Evaluating Meaningful Changes in Patient-Reported Outcome Measurement Information System-Fatigue Scores from Three Phase 3 Clinical Trials of Sarilumab for Patients With Rheumatoid Arthritis.

ABSTRACT:

Objective

The aim of this study was to evaluate changes in fatigue measured by Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue scores in patients with rheumatoid arthritis (RA) who received sarilumab and to assess the proportion of patients achieving clinically meaningful change.

Methods

Data from three phase 3 randomized controlled trials of patients with RA who received sarilumab-MOBILITY, TARGET, and MONARCH-were evaluated. The 10 RA-relevant items from the 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue were scored in the PROMIS T score metric. Mean changes in 10-item PROMIS-Fatigue T score (PROMIS-Fatigue 10a) were compared, proportions of patients reporting meaningful within-person change thresholds were assessed, and r

SUBMITTER: Bingham CO 

PROVIDER: S-EPMC11694253 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature