Correction To: Improvements in Cognitive Processing Speed, Disability, and Patient‑Reported Outcomes in Patients with Early Relapsing‑Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4‑year, Real‑World, Open‑Label Study

Overview

Journal CNS Drugs

Specialties Neurology
Pharmacology

Date 2023 Feb 13

PMID 36780107

Authors

Jai Perumal

Roumen Balabanov

Ray Su

Roger Chang

Laura J Balcer

Steven L Galetta

Robin L Avila

Danette Rutledge

Robert J Fox

Affiliations

Soon will be listed here.

Abstract

Background: STRIVE was a prospective, 4-year, multicenter, observational, open-label, single-arm study of natalizumab treatment in anti-JC virus antibody-negative patients with early relapsing-remitting multiple sclerosis (RRMS).

Objective: Study objectives examined the effects of natalizumab on cognitive processing speed, confirmed disability improvement (CDI), and patient-reported outcomes (PROs).

Methods: Clinical and PRO secondary endpoints were assessed annually over 4 years in STRIVE. The Symbol Digit Modalities Test (SDMT) was used as a measure of cognitive processing speed. PROs were assessed using the Multiple Sclerosis Impact Score (MSIS-29) and the Work Productivity and Activity Impairment Questionnaire (WPAI).

Results: At all four annual assessments, the proportion of patients in the intent-to-treat (ITT) population (N = 222) who exhibited clinically meaningful improvement in their SDMT score from baseline (i.e., change ≥ 4 points) ranged from 41.9 to 54.0%. The cumulative probability of CDI at 4 years in patients in the ITT population with a baseline Expanded Disability Status Scale score ≥ 2 (N = 133) was 43.9%. Statistically significant reductions in the mean change from screening in the MSIS-29 physical and psychological scores, indicating improved quality of life, were observed over all 4 years (P ≤ 0.0012 for all). A statistically significant decrease from screening in the impact of MS on regular activities, signifying an improvement in this WPAI measure, was also observed over all 4 years of the study.

Conclusion: These results further extend our knowledge of the effectiveness, specifically regarding improvements in cognitive processing speed, disability and PROs, of long-term natalizumab treatment in early RRMS patients.

Clinicaltrials: GOV: NCT01485003 (5 December 2011).

Citing Articles

Cognitive impairment in multiple sclerosis: from phenomenology to neurobiological mechanisms.

Jellinger K J Neural Transm (Vienna). 2024; 131(8):871-899.

PMID: 38761183 DOI: 10.1007/s00702-024-02786-y.

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