Author Of 2 Presentations
P0177 - Treatment Persistency for Patients in a Phase 2 Long-Term Extension Study of Ponesimod (ID 1700)
Abstract
Background
Multiple Sclerosis (MS) is a disorder of the central nervous system characterized by inflammation, demyelination, and degenerative changes. For chronic conditions requiring a potential lifetime of treatment, treatment discontinuation may result in significant clinical issues, including relapse risk and disease progression. There can be a number of factors contributing to treatment discontinuation, but several studies have demonstrated that adverse events and the lack of efficacy represented by continued disease progression are the leading causes. In MS, patient satisfaction with treatment is essential for sustained persistency and positive long-term health outcomes.
Objectives
Understanding the long-term safety and efficacy considerations of a potential treatment in a chronic disease such as MS is critical to both patients and providers. The aim of this analysis is to understand the frequency and reason leading to premature treatment discontinuation from the long-term extension for patients on the 20mg of ponesimod.
Methods
In the main phase 2 study (B201), a total of 464 subjects were randomized in a 1:1:1:1 ratio to receive ponesimod 10 mg (N=108), ponesimod 20 mg (N=116), ponesimod 40 mg (N=119), or placebo (N=121), resulting in a total of 462/464 (99.6%) treated subjects, of whom 393 completed the 24-week double-blind treatment period. Of the 393 subjects who completed treatment in the core study, subjects were eligible to be enrolled into of the extension study (B202) of three treatment phases (TP1, TP2, and TP3) maintaining the either the same dose or for placebo patients rerandomized to 10, 20 or 40mg (although the 40mg was discontinued after TP1).
Results
As of the 31 March 2019 (8.3 years after initiation), a total of 60.7% of subjects in the 20mg arm had maintained therapy on ponesimod over the course of the study and subsequent extensions. For those patients with premature discontinuations, reasons for discontinuation: 40.4% unknown subject decision, 28.1% tolerability/AE related, 17.5% efficacy related, and 14% other reasons.
Conclusions
Patient satisfaction with treatment is key to ensure adherence in a long-term chronic disease. The retention of over 60% of patients during an 8 year, phase 2 long term extension study suggests a high degree of patient satisfaction with the tolerability, safety and efficacy of ponesimod.
P0857 - Comorbidity and Economic Burdens of Fatigue Among Patients with Relapsing-Remitting Multiple Sclerosis in the United States (ID 1686)
Abstract
Background
Multiple Sclerosis (MS)-related fatigue is a common symptom of relapsing remitting MS (RRMS). However, the demographic and clinical characteristics of these patients, as well as associated economic and health burden of MS-related fatigue, are poorly understood.
Objectives
To describe demographics, comorbidities, and healthcare resources of adults with RRMS with low level and high level of fatigue, compared to adults without MS.
Methods
This cross-sectional study included data from the 2017 and 2019 US National Health and Wellness Survey, a nationally representative self-report survey of the US general adult population. Respondents reporting physician-diagnosed MS with RRMS were stratified by low/high levels of fatigue (RRMS+LF, RRMS+HF), based on the Modified Fatigue Impact Scale-5 score (0-14=LF, 15-20=HF). Descriptive statistics compared patients with RRMS+HF to respondents with RRMS+LF and unmatched non-MS controls on healthcare resource use, income, employment, and clinical characteristics.
Results
In total, 123 respondents with RRMS+HF, 375 with RRMS+LF, and 145,669 non-MS controls were analyzed. Mean age was similar across groups, and 75% (RRMS+HF), 74% (RRMS+LF), and 55% (non-MS) were female. Depression (65% vs 33% and 20%), anxiety (48% vs 25% and 19%), and insomnia (26% vs 16% and 8%) were more commonly reported by those with RRMS+HF than RRMS+LF and non-MS, respectively. Higher Charlson Comorbidity Index scores were reported by patients with RRMS+HF (1.2±1.8), compared to 0.7±2.9 for RRMS+LF and 0.4±1.0 for non-MS. Annualized number of outpatient visits, emergency room visits, and hospitalizations were greater for those with RRMS+HF (15.5±15.4, 1.3±3.5, 0.9±2.6), compared to RRMS+LF (11.5±17.6, 0.7±2.0, 0.4±1.6) and non-MS (7.4±11.3, 0.5±2.5, 0.4±2.8), translating to annual medical care costs of $19,508±$43,614 for RRMS+HF, $10,406±$28,081 for RRMS+LF, and $8,493±$45,661 for non-MS. Patients with RRMS+HF were less likely to be employed full-time (18%) than those with RRMS+LF (31%) and non-MS (43%) and were more likely to have lower annual household income. Moreover, percentages on long-term disability were 38%, 14%, and 3%, respectively.
Conclusions
Higher comorbidity and economic burdens were reported by patients with RRMS+HF, compared to those with RRMS+LF and non-MS. These findings can facilitate identification of patients with MS who may require additional treatment and support to manage MS-related fatigue.
Presenter Of 1 Presentation
P0857 - Comorbidity and Economic Burdens of Fatigue Among Patients with Relapsing-Remitting Multiple Sclerosis in the United States (ID 1686)
Abstract
Background
Multiple Sclerosis (MS)-related fatigue is a common symptom of relapsing remitting MS (RRMS). However, the demographic and clinical characteristics of these patients, as well as associated economic and health burden of MS-related fatigue, are poorly understood.
Objectives
To describe demographics, comorbidities, and healthcare resources of adults with RRMS with low level and high level of fatigue, compared to adults without MS.
Methods
This cross-sectional study included data from the 2017 and 2019 US National Health and Wellness Survey, a nationally representative self-report survey of the US general adult population. Respondents reporting physician-diagnosed MS with RRMS were stratified by low/high levels of fatigue (RRMS+LF, RRMS+HF), based on the Modified Fatigue Impact Scale-5 score (0-14=LF, 15-20=HF). Descriptive statistics compared patients with RRMS+HF to respondents with RRMS+LF and unmatched non-MS controls on healthcare resource use, income, employment, and clinical characteristics.
Results
In total, 123 respondents with RRMS+HF, 375 with RRMS+LF, and 145,669 non-MS controls were analyzed. Mean age was similar across groups, and 75% (RRMS+HF), 74% (RRMS+LF), and 55% (non-MS) were female. Depression (65% vs 33% and 20%), anxiety (48% vs 25% and 19%), and insomnia (26% vs 16% and 8%) were more commonly reported by those with RRMS+HF than RRMS+LF and non-MS, respectively. Higher Charlson Comorbidity Index scores were reported by patients with RRMS+HF (1.2±1.8), compared to 0.7±2.9 for RRMS+LF and 0.4±1.0 for non-MS. Annualized number of outpatient visits, emergency room visits, and hospitalizations were greater for those with RRMS+HF (15.5±15.4, 1.3±3.5, 0.9±2.6), compared to RRMS+LF (11.5±17.6, 0.7±2.0, 0.4±1.6) and non-MS (7.4±11.3, 0.5±2.5, 0.4±2.8), translating to annual medical care costs of $19,508±$43,614 for RRMS+HF, $10,406±$28,081 for RRMS+LF, and $8,493±$45,661 for non-MS. Patients with RRMS+HF were less likely to be employed full-time (18%) than those with RRMS+LF (31%) and non-MS (43%) and were more likely to have lower annual household income. Moreover, percentages on long-term disability were 38%, 14%, and 3%, respectively.
Conclusions
Higher comorbidity and economic burdens were reported by patients with RRMS+HF, compared to those with RRMS+LF and non-MS. These findings can facilitate identification of patients with MS who may require additional treatment and support to manage MS-related fatigue.