title: Natalizumab discontinuation after PML risk stratification: outcome from a shared and informed decision.
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.
authors.affiliation: Clinical Neuroimmunology Unit, Multiple Sclerosis Centre of Catalonia (Centre d'Esclerosi Múltiple de Catalunya, CEM-Cat), Vall d'Hebron University Hospital, Barcelona, Spain. ctur@cem-cat.org
authors.forename: Carmen
authors.initials: C
authors.lastname: Tur
authors.forename: Mar
authors.initials: M
authors.lastname: Tintoré
authors.forename: Angela
authors.initials: A
authors.lastname: Vidal-Jordana
authors.forename: Joaquín
authors.initials: J
authors.lastname: Castilló
authors.forename: Ingrid
authors.initials: I
authors.lastname: Galán
authors.forename: Jordi
authors.initials: J
authors.lastname: Río
authors.forename: Georgina
authors.initials: G
authors.lastname: Arrambide
authors.forename: Manuel
authors.initials: M
authors.lastname: Comabella
authors.forename: M Jesús
authors.initials: MJ
authors.lastname: Arévalo
authors.forename: Rosalía
authors.initials: R
authors.lastname: Horno
authors.forename: M José
authors.initials: MJ
authors.lastname: Vicente
authors.forename: Ana
authors.initials: A
authors.lastname: Caminero
authors.forename: Carlos
authors.initials: C
authors.lastname: Nos
authors.forename: Jaume
authors.initials: J
authors.lastname: Sastre-Garriga
authors.forename: Xavier
authors.initials: X
authors.lastname: Montalban
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D000914:Antibodies, Viral / Q000097:blood; D001291:Attitude of Health Personnel; D002755:Choice Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects*; D007166:Immunosuppressive Agents / Q000009:adverse effects; D007577:JC Virus / Q000276:immunology; D007968:Leukoencephalopathy, Progressive Multifocal / Q000139:chemically induced* / Q000821:virology; D016015:Logistic Models; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy*; D015999:Multivariate Analysis; D000069442:Natalizumab; D016017:Odds Ratio; D010358:Patient Participation; D010817:Physician-Patient Relations; D027601:Polyomavirus Infections / Q000150:complications / Q000821:virology; D018570:Risk Assessment; D012307:Risk Factors; D013030:Spain
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000914:Antibodies, Viral; D007155:Immunologic Factors; D007166:Immunosuppressive Agents; D000069442:Natalizumab