Long-term tolerability, safety and efficacy of rituximab in neuromyelitis optica spectrum disorder: a prospective study

Shaygannejad, Vahid; Fayyazi, Emad; Badihian, Shervin; Mirmosayyeb, Omid; Manouchehri, Navid; Ashtari, Fereshteh; Asgari, Nasrin

doi:10.1007/s00415-019-09180-9

Cited by 27 publications

(20 citation statements)

References 35 publications

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“…In the first study, which was done on different doses of rituximab, the most prevalent side effects were minor infections. But in the second one, infusion reactions were more common that was similar to our study (15,16). In 2019, Moghaddasi et al reported their data about rituximab, which mainly focused on the term of efficacy rather than safety.…”

Section: Comparison Of Other Results Conducted On Iranian Populationsupporting

confidence: 88%

Infusion-Related, Short-term, and Delayed Side Effects of Rituximab in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder

2020

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Background: Rituximab is a monoclonal antibody against CD20 antigen present on mature B lymphocytes. It is commonly used in some hematologic, rheumatologic as well as neurologic disorders, including multiple sclerosis (MS) and neuromyelitis optica (NMO). Although there are some data about the safety of rituximab in patients with MS and NMO, there are few experiences regarding its safety in the Iranian population with MS, and known complications are often related to the studies conducted on the patients in other countries or with other autoimmune diseases and malignancies that are different from the population of patients with MS in terms of the underlying disease status and the concomitant medications or previous medications used. Objectives: The aim of this study was to investigate the short-term and delayed side effects of rituximab on patients with MS and NMO in the population of the south of Iran. Methods: This was a longitudinal study on patients with MS and neuromyelitis optica who were referred to the health centers affiliated to Shiraz University of Medical Sciences from September 2018 to February 2019 and received Rituximab. They were observed for side effects from the first infusion of the drug to at least 6 months later. A checklist prepared by the researcher was used to collect the data. Independent t-test and chi-square test were used for data analysis. The significance level was considered 0.05 in this study. Results: In this study, 37% of the patients had at least one side effect during the first infusion. The most common side effect was chills (shivering). Short-term side effects occurred in 15.5% of the patients. The most common type was skin manifestations. These side effects led to hospitalization in two patients. Delayed side effect was developed in 20.7% of the patients. The most common delayed side effect was skin manifestations. Conclusions: Overall, there was no unexpected side effect in patients under the study and the side effects developed were comparable to previous studies as well as those conducted on patients other than patients with MS and neuromyelitis optica. Side effects were often mild, with only two cases leading to hospitalization, both of which were self-limiting as well, and there were no serious life-threatening side effects, except for one case with bradycardia.

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Section: Comparison Of Other Results Conducted On Iranian Populationsupporting

confidence: 88%

Infusion-Related, Short-term, and Delayed Side Effects of Rituximab in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder

2020

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“…Effects of B-cell-depleting therapy in NMOSD. A popular therapy for NMOSD is B-cell depletion with anti-CD20 antibody 21 . In our cohort, 62% of the patients were on rituximab at the time of serum sample collection (Supplementary Table 1).…”

Section: Resultsmentioning

confidence: 99%

Transcriptomics and proteomics reveal a cooperation between interferon and T-helper 17 cells in neuromyelitis optica

Agasing

Khatri

et al. 2020

Nat Commun

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Type I interferon (IFN-I) and T helper 17 (TH17) drive pathology in neuromyelitis optica spectrum disorder (NMOSD) and in TH17-induced experimental autoimmune encephalomyelitis (TH17-EAE). This is paradoxical because the prevalent theory is that IFN-I inhibits TH17 function. Here we report that a cascade involving IFN-I, IL-6 and B cells promotes TH17mediated neuro-autoimmunity. In NMOSD, elevated IFN-I signatures, IL-6 and IL-17 are associated with severe disability. Furthermore, IL-6 and IL-17 levels are lower in patients on anti-CD20 therapy. In mice, IFN-I elevates IL-6 and exacerbates TH17-EAE. Strikingly, IL-6 blockade attenuates disease only in mice treated with IFN-I. By contrast, B-cell-deficiency attenuates TH17-EAE in the presence or absence of IFN-I treatment. Finally, IFN-I stimulates B cells to produce IL-6 to drive pathogenic TH17 differentiation in vitro. Our data thus provide an explanation for the paradox surrounding IFN-I and TH17 in neuro-autoimmunity, and may have utility in predicting therapeutic response in NMOSD.

