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Diroximel fumarate (DRF) in patients with relapsing-remitting multiple sclerosis: Interim safety and efficacy results from the phase 3 EVOLVE-MS-1 study
Naismith, Robert T; Wolinsky, Jerry S; Wundes, Annette; LaGanke, Christopher; Arnold, Douglas L; Obradovic, Dragana; Freedman, Mark S; Gudesblatt, Mark; Ziemssen, Tjalf; Kandinov, Boris; Bidollari, Ilda; Lopez-Bresnahan, Maria; Nangia, Narinder; Rezendes, David; Yang, Lili; Chen, Hailu; Liu, Shifang; Hanna, Jerome; Miller, Catherine; Leigh-Pemberton, Richard
BACKGROUND:Diroximel fumarate (DRF) is a novel oral fumarate for patients with relapsing-remitting multiple sclerosis (RRMS). DRF and the approved drug dimethyl fumarate yield bioequivalent exposure to the active metabolite monomethyl fumarate; thus, efficacy/safety profiles are expected to be similar. However, DRF's distinct chemical structure may result in a differentiated gastrointestinal (GI) tolerability profile. OBJECTIVE:To report interim safety/efficacy findings from patients in the ongoing EVOLVE-MS-1 study. METHODS:EVOLVE-MS-1 is an ongoing, open-label, 96-week, phase 3 study assessing DRF safety, tolerability, and efficacy in RRMS patients. Primary endpoint is safety and tolerability; efficacy endpoints are exploratory. RESULTS: < 0.0001) and adjusted annualized relapse rate was low (0.16; 95% confidence interval: 0.13-0.20). CONCLUSION:Interim data from EVOLVE-MS-1 suggest DRF is a well-tolerated treatment with a favorable safety/efficacy profile for patients with RRMS.
PMCID:7604551
PMID: 31680631
ISSN: 1477-0970
CID: 5342242
A comparison of digital gait technologies in a population of people with ms -when the same isn't always exactly the same [Meeting Abstract]
Kaczmarek, O.; Srinivasan, J.; Burke, C.; Khokhar, A.; Zarif, M.; Bumstead, B.; Golan, D.; Buhse, M.; Ofori, E.; Gudesblatt, M.
ISI:000596547100248
ISSN: 1352-4585
CID: 5342802
The Association Between MRI Brain Volumes and Computerized Cognitive Scores of People with Multiple Sclerosis [Meeting Abstract]
Golan, Daniel; Srinivasan, Jared; Zarif, Myassar; Bumstead, Barbara; Buhse, Marijean; Fafard, Lori; Wilken, Jeffrey; Sullivan, Cynthia; Fratto, Timothy; VanVlierberghe, Eline; Sima, Diana; VanHecke, Wim; Gudesblatt, Mark
ISI:000536058008072
ISSN: 0028-3878
CID: 5342752
Multiple Sclerosis Management And EDSS: A Great Start, But A Reason For Change Was Never So Apparent And Needed [Meeting Abstract]
Gudesblatt, M.; Srinivasan, J.; Bumstead, B.; Zarif, M.; Giovannoni, G.
ISI:000532412600070
ISSN: 1352-4585
CID: 5342702
Multiple sclerosis and cognitive impairment: computerized cognitive assessment and promis-cognitive function questionnaire: an unfulfilled promis [Meeting Abstract]
Kaczmarek, O.; Srinivasan, J.; Zarif, M.; Bumstead, B.; Buhse, M.; Golan, D.; Wilken, J.; Jaenicke, K.; Doroski, W.; Lund, D.; Gudesblatt, M.
ISI:000596547100344
ISSN: 1352-4585
CID: 5342822
Analysis of association between expanded disability status scale and patient determined disease steps [Meeting Abstract]
Makin, C.; Altincatal, A.; Gudesblatt, M.; Kieseier, B.; De Moor, C.
ISI:000596547100255
ISSN: 1352-4585
CID: 5342812
The Association Between MRI Brain Volumes And Computerized Multi-domain Cognitive Scores Of People With Multiple Sclerosis [Meeting Abstract]
Golan, D.; Srinivasan, J.; Gudesblatt, M.
ISI:000532412600206
ISSN: 1352-4585
CID: 5342712
Multiple Sclerosis Management: Predicting Disease Trajectory Of Multiple Sclerosis On Multi-dimensional Data Including Digital Cognitive Assessments And Patient Reported Outcomes Using Machine Learning Techniques [Meeting Abstract]
Srinivasan, J.; Gudesblatt, M.
ISI:000532412600212
ISSN: 1352-4585
CID: 5342722
Efficacy of Diroximel Fumarate in Relapsing-Remitting MS Patients Who Are Newly Diagnosed or Previously Treated With Interferons or Glatiramer Acetate [Meeting Abstract]
Jasinska, E.; Wray, S.; Ziemssen, T.; Leigh-Pemberton, R.; Chen, H.; Kapadia, S.; Hanna, J.; Gudesblatt, M.
ISI:000534616801030
ISSN: 1351-5101
CID: 5342732
Quantitative MRI Brain Atrophy and IgG Subclass Profile: Cross Sectional Relationship In A Population of People with MS (PwMS) [Meeting Abstract]
Srinivasan, Jared; Dasaro, Christopher; Kaczmarek, Olivia; Bumstead, Barbara; Jaenicke, Kaitlyn; Buhse, Marijean; Golan, Daniel; Zarif, Myassar; Gudesblatt, Mark
ISI:000536058008066
ISSN: 0028-3878
CID: 5342742