Natalizumab discontinuation after PML risk stratification: outcome from a shared and informed decision

Mult Scler. 2012 Aug;18(8):1193-6. doi: 10.1177/1352458512439238. Epub 2012 Mar 1.

Abstract

Multifocal progressive leukoencephalopathy (PML) is associated with JC virus (JCV) seropositivity, past immunosuppression, and natalizumab treatment for two years or more. The aim of our study was to investigate the rate of treatment discontinuation after stratifying for the three risk factors in a group of 104 natalizumab-treated patients with relapsing-remitting multiple sclerosis. We investigated JCV serological status in our population. We then divided patients into groups according to their PML risk. Treatment indication was reassessed. Of the patients, 64 (61.5%) were JCV seropositive. Amongst seropositive patients on natalizumab for 2 years or more, 10 had received immunosuppression (group A), and 38 had not (group B). After an informed and shared decision-making process, 6/10 (60%) from group A compared with 9/38 (23.7%) from group B discontinued treatment (p=0.027). In groups A and B, discontinuation also depended upon doctors' views (p=0.019, group A; p=0.010, group B) and clinical outcomes (p=0.021, group A). No-one from low-intermediate risk groups discontinued. The decision to discontinue natalizumab treatment is complex, even when clear PML risk rates are described. Clinical outcomes and doctors' idiosyncrasies play a crucial part in patients' final choice.

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Antibodies, Viral / blood
  • Attitude of Health Personnel*
  • Choice Behavior
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Immunologic Factors / adverse effects*
  • Immunosuppressive Agents / adverse effects
  • JC Virus / immunology
  • Leukoencephalopathy, Progressive Multifocal / chemically induced*
  • Leukoencephalopathy, Progressive Multifocal / virology
  • Logistic Models
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / diagnosis
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multivariate Analysis
  • Natalizumab
  • Odds Ratio
  • Patient Participation*
  • Physician-Patient Relations
  • Polyomavirus Infections / complications
  • Polyomavirus Infections / virology
  • Risk Assessment
  • Risk Factors
  • Spain

Substances

  • Antibodies, Monoclonal, Humanized
  • Antibodies, Viral
  • Immunologic Factors
  • Immunosuppressive Agents
  • Natalizumab