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“…However, this study is limited by its small sample size and the inclusion of participants with mild disease activity (EDSS < = 7). Shaygannejad and colleagues reported a prospective study exploring the long-term tolerability, safety and efficacy of RTX for NMOSDs ( 20 ). The induction dose was 500 mg/week for 4 consecutive weeks, and the maintenance regimen was 1000 mg every 6 months.…”

Section: Discussionmentioning

confidence: 99%

Retrospective Observation of Low-Dose Rituximab Treatment in Chinese Patients With Neuromyelitis Optica Spectrum Disorders in a Real-World Setting

Xiao

Zeng

et al. 2020

Front. Neurol.

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Objective: This study aimed to investigate the efficacy and safety of low-dose rituximab (RTX) in the treatment of neuromyelitis optica spectrum disorders (NMOSD) patients. Methods: NMOSD patients were treated with RTX at ~25% of the standard dose. The annualized relapse rate (ARR), expanded disability status scale (EDSS) score, visual function system scale (VFSS) and length of spinal cord lesions before and after treatment were statistically compared. The dynamic changes in the proportion of CD19 + B lymphocytes after treatment were monitored, and adverse reactions were recorded. Results: In total, 36 NMOSD patients who received a low-dose RTX treatment (375-mg/m 2 induction dose and 500 mg every 6 months) were recruited. The mean follow-up time after the RTX treatment was 19.83 ± 7.74 months. After the treatment, the ARR decreased from 1.97 ± 1.93 to 0.12 ± 0.32, the EDSS score decreased from 3.43 ± 1.49 to 3.10 ± 1.88, and the spinal cord lesion length decreased from 5.54 ± 3.96 to 4.31 ± 3.73. These differences were all statistically significant. The subgroup analysis of the patients who had previously received non-steroidal immunosuppressants (NSISs) ( n = 20) showed that after the RTX treatment, the ARR decreased from 0.66 ± 0.51 to 0.08 ± 0.26, the EDSS score decreased from 3.65 ± 1.22 to 3.40 ± 1.99, and the spinal cord lesion length decreased from 5.68 ± 3.73 to 4.21 ± 3.58. These differences were all statistically significant. The VFSS scores did not show a significant change. The Kaplan-Meier analysis showed that low-dose RTX significantly delayed recurrence, which was also observed in the subgroup analysis of patients who previously received NSISs. Five relapses in 5 cases were noted after the low-dose RTX administration, and the percentage of CD19 + B cells remained < 1% in 3 cases during relapse. During the RTX treatment and subsequent follow-up, 8 (22.2%) patients reported adverse reactions, all of which were minor. Conclusion: Low-dose RTX is an effective and safe treatment method for NMOSDs. This method is worth popularizing in developing countries or regions, especially in areas where RTX is not covered by medical insurance.

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Long-term tolerability, safety and efficacy of rituximab in neuromyelitis optica spectrum disorder: a prospective study

Cited by 27 publications

References 35 publications

Infusion-Related, Short-term, and Delayed Side Effects of Rituximab in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder

Infusion-Related, Short-term, and Delayed Side Effects of Rituximab in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder

Transcriptomics and proteomics reveal a cooperation between interferon and T-helper 17 cells in neuromyelitis optica

Retrospective Observation of Low-Dose Rituximab Treatment in Chinese Patients With Neuromyelitis Optica Spectrum Disorders in a Real-World Setting

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