Biologics

Question 1

What is the PBS criteria for dupilumab?

Answer 1

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

Question 2

What are the contraindications to dupilumab?

Answer 2

Hypersensitivity
Pregnancy/lactation
Helminth infestation
HsV keratitis

Question 3

What are the adverse effects of dupilumab?

Answer 3

Common: injection site reaction, conjunctivitis, URTI, HSV

Serious: hypersensitivity reaction, serum sickness like reaction, eosinophilic pneumonia

Question 4

What baseline and ongoing monitoring is needed for dupilumab?

Answer 4

Baseline: immunosuppression screen + strongyloides

Ongoing: nil

Question 5

What is the PBS criteria for omalizumab?

Answer 5

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

Question 6

How is omalizumab dosed and initiated?

Answer 6

300mg every 4 weeks subcutaneously

First 3 doses need to be supervised

Question 7

What are the contraindications to omalizumab?

Answer 7

Hypersensitivity
Previous anaphylaxis
Pregnancy/lactation
Latex allergy
Helminth infestation

Question 8

What are the adverse effects of omalizumab?

Answer 8

Common: LISR, URTI sx, GI effects, arthralgias

Rare: anaphylaxis, serum sickness-like reactions, helminth infestation

MI, CVA, VTE

Question 9

What are the contraindications to the IL-17 blockers?

Answer 9

Hypersensitivity
Pregnancy/lactation
IBD
Candidal infections

Question 10

What are the adverse effects of the IL-17 blockers?

Answer 10

Common: LISR, URTI sx, oral candidiasis, headache, diarrhoea

Rare/serious: hypersensitivity reactions, IBD, neutropenia, NMSC

Question 11

What are the two IL-17 blockers used in Australia and what are their dosing regimes?

Answer 11

Ixekizumab
- 160mg loading
- 80mg every 2 weeks for 3 months
- 80mg monthly

Secukinumab
- 300mg loading
- 300mg weekly for 1 month
- 300mg monthly

Question 12

What are the contraindications to the IL-12/23 blockers?

Answer 12

Hypersensitivity
Pregnancy/lactation
Active/recently-treated infection
Active/recently-treated malignancy
High risk of ACS/CVA (ustekinumab)

Question 13

What are the adverse effects of the IL-12/23 blockers?

Answer 13

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

Question 14

What are the IL-12/23 blockers used in Australia and how are they dosed?

Answer 14

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

Question 15

What baseline and ongoing monitoring is required for IL-12/23 blockers?

Answer 15

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

Question 16

What are the non psoriasis indications for TNF inhibitors?

Answer 16

Hidradenitis suppurativa
Granulomatous disease
Neutrophilic dermatosis
Pityriasis rubra pilaris
SJS/TEN

Question 17

What are the contraindications to TNF inhibitors?

Answer 17

Hypersensitivity
Pregnancy/lactation
Heart failure
Multiple sclerosis
Active/recently treated infection/malignancy

Question 18

What are the adverse effects of TNF inhibitors?

Answer 18

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

Question 19

What are the TNF inhibitors used in Australia and what are their dosing regimes?

Answer 19

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

Question 20

What are the contraindications to rituximab?

Answer 20

Hypersensitivity, Hx of angiooedema, bronchospasm, hypotension
Pregnancy
Active/recent treated infection/cancer
Immunodeficiency
Progressive multifocal leukoencephalopathy
Severe cardiac failure

Question 21

What drugs interact with rituximab?

Answer 21

Live vaccines
Other monoclonal antibodies
Other immunosuppressants
Cytotoxic agents

Question 22

What are the side effects of rituximab?

Answer 22

Infusion reactions, anaphylaxis
URTI sx
GI: nausea, bowel obstruction/perforation
CNS: headache, dizziness, tremor
Cytopaenias
Infections eg. JC virus, HBV
Malignancy, tumour lysis syndrome

Question 23

How do you administer rituximab for pemphigus?

Answer 23

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

Question 24

What monitoring is required for rituximab?

Answer 24

FBC after each dose, then 1-3 monthly
B cell subsets, Ig every 3-6 months

Question 25

What baseline screening is required for rituximab?

Answer 25

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