Table 4 Events of special interest

Aplastic anaemia, pancytopenia, serious neutropenia

–

Cerebrovascular accident

Stroke and/or transient ischaemic attack.

Demyelination, optic neuritis

–

Mental health

≥1 new prescription for depressive illness and/or ≥ 1 new prescription for anxiety/nervousness.

Hepatitis B reactivation

–

Hypersensitivity reaction

Including skin eruptions and rashes, oedemas, anaphylactic reactions, and non-specific hypersensitivity – e.g. Stevens Johnson syndrome, erythema multiforme, toxic epidermal necrosis. Life-threatening anaphylactoid reactions including effects on blood pressure and respiratory effects as defined for anaphylaxis [21].

Inflammatory bowel disease

Worsening of existing condition, or new onset.

Lymphoproliferative malignancy

–

Malignancy, skin cancer, Bowen’s disease

Including solid tumours, haematological tumours, melanoma, and non-melanoma skin cancers.

Major adverse cardiovascular events

Including all incident myocardial infarctions and acute coronary syndrome. Sudden cardiac death, death due to myocardial infarction, heart failure, stroke and other cardiovascular causes; myocardial infarction and non-fatal stroke.

Pregnancy

–

Psoriasis flare

Worsening of existing psoriasis, or paradoxical psoriasis onset.

Pulmonary embolism

–

Serious congestive heart failure

–

Infection

Serious infection – i.e. infection resulting in death, or is life threatening and/or requiring hospitalisation and/or intravenous antibiotics. Systemic candida infection, and all recurrent candida and other fungal infections.

Serious hepatic dysfunction or failure

–

Serious lower GI ulcer, bleed or perforation

–

Serious lupus, or lupus-like illness

–

Serious haemorrhage

–

Suicide behaviours

Including suicide ideation, suicide attempt, and suicide.

Tachyarrhythmia

Including atrial fibrillation and flutter, supraventricular tachyarrhythmia and tachycardia, and ventricular tachycardia, fibrillation, and flutter.

Tuberculosis

–

Vasculitis

Including renal and nodular vasculitis, polyarteritis nodosa, temporal arteritis, and all other vasculitis conditions.