A multicenter, non-interventional study to evaluate the disease activity in Multiple Sclerosis after withdrawal of Natalizumab in Portugal

Ladeira, Filipa; Braz, Luís; Salgado, Paula; Vaz, Soraia; Leitão, Luís; Félix, Catarina; Correia, Ana Sofia; Silva, Ana Martins da; Salgado, Vasco; Ferreira, Fátima; Vale, José; Sá, María José; Capela, Carlos

doi:10.1016/j.clineuro.2019.105390

Cited by 4 publications

(3 citation statements)

References 29 publications

(73 reference statements)

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“…The selected published clinical trial reports as per the defined inclusion-exclusion criteria were screened, and data were extracted in an excel sheet under the following fields: author name, year of publication, study design, sample size, approved doses of monoclonal antibodies, mean/average duration of the disease at the time of entry in the trial, subject mean age data, and adverse events (% AEs; Table 1). [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25]…”

Section: Data Extractionmentioning

confidence: 99%

Systematic Review and Meta-Analysis Comparing the Safety of Natalizumab, Ocrelizumab, and Alemtuzumab in Treating Relapsing–Remitting, Primary Progressive, and Secondary Progressive Multiple Sclerosis

Raina

Basu

Goyal

et al. 2022

Journal of Pharmacology and Pharmacotherapeutics

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Three monoclonal antibodies—natalizumab (NTZ), ocrelizumab (OCR), and alemtuzumab (ALM)—are the mainstays for the treatment of both relapsing and progressive forms of multiple sclerosis (MS). Here, their safety in patients with MS is analyzed and compared for rational use, especially during the COVID-19 pandemic. All clinical studies published between 2016 and 2020 with the primary outcome of the occurrence of adverse events (AEs) with the use of NTZ, OCR, and ALM in the treatment of MS were systematically searched in the PubMed database. In this review, the percentage of patients reporting AEs was calculated and compared. The most common AEs associated with the use of NTZ, OCR, and ALM were infection and infestation. The percentage of patients reporting urinary tract infection, upper respiratory tract infection, and herpes was 16% using natalizumab, 7% using natalizumab and ocrelizumab, and 2% with ocrelizumab, respectively. The most common AEs, such as rashes, pyrexia, and influenza, were reported with ocrelizumab and alemtuzumab. Additionally, alemtuzumab was associated with immune thrombocytopenia (2%), respiratory infections (7%), and thyroid dysfunction (43%). All these data outcomes show that of the three monoclonal antibodies, natalizumab and ocrelizumab were associated with a reduced incidence of adverse events, making them a safer choice for MS.

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Section: Data Extractionmentioning

confidence: 99%

Systematic Review and Meta-Analysis Comparing the Safety of Natalizumab, Ocrelizumab, and Alemtuzumab in Treating Relapsing–Remitting, Primary Progressive, and Secondary Progressive Multiple Sclerosis

Raina

Basu

Goyal

et al. 2022

Journal of Pharmacology and Pharmacotherapeutics

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“…Lymphopenia occurring during the first 3 months of treatment with fingolimod has been proposed as a possible marker of patients at most risk of MS reactivation following withdrawal of this agent [ 60 ]. Higher disease activity and longer duration of MS were described as risk factors for disease reactivation following withdrawal of natalizumab [ 65 ]. A longer washout period before pregnancy predicted a higher risk of relapse following withdrawal of fingolimod or natalizumab [ 60 , 64 ].…”

Section: Consensus Recommendations On the Use Of Dmds During Pregnancmentioning

confidence: 99%

Disease-Modifying Drugs and Family Planning in People with Multiple Sclerosis: A Consensus Narrative Review from the Gulf Region

