Quality of life outcomes with BG-12 (dimethyl fumarate) in patients with relapsing–remitting multiple sclerosis: The DEFINE study

2013 ◽  
Vol 20 (2) ◽  
pp. 243-252 ◽  
Author(s):  
Ludwig Kappos ◽  
Ralf Gold ◽  
Douglas L Arnold ◽  
Amit Bar-Or ◽  
Gavin Giovannoni ◽  
...  

Background: Oral BG-12 (dimethyl fumarate), approved for the treatment of the relapsing forms of MS, has demonstrated clinical efficacy with an acceptable safety profile in the Phase III “Determination of the Efficacy and Safety of Oral Fumarate in Relapsing–Remitting Multiple Sclerosis (RRMS)” (DEFINE) and “Comparator and an Oral Fumarate in RRMS” (CONFIRM) studies. Objectives: To evaluate the health-related quality of life (HRQoL) impairment that is associated with RRMS and to assess the effects of BG-12 on HRQoL in the DEFINE study. Methods: Patients with RRMS were randomized to BG-12 240 mg twice (BID) or three times (TID) daily, or placebo, for 2 years. HRQoL was assessed by the Short Form-36 (SF-36), global assessment of well-being visual analog scale and the EuroQol-5D. Results: In the 1237 patients from DEFINE, HRQoL impairment was greatest in patients who had higher disability scores and in those who had experienced relapse. Change in SF-36 physical component summary scores during 2 years’ treatment significantly favored BG-12 over placebo (both doses: p < 0.001). We saw similar benefits in other measures of functioning and general well-being as early as Week 24. These benefits were maintained during the study. Conclusions: Our results add to evidence for a negative impact of RRMS on HRQoL and they demonstrate the benefits of BG-12 on HRQoL measures, which coupled with significant clinical efficacy, further support its use as a new treatment for RRMS.

2016 ◽  
Vol 23 (10) ◽  
pp. 1367-1376 ◽  
Author(s):  
Rafael Arroyo González ◽  
Mariko Kita ◽  
Heidi Crayton ◽  
Eva Havrdova ◽  
David H Margolin ◽  
...  

Background: Alemtuzumab was superior on clinical and magnetic resonance imaging (MRI) outcomes versus subcutaneous interferon beta-1a in phase 3 trials in patients with relapsing-remitting multiple sclerosis. Objective: To examine quality-of-life (QoL) outcomes in the alemtuzumab phase 3 trials. Methods: Patients who were treatment naive (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis I [CARE-MS I]) or had an inadequate response to prior therapy (CARE-MS II) received annual courses of alemtuzumab 12 mg/day at baseline (5 days) and Month 12 (3 days) or subcutaneous interferon beta-1a 44 µg three times/week. QoL was measured every 6 or 12 months using Functional Assessment of Multiple Sclerosis (FAMS), European Quality of Life-5 Dimensions (EQ-5D) and its visual analog scale (EQ-VAS), and 36-Item Short-Form Survey (SF-36). Results: Statistically significant improvements from baseline with alemtuzumab were observed on all three QoL instruments at the earliest post-baseline assessment and sustained through Year 2. Statistically significant greater QoL improvements over subcutaneous interferon beta-1a were seen at all time points in CARE-MS II with FAMS, EQ-VAS and SF-36 physical component summary, and in CARE-MS I with FAMS. Conclusion: Patients treated with alemtuzumab had improvements in physical, mental, and emotional QoL regardless of treatment history. Improvements were significantly greater with alemtuzumab versus subcutaneous interferon beta-1a on both disease-specific and general measures of QoL.


2018 ◽  
Vol 23 ◽  
pp. 2515690X1774874 ◽  
Author(s):  
Laura K. Case ◽  
Paula Jackson ◽  
Revere Kinkel ◽  
Paul J. Mills

Multiple sclerosis is a disabling and progressive neurological disease that has significant negative effects on health-related quality of life. This exploratory efficacy study examined the effects of Healing Light Guided Imagery (HLGI), a novel variant of guided imagery, compared with a wait-list control in patients with relapsing-remitting multiple sclerosis. Changes in the Beck Depression Inventory, Fatigue Severity Scale, and Multiple Sclerosis Quality of Life instrument (physical and mental components) were compared between groups. Patients who completed HLGI (N = 9) showed significant reductions in depressed mood ( P < .05) and fatigue ( P < .01) and showed significant gains in physical ( P = .01) and mental ( P < .01) quality of life compared with journaling (N = 8). Our results suggest that HLGI can improve self-reported physical and mental well-being in patients with relapsing-remitting multiple sclerosis. Further research is needed to study the effectiveness of this therapy, as well as its mind-body mechanisms of action.


Biomédica ◽  
2020 ◽  
Vol 40 (1) ◽  
pp. 129-136
Author(s):  
Elkin Beltrán ◽  
Diana Díaz ◽  
Cindy Díaz ◽  
Luis Zarco

Introduction: Multiple sclerosis is a chronic inflammatory demyelinating disease associated with neurological disability. Clinical features include motor, cerebellar, visual, and sensory function alterations, as well as psychiatric comorbidities, such as depression, anxiety, and irritability. There is little literature available on the quality of life of patients and their caregivers.Objective: To assess the quality of life of patients with multiple sclerosis and their caregivers in Colombia given that there is no information on the subject in this particular population to establish comprehensive management plans.Materials and methods: We used the MusiQol and CareQol questionnaires and the Beck Depression Inventory. A prospective analytical observational protocol was designed to include patients aged 18 to 65 years with a diagnosis of relapsing-remitting multiple sclerosis between October, 2014, and October, 2015, at the Hospital Universitario San Ignacio. We evaluated quantitative variables and Spearman correlations. The data analysis was carried out with Student t and Mann-Whitney U tests.Results: A total of 55 patients with relapsing-remitting multiple sclerosis participated in the study. Chronic fatigue was the most common comorbidity in 27%. The MusiQol questionnaire revealed a good basal quality of life, which remained at similar levels in the follow-ups at six and 12 months. Quality of life was good during the study since there were no statistically significant differences between baseline and follow-up MusiQol scores. Good quality of life was also observed in caregivers.Conclusions: The quality of life of several Colombian patients diagnosed with multiple sclerosis was very good. This positive result was also observed in caregivers as evidenced by the results of the CareQol questionnaire. We also observed and indicated an inversely proportional correlation between the Expanded Disability Status Scale and the quality of life indexes.


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