Patients having a relapse, confirmed disability accumulation, or worsening in fatigue had significant negative impact on each of the work productivity and activity impairment measures.
Analyses from 2 studies presented at ACTRIMS Forum 2021, February 25–27, revealed that fatigue occurs in most patients with multiple sclerosis (MS) and can adversely influence patient’s daily functioning and leave a substantial burden on work productivity loss.1,2
The first was a real-world study that included 300 participants with relapsing MS (RMS) who completed questionnaires on disease history, disease status, sleep, social and emotional functioning, and the Fatigue Symptoms and Impacts Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS), each of which were administered daily for 7 days.1
At the end of the assessment, fatigue was reported as the symptom with the great impact on daily functioning. Using a score range from 0 to 100 (higher score equaling greater severity), fatigue was rated as severe, indicated by a mean score of 57.3 for the FSIQ-RMS symptom domain. The 3 impact sub-domain scores were 42.3, 43.4, and 50.1, which accounted for physical, cognitive/emotional, and coping, respectively.
"Especially for symptoms like fatigue which can be ‘invisible’ of sorts, the real-world data is especially important. It allows you to use the power of patient insights to generate data,” Allitia DiBernardo, MD, global head of medical affairs, neurology, Janssen Pharmaceutical, told NeurologyLive. These effects of fatigue were seen regardless of receiving high efficacy dose disease-modifying therapies (DMTs) medication (44%; n = 111) vs other DMTs (56%; n = 143).
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In total, 44% of patients with MS reported that because of their condition, they did not work. Among those who were working currently (48%), the impact of fatigue on professional life was rated as 4.5 out of 10. Additionally, 49% of the patient population discussed fatigue at each visit with their neurologists and 35% discussed it at most visits, with impact of fatigue on quality of life being the most discussed topic (65% of 289).
"We’re at a historical moment where the field is seeing many options that can be tailored to different patient needs. This is the moment where these residual symptoms that have not been previously addressed, such as fatigue, can rise to a level of scientific inquiry,” DiBernardo added.
The second of the 2 studies used data from the phase 3 OPTIMUM study (NCT02425644), and estimated the impact of MS disease activity and worsening of fatigue on work productivity and activity impairment (WPAI), as assessed by the WPAI-MS.2
This measure, with a recall period of 7 days, contained a 6-item patient-reported assessment of absenteeism, presenteeism, overall work productivity, and activity impairment attributable to MS.
Among a cohort of 1029 patients who completed WPAI at baseline, the mean percent activity impairment was 33%, and approximately 60% (n = 621) were employed but reported a mean of 26% overall work impairment. Absenteeism and presenteeism was also reported in 10% and 23% of those employed, respectively.
Patients were assessed using the FSIQ-RMS at baseline and weeks 12, 24, 60, 84, and 108. A mixed effects model was used to estimate the overall average effect of time-varying covariates, specifically including relapse (yes/no), confirmed disability accumulation (CDA) over 12 and 24 weeks (yes/no), and experience of a worsening in fatigue (yes/no), on each of the WPAI outcomes, controlling for relevant covariates.
Those who reported having a relapse, worsening in fatigue, or CDA (both 12 and 24 weeks) had a significant negative impact (P <.05) on each of the WPAI measures, with estimated differences in mean percent of time missed or impaired per week by approximately 5 to 10% more, compared to those not experiencing any of the events.
The authors of the study concluded that DMTs that address these specific aspects of the disease may yield a considerable positive effect on these outcomes in patients with RMS.
"We should be treating the whole patient. We can target pathways and mechanisms, but we should not lose sign of the entire needs of the patient. We’re really proud to take part in that work, specifically characterizing the impacts of fatigue in MS patients,” DiBernardo concluded.
For more coverage of ACTRIMS 2021, click here.