et al. 2020

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Most disease-modifying drugs (DMDs) are contraindicated in pregnancy. Management of MS is especially challenging for pregnant patients, as withdrawal of DMDs leave the patient at risk of increased disease activity. We, a group of experts in MS care from countries in the Arab Gulf, present our consensus recommendations on the management of MS in these patients. Where possible, a patient planning pregnancy can be switched to a DMD considered safe in this setting. Interferon β now can be used during pregnancy, where there is a clinical need to maintain treatment, in addition to glatiramer acetate. Natalizumab (usually to 30 weeks’ gestation for patients with high disease activity at high risk of relapse and disability progression) may also be continued into pregnancy. Cladribine tablets and alemtuzumab have been hypothesised to act as immune reconstitution therapies (IRTs). These drugs provide a period of prolonged freedom from relapses for many patients, but the patient must be prepared to wait for up to 20 months from initiation of therapy before becoming pregnant. If a patient becomes pregnant while taking fingolimod, and requires continued DMD treatment, a switch to interferon β or natalizumab after a variable washout period may be prescribed, depending on the level of disease activity. Women who wish to breastfeed should be encouraged to do so, and interferon β may also be used during breastfeeding. There is a lack of data regarding the safety of using other DMDs during breastfeeding.

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“…The immunomodulatory and immunosuppressant drugs used to treat MS are associated with significant adverse effects. , Although these drugs decrease the risk of relapse, they are also immunosuppressive, and they generally do not delay disease progression. − In this scenario, it is essential to study auxiliary therapies that reduce the negative effects of the disease.…”

Section: Introductionmentioning

confidence: 99%

Neuroinflammatory Regulation of Gold Nanoparticles Conjugated to Ethylene Dicysteine Diethyl Ester in Experimental Autoimmune Encephalomyelitis

Souza

Zaccaron

Vasconcellos

et al. 2021

ACS Biomater. Sci. Eng.

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Multiple sclerosis (MS) is a demyelinating chronic autoimmune inflammatory disease of the central nervous system (CNS). A large amount of proinflammatory cytokines is released in the CNS from the self-reactive T cells infiltrate, leading to the destruction of the myelin sheath and contributing to the development of MS. Several drugs have emerged in recent years to treat MS, and studies have shown that gold nanoparticles (GNPs) have anti-inflammatory properties in autoimmune diseases. Thus, the effects of GNP conjugation to ethylene dicysteine diethyl ester (ECD) were evaluated in C57BL/6 female mice exposed to experimental MS. Animals were exposed to experimental autoimmune encephalitis (EAE) induced by myelin oligodendrocyte glycoprotein (MOG35-55) in complete Freund’s adjuvant supplemented with Mycobacterium tuberculosis. The clinical and cerebral effects of the different doses of ECD–GNPs (0.3, 0.6, and 1.0 mg/kg) were first studied, and the results showed that the group treated with 0.6 mg/kg ECD–GNPs improved clinical symptoms, inflammatory infiltrate, and myelin integrity. In the following step, GNPs and ECD–GNPs (0.6 mg/kg) showed improvements in the clinical signs of the disease. Moreover, there was a reduction in the levels of proinflammatory cytokines in both groups compared to EAE, and only the isolated use of GNPs increased IL-4 expression. Both NF-κB and TGFβ immunoexpression were significantly reduced following EAE + GNPs and EAE + ECD–GNPs treatment. In conclusion, GNPs and ECD–GNPs at 0.6 mg/kg attenuate the neurological signs of EAE likely due to inhibition of neuroinflammation induced by EAE.

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A multicenter, non-interventional study to evaluate the disease activity in Multiple Sclerosis after withdrawal of Natalizumab in Portugal

Cited by 4 publications

References 29 publications

Systematic Review and Meta-Analysis Comparing the Safety of Natalizumab, Ocrelizumab, and Alemtuzumab in Treating Relapsing–Remitting, Primary Progressive, and Secondary Progressive Multiple Sclerosis

Systematic Review and Meta-Analysis Comparing the Safety of Natalizumab, Ocrelizumab, and Alemtuzumab in Treating Relapsing–Remitting, Primary Progressive, and Secondary Progressive Multiple Sclerosis

Disease-Modifying Drugs and Family Planning in People with Multiple Sclerosis: A Consensus Narrative Review from the Gulf Region

Neuroinflammatory Regulation of Gold Nanoparticles Conjugated to Ethylene Dicysteine Diethyl Ester in Experimental Autoimmune Encephalomyelitis

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