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Deprescribing of Disease Modifying Agents in Older Adults with Multiple Sclerosis

Award Number: R01HS029501
ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY
OPDIV: AHRQ
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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Deprescribing of Disease Modifying Agents in Older Adults with Multiple Sclerosis - PROJECT SUMMARY/ABSTRACT Disease Modifying Agents (DMAs) are vital for reducing inflammation and limiting disease activity in multiple sclerosis (MS). However, there is a decline in inflammation and disease activity in older adults with MS due to natural disease progression. In fact, most patients with MS over age 65 have very limited disease activity and relapses. DMAs are not effective in preventing disability and disease progression associated with aging. There is also very limited data on the effectiveness of DMAs in older adults with MS. Also, DMA use is associated with increased infections, malignancy, and other adverse events. Continued DMA use in older adults is highly debated due to no proven efficacy, safety concerns, and high prescription costs. Therefore, there is an urgent need to evaluate the benefits and safety of DMA discontinuation in older adults. Although some studies with limited samples found preliminary evidence for DMA discontinuation, no large-scale pharmacoepidemiological study evaluated both the safety and effectiveness of DMA deprescribing in older adults. Our previous based study found that older adults with MS received injectables (55%), followed by orals (32%). However, over 35% of older adults discontinued their DMAs after 12 months. The overall goal of this research is to evaluate deprescribing and associated effectiveness and safety outcomes in older adults with MS. The specific objectives of the research are to: (1) examine DMA use and deprescribing in older adults with MS; (2) evaluate the effect of DMA deprescribing on relapse rates and frailty; and (3) evaluate the effect of DMA deprescribing on serious infections and all-cause mortality in older adults with MS. This study will involve a longitudinal national cohort of older adults over 65 years of age with MS and DMA use based on ten-year Medicare claims data involving Parts A, B, and D. The study will test the hypotheses that (i) there is no difference in relapse rates and frailty in older adults who are deprescribed and those who continue DMA, (ii) and DMA deprescribing is associated with decreased infection rates and all-cause mortality in older adults with MS. Deprescribing will be defined as the discontinuation of DMAs for at least 12 months with a one-year baseline adherence of DMAs (proportion of days covered of >0.80). The comparator group will be those continuing their DMAs. The relapse rates and frailty will be operationalized using validated claims-based algorithms. The risk of serious infections and specific types of infection, along with mortality, will also be evaluated. The study will involve a propensity score-matched cohort design based on generalized boosted models to adjust for the selection bias within the multivariate context of the Andersen Behavioral Model. Multivariable models within propensity score-matched sets will be used to evaluate the effectiveness and safety outcomes. Multiple sensitivity analyses involving differing analytical considerations will be conducted to assess the robustness of the findings. This will be the first national study to provide valuable real-world evidence regarding DMA deprescribing and associated outcomes with significant clinical and policy implications for improving prescribing practices and quality of care in older adults with MS.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $397,090 )
2025	2025	UNIVERSITY OF HOUSTON SYSTEM	4300 MARTIN LUTHER KING BLVD	HOUSTON	TX	77204	HARRIS	USA	Research on Healthcare Costs, Quality and Outcomes	000	3	6/6/2025	NON-COMPETING CONTINUATION	$397,090
														Subtotal = $397,090

Issue Date FY: 2024 ( Subtotal = $399,999 )
2024	2024	UNIVERSITY OF HOUSTON SYSTEM	4300 MARTIN LUTHER KING BLVD	HOUSTON	TX	77204	HARRIS	USA	Research on Healthcare Costs, Quality and Outcomes	000	2	4/24/2024	NON-COMPETING CONTINUATION	$399,999
														Subtotal = $399,999

Issue Date FY: 2023 ( Subtotal = $399,999 )
2023	2023	UNIVERSITY OF HOUSTON SYSTEM	4300 MARTIN LUTHER KING BLVD	HOUSTON	TX	77204	HARRIS	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	6/30/2023	NEW	$399,999
														Subtotal = $399,999

Grand Total All Awards = $1,197,088

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Deprescribing of Disease Modifying Agents in Older Adults with Multiple Sclerosis

Award Number: R01HS029501

ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY

OPDIV: AHRQ

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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