Systemic lupus erythematosus and adverse events related to hepatitis B vaccination: from level of evidence to prescription.

Introduction. - Case reports focusing on immunological diseases occurring s ubsequently to vaccination are often described in the literature. Reporting of such cases may influence physicians' perception of risks related to imm unization, 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 fo r available data supporting such causality before taking the decision to in troduce vaccination against hepatitis B in a female patient with systemic l upus erythematosus (SLE). Current knowledge and key points. - Data extracted from Medline and surveil lance system showed that : 1) biologic plausibility of a relationship betwe en the HBs antigen and SLE was unlikely; 2) case reports or case series wer e seldom and not convincing regarding potential causality; and 3) there wer e 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 vacci nation against hepatitis B and the occurrence of an adverse event in patien ts 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 thes e results and guide the decision whether or not vaccination should be intro duced. Future prospects and projects. - The type of reasoning reported in this pap er 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. (C) 2000 Editions scient ifiques et medicales Elsevier SAS.