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MyDermatology-Bolognia > Biologics > Flashcards

Biologics Flashcards

1
Q

What are the 4 broad categories of biologics for Psoriasis?

A

TNF
17
23
12/23

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2
Q

List 5 TNF-alpha inhibitors:

A

Adalimumab/humira
Infliximab/remicade
Etanercept/Enbrel
Certolizumab/cimzia

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3
Q

3) Given an example of an IL-12/23 inhibitor:

A

stelara/ustekinumab

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4
Q

4) List 4 IL-17 inhibitors:

A

Ixekizumab-talz
Brodalumab- siliq
secukinumab- cosentyx
Bimekizumab (Bimzelx)

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5
Q

5) List 3 IL-23 inhibitors:

A

Guselkumab (Tremfya)
Rizankizumab (Skyrizi)
Tildrakizumab (Ilumya)

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6
Q

Humira - 1) What is the source and structure?

A

Fully human monoclonal IgG1 ab

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7
Q

Humira- What is MOA?

A

a. Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF-expressing cells in vitro in thepresence of complement.
b. *unclear on membrane bound tnf alpha

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8
Q

What is pregnancy category for humira, infliximab and etanercept

A

Class B

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9
Q

7) List 7 FDA approved indications for humira

A

Psoriasis
HS
Chrons-adult and paediatric
UC
PsA
Ankylosing spondylitis
RA
polyarticular JIA
Uveitis

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10
Q

List 5 off-label uses humira

A

PG
Behcets
Sarcoidosis
Vasculitis
PRP

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11
Q

How is it supplied?

A

a. Single use pens or single use prefilled syringes, given SC

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12
Q

10) What is the starting dosing? For Psoriasis vs. HS? What is the maintenance dose? for Humira

A

Psoriasis:
80 mg day 0, 40 at week 1, then 40 mg q2 weekly

HS: 160 day 0, then 80 week at 2 weeks, then 40 mg at 4 weeks, then 40 mg weekly

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13
Q

What baseline blood work would you order before starting TNFs

A

CBC diff, Liver enzymes, Cr/urea
Hep B serology
Hep C serology
TBST + CXR or IGRA + CXR
Strongy serology

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14
Q

12) What is the PASI-75 of Humira at 16 weeks?
Infliximab at 10 weeks? Etanercept at 10 weeks

A

Humira- 70%
Infliximab-80%
Etanercept- 50%
(12 weeks 50%, 24 wks60%)

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15
Q

13) How quickly does humira work? Onset of response?
Infliximab?
Etanercept?

A

1-2 weeks Humira
2 weeks infliximab
4 weeks etanercept

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16
Q

14) What is the bioavailability of humira? Inflximab? Etanercept?

A

64%- humira
100% - infliximab
58% etanercept

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17
Q

15) After how long are peak levels achieved for humira? Infliximab? Etanercept

A

5.5 days- humira
infliximab-immediate post infusion
Etanercept 2 days

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18
Q

Half life of humira? infliximab? Etanercept?

A

14 days- humira
7-9 days infliximab
5 days etanercept

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19
Q

17) How is infliximab, humira and etanercept metabolized?

A

proteolysis

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20
Q

18) How are humira, infliximab and etanercept excreted?

A

Fragments into bile and urine

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21
Q

Infliximab - What is the source and structure?

A

a. 25% mouse, 75% human chimeric IgG1 monoclonal Ab

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22
Q

What is the mechanism of action of infliximab

A

Binds to soluble and membrane bound TNF alpha

The antibodies also activate complement mediated cytotoxicity and induce cellular apoptosis.

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23
Q

List 10 adverse effects of infliximab, humira and etanercept

A

Infusion reaction
Allergic reaction including anaphylaxis
Increased risk reactivation TB, HepB
Increased risk serious and OIs
Increased risk malignancy-NMSC and lymphoma
Increased risk of new onset or worsening demyelinating disease
Increased risk new onset or worsening CHF
Drug induced ANA+ and lupus
Drug induced vaculitis
Drug induced lupus
paradoxical pso
Cytopenias

Differences:
-increased risk AI hepatitis and hepatoxicity infliximab
-Etanercept high risk injection site reactions, increased risk demyelinating d/o

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24
Q

What are absolute contraindications? List 3 for infliximab, humira and etanercept

A

Known hypersensitivity to infliximab or murine proteins

Concurrent administration with anakinra (IL-1 receptor antagonist)

Active infections/Chronic or localized infections—including TB

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25
Q

5) What are relative contraindication? List 2 for infliximab, humira and etanercept

