Background
Little is known about quality of life (QOL) at the time of multiple sclerosis (MS) or clinically isolated syndrome (CIS) diagnosis and how it evolves in the critical adjustment period ...immediately following a new diagnosis.
Objectives
To (1) describe QOL trajectory in the first year post-MS/CIS diagnosis and (2) examine associations of demographic and biopsychosocial factors with QOL at baseline and as it evolves over the first year post-MS/CIS diagnosis.
Methods
Participants were
N
= 250 individuals newly diagnosed with MS or CIS. Participants completed self-report assessments of QOL, demographics, and biopsychosocial factors at 1, 2, 3, 6, 9, and 12 months post-diagnosis using validated measures.
Results
At 1-month post-diagnosis, QOL
M
= 75.2/100 with subsequent assessments revealing consistent ratings on average. Modelling revealed a small number of variables that were predictive of QOL at baseline and/or change in QOL over time.
Conclusion
QOL in the first year post-MS/CIS diagnosis was, on average, high and stable. A subset of modifiable factors across the biopsychosocial spectrum was associated with baseline level of QOL and change in QOL over time. The stability in QOL suggests that patients can be assessed early after diagnosis for key variables that are predictive of both current and future QOL.
Background:
Diroximel fumarate (DRF) is approved for adults with relapsing–remitting multiple sclerosis (RRMS) in Europe and for relapsing forms of MS in the United States. DRF and dimethyl fumarate ...(DMF) yield bioequivalent exposure of the active metabolite monomethyl fumarate. Prior studies indicated fewer gastrointestinal (GI)-related adverse events (AEs) with DRF compared with DMF.
Objective:
To report final outcomes from EVOLVE-MS-1.
Methods:
EVOLVE-MS-1 was an open-label, 96-week, phase 3 study assessing DRF safety, tolerability, and efficacy in patients with RRMS. The primary endpoint was safety and tolerability; efficacy endpoints were exploratory.
Results:
Overall, 75.7% (800/1057) of patients completed the study; median exposure was 1.8 (range: 0.0–2.0) years. AEs occurred in 938 (88.7%) patients, mostly of mild (28.9%) or moderate (50.3%) severity. DRF was discontinued due to AEs in 85 (8.0%) patients, with < 2% discontinuing due to GI or flushing/flushing-related AEs. At Week 96, mean number of gadolinium-enhancing lesions was significantly reduced from baseline (72.7%; p < 0.0001); adjusted annualized relapse rate was 0.13 (95% confidence interval: 0.11–0.15).
Conclusion:
DRF was generally well tolerated over 2 years, with few discontinuations due to AEs; radiological measures indicated decreased disease activity from baseline. These outcomes support DRF as a treatment option in patients with RRMS.
Background:
Low exposure to ultraviolet radiation (UVR) from sunlight may be a risk factor for developing multiple sclerosis (MS). Possible pathways may be related to effects on immune system ...function or vitamin D insufficiency, as UVR plays a role in the production of the active form of vitamin D in the body.
Objective:
This study examined whether lower levels of residential UVR exposure from sunlight were associated with increased MS risk in a cohort of radiologic technologists.
Methods:
Participants in the third and fourth surveys of the US Radiologic Technologists (USRT) Cohort Study eligible (N = 39,801) for analysis provided complete residential histories and reported MS diagnoses. MS-specialized neurologists conducted medical record reviews and confirmed 148 cases. Residential locations throughout life were matched to satellite data from NASA’s Total Ozone Mapping Spectrometer (TOMS) project to estimate UVR dose.
Results:
Findings indicate that MS risk increased as average lifetime levels of UVR exposures in winter decreased. The effects were consistent across age groups <40 years. There was little indication that low exposures during summer or at older ages were related to MS risk.
Conclusion:
Our findings are consistent with the hypothesis that UVR exposure reduces MS risk and may ultimately suggest prevention strategies.
Background
Diroximel fumarate (DRF) is a novel oral fumarate approved in the USA for relapsing forms of multiple sclerosis. DRF is converted to monomethyl fumarate, the pharmacologically active ...metabolite of dimethyl fumarate (DMF). DRF 462 mg and DMF 240 mg produce bioequivalent exposure of monomethyl fumarate and are therefore expected to have similar efficacy/safety profiles; the distinct chemical structure of DRF may contribute to its tolerability profile.
Objectives
The objective of this study was to compare the gastrointestinal tolerability of DRF and DMF over 5 weeks in patients with relapsing–remitting multiple sclerosis.
Methods
EVOLVE-MS-2 was a phase III, randomized, double-blind, head-to-head, 5-week study evaluating the gastrointestinal tolerability of DRF 462 mg vs DMF 240 mg, administered twice daily in patients with relapsing–remitting multiple sclerosis, using two self-administered gastrointestinal symptom scales: Individual Gastrointestinal Symptom and Impact Scale (IGISIS) and Global Gastrointestinal Symptom and Impact Scale (GGISIS). The primary endpoint was the number of days with an IGISIS intensity score ≥ 2 relative to exposure. Other endpoints included the degree of gastrointestinal symptom severity measured by IGISIS/GGISIS and assessment of safety/tolerability.
Results
DRF-treated patients experienced a statistically significant reduction (46%) in the number of days with an IGISIS symptom intensity score ≥ 2 compared with DMF-treated patients (rate ratio 95% confidence interval: 0.54 0.39–0.75;
p
= 0.0003). Lower rates of gastrointestinal adverse events (including diarrhea, nausea, vomiting, and abdominal pain) were observed with DRF than DMF (34.8% vs 49.0%). Fewer patients discontinued DRF than DMF because of adverse events (1.6% vs 5.6%) and gastrointestinal adverse events (0.8% vs 4.8%).
Conclusions
DRF demonstrated an improved gastrointestinal tolerability profile compared with DMF, with less severe gastrointestinal events and fewer days of self-assessed gastrointestinal symptoms, fewer gastrointestinal adverse events, and lower discontinuation rates because of gastrointestinal adverse events.
Clinical Trials Registration
ClinicalTrials.gov (NCT03093324).
Progressive multifocal leukoencephalopathy (PML) is a serious complication of natalizumab pharmacotherapy, caused by the JC virus (JCV), against which 60% of adults have detectable serum antibodies. ...super(1) The most common symptoms of PML are cognitive impairment, motor dysfunction, visual abnormalities, and speech deficit. super(2) Although the mortality rate of 23% super(3) in natalizumab-associated cases is lower compared to PML from other causes, most survivors have a poor functional outcome. super(4) As of March 3, 2015, Biogen had reported 541 cases of natalizumab-related PML. Of 278 cases with available data, only 2 were negative for anti-JCV antibody; these 2 patients had tests dating from 8 and 9 months prior to diagnosis. super(3)
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