 6 [total limitation]) and domain scores are summed to calculate a total score ranging from 0 to 72. SymptoMScreen is used in the ongoing, open-label, single-arm, Phase IIIb CASTING clinical trial (NCT02861014).

Objectives

To report 2-year changes in SymptoMScreen scores among patients with relapsing-remitting MS (RRMS) from CASTING.

Methods

In CASTING, patients with RRMS (Expanded Disability Status Scale [EDSS] score ≤4.0 at screening; disease duration ≤10 years) and a prior suboptimal response to ≥6 months of treatment with one or two disease-modifying therapies (DMTs; including orals and injectables) received intravenous ocrelizumab 600 mg every 24 weeks for 96 weeks. SymptoMScreen was performed at baseline, Week 48 (1-year interim data) and Week 96 (2-year final data).

Results

A total of 680 patients (female, 64%; mean [SD] baseline EDSS score, 2.1 [1.1]) who were previously treated with one (n=414 [60.4%]) or two (n=269 [39.6%]) DMTs were enrolled (most frequently for MRI with relapse activity [40.4%]) and evaluated in the intent-to-treat population; 644 patients completed treatment. Total SymptoMScreen mean (SD) score reflected mild symptom burden at baseline (15.19 [12.67]) and improved significantly through Year 2 (13.62 [12.51]; p<0.001 [p values were not adjusted for multiplicity]). Statistically significant improvements after 2 years were observed for sensory symptoms (Δ-0.28; p<0.001), fatigue (Δ-0.23; p<0.001), vision (Δ-0.21; p<0.001), depression (Δ-0.15; p<0.01) and dizziness (Δ-0.14; p<0.01) domains. Non-significant improvements in symptom burden after 2 years (p>0.05) were observed in walking (Δ-0.1), cognition (Δ-0.10), anxiety (Δ-0.07), bodily pain (Δ-0.05), hand function (Δ-0.03) and bladder control (Δ-0.01), while a non-significant worsening was observed in the spasticity domain (Δ+0.04). The proportion of patients with at least one symptom causing at least moderate limitation (domain score ≥4) decreased from 31.6% at baseline to 26.3% at Year 2.

Conclusions

Patients with RRMS and a suboptimal response to therapy who switched to ocrelizumab experienced an improvement in symptom burden in the majority of SymptoMScreen domains after 2 years, which was most pronounced in sensory, fatigue and vision.

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