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Table 4 Events of special interest

From: The BSR-PsA: study protocol for the British Society for Rheumatology psoriatic arthritis register

Event of special interest Further explanation
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.