Multiple sclerosis and related disorders · 2025
Comparative effectiveness and safety of glatopa and copaxone in patients with multiple sclerosis.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Lyu Ning, Li Jieni, Hutton George J, Liu Xinli, Aparasu Rajender R
Аннотация
BACKGROUND: In 2015, Glatopa (generic name: Glatiramer Acetate) was the first US Food and Drug Administration-approved generic disease-modifying agent for multiple sclerosis (MS) patients based on structural and functional equivalence to Copaxone, the branded counterpart. However, there is limited comparative effectiveness and safety evidence of Glatopa and Copaxone.
OBJECTIVES: This study compared the risk of MS relapse and serious infections in patients using Glatopa and Copaxone.
METHODS: A retrospective cohort study that included MS patients aged 18-64 was conducted using the 2017-2019 Merative MarketScan® Commercial Claims data. The index was the first Glatopa or Copaxone prescription, with a 6-month washout period with no disease-modifying agents. The inverse probability of treatment weighting (IPTW) based on the Cox proportional hazards (CPH) regression models were conducted to compare the time to the first MS relapse and serious infection for Glatopa and Copaxone users during the 6-month follow-up period.
RESULTS: Among 3193 MS patients who initiated GA, 20.9 % (n = 668) initiated Glatopa, while 79.1 % (n = 2525) received Copaxone. Bivariate analyses found no significant difference between Glatopa and Copaxone users with respect to relapse (11.9 % vs. 12.5 %; p = 0.9445) and serious infections (0.3 % vs. 0.4 %; p = 0.4292) during the folow-up period. The IPTW-based CPH model revealed no significant difference in the risk of MS relapse (adjusted hazard ratio [aHR] 0.93; 95 % confidence interval [CI], 0.81-1.08) and serious infection (aHR 0.74; 95 % CI, 0.33-1.64) between Glatopa and Copaxone users.
CONCLUSIONS: This real-world study found that Glatopa was associated with comparable effectiveness (relapses) and safety (serious infections) to Copaxone.
OBJECTIVES: This study compared the risk of MS relapse and serious infections in patients using Glatopa and Copaxone.
METHODS: A retrospective cohort study that included MS patients aged 18-64 was conducted using the 2017-2019 Merative MarketScan® Commercial Claims data. The index was the first Glatopa or Copaxone prescription, with a 6-month washout period with no disease-modifying agents. The inverse probability of treatment weighting (IPTW) based on the Cox proportional hazards (CPH) regression models were conducted to compare the time to the first MS relapse and serious infection for Glatopa and Copaxone users during the 6-month follow-up period.
RESULTS: Among 3193 MS patients who initiated GA, 20.9 % (n = 668) initiated Glatopa, while 79.1 % (n = 2525) received Copaxone. Bivariate analyses found no significant difference between Glatopa and Copaxone users with respect to relapse (11.9 % vs. 12.5 %; p = 0.9445) and serious infections (0.3 % vs. 0.4 %; p = 0.4292) during the folow-up period. The IPTW-based CPH model revealed no significant difference in the risk of MS relapse (adjusted hazard ratio [aHR] 0.93; 95 % confidence interval [CI], 0.81-1.08) and serious infection (aHR 0.74; 95 % CI, 0.33-1.64) between Glatopa and Copaxone users.
CONCLUSIONS: This real-world study found that Glatopa was associated with comparable effectiveness (relapses) and safety (serious infections) to Copaxone.