Author Of 2 Presentations
P1004 - A real-world study characterizing symptoms and impacts of fatigue in US adults with relapsing multiple sclerosis using a novel disease specific scale (ID 1135)
Abstract
Background
Fatigue is among the most frequent and disabling symptoms in relapsing multiple sclerosis (RMS) patients. A greater understanding of MS fatigue and associated, MS-specific patient reported outcomes tools to characterize fatigue and its impact would improve patient care.
Objectives
To measure MS fatigue and its impact on daily life in a real-world population using a survey including the RMS-specific Fatigue Symptoms and Impacts Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS).
Methods
This is an ongoing noninterventional prospective study of ambulatory adult RMS patients recruited across the USA via an online survey. Participants completed demographic and clinical questionnaires including disease history and status, sleep, social and emotional functioning, along with the FSIQ-RMS, administered daily for 7 days. The FSIQ-RMS addresses the symptoms of fatigue, rated for severity based on the mean of the 7-day symptom assessment, and corresponding impacts of fatigue on 3 domains: physical, cognitive/emotional, and coping. The FSIQ-RMS scores range from 0-100 (higher score indicates greater severity). Data were collected via an online patient platform (Carenity).
Results
A total of 142 RMS patients completed the 7-day assessment: mean age: 43.5 yrs; 87% women; mean age at diagnosis: 33.2 yrs. Fatigue levels were severe and had high impact with a mean score during the 7-day period of 59.5 for the FSIQ-RMS symptom domain; 3 impact sub-domain scores were 45.1, 44.9 and 50.6 (physical, cognitive/emotional, and coping). The most impactful symptom on daily functioning was walking difficulties, followed by fatigue. A majority of patients (56%) experienced fatigue before MS diagnosis. Most patients (72%) were not currently relapsing and had a mean fatigue symptom domain score of 56.2 (vs 68 in relapsing patients). Those with lower disability tended to rate fatigue as the most impactful symptom on daily life. A majority of patients were not depressed (56%) nor reported a sleep disorder (72%), yet still reported mean fatigue symptom domain scores of 53.7, 58.1 respectively (vs 67, 63.3 in those with depression or sleep disorder). Heat exposure (82%) was the most common triggering factor for fatigue.
Conclusions
In this survey including the novel RMS specific FSIQ-RMS, fatigue occurred in most MS patients and had an influence on daily functioning. The FSIQ-RMS measures fatigue symptoms and impacts, which are relevant and meaningful to patients.
P1027 - Establishing Meaningful Change Threshold in Multiple Sclerosis related Fatigue on Fatigue Symptoms & Impacts Questionnaire-Relapsing MS (FSIQ-RMS) (ID 1249)
Abstract
Background
Fatigue, one of the most common symptoms in patients with multiple sclerosis (MS), impairs activity and limits physicial functioning in patients. A new patient reported outcome (PRO) instrument, the Fatigue Symptoms and Impact Questionnaire – Relapsing Multiple Sclerosis (FSIQ-RMS) has been developed with input from MS patients, to capture patient experience of MS related fatigue and addresses the limitations of existing fatigue instruments. The FSIQ-RMS is an MS specific, content-valid, concise instrument to assess symptoms relevant to MS and the impact of these symptoms on patients' lives.
Objectives
The aim of this research was to establish a meaningful change threshold (MCT) for patients with MS associated fatigue on the FSIQ-RMS symptoms domain. Within-subject change of fatigue is critical for interpreting the individual effect of treatment on patients in terms of treatment response.
Methods
Data from the OPTIMUM study (NCT02425644) were obtained to derive MCT on the FSIQ-RMS symptoms domain score. The symptoms domain comprises seven items scored on an 11-point scale (0–10); with standardized domain score range from 0 to 100 with a higher score indicating greater fatigue. The Patient Global Impression of Severity of fatigue (PGI-S) assessed the patient’s fatigue severity on a 11-point Numeric Rating Scale from 0-10, anchored at 0 = “not severe at all” and 10 =”very severe”. The PGI-S was used as an anchor to establish and assess potential range of MCTs based on the magnitude of correlation between FSIQ-RMS symptoms domain score and PGI-S, and variability of change. Cumulative distribution function and kernel density plots (probability density functions [PDFs]) were also generated.
Results
Correlation between the scales measuring change from baseline to end of treatment (Week 108) was above the acceptable threshold (0.35 [r=0.471]). Final analyses of the blinded OPTIMUM study data showed that an MCTof -6.3 points on the FSIQ-RMS symptom scale was equivalent to a 3-point improvement on the PGI-S, and captured all patients reporting improvement on the PGI-S without overlapping with patients reporting no change. The MCT of ‑6.3 points also exhibited a moderate effect size consistent with established guidelines.
Conclusions
Development of the MCT for the FSIQ-RMS provides an important metric to understand within patient improvement in fatigue symptoms using a PRO developed to specifically measure symptoms of MS fatigue.