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.

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.