Effectiveness and safety of Rituximab in demyelinating diseases spectrum: An Italian experience

D’Amico, Emanuele; Zanghì, Aurora; Chisari, Clara Grazia; Fermo, Salvatore Lo; Toscano, Simona; Arena, Sebastiano; Patti, Francesco; Zappia, Mario

doi:10.1016/j.msard.2018.09.041

Cited by 39 publications

(34 citation statements)

References 13 publications

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“…Although these conditions commonly may not meet standard criteria for an SAE, they are a significant safety concern as critically low lab values may contribute to serious infections as demonstrated in rituximab‐treated rheumatoid arthritis (RA) patients 10 . However, there is limited data on their prevalence and incidence in neurologic disorders and their impact on infection rates 11–14 …”

Section: Introductionmentioning

confidence: 99%

Serious safety events in rituximab‐treated multiple sclerosis and related disorders

Vollmer

Wallach

Corboy

et al. 2020

Ann Clin Transl Neurol

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Introduction Studies investigating rates and risk factors for serious safety events (SSEs) during rituximab treatment of multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and related disorders are limited. Methods Rituximab‐treated patients with MS, NMOSD, or related disorders at the Rocky Mountain and New York University MS Care Centers were included. The follow‐up period was defined as the time from the initial dose of rituximab up to 12 months of last dose of rituximab or ocrelizumab (in patients who switched). Clinician‐reported and laboratory data were retrospectively collected from electronic medical records. Results One‐thousand patients were included comprising 907 MS, 77 NMOSD, and 16 related disorders. Patients had a mean follow‐up of 31.1 months and a mean cumulative rituximab dose of 4012 mg. Of the 169 patients who switched to ocrelizumab, the mean ocrelizumab dose was 1141 mg. Crude incidence rate per 1000 person‐years (PY) for lymphopenia was 19.2, neutropenia 5.6, and hypogammaglobulinemia 17.8. Infections resulting in either hospitalization, IV antibiotics, or using antibiotics ≥14 days occurred at a rate of 38.6/1000 PY. Risk factors for infection were duration of therapy, male gender, increased disability, prior exposure to immunosuppression/chemotherapy, lymphopenia, and hypogammaglobulinemia. Particularly, wheelchair‐bound patients had 8.56‐fold increased odds of infections. Crude incidence rates of malignant cancer were 3.5, new autoimmune disease 2.3, thromboembolic event 3.1, and mortality of 5.4 per 1000 PY. Interpretation Rates of SSEs in patients with MS, NMOSD, and related disorders were low. Through properly assessing risk:benefit of B‐cell depleting therapy in neuroinflammatory disorders and continual monitoring, clinicians may decrease the risk of serious infections.

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Section: Introductionmentioning

confidence: 99%

Serious safety events in rituximab‐treated multiple sclerosis and related disorders

Vollmer

Wallach

Corboy

et al. 2020

Ann Clin Transl Neurol

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“…Off-label use of rituximab in the treatment of MS is widespread throughout the world (Alcala et al, 2018;Alldredge et al, 2018;Barra et al, 2016;Berenguer-Ruiz et al, 2016;D'Amico et al, 2018;de Flon et al, 2016de Flon et al, , 2017Memon et al, 2018;Nielsen et al, 2012;Rommer et al, 2016;Salzer et al, 2016aSalzer et al, , 2016bScotti et al, 2018;Topping et al, 2016), and our retrospective study indicates that rituximab is also a usable treatment option among Finnish MS patients. We observed significant reduction in the ARR among RRMS and SPMS patients, and in the number of gadolinium-enhancing lesions among RRMS patients after rituximab initiation.…”

Section: Discussionmentioning

confidence: 55%

“…Due to the high efficacy, safety and convenient administration (one infusion every 6 months) of B-cell depleting medications, and the relatively low cost of rituximab compared to other MS medications, the Bcell drugs were introduced in treatment of MS already before ocrelizumab was officially authorized. Due to this, there is abundant published real-world research data about rituximab experience in MS treatment (Alcala et al, 2018;Alldredge et al, 2018;Barra et al, 2016;D'Amico et al, 2018;Rommer et al, 2016). In Sweden, off-label use of rituximab in the treatment of MS patients has become common and the Swedish experience has been reported in large retrospective registry studies (Alping et al, 2016;Salzer et al, 2016b).…”

