Table 1.

Criteria for the diagnosis of ASIA

Major criteria

• Exposure to an external stimulus (infection, vaccine, silicone, adjuvant) prior to clinical manifestations

• The appearance of ‘typical’ clinical manifestations:

- Myalgia, Myositis or muscle weakness

- Arthralgia and/or arthritis

- Chronic fatigue, un-refreshing sleep or sleep disturbances

- Neurological manifestations (especially associated with demyelination)

- Cognitive impairment, memory loss

- Pyrexia, dry mouth

• Removal of inciting agent induces improvement

• Typical biopsy of involved organs

Minor criteria

• The appearance of autoantibodies or antibodies directed at the suspected adjuvant

• Other clinical manifestations (i.e. irritable bowel syndrome)

• Specific HLA (i.e. HLA DRB1, HLA DQB1)

• Evolvement of an autoimmune disease (i.e. multiple sclerosis, systemic sclerosis)

ASIA autoimmune/inflammatory syndrome induced by adjuvants