No evidence of beneficial effects of plasmapheresis in natalizumab-associated PML

Doriana Landi, Nicola De Rossi, Sara Zagaglia, Cristina Scarpazza, Luca Prosperini, Maria Albanese, Fabio Buttari, Francesco Mori, Girolama Alessandra Marfia, Maria Pia Sormani, Ruggero Capra, Diego Centonze, Italian PML study group

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

OBJECTIVE: To examine retrospectively the effects of plasmapheresis (PLEX) on the survival and clinical outcomes of patients with multiple sclerosis (MS) and natalizumab (NTZ)-associated progressive multifocal leukoencephalopathy (PML).

METHODS: The medical literature was searched for the terms natalizumab and progressive multifocal leukoencephalopathy. A total of 193 international and 34 Italian NTZ-PML cases were included. Clinical outcome was determined by comparing the patients' clinical status at PML diagnosis with status after PML resolution. The effects on survival and clinical outcome of PLEX, sex, age, country, pre-PML Expanded Disability Status Scale score, NTZ infusion number, prior immunosuppressant exposure, PML symptoms, PML lesion location at diagnosis, CSF JC virus status and copies, additional PML treatments and steroids, and PML immune reconstitution inflammatory syndrome (IRIS) development were investigated with both univariate and multivariate analyses.

RESULTS: A total of 219 NTZ-PML cases were analyzed, and 184 (84%) underwent PLEX, which did not reduce the mortality risk or the likelihood of poor vs favorable outcomes. Country was predictive of mortality and poor outcome, while PML-IRIS development was predictive of poor outcome.

CONCLUSIONS: PLEX did not improve the survival or clinical outcomes of Italian or international patients with MS and NTZ-PML, suggesting that this treatment should be performed cautiously in the future.

CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with NTZ-PML, PLEX does not improve survival. The study lacks the statistical precision to exclude an important benefit or harm of PLEX.

Original languageEnglish
Pages (from-to)1144-1152
Number of pages9
JournalNeurology
Volume88
Issue number12
DOIs
Publication statusPublished - Mar 21 2017

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Progressive Multifocal Leukoencephalopathy
Plasmapheresis
Immune Reconstitution Inflammatory Syndrome
Survival
Natalizumab
Multiple Sclerosis
JC Virus
Mortality
Immunosuppressive Agents

Keywords

  • Adult
  • Disability Evaluation
  • Female
  • Humans
  • Immunologic Factors
  • Leukoencephalopathy, Progressive Multifocal
  • Male
  • Middle Aged
  • Multiple Sclerosis
  • Natalizumab
  • Plasmapheresis
  • PubMed
  • Retrospective Studies
  • Statistics, Nonparametric
  • Treatment Outcome
  • Journal Article

Cite this

Landi, D., De Rossi, N., Zagaglia, S., Scarpazza, C., Prosperini, L., Albanese, M., ... Italian PML study group (2017). No evidence of beneficial effects of plasmapheresis in natalizumab-associated PML. Neurology, 88(12), 1144-1152. https://doi.org/10.1212/WNL.0000000000003740

No evidence of beneficial effects of plasmapheresis in natalizumab-associated PML. / Landi, Doriana; De Rossi, Nicola; Zagaglia, Sara; Scarpazza, Cristina; Prosperini, Luca; Albanese, Maria; Buttari, Fabio; Mori, Francesco; Marfia, Girolama Alessandra; Sormani, Maria Pia; Capra, Ruggero; Centonze, Diego; Italian PML study group.

In: Neurology, Vol. 88, No. 12, 21.03.2017, p. 1144-1152.

Research output: Contribution to journalArticle

Landi, D, De Rossi, N, Zagaglia, S, Scarpazza, C, Prosperini, L, Albanese, M, Buttari, F, Mori, F, Marfia, GA, Sormani, MP, Capra, R, Centonze, D & Italian PML study group 2017, 'No evidence of beneficial effects of plasmapheresis in natalizumab-associated PML', Neurology, vol. 88, no. 12, pp. 1144-1152. https://doi.org/10.1212/WNL.0000000000003740
Landi D, De Rossi N, Zagaglia S, Scarpazza C, Prosperini L, Albanese M et al. No evidence of beneficial effects of plasmapheresis in natalizumab-associated PML. Neurology. 2017 Mar 21;88(12):1144-1152. https://doi.org/10.1212/WNL.0000000000003740
Landi, Doriana ; De Rossi, Nicola ; Zagaglia, Sara ; Scarpazza, Cristina ; Prosperini, Luca ; Albanese, Maria ; Buttari, Fabio ; Mori, Francesco ; Marfia, Girolama Alessandra ; Sormani, Maria Pia ; Capra, Ruggero ; Centonze, Diego ; Italian PML study group. / No evidence of beneficial effects of plasmapheresis in natalizumab-associated PML. In: Neurology. 2017 ; Vol. 88, No. 12. pp. 1144-1152.
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abstract = "OBJECTIVE: To examine retrospectively the effects of plasmapheresis (PLEX) on the survival and clinical outcomes of patients with multiple sclerosis (MS) and natalizumab (NTZ)-associated progressive multifocal leukoencephalopathy (PML).METHODS: The medical literature was searched for the terms natalizumab and progressive multifocal leukoencephalopathy. A total of 193 international and 34 Italian NTZ-PML cases were included. Clinical outcome was determined by comparing the patients' clinical status at PML diagnosis with status after PML resolution. The effects on survival and clinical outcome of PLEX, sex, age, country, pre-PML Expanded Disability Status Scale score, NTZ infusion number, prior immunosuppressant exposure, PML symptoms, PML lesion location at diagnosis, CSF JC virus status and copies, additional PML treatments and steroids, and PML immune reconstitution inflammatory syndrome (IRIS) development were investigated with both univariate and multivariate analyses.RESULTS: A total of 219 NTZ-PML cases were analyzed, and 184 (84{\%}) underwent PLEX, which did not reduce the mortality risk or the likelihood of poor vs favorable outcomes. Country was predictive of mortality and poor outcome, while PML-IRIS development was predictive of poor outcome.CONCLUSIONS: PLEX did not improve the survival or clinical outcomes of Italian or international patients with MS and NTZ-PML, suggesting that this treatment should be performed cautiously in the future.CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with NTZ-PML, PLEX does not improve survival. The study lacks the statistical precision to exclude an important benefit or harm of PLEX.",
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AU - Landi, Doriana