A

Moderate to severe (New York Classification III or IV) congestive heart failure (OK with doses ≤5 mg/kg)

Family history of demyelinating disease (including multiple sclerosis)

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26
Q

7) List 5 FDA approved indications for infliximab

A

Pso
PsA
Chrons
Colitis
Ank Spond
RA
JIA

*Not HS, not Uveitis

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27
Q

8) List 10 off-label uses infliximab and etanercept

A

1, 2. Neutrophilic (PG, Behcets)
3, 4, 5 , 6Granulomatous (sarcoidosis, GA, granulomatous cheilitis, necrobiosis lipoidica diabetocorum),
7, 8Vasculitis ( GCA, GPA),

9,10Autoinflammatory keratinization d/o (HS, PRP),

11 AI-CTD (DM),

12-14. Others: Reactive arthritis, GVDH, multricentric reticulohistiocytosis

SJS/TEN

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28
Q

How is infliximab supplied

A

Lypophilized powder for reconstitution, single use vial, infusion IV

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29
Q

10) What is the starting dosing for infliximab? Maintenance?

A

3-5 mg/kg at 0,2,6,8 weeks then q8

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30
Q

20) Mean time to relapse after discontinuation infliximab

A

12 weeks

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31
Q

Source and structure etanercept

A

Fully human dimeric fusion protein: 2 binding domains of p75 receptor bound to Fc portion of IgG1

Produced in Chinese hamster ovaries

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32
Q

MOA etanercept

A

Binds TNF-alpha and TNF-beta, soluble and transmembrane

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33
Q

Name FDA indications etanercept

A

Pso
PsA
RA
JIA
Ank spond

*Not IBD

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34
Q

8) How is it supplied?

A

Prefilled syringes, autoinjector, lypophilized powder requiring reconstitution

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35
Q

Dosing for etanercepts

A

50 mg SC twice weekly x12 weeks then
50 mg SC weekly

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36
Q

19) Mean time to relapse after discontinuation? Etanercept

A

12 weeks

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37
Q

20) List 7 live vaccine:

A

Mumps
Measles
Rubella
Varicella
Yellow Fever
Intranasal flu
Old shingles (Zostavax)
BCG
Oral polio/typhoid
Rotavirus

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38
Q

What enzyme cleaves membrane bound TNF-alpha into its more potent soluble form?

A

TNF alpha converting enzyme

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39
Q

2) What are the two TNF-alpha receptors? Where are they found?

A

P55-most cells, epidermal cells –> tnf alpha action usually through this
P75- immune cells only

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40
Q

Which TNF highest risk injection site rxn

A

etanercept

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41
Q

4) Most likely to induce ANA positivity.

A

Inflix

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42
Q

5) Showed an increased incidence of serious infections when used with anakinra. *

A

a. Etancercept

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43
Q

6) Concomitant use of methotrexate can reduce its clearance by 44%.

A

Adalimumab

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44
Q

10) Mean terminal half-life is 14 day

A

Ada

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45
Q

11) Least likely to have associated tachyphylaxis.

A

Etanercept

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46
Q

12) Most likely to stimulate the development of human anti-human antibodies.

A

Ada

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47
Q

13) Least likely to cause hepatitis

A

Etanercept

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48
Q

15) Most associated with the development of histoplasmosis.

A

Infliximab

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49
Q

16) Least likely to have measurable anti-drug antibodies.

A

etaner

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50
Q

17) Least likely to reactivate tuberculosis.

A

Etaner

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51
Q

18) Mean terminal half-life is 7 days.a.

A

Infliximab

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52
Q

19) Does not fix complement binding both membrane and soluble forms of TNF

A

a. Certolizumab

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53
Q

When giving a live vaccine, should wait 42-70 days, give vaccine, wait another 10-14 days and then restart drug

A

a. Adalimumab
(half life 2 weeks

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54
Q

21) When giving a NON live vaccine, must wait 10-14 days, give vaccine, wait another 10-14 days and then restart

A

adalimumab

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55
Q

22) Binds to lymphotoxin B.

A

Etanercept

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56
Q

23) Results in a PASI75 of 80% at week 10 with over one half of patients achieving a PASI90.

A

infliximab

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57
Q

MOA CERTO, STRUCTURE AND FUNCTION

A

Certolizumab pegol (CZP) is a recombinant, humanized antibody fragment composed of a Fab’ antibody fragment conjugated with polyethylene glycol (PEG) that acts by neutralizing both membrane-bound and soluble TNF-α.

