Lancet regional health. Americas · 2026
Risk of infection in ocrelizumab-treated adults with multiple sclerosis aged 55 years and older: a retrospective cohort study.
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Lee Seungwon, Scheu Raphael, Enkhtsetseg Nomin, Hill Justin, Sadok Joseph, Mastick Maya, Satish Siddharth, Mateen Farrah J
Аннотация
BACKGROUND: Pivotal trials for ocrelizumab in multiple sclerosis (MS) excluded adults >55 years old. This study aimed to compare rates of infection and infection-related hospitalization between ocrelizumab-treated and unexposed older adults with MS.
METHODS: A retrospective cohort study was performed, analyzing the electronic medical records, June 2017-January 2026, at the Massachusetts General Hospital, comparing 800 older adults with MS who received at least 600 mg of ocrelizumab IV to 800 older adults who never received B-cell depleting therapies. Infection and related hospitalization rates were modeled using inverse probability of treatment weighting and negative binomial regression with person-time offsets.
FINDINGS: Among 1600 adults (n = 1111, 69.4% female; n = 1496, 93.5% White; median ages 64 (range 55-88) for ocrelizumab and 67 years (range 55-98) for unexposed), median follow-up was 3.5 vs. 8.2 years. There were 429 infection-related hospitalizations (164 ocrelizumab, 265 unexposed), 10 infection-associated deaths (2 ocrelizumab, 8 unexposed), and 4538 infections (1597 ocrelizumab, 2941 unexposed). After adjustment, ocrelizumab was associated with a higher infection-associated hospitalization rate (IRR 1.67; 95% CI 1.15-2.43; p = 0.008) and infections (IRR 1.42; 95% CI 1.20-1.68; p < 0.001). Higher disability and comorbidity independently increased the risk of both outcomes. Female sex was associated with a higher infection risk (IRR 1.36, 95% CI 1.12-1.64, p = 0.002), driven mostly by urinary tract infections, which accounted for 91.46% of the observed sex difference.
INTERPRETATION: In adults aged ≥55 years with MS, ocrelizumab was associated with higher rates of infection-related hospitalization and infections. Findings support individualized risk-benefit discussion, especially regarding UTIs in older patients of female sex, dedicated UTI monitoring and prevention protocols for older ocrelizumab-treated patients, and inclusion of this age group in future clinical trials.
FUNDING: Investigator-initiated grant from Genentech.
METHODS: A retrospective cohort study was performed, analyzing the electronic medical records, June 2017-January 2026, at the Massachusetts General Hospital, comparing 800 older adults with MS who received at least 600 mg of ocrelizumab IV to 800 older adults who never received B-cell depleting therapies. Infection and related hospitalization rates were modeled using inverse probability of treatment weighting and negative binomial regression with person-time offsets.
FINDINGS: Among 1600 adults (n = 1111, 69.4% female; n = 1496, 93.5% White; median ages 64 (range 55-88) for ocrelizumab and 67 years (range 55-98) for unexposed), median follow-up was 3.5 vs. 8.2 years. There were 429 infection-related hospitalizations (164 ocrelizumab, 265 unexposed), 10 infection-associated deaths (2 ocrelizumab, 8 unexposed), and 4538 infections (1597 ocrelizumab, 2941 unexposed). After adjustment, ocrelizumab was associated with a higher infection-associated hospitalization rate (IRR 1.67; 95% CI 1.15-2.43; p = 0.008) and infections (IRR 1.42; 95% CI 1.20-1.68; p < 0.001). Higher disability and comorbidity independently increased the risk of both outcomes. Female sex was associated with a higher infection risk (IRR 1.36, 95% CI 1.12-1.64, p = 0.002), driven mostly by urinary tract infections, which accounted for 91.46% of the observed sex difference.
INTERPRETATION: In adults aged ≥55 years with MS, ocrelizumab was associated with higher rates of infection-related hospitalization and infections. Findings support individualized risk-benefit discussion, especially regarding UTIs in older patients of female sex, dedicated UTI monitoring and prevention protocols for older ocrelizumab-treated patients, and inclusion of this age group in future clinical trials.
FUNDING: Investigator-initiated grant from Genentech.