Severe chronic plaque psoriasis toxicity criteria and severity descriptors

Toxicity criteria and severity descriptors for the listing of biological agents on the PBS for adults

.

Acitretin

At least 0.4mg/kg/day

Adverse event Brief description of minimum grade of toxicity National Institutes of Health
common toxicity criteria grade
Bilirubin > 1.5 x ULN 2 (or higher)
Transaminases ALT and/or AST > 2.5 x ULN or ALT and/or AST > 1.5 x ULN on three occasions over a three month period 2 (or higher)
g Serum alkaline phosphatase 2.5 x ULN 2 (or higher)
Use contraindicated in those with pre-existing significant renal disease Creatinine > 1.5 ULN 2 (or higher)
Retinoic acid syndrome Symptoms of a degree to indicate steroid use 2 (or higher)
Pseudotumour cerebri Headache, nausea and vomiting associated with raised intracranial pressure
Nausea Oral intake significantly decreased 2 (or higher)
Skin peeling Development of fissures on the palms and soles which cause sufficient discomfort and pain to prevent normal day-to-day duties, and which have not responded to regular and liberal applications of a moisturising agent
Skin burning Sufficient to disturb activities of daily living and to disturb the normal sleep pattern

Cyclosporin

At least 2mg/kg/day

Adverse event Brief description of minimum grade of toxicity National Institutes of Health
common toxicity criteria grade
Blood/bone marrow
Anaemia Haemoglobin < 80 g/L 3 (or higher)
Leukopenia Total WCC < 3 x 109/L 2 (or higher)
Thrombocytopenia Platelets < 50 x 109/L 3 (or higher)
Neutropenia Total neutrophils < 1.0 x 109/L 3 (or higher)
Cardiovascular
Hypertension Recurrent/persistent rise of > 20 mmHg diastolic BP or rise to > 150/90 on two occasions if BP previously normal 2 (or higher)
Fluid retention Symptomatic, limiting function, unresponsive to therapy or requiring drug discontinuation 3 (or higher)
Dermatology/skin
Rash/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/day over pre-treatment 2 (or higher)
Nausea Oral intake significantly decreased 2 (or higher)
Pancreatitis Abdominal pain with pancreatic enzyme elevation 3 (or higher)
Vomiting 2 or more episodes/24 hours over pre-treatment 2 (or higher)
Weight gain/loss 20% or more weight gain or loss 3 (or higher)
Hepatic
Bilirubin > 1.5 x ULN 2 (or higher)
Transaminases ALT and/or AST > 2.5 x ULN or ALT and/or AST > 1.5 x ULN on three occasions over a three month period 2 (or higher)
g Serum alkaline phosphatase 2.5 x ULN 2 (or higher)
Musculoskeletal
Muscle weakness Symptomatic and interfering with function 2 (or higher)
Neurology/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 that 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)
Renal
Haematuria Macroscopic (or dipstick +++) confirmed on two separate occasions 2 (or higher)
Proteinuria > 1.0g/24 hours, elevated urine protein/creatinine ratios, (dipstick protein ++ or greater), confirmed on two separate occasions 2 (or higher)
Renal impairment Creatinine > 1.5 ULN or creatinine clearance < 30mL/min 2 (or higher)
Other
Allergic reaction Urticaria, drug fever > 38°C and/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)
Hyperkalaemia Potassium > 6 mmol/L 3 (or higher)
Infection Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation 3 (or higher)
Secondary malignancy Secondary malignancy present 4

Methotrexate

At least 10mg weekly

Adverse event Brief description of minimum grade of toxicity National Institutes of Health
common toxicity criteria grade
Blood/bone marrow
Anaemia Haemoglobin < 80 g/L 3 (or higher)
Leukopenia Total WCC < 3 x 109/L   2 (or higher)
Thrombocytopenia Platelets < 50 x 109/L 3 (or higher)
Neutropenia Total neutrophils < 1.0 x 109/L 3 (or higher)
Cardiovascular
Pericardial effusion/pericarditis Pericarditis (pericardial rub, ECG changes or chest pain) 2 (or higher)
Thrombosis/embolism Requiring anticoagulant therapy 3 (or higher)
Dermatology/skin
Alopecia Pronounced hair loss 2 (or higher)
Rash/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/day over pre-treatment 2 (or higher)
Nausea Oral intake significantly decreased, and symptoms do not improve with at least two of the following measures:
  1. reduction of the methotrexate dose
  2. folinic acid/folic acid supplementation
  3. switching from oral to intramuscular dosing
  4. dividing the methotrexate dose over 12 hours.

A minimum of three 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/24 hours over pre-treatment 2 (or higher)
Hepatic
Bilirubin > 1.5 x ULN 2 (or higher)
Transaminases ALT and/or AST > 2.5 x ULN or ALT and/or AST > 1.5 x ULN on three occasions over a three month period 2 (or higher)
g Serum alkaline phosphatase 2.5 x ULN 2 (or higher)
Musculoskeletal
Osteonecrosis Symptomatic and interfering with function 2 (or higher) (avascular necrosis)
Osteoporosis Symptomatic and requiring treatment 3 (or higher)
Neurology/senses
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 that 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)
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/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 (e.g. cough, dyspnoea, fever,
Renal
Haematuria Macroscopic (or dipstick +++) confirmed on two separate occasions 2 (or higher)
Renal impairment Creatinine > 1.5 ULN or creatinine clearance < 30mL/min 2 (or higher)
Other
Allergic reaction Urticaria, drug fever > 38°C and/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)
Secondary malignancy Secondary malignancy present 4

Phototherapy toxicity

Required minimum dose of three treatments per week

Adverse event Brief description of minimum grade of toxicity National Institutes of Health
common toxicity criteria grade
Severe photosensitivity reaction Erythema with desquamation 3 (or higher)
Pruritis Intense or widespread and interfering with activities of daily living (ADLs) 3 (or higher)
Development of melanoma
Development of non melanoma skin cancer
Development of more than 10 actinic keratoses
Nausea (PUVA) Oral intake significantly decreased. A minimum of three doses should be trialled 2 (or higher)
More than 200 combined phototherapy treatments

Page last updated: 25 January 2016

This information was printed Monday 5 December 2016 from humanservices.gov.au/health-professionals/enablers/severe-chronic-plaque-psoriasis-toxicity-criteria-and-severity It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.