TY - JOUR
T1 - Characterizing Long-term Disability Progression and Employment in NARCOMS Registry Participants with Multiple Sclerosis Taking Dimethyl Fumarate
AU - Salter, Amber
AU - Lancia, Samantha
AU - Cutter, Gary
AU - Fox, Robert J.
AU - Marrie, Ruth Ann
AU - Mendoza, Jason P.
AU - Lewin, James B.
N1 - Funding Information:
Funding/Support: This study was sponsored by Biogen. The NARCOMS Registry is a project of the CMSC.
Funding Information:
Financial Disclosures: Dr Salter was a statistical editor for Circulation: Cardiovascular Imaging. Dr Cutter has served on data/ safety monitoring committees for AMO, BioLineRx, BrainStorm Cell Therapeutics, Galmed, Horizon, Hisun, Merck, Merck/Pfizer, OPKO Biologics, Neurim, Novartis, Orphazyme, Sanofi, Reata, Receptos/Celgene, Teva, the National Heart, Lung, and Blood Institute (Protocol Review Committee), and the National Institute of Child Health and Human Development (OPRU oversight committee) and on consulting/advisory boards for Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Klein Buendel, MedImmune, MedDay, Novartis, Osmotica, Perception Neuroscience, Recursion, Roche, Somahlution, and TG Therapeutics. Dr Fox has received consulting fees from Actelion, Biogen, Celgene, EMD Serono, Genentech, Immunic, Novartis, and Teva; served on advisory committees for Actelion, Biogen, Immunic, and Novartis; and received research grant funding from Novartis. Dr Marrie is a journal editor/editorial board member for Multiple Sclerosis Journal: Experimental, Translational and Clinical; receives research funding from the Arthritis Society, Canadian Institutes of Health Research, Consortium for Multiple Sclerosis Centers (CMSC), Crohn’s and Colitis Canada, MS Society of Canada, MS Scientific Research Foundation, National MS Society, and US Department of Defense; and is supported by the Waugh Family Chair in Multiple Sclerosis. Drs Mendoza and Lewin are employees of and hold stock/stock options in Biogen. Ms Lancia declares no conflicts of interest.
Publisher Copyright:
© 2021 Consortium of Multiple Sclerosis Centers.
PY - 2021/11
Y1 - 2021/11
N2 - Background: Delayed-release dimethyl fumarate (DMF) is effective in relapsing-remitting multiple sclerosis (RRMS), but long-term effects of DMF on disability and disease progression in clinical settings are unknown. We evaluated disability and employment outcomes in persons with RRMS treated with DMF for up to 5 years. Methods: This longitudinal study included US North American Research Committee on Multiple Sclerosis (NARCOMS) Registry participants with RRMS reporting DMF initiation in fall 2013 through spring 2018 with 1 year or more of follow-up. Time to 6-month confirmed disability progression (≥1-point increase in Patient-Determined Disease Steps [PDDS] score) and change in employment status were evaluated using Kaplan-Meier analysis. Participants were censored at last follow-up or at DMF discontinuation, whichever came first. Results: During the study, 725 US participants with RRMS had at least 1 year of DMF follow-up data, of whom most were female and White. At year 5, 69.9% (95% CI, 65.4%-73.9%) of these participants were free from 6-month confirmed disability progression, and 84.7% (95% CI, 78.6%- 89.2%) were free from conversion to secondary progressive MS. Of 116 participants with data at baseline and year 5, most had stable or improved PDDS and Performance Scales scores over 5 years. Of 322 participants 62 years and younger and employed at the index survey, 66.0% (95% CI, 57.6%- 73.1%) were free from a negative change in employment type over 5 years. Conclusions: Most US NARCOMS Registry participants treated up to 5 years with DMF remained free from 6-month confirmed disability progression and conversion to secondary progressive MS and had stable disability and employment status. These results support the long-term stability of disability and work-related outcomes with disease-modifying therapy. Int J MS Care. 2021;23:239-244.
AB - Background: Delayed-release dimethyl fumarate (DMF) is effective in relapsing-remitting multiple sclerosis (RRMS), but long-term effects of DMF on disability and disease progression in clinical settings are unknown. We evaluated disability and employment outcomes in persons with RRMS treated with DMF for up to 5 years. Methods: This longitudinal study included US North American Research Committee on Multiple Sclerosis (NARCOMS) Registry participants with RRMS reporting DMF initiation in fall 2013 through spring 2018 with 1 year or more of follow-up. Time to 6-month confirmed disability progression (≥1-point increase in Patient-Determined Disease Steps [PDDS] score) and change in employment status were evaluated using Kaplan-Meier analysis. Participants were censored at last follow-up or at DMF discontinuation, whichever came first. Results: During the study, 725 US participants with RRMS had at least 1 year of DMF follow-up data, of whom most were female and White. At year 5, 69.9% (95% CI, 65.4%-73.9%) of these participants were free from 6-month confirmed disability progression, and 84.7% (95% CI, 78.6%- 89.2%) were free from conversion to secondary progressive MS. Of 116 participants with data at baseline and year 5, most had stable or improved PDDS and Performance Scales scores over 5 years. Of 322 participants 62 years and younger and employed at the index survey, 66.0% (95% CI, 57.6%- 73.1%) were free from a negative change in employment type over 5 years. Conclusions: Most US NARCOMS Registry participants treated up to 5 years with DMF remained free from 6-month confirmed disability progression and conversion to secondary progressive MS and had stable disability and employment status. These results support the long-term stability of disability and work-related outcomes with disease-modifying therapy. Int J MS Care. 2021;23:239-244.
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U2 - 10.7224/1537-2073.2020-109
DO - 10.7224/1537-2073.2020-109
M3 - Article
C2 - 35035294
AN - SCOPUS:85123602396
SN - 1537-2073
VL - 23
SP - 239
EP - 244
JO - International Journal of MS Care
JF - International Journal of MS Care
IS - 6
ER -