Multiple sclerosis and related disorders · 2026
Extended interval dosing of off-label rituximab in multiple sclerosis: A real-world retrospective analysis of clinical efficacy and safety.
СтатьяНазвание и аннотация: Перевод в очереди
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Paybast Sepideh, Jameie Melika, Tajabadi Zohreh, Azizmohammad Looha Mehdi, Basti Fatemeh A, Amanollahi Mobina, Amani Kiana, Mousavi Marziyeh, Mohammadianinejad Seyed Ehsan, Harirchian Mohammad Hossein
Аннотация
OBJECTIVES: Rituximab, an anti-CD20 monoclonal antibody, is increasingly used off-label as a high-efficacy disease-modifying therapy (DMT) in multiple sclerosis (MS). Given an increasing interest to extended interval dosing (EID) (6-month infusion intervals +≥ 4 weeks) regimen as a strategy to mitigate the risk of infection associated with anti-CD20s, herein we aimed to investigate the treatment outcomes of patients with MS (PwMS) receiving EID vs. standard interval dosing (SID) of rituximab.
METHODS: Between January 2020 and January 2022, PwMS prescribed rituximab at Imam Khomeini MS Center in Tehran, Iran, were identified. Clinician-reported data were retrospectively collected.
RESULTS: Eighty-nine PwMS (67.4% with progressive MS; mean age: 41.2 ± 10.1 years; 58.4% female) were enrolled. Fifty-two received EID (9.40 ± 1.26 month) and 37 received SID. After adjusting for covariates, there was no significant inter-group difference for disability progression (P = 0.33). Except for one patient in the EID group, all remained relapse-free for one year. CD19+ B-cell reconstitution patterns were significantly different between the two groups (P = 0.021), showing a gradual rather than rapid peripheral CD19+ B-cell repopulation in the EID group. While the overall adverse event rates were similar, patients in the EID group had a significantly lower incidence of serious infectious adverse events at both 6 months (P = 0.03) and 12 months (P = 0.04).
CONCLUSIONS: In this real-world cohort, EID regimen of rituximab was associated with reduced risk of serious infections, without compromising disease control or disability progression. Further prospective studies are warranted to validate our findings.
METHODS: Between January 2020 and January 2022, PwMS prescribed rituximab at Imam Khomeini MS Center in Tehran, Iran, were identified. Clinician-reported data were retrospectively collected.
RESULTS: Eighty-nine PwMS (67.4% with progressive MS; mean age: 41.2 ± 10.1 years; 58.4% female) were enrolled. Fifty-two received EID (9.40 ± 1.26 month) and 37 received SID. After adjusting for covariates, there was no significant inter-group difference for disability progression (P = 0.33). Except for one patient in the EID group, all remained relapse-free for one year. CD19+ B-cell reconstitution patterns were significantly different between the two groups (P = 0.021), showing a gradual rather than rapid peripheral CD19+ B-cell repopulation in the EID group. While the overall adverse event rates were similar, patients in the EID group had a significantly lower incidence of serious infectious adverse events at both 6 months (P = 0.03) and 12 months (P = 0.04).
CONCLUSIONS: In this real-world cohort, EID regimen of rituximab was associated with reduced risk of serious infections, without compromising disease control or disability progression. Further prospective studies are warranted to validate our findings.