Section: Introductionmentioning

confidence: 99%

Rituximab in the treatment of multiple sclerosis in the Hospital District of Southwest Finland

Airas

Nylund

Mannonen

et al. 2020

Multiple Sclerosis and Related Disorders

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Background: There are already numerous B-cell depleting monoclonal anti-CD20 antibodies which have been used to reduce the inflammatory burden associated with multiple sclerosis (MS). We describe here our experience of treating MS-patients with B-cell depleting rituximab. Patients and methods: All MS-patients (n = 72) who had received rituximab treatment for at least six months by January 2019 were identified from the patient charts at the Turku University Hospital. Information about MS disease subtype, disease severity, MR-imaging outcomes and B-cell counts were collected from the charts. Results: Rituximab was well received and well tolerated by the patients. There were no serious infusion-related side effects. The most serious adverse event that led to treatment discontinuation was neutropenia. After rituximab initiation the annual number of relapses was decreased in the relapsing remitting and secondary progressive MS groups and the mean number of gadolinium-enhancing lesions was decreased in relapsing remitting MS. Our study confirms the usability of rituximab treatment for MS in the Finnish health care environment. Conclusions: Off-label rituximab-treatment can be successfully used to reduce MS disease burden for the benefit of MS patients.

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“…Ferner lieferten zahlreiche retrospektive Analysen und eine Subgruppenanalyse Hinweise dafür, dass Rituximab sowohl effektiv bei aggressiver RMS bzw. progressiver MS sein kann [33][34][35][36][37][38][39] als auch den MS-Therapien der 1. Generation (i.e.…”

Section: Zusammenfassung • Abstractunclassified

Ocrelizumab zur Behandlung der Multiplen Sklerose

et al. 2020

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Abb. 1 8 Zelluläre Ziele der CD20-Depletion. Während der B-Zell-Reifung werden unterschiedliche Differenzierungsantigene auf der Oberfläche der Zellen exprimiert, die von den therapeutisch eingesetzten monoklonalen Antikörpern erkannt werden. Die Bindung führt schließlich über antikörper-oder komplementabhängige zytotoxische Mechanismen zur Depletion. Von Bedeutung ist, dass die frühesten und spätesten Reifungsstufen wegen fehlender CD20-Expression nicht depletiert werden. Somit ist die Fähigkeit zur B-Zell-Repopulation erhalten sowie auch das humorale Immungedächtnis unbeeinträchtigt. Dadurch werden natürliche Abwehrmechanismen in ihrer Funktionalität bewahrt. Atacicept ist ein Wirkstoff, der die Differenzierung der B-Zelle hemmt. Atacicept ist ein rekombinantes Fusionsprotein, welches zwei für B-Zell-Reifung,-Funktion und-Überleben notwendige Zytokine, "B-lymphocyte stimulator" (BlyS) und "A proliferation-inducing ligand" (APRIL), über den Fc-Teil von Immunglobulin bindet und somit neutralisiert. (Adaptiert aus [7]) T-Zelle B-Zelle Makrophage ZNS-gerichtete Autoimmunantwort Relativ homogen, warten passiv auf T-Zell-Hilfe, um Antikörper zu produzieren Proinflammatorische Makrophagen (IL-12, IL-23, IL-6 and IL-1b) Anti-inflammatorische Makrophagen

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Effectiveness and safety of Rituximab in demyelinating diseases spectrum: An Italian experience

Cited by 39 publications

References 13 publications

Serious safety events in rituximab‐treated multiple sclerosis and related disorders

Serious safety events in rituximab‐treated multiple sclerosis and related disorders

Rituximab in the treatment of multiple sclerosis in the Hospital District of Southwest Finland

Ocrelizumab zur Behandlung der Multiplen Sklerose

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