Ankylosing spondylitis toxicity criteria and severity descriptors

Details of the toxicities to Nonsteroidal Anti-inflammatory Drug (NSAID) therapy, including severity, which are accepted for PBS subsidised biological agents for treatment of ankylosing spondylitis.

Use the following toxicity criteria and severity descriptors in conjunction with the authority application when demonstrating 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: 5 July 2018