Ankylosing spondylitis toxicity and severity descriptors

Toxicity and severity descriptors for Nonsteroidal Anti-inflammatory Drug (NSAID) therapy required to be trialled before accessing PBS-subsidised biological medicines to treat ankylosing spondylitis.

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

Adverse eventBrief description of minimum gradeNational Institutes of Health common toxicity criteria grade
Blood or bone marrow
AnaemiaHaemoglobin <80 g per L3 (or higher)
HaemolysisEvidence of red cell destruction and >20 g per L drop in haemoglobin, no transfusion required2 (or higher)
LeukopaeniaTotal white cell count < 3 × 109 per L2 (or higher)
NeutropaeniaNeutrophils <1.0 × 109 per L3 (or higher)
ThrombocytopaeniaPlatelets <50 × 109 per L3 (or higher)
Cardiovascular
ArrhythmiaSymptomatic and requiring therapy3 (or higher)
Cardiac left ventricle functionCongestive cardiac failure responsive to treatment3 (or higher)
HypertensionRecurrent or persistent rise of >20 mmHg diastolic blood pressure or rise to >150/90 on 2 occasions if blood pressure previously normal2 (or higher)
Myocardial ischaemia or infarctionUnstable angina or myocardial infarction3 (or higher)
OedemaSymptomatic, limiting function, unresponsive to therapy or requiring drug discontinuation3 (or higher)
Coagulation
Prothrombin timeProthrombin time >2 × upper limit of normal3 (or higher)
Dermatology or skin
AlopeciaPronounced hair loss2 (or higher)
PhotosensitivityPainful erythema or bullae2 (or higher)
PruritisIntense or widespread and poorly controlled despite treatment3 (or higher)
Rash or desquamationScattered 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 surface2 (or higher)
UrticariaRequiring topical, oral or IV medication for <24 hours2 (or higher)
Gastrointestinal
Abdominal painModerate pain, interfering with function2 (or higher)
AnorexiaOral intake significantly decreased2 (or higher)
ConstipationRequiring use of laxatives and enemas3 (or higher)
DiarrhoeaIncrease of 4-6 stools per day over pretreatment2 (or higher)
DyspepsiaModerate or severe, unresponsive to standard therapy, recurs on rechallenge2 (or higher)
NauseaOral intake significantly decreased2 (or higher)
PancreatitisAbdominal pain with pancreatic enzyme elevation3 (or higher)
Peptic ulcerRequiring medical management2 (or higher)
StomatitisPainful erythema, oedema or ulcers but able to eat or swallow2 (or higher)
Vomiting2 or more episodes per 24 hours over pre-treatment2 (or higher)
Haemorrhage
Melena or gastrointestinal bleedingRequiring transfusion3 (or higher)
PurpuraGeneralised purpura3 (or higher)
Hepatic
Bilirubin>1.5 × upper limit of normal2 (or higher)
TransaminasesAlanine 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 ischaemiaTransient ischaemic attack or cerebrovascular accident3 (or higher)
Decreased level of consciousnessSomnolence or sedation, interfering with function but not interfering with activities of daily living2 (or higher)
Headaches (severe)Severe pain. Pain or analgesics severely interfering with activities of daily living3 (or higher)
Inner ear or hearingTinnitus or hearing loss not requiring hearing aid or treatment2 (or higher)
InsomniaFrequent difficulty sleeping, interfering with activities of daily living3 (or higher)
Mood alterationModerate mood alteration, interfering with function but not interfering with activities of daily living2 (or higher)
Neuropathy - sensoryObjective sensory loss or paraesthesia, interfering with function but not interfering with activities of daily living2 (or higher)
VertigoInterfering with activities of daily living3 (or higher)
VisionSymptomatic and interfering with function but not interfering with activities of daily living2 (or higher)
Pulmonary
AsthmaModerate2 (or higher)
Cough (severe)Severe cough or coughing spasm, poor control or unresponsive to treatment. Evidence of reversal on cessation of treatment3 (or higher)
Pneumonitis or pulmonary infiltratesRadiographic changes, respiratory function test abnormalities and requiring steroids or diuretics2 (or higher)
Renal
HaematuriaMacroscopic haematuria2 (or higher)
Hyperkalaemia>6.0 mmol per L3 (or higher)
Proteinuria>1.0 g per 24 hours, elevated urine protein:creatinine ratios >100 mg per mmol, dipstick protein ++ or greater, confirmed on 2 separate occasions2 (or higher)
Renal impairmentCreatinine >1.5 upper limit of normal or creatinine clearance <30 mL per min2 (or higher)
Other
Allergic reaction or hypersensitivityUrticaria, drug fever >38 °C or bronchospasm2 (or higher)
Fatigue, malaiseSevere, loss of ability to perform some activities3 (or higher)
InfectionSevere, systemic infection, requiring IV antimicrobial treatment or hospitalisation3 (or higher)
Page last updated: 1 March 2024.
QC 41436