AU - De Rossi, Nicola

AU - Zagaglia, Sara

AU - Scarpazza, Cristina

AU - Prosperini, Luca

AU - Albanese, Maria

AU - Buttari, Fabio

AU - Mori, Francesco

AU - Marfia, Girolama Alessandra

AU - Sormani, Maria Pia

AU - Capra, Ruggero

AU - Centonze, Diego

AU - Italian PML study group

N1 - © 2017 American Academy of Neurology.

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N2 - OBJECTIVE: To examine retrospectively the effects of plasmapheresis (PLEX) on the survival and clinical outcomes of patients with multiple sclerosis (MS) and natalizumab (NTZ)-associated progressive multifocal leukoencephalopathy (PML).METHODS: The medical literature was searched for the terms natalizumab and progressive multifocal leukoencephalopathy. A total of 193 international and 34 Italian NTZ-PML cases were included. Clinical outcome was determined by comparing the patients' clinical status at PML diagnosis with status after PML resolution. The effects on survival and clinical outcome of PLEX, sex, age, country, pre-PML Expanded Disability Status Scale score, NTZ infusion number, prior immunosuppressant exposure, PML symptoms, PML lesion location at diagnosis, CSF JC virus status and copies, additional PML treatments and steroids, and PML immune reconstitution inflammatory syndrome (IRIS) development were investigated with both univariate and multivariate analyses.RESULTS: A total of 219 NTZ-PML cases were analyzed, and 184 (84%) underwent PLEX, which did not reduce the mortality risk or the likelihood of poor vs favorable outcomes. Country was predictive of mortality and poor outcome, while PML-IRIS development was predictive of poor outcome.CONCLUSIONS: PLEX did not improve the survival or clinical outcomes of Italian or international patients with MS and NTZ-PML, suggesting that this treatment should be performed cautiously in the future.CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with NTZ-PML, PLEX does not improve survival. The study lacks the statistical precision to exclude an important benefit or harm of PLEX.

AB - OBJECTIVE: To examine retrospectively the effects of plasmapheresis (PLEX) on the survival and clinical outcomes of patients with multiple sclerosis (MS) and natalizumab (NTZ)-associated progressive multifocal leukoencephalopathy (PML).METHODS: The medical literature was searched for the terms natalizumab and progressive multifocal leukoencephalopathy. A total of 193 international and 34 Italian NTZ-PML cases were included. Clinical outcome was determined by comparing the patients' clinical status at PML diagnosis with status after PML resolution. The effects on survival and clinical outcome of PLEX, sex, age, country, pre-PML Expanded Disability Status Scale score, NTZ infusion number, prior immunosuppressant exposure, PML symptoms, PML lesion location at diagnosis, CSF JC virus status and copies, additional PML treatments and steroids, and PML immune reconstitution inflammatory syndrome (IRIS) development were investigated with both univariate and multivariate analyses.RESULTS: A total of 219 NTZ-PML cases were analyzed, and 184 (84%) underwent PLEX, which did not reduce the mortality risk or the likelihood of poor vs favorable outcomes. Country was predictive of mortality and poor outcome, while PML-IRIS development was predictive of poor outcome.CONCLUSIONS: PLEX did not improve the survival or clinical outcomes of Italian or international patients with MS and NTZ-PML, suggesting that this treatment should be performed cautiously in the future.CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with NTZ-PML, PLEX does not improve survival. The study lacks the statistical precision to exclude an important benefit or harm of PLEX.

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KW - Middle Aged

KW - Multiple Sclerosis

KW - Natalizumab

KW - Plasmapheresis

KW - PubMed

KW - Retrospective Studies

KW - Statistics, Nonparametric

KW - Treatment Outcome

KW - Journal Article

U2 - 10.1212/WNL.0000000000003740

DO - 10.1212/WNL.0000000000003740

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C2 - 28228569

VL - 88

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JO - Neurology

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SN - 0028-3878

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