Psoriatic arthritis toxicity and severity descriptors

Details of the toxicities to Disease Modifying Anti Rheumatic Drug (DMARD) treatment, including severity, which are accepted for PBS subsidised biological agents for treatment of psoriatic arthritis.

Use the following toxicity and severity descriptors in conjunction with the authority application when demonstrating patient’s intolerance to Disease Modifying Anti Rheumatic Drug (DMARD) treatment.

  • ALT - alanine aminotransferase
  • AST - aspartate aminotransferase
  • BP - blood pressure
  • ECG - electrocardiogram
  • IV - intravenous
  • LV - left ventricle
  • NIH - National Institutes of Health
  • PT - Prothrombin time
  • ULN - upper limit of normal
  • WCC - white cell count
Adverse event Brief description of minimum grade NIH common toxicity criteria grade
Blood or bone marrow
Anaemia Haemoglobin < 80 g per L 3 (or higher)
Leukopenia Total WCC < 3 x 109 per L 2 (or higher)
Thrombocytopenia Platelets < 50 x 109 per L 3 (or higher)
Neutropenia Total neutrophils < 1.0 x 109 per L 3 (or higher)
Cardiovascular
Arrhythmia Symptomatic and requiring therapy 3 (or higher)
Cardiac LV function Congestive cardiac failure responsive to treatment 3 (or higher)
Fluid retention Symptomatic, limiting function, unresponsive to therapy or requiring drug discontinuation 3 (or higher)
Hypertension Recurrent or persistent rise of > 20 mmHg diastolic BP or rise to > 150 over 90 on 2 occasions if BP previously normal 2 (or higher)
Pericardial effusion or pericarditis Pericarditis (pericardial rub, ECG changes or chest pain) 2 (or higher)
Thrombosis or embolism Requiring anticoagulant therapy 3 (or higher)
Coagulation
Prothrombin time PT > 2 x ULN 3 (or higher)
Dermatology or skin
Alopecia Pronounced hair loss 2 (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 2 (or higher)
Gastrointestinal
Diarrhoea Increase of 4-6 stools per day over pretreatment 2 (or higher)
Nausea Oral intake significantly decreased, and where the causative DMARD is methotrexate, symptoms that do not respond to at least 2 of the following:
  • reduction of the methotrexate dose
  • folinic acid or folic acid supplementation
  • switching from oral to intramuscular dosing
  • dividing the methotrexate dose over 12 hours

A minimum of 3 doses of methotrexate should have been trialled

2 (or higher)
Pancreatitis Abdominal pain with pancreatic enzyme elevation 3 (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)
Weight gain or loss 20% or more weight gain or loss 3 (or higher)
Hepatic
Bilirubin > 1.5 x ULN 2 (or higher)
Transaminases ALT or AST > 2.5 x ULN, or ALT or AST > 1.5 x ULN on 3 occasions over a 3-month period 2 (or higher)
Ç Serum alkaline phosphatase 2.5 x ULN 2 (or higher)
Neurology or senses
Ataxia (incoordination) Mild symptoms interfering with function but not interfering with activities of daily living 2 (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 interfere with activities of daily living 3 (or higher)
Hearing Tinnitus or hearing loss not requiring hearing aid or treatment 2 (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)
Seizure(s) Seizures in which consciousness is altered 3 (or higher)
Vision Symptomatic and interfering with function but not interfering with activities of daily living 2 (or higher)
Pulmonary
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)
Pulmonary fibrosis Respiratory function test abnormalities and requiring steroids or diuretics 2 (or higher)
Pulmonary symptoms
new or worsening (probable drug-induced pneumonitis)
Development of syndrome consistent with drug-induced pneumonitis (for example, cough, dyspnoea, fever, hypoxaemia) with lung infiltrates on imaging
(refer Searles McKendry criteria)
 
Renal
Haematuria Macroscopic (or dipstick +++) confirmed on 2 separate occasions 2 (or higher)
Proteinuria > 1.0 g per 24 hours, elevated urine protein-creatinine ratios, (dipstick protein ++ or greater), confirmed on 2 separate occasions 2 (or higher)
Renal impairment Creatinine > 1.5 ULN or creatinine clearance < 30 mL per min 2 (or higher)
Other
Allergic reaction Urticaria, drug fever > 38 °C or bronchospasm 2 (or higher)
Fatigue, malaise Severe, loss of ability to perform some activities 3 (or higher)
Fever (in the absence of neutropenia) Body temp > 39 °C (oral or tympanic) 2 (or higher)
Infection Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation 3 (or higher)
Nodulosis (following introduction of methotrexate therapy) Development of multiple new nodules causing significant local pressure symptoms and distress to patient  
Secondary malignancy Secondary malignancy present 4

Page last updated: 1 December 2018