title: [Systemic lupus erythematosus and risk of hepatitis B vaccination: from level of evidence to prescription].
abstract: BACKGROUND
  Case reports focusing on immunological diseases occurring subsequently to vaccination are often described in the literature. Reporting of such cases may influence physicians' perception of risks related to immunization, and thereby immunization practices. The decision to vaccinate a patient with an immunological disease should not rely on such case reports, but on the level of evidence of a causal relationship between vaccination and the occurrence of an adverse event. This article describes the search for available data supporting such causality before taking the decision to introduce vaccination against hepatitis B in a female patient with systemic lupus erythematosus (SLE).
  
  
  BACKGROUND
  Data extracted from Medline and surveillance system showed that: 1) biologic plausibility of a relationship between the HBs antigen and SLE was unlikely; 2) case reports or case series were seldom and not convincing regarding potential causality; and 3) there were neither controlled observational studies nor controlled clinical trials. The only available clinical study was of poor quality and did not show any adverse event. The level of evidence of a causal relationship between vaccination against hepatitis B and the occurrence of an adverse event in patients with SLE was low, in-between levels 4 and 5 as defined by the Center for evidence-based medicine. The risk-benefit ratio may therefore rely on these results and guide the decision whether or not vaccination should be introduced.
  
  
  CONCLUSIONS
  The type of reasoning reported in this paper can be used for other vaccines or other immunological diseases, and have wider applicability in terms of therapeutic risk management when data and evaluation are lacking that could guide decisions.
authors.affiliation: Service de médecine interne et néphrologie, université Paris 5, hôpital Ambroise-Paré, Boulogne Billancourt, France.
authors.forename: T
authors.initials: T
authors.lastname: Hanslik
authors.forename: J N
authors.initials: JN
authors.lastname: Vaillant
authors.forename: L
authors.initials: L
authors.lastname: Audrain
authors.forename: V
authors.initials: V
authors.lastname: Jubault
authors.forename: J
authors.initials: J
authors.lastname: Prinseau
authors.forename: A
authors.initials: A
authors.lastname: Baglin
authors.forename: A
authors.initials: A
authors.lastname: Flahault
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D015984:Causality; D003657:Decision Making; D011307:Drug Prescriptions; D019317:Evidence-Based Medicine; D005260:Female; D017325:Hepatitis B Vaccines / Q000009:adverse effects*; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000209:etiology*; D018579:Patient Selection; D011159:Population Surveillance; D012107:Research Design / Q000592:standards*; D012307:Risk Factors
chemical_list: D017325:Hepatitis B Vaccines