Signals of progressive multifocal leukoencephalopathy for immunosuppressants: a disproportionality analysis of spontaneous reports within the US Adverse Event Reporting System (AERS)

Schmedt, Niklas; Andersohn, Frank; Garbe, Edeltraut

doi:10.1002/pds.3320

Cited by 63 publications

(42 citation statements)

References 13 publications

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“…Stopping NTZ due to fear of PML, as is the case in most patients, may therefore limit the use of azathioprine, fingolimod, and fumarate, given the reported cases of PML brain infection [27,31,32]. Signals of PML for these drugs have been identified only in patients not previously treated with NTZ and considered at lowest risk.…”

Section: Discussionmentioning

confidence: 99%

“…Signals of PML for these drugs have been identified only in patients not previously treated with NTZ and considered at lowest risk. Nonetheless, the occurrence of new cases with upcoming therapies would be not surprising because of the immunosuppressive activity and possible interactions between the different drugs [27]. …”

Section: Discussionmentioning

confidence: 99%

“…The best strategy to prevent disease reactivation after NTZ suspension should be based on pre-NTZ history and PML signals in the case of immunosuppressive drugs [27]. Because PML occurs not only after switching from NTZ to fingolimod [28,29,30] but also under fingolimod and dimethyl fumarate in patients who never received NTZ [31,32], the impact of the gradual use of immunosuppressants is still questioned.…”

Section: Introductionmentioning

confidence: 99%

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Observational Study of Switching from Natalizumab to Immunomodulatory Drugs

et al. 2017

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Objective: To determine the effect of disease-modifying drugs (DMDs) on disease activity rebound in patients discontinuing natalizumab (NTZ). Methods: Twenty-one patients with relapsing-remitting multiple sclerosis (RRMS) treated with NTZ for ≥1 year and who switched to DMDs (glatiramer acetate [GA] or interferon) were followed up for 12 months in clinical practice. Clinical outcomes after NTZ cessation were assessed every 3 months for 1 year and MRI was performed at 12 months. Results: Twelve months after switching from NTZ to DMDs, there were no significant differences in the annualized relapse rate (ARR) compared to the days that NTZ was used (0.3 vs. 0.1; p = 0.083); and the ARR never reached similar values to those prior to NTZ use (1.61; p < 0.001). The percentage of relapse-free patients after switching from NTZ was 71.4%. These patients did not have lower disease activity before NTZ compared with those with clinical relapses (1.3 vs. 1.7; p = 0.302), but they had lower Expanded Disability Status Scale scores (3.4 vs. 5.7; p = 0.001). DMDs had beneficial effects on MRI parameters, as 10 of 16 patients (62.5%) presented no evidence of radiological activity 12 months after NTZ discontinuation. Conclusions: Patients with RRMS and moderate disability who discontinued NTZ for safety reasons may benefit from the DMDs GA and interferon with no known risk for progressive multifocal leukoencephalopathy.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Observational Study of Switching from Natalizumab to Immunomodulatory Drugs

et al. 2017

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“…One important cause of progressive multifocal leukoencephalopathies immunosuppressive drug therapy, such as rituximab. 8 Although the pathogenesis and exact mechanism of action of particular drugs leading to progressive multifocal leukoencephalopathy are not completely understood, the association between progressive multifocal leukoencephalopathy and rituximab are well established. 9 We could not prevent our patient from developing progressive multifocal leukoencep halopathy from the use of rituximab, because he might have had a dysmyelinating disorder.…”

Section: Discussionmentioning

confidence: 99%

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Kobayashi

Hayashi²,

Ishii³

et al. 2014

Exp Clin Transplant

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To our knowledge, this is the first report of an ABO-incompatible living-donor renal transplant without a splenectomy performed in a patient with renal coloboma syndrome, a rare disorder caused by PAX2 gene mutations, and that presents with renal and optic nerve hypodysplasia and disorders of the central nervous system. Many patients with renal coloboma syndrome develop end-stage renal disease requiring renal replacement therapy. Few reports of a well-defined course of renal transplant for coloboma syndrome have been published. We treated a 22-year-old man who had end-stage renal disease from renal coloboma syndrome. We performed an ABO-incompatible living-donor renal transplant with a kidney donated by his father. Two years after the transplant, the patient has good preserved renal function, and his compliance with the immunosuppressive regimen was good.

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“…However, leflunomide's safety profile is relevant for teriflunomide and some rare serious side effects have been observed with this predecessor drug, including 3 cases of PML (in > 2 million patient-years of leflunomide use). Two patients had previously been treated with other immunosuppressants [33,34], and there is limited information on the third [35]. A safety concern relevant for many young female patients with MS is the probable teratogenic potential of leflunomide and teriflunomide.…”

Section: Teriflunomidementioning

confidence: 99%

Advances in and Algorithms for the Treatment of Relapsing-Remitting Multiple Sclerosis

2016

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Treatment options in relapsing-remitting multiple sclerosis have increased considerably in recent years; currently, a dozen different preparations of diseasemodifying therapies are available and some more are expected to be marketed soon. For the treating neurologist this broad therapeutic repertoire not only greatly improves individualized management of the disease, but also makes choices more complex and difficult. A number of factors must be considered, including disease activity and severity, safety profile, and patient preference. We here discuss the currently existing options and suggest treatment algorithms for managing relapsing-remitting multiple sclerosis.

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Signals of progressive multifocal leukoencephalopathy for immunosuppressants: a disproportionality analysis of spontaneous reports within the US Adverse Event Reporting System (AERS)

Cited by 63 publications

References 13 publications

Observational Study of Switching from Natalizumab to Immunomodulatory Drugs

Observational Study of Switching from Natalizumab to Immunomodulatory Drugs

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Advances in and Algorithms for the Treatment of Relapsing-Remitting Multiple Sclerosis

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