Ankylosing spondylitis toxicity and severity descriptors

Accepted toxicities to Nonsteroidal Anti-inflammatory Drug (NSAID) therapy, including severity, for PBS subsidised biological agents for treating ankylosing spondylitis.

Use the following toxicity and severity descriptors with the authority application when demonstrating a patient’s intolerance to NSAID treatment.

Adverse event Brief description of minimum grade National Institutes of Health common toxicity criteria grade
Blood or bone marrow
Anaemia Haemoglobin <80 g per L 3 (or higher)
Haemolysis Evidence of red cell destruction and >20 g per L drop in haemoglobin, no transfusion required 2 (or higher)
Leukopaenia Total white cell count < 3 × 109 per L 2 (or higher)
Neutropaenia Neutrophils <1.0 × 109 per L 3 (or higher)
Thrombocytopaenia Platelets <50 × 109 per L 3 (or higher)
Cardiovascular
Arrhythmia Symptomatic and requiring therapy 3 (or higher)
Cardiac left ventricle function Congestive cardiac failure responsive to treatment 3 (or higher)
Hypertension Recurrent or persistent rise of >20 mmHg diastolic blood pressure or rise to >150/90 on 2 occasions if blood pressure previously normal 2 (or higher)
Myocardial ischaemia or infarction Unstable angina or myocardial infarction 3 (or higher)
Oedema Symptomatic, limiting function, unresponsive to therapy or requiring drug discontinuation 3 (or higher)
Coagulation
Prothrombin time Prothrombin time >2 × upper limit of normal 3 (or higher)
Dermatology or skin
Alopecia Pronounced hair loss 2 (or higher)
Photosensitivity Painful erythema or bullae 2 (or higher)
Pruritis Intense or widespread and poorly controlled despite treatment 3 (or higher)
Rash or desquamation Scattered macular or papular eruption or erythema with pruritis or other associated symptoms covering <50% of body surface, or localised desquamation or other lesions covering <50% of body surface 2 (or higher)
Urticaria Requiring topical, oral or IV medication for <24 hours 2 (or higher)
Gastrointestinal
Abdominal pain Moderate pain, interfering with function 2 (or higher)
Anorexia Oral intake significantly decreased 2 (or higher)
Constipation Requiring use of laxatives and enemas 3 (or higher)
Diarrhoea Increase of 4-6 stools per day over pretreatment 2 (or higher)
Dyspepsia Moderate or severe, unresponsive to standard therapy, recurs on rechallenge 2 (or higher)
Nausea Oral intake significantly decreased 2 (or higher)
Pancreatitis Abdominal pain with pancreatic enzyme elevation 3 (or higher)
Peptic ulcer Requiring medical management 2 (or higher)
Stomatitis Painful erythema, oedema or ulcers but able to eat or swallow 2 (or higher)
Vomiting 2 or more episodes per 24 hours over pretreatment 2 (or higher)
Haemorrhage
Melena or gastrointestinal bleeding Requiring transfusion 3 (or higher)
Purpura Generalised purpura 3 (or higher)
Hepatic
Bilirubin >1.5 × upper limit of normal 2 (or higher)
Transaminases Alanine aminotransferase or
aspartate aminotransferase >2.5 × upper limit of normal or
alanine aminotransferase or
aspartate aminotransferase >1.5 × upper limit of normal on 3 occasions over a 3-month period
2 (or higher)
Neurology or senses
Central nervous system cerebrovascular ischaemia Transient ischaemic attack or cerebrovascular accident 3 (or higher)
Decreased level of consciousness Somnolence or sedation, interfering with function but not interfering with activities of daily living 2 (or higher)
Headaches (severe) Severe pain. Pain or analgesics severely interfering with activities of daily living 3 (or higher)
Inner ear or hearing Tinnitus or hearing loss not requiring hearing aid or treatment 2 (or higher)
Insomnia Frequent difficulty sleeping, interfering with activities of daily living 3 (or higher)
Mood alteration Moderate mood alteration, interfering with function but not interfering with activities of daily living 2 (or higher)
Neuropathy - sensory Objective sensory loss or paraesthesia, interfering with function but not interfering with activities of daily living 2 (or higher)
Vertigo Interfering with activities of daily living 3 (or higher)
Vision Symptomatic and interfering with function but not interfering with activities of daily living 2 (or higher)
Pulmonary
Asthma Moderate 2 (or higher)
Cough (severe) Severe cough or coughing spasm, poor control or unresponsive to treatment. Evidence of reversal on cessation of treatment 3 (or higher)
Pneumonitis or pulmonary infiltrates Radiographic changes, respiratory function test abnormalities and requiring steroids or diuretics 2 (or higher)
Renal
Haematuria Macroscopic haematuria 2 (or higher)
Hyperkalaemia >6.0 mmol per L 3 (or higher)
Proteinuria >1.0g per 24 hours, elevated urine protein:creatinine ratios >100 mg per mmol, dipstick protein ++ or greater, confirmed on 2 separate occasions 2 (or higher)
Renal impairment Creatinine >1.5 upper limit of normal or creatinine clearance <30 mL per min 2 (or higher)
Other
Allergic reaction or hypersensitivity Urticaria, drug fever >38 °C or bronchospasm 2 (or higher)
Fatigue, malaise Severe, loss of ability to perform some activities 3 (or higher)
Infection Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation 3 (or higher)

Page last updated: 1 November 2018