Biologics Flashcards
What is the PBS criteria for dupilumab?
12 years of age or older
Disease duration >6 months
EASI score of 20 or more
PGA score of 4
Sole PBS subsidised biologic for this indication
Not previously failed this biologic for this indication
Use of medium-high potency topical corticosteroid for last (at least) 4 weeks
Patient treated by dermatologist or clinical immunologist
What are the contraindications to dupilumab?
Hypersensitivity
Pregnancy/lactation
Helminth infestation
HsV keratitis
What are the adverse effects of dupilumab?
Common: injection site reaction, conjunctivitis, URTI, HSV
Serious: hypersensitivity reaction, serum sickness like reaction, eosinophilic pneumonia
What baseline and ongoing monitoring is needed for dupilumab?
Baseline: immunosuppression screen + strongyloides
Ongoing: nil
What is the PBS criteria for omalizumab?
Severe CSU of at least 6 weeks duration despite use of H1 antihistamines
Failed at least 2 weeks of standard therapy (H1, H2, montelukast, doxepin)
UAS7 score of at least 28
Itch score of at least 8
Exclusion of physical triggers
Treated by dermatologist, allergist, clinical immunologist
How is omalizumab dosed and initiated?
300mg every 4 weeks subcutaneously
First 3 doses need to be supervised
What are the contraindications to omalizumab?
Hypersensitivity
Previous anaphylaxis
Pregnancy/lactation
Latex allergy
Helminth infestation
What are the adverse effects of omalizumab?
Common: LISR, URTI sx, GI effects, arthralgias
Rare: anaphylaxis, serum sickness-like reactions, helminth infestation
MI, CVA, VTE
What are the contraindications to the IL-17 blockers?
Hypersensitivity
Pregnancy/lactation
IBD
Candidal infections
What are the adverse effects of the IL-17 blockers?
Common: LISR, URTI sx, oral candidiasis, headache, diarrhoea
Rare/serious: hypersensitivity reactions, IBD, neutropenia, NMSC
What are the two IL-17 blockers used in Australia and what are their dosing regimes?
Ixekizumab
- 160mg loading
- 80mg every 2 weeks for 3 months
- 80mg monthly
Secukinumab
- 300mg loading
- 300mg weekly for 1 month
- 300mg monthly
What are the contraindications to the IL-12/23 blockers?
Hypersensitivity
Pregnancy/lactation
Active/recently-treated infection
Active/recently-treated malignancy
High risk of ACS/CVA (ustekinumab)
What are the adverse effects of the IL-12/23 blockers?
Common: local injection site reaction, URTI sx, GI effects, UTI
Serious: hypersensitivity, reactivation of infection or malignancy
Ustekinumab specific
- posterior reversible encephalopathy syndrome
- major cardiovascular events
What are the IL-12/23 blockers used in Australia and how are they dosed?
Ustekinumab
<100kg 45mg
>100kg 90mg
Given at weeks 0, 4 and then 3 monthly
Guselkumab
100mg, week 0, 4 and then every 2 months
Tildrakizumab
100mg, week 0, 4 and then every 3 months
Rizankizumab
150mg, week 0, 4 and then every 3 months
What baseline and ongoing monitoring is required for IL-12/23 blockers?
Baseline
Full examination inc. skin and LNs
FBC, UEC, LFT, BhCG, BSL, lipids
Immunosuppression screen
Ongoing
FBC, UEC, LFT every 6 months
BSL, lipids, immunosuppression screen every 12/12 or as risk changes
What are the non psoriasis indications for TNF inhibitors?
Hidradenitis suppurativa
Granulomatous disease
Neutrophilic dermatosis
Pityriasis rubra pilaris
SJS/TEN
What are the contraindications to TNF inhibitors?
Hypersensitivity
Pregnancy/lactation
Heart failure
Multiple sclerosis
Active/recently treated infection/malignancy
What are the adverse effects of TNF inhibitors?
Common: LISR, URTI, headache
Serious:
Hypersensitivity reactions
Infection & malignancy
Exacerbation of CCF or MS
Cytopaenias
Hepatotoxicity
SJS/TEN
Skin
vasculitis
Subacute lupus
Lichenoid drug eruption
Pityriasiform eruption
Sweet syndrome
Granulomatous: EN, Sarcoidosis, granuloma annulare
What are the TNF inhibitors used in Australia and what are their dosing regimes?
Infliximab 5mg/kg
Weeks 0, 2 & 6 and then every 2 months
Etanercept 50mg Weekly
Adalimumab
80mg loading dose
40mg every 2 weeks
Certolizumab 200-400mg every 2 weeks
What are the contraindications to rituximab?
Hypersensitivity, Hx of angiooedema, bronchospasm, hypotension
Pregnancy
Active/recent treated infection/cancer
Immunodeficiency
Progressive multifocal leukoencephalopathy
Severe cardiac failure
What drugs interact with rituximab?
Live vaccines
Other monoclonal antibodies
Other immunosuppressants
Cytotoxic agents
What are the side effects of rituximab?
Infusion reactions, anaphylaxis
URTI sx
GI: nausea, bowel obstruction/perforation
CNS: headache, dizziness, tremor
Cytopaenias
Infections eg. JC virus, HBV
Malignancy, tumour lysis syndrome
How do you administer rituximab for pemphigus?
30 mins before
- cetirizine 10mg PO
- paracetamol 1g PO
- hydrocortisone 100mg IV
1g rituximab STAT, repeat 2 weeks later, repeat at 6-12 months
Monitor for 2 hours post infusion
Consider PCP prophylaxis
What monitoring is required for rituximab?
FBC after each dose, then 1-3 monthly
B cell subsets, Ig every 3-6 months
What baseline screening is required for rituximab?
Hx and exam (infection, malignancy, skin check)
Vaccinations up to date
Contraception 12 months after last dose
FBC, UEC, LFT, BHcG, age appropriate malignancy screen
Immunosuppression screen, B cell subsets
