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Comparative Study
. 2025 Jan:190:108180.
doi: 10.1016/j.ypmed.2024.108180. Epub 2024 Nov 16.

Comparative effectiveness of high-efficacy and moderate efficacy disease-modifying agents in reducing the annualized relapse rates among multiple sclerosis patients in the United States

Jieni Li  1 , George J Hutton  2 , Tyler J Varisco  3 , Ying Lin  4 , Ekere J Essien  1 , Rajender R Aparasu  5
Affiliations
Comparative Study

Comparative effectiveness of high-efficacy and moderate efficacy disease-modifying agents in reducing the annualized relapse rates among multiple sclerosis patients in the United States

Jieni Li et al. Prev Med. 2025 Jan.

Abstract

Objective: The optimal treatment strategy for the management of multiple sclerosis is widely discussed due to the increasing availability of high-efficacy disease-modifying agents (heDMAs). This study evaluated the comparative effectiveness of heDMA and moderate-efficacy disease-modifying agents (meDMAs) use in reducing annualized relapse rate (ARR) among multiple sclerosis patients.

Methods: A retrospective cohort study was conducted using the 2015-2019 United States Merative MarketScan Commercial Claims Data. Adult (18-64 years) patients with incident disease-modifying agents (DMA) use were included. Claim-based relapse algorithms were applied to measure relapse events. The inverse probability treatment weighting (IPTW) based negative binomial regression model with the offset of the follow-up period was used to compare the ARR. The moderation effect of sex on ARR was also examined.

Results: This study included 10,003 incident DMA users, with 22.9 % initiated heDMAs. The average ARR during follow-up among heDMA users was lower than meDMA users (0.25 vs. 0.28, p < 0.01). The IPTW-based regression found that sex moderated the relationship between the types of DMAs and ARR. Stratified analyses revealed that heDMAs were associated with a lower ARR in males (adjusted incidence rate ratio [aIRR] 0.74; 95 % confidence interval [CI] 0.59-0.94) compared with meDMAs. No significant differences were noted among females (aIRR 0.99; 95 % CI: 0.88-1.21).

Conclusion: The study found that sex moderated the effect of heDMAs, with male multiple sclerosis patients using heDMAs associated with a 26 % decreased risk of relapse than those with meDMAs. However, there was no difference in comparative effectiveness for females.

Keywords: Comparative effectiveness; High-efficacy disease-modifying agents; Moderation effect; Multiple sclerosis; Real-world evidence.

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Conflict of interest statement

Declaration of competing interest Dr. Aparasu has received research funding from Astellas Inc., Incyte Corp., Gilead, and Novartis Inc. for projects unrelated to the current work. Dr. Hutton reports grants from Biogen, Novartis, MedImmune, Hoffman-LaRoche, E.M.D. Serono, Sanofi, and personal fees from Novartis, Sanofi, and Celgene outside the submitted work. The other authors declare no conflicts of interest for this article.

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