Abstract
Despite the availability of a lot of effective disease-modifying drugs, multiple sclerosis (MS) (in particular the progressive forms) still represents an important unmet medical need, because of issues in terms of effectiveness, duration of response, safety, and patient compliance. An increasing body of evidence from randomized clinical trials and real-world data suggest that rituximab is a highly effective alternative in both relapsing and progressive MS, with a low discontinuation rate, related to a good benefit/risk profile, and a good compliance. To date, the use of rituximab in patients with multiple sclerosis is not in accordance with the authorized product information (off-label use). However, the use of this medicine is widespread in several countries, and in some cases, it is the most commonly used disease-modifying drug for MS subtypes. This use could be officially recognized by national regulatory authorities, according to specific procedures, to ensure equal access for patients to a safe and effective option.
Highlights
Multiple sclerosis (MS) is the most common chronic demyelinating disorder of the central nervous system (CNS), affecting more than 2.8 million people worldwide in 2020, with a global median prevalence of 36 cases per 100,000 people, and an average incidence rate of 2.1 per 100,000 people per year [1, 2]
No significant group differences were observed for GAD-enhancing lesions and for patient-reported outcomes regarding disability or quality of life. These results suggest that a single cycle of rituximab followed by a moderate efficacy/high safety disease modifying therapies (DMTs) as glatiramer acetate may provide a superior efficacy than glatiramer acetate alone in RRMS, this benefit does not seem to be long-lasting
In the suspended rituximab women, only one maternal relapse occurred during pregnancy and only one of four patients who relapsed in the first quarter after delivery experienced new GAD+ lesions. These results suggest a prolonged protective effect on MS disease activity of rituximab, which can encompass pregnancy and postpartum period, without the high risk of disease reactivation or rebound described with natalizumab withdrawal before pregnancy [111]
Summary
Multiple sclerosis (MS) is the most common chronic demyelinating disorder of the central nervous system (CNS), affecting more than 2.8 million people worldwide in 2020, with a global median prevalence of 36 cases per 100,000 people, and an average incidence rate of 2.1 per 100,000 people per year [1, 2]. Retrospective Italian-Swiss study, analyzing data from over 350 RR and progressive MS patients treated with rituximab, showed a significant reduction of ARR in the 2 years after the treatment start from 0.86 (95% CI: 0.73– 0.99) to 0.09 (95% CI: 0.07–0.13) in RRMS and from 0.34 (95% CI: 0.25–0.45) to 0.06 (95% CI: 0.04–0.10) in SPMS patients (p
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