*DOES NOT FIX COMPLEMENT (DIFFERS FROM others)

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58
Q

MOA ALL 4 TNF inhibitors:

A

Adalimumab:
-Binds soluble TNF-alpha, “prevents interaction with p55/-75 TNF transmembrane receptor”
-fixes complement and it can lyse cells that express TNF-α on their surface
*unclear re: membrane bound tnf alpha”

Infliximab:
- Solublizes soluble TNF alpha and blocks membrane bound TNF-alpha,
-fixes complement and can lyse cells that express TNF-α on their surface

Etanercept:
-Binds soluble AND transmembrane TNF-alpha + also binds TNF-beta.

Certolizumab:
- binds both membrane-bound and soluble TNF-α.
-does NOT fix complement bc it does NOT contain Fc

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59
Q

most associated AI hepatitis

A

infliximab

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60
Q

25) Given subcutaneously at 80 mg followed by 40 mg one week later and then 40 mg every two weeks thereafter.

A

ada

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61
Q

x26) Contraindicated in patients with a hypersensitivity to murine proteins

A

inflicting

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62
Q

27) Full human monoclonal antibody that can fix complement and inhibits binding to transmembrane TNF-alpha

A

ada

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63
Q

28) Binds both membrane-bound and soluble forms of TNF-alpha and binds complement

A

influx and ADA

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64
Q

31) Produced in Chinese hamster ovary cells.

A

Etan

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65
Q

32) Associated with human anti-chimeric antibodies.

A

Inflixi

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66
Q

33) Second most-likely to cause histoplasmosis.

A

Ada

67
Q

35) Uses limited use code 417 under the Trillium benefits Program in Ontario

A

Ada

68
Q

36) Uses LU code 418

A

Etan

69
Q

37) Uses LU code 471

A

Infliximab

70
Q

38) Least associated with acute liver failure

A

Etan

71
Q

39) Gives a PASI75 of 49% at 12 weeks and 59% at 24 weeks

A

Etanercept

72
Q

1) What is the source and structure of ustekinumab

A

a. Fully human IgG1 monoclonal antibody against the P40 subunit shared between IL-12/23

73
Q

MOA ustekinumab

A

Binds to common P40 subunit of IL-12/23, prevents interaction with receptor IL-12RB1, prevents differentiation of T-helper cells into Th1 and Th17.

74
Q

3) List 6 adverse effects ustekinumab

A

a. Increased risk infections-MC nasopharyngitis, pneumonia
b. TB reactivation
c. Injection site reactions
d. Hypersensitivity-e.g. anaphylaxis, angioedema, skin rashes
e. Reversible posterior leukoenceophalopathy-rare
f. Worsening psoriasis
g. Headache
nasopharyngitis
*no malignancy risk

75
Q

4) What are absolute contraindications to ustekinumab

A

known hypersensitivity
uncontrolled infection

76
Q

pregnancy category ustekinumab

A

b

77
Q

FDA indications stelara

A

pso 6 yrs
psa 6 yrs
IBD

78
Q

7) How is it supplied? uste

A

prefilled syringe
single use vial

79
Q

What is dosing for Stelara for pso for <100 kg, >100 kg,

A

< 100 kg: 45 mg SC 0, week 4 then q12
>100 kg: 90 sC 0, week 4 then q12

80
Q

10) What baseline blood work would you order before starting?

A

a. CBC, liver, kidney, TBST, HepB/C

81
Q

PASI75 ustekinumab at 12 weeks

A

a. 66% at 12 weeks in phoenix trials phase 3

82
Q

12) What are 4 Risk factors for poor response when using Stelera?

A

a. Psoriatic arthritis
b. Long history psoriasis
c. Obese
d. Resistance to other biologics

83
Q

13) How quickly does it work? Onset of response?

A

2 weeks onset, max at 6 mo

84
Q

14) What is the bioavailability stelara

A

~60%

85
Q

half life stelara

A

3 weeks

86
Q

how is stelara metabolized or exerted

A

unknown

87
Q

20) What is the size of the common sub-unit shared by IL-12 and IL-23 that is targeted by ustekinumab?

A

40

88
Q

22) What cytokine inhibited by ustekinumab is critical for expanding the TH17 cell population?

A

23

89
Q

23) From the PHOENIX2 trial data, how would you dose escalate a 130 kg patient who has only a partial response at 90 mg at week 48?

A

a. Increase to 90 mg q8weeks

90
Q

24) What serious adverse event caused the early termination of phase 3 studies for the IL-12/23 inhibitor Briakinumab and has had a questionable signal with early studies of Ustekinumab?

A

MACE

91
Q

25) What were the two most common adverse effects of ustekinumab in the Phase 3 studies?

A

HA
nasopharyngitis

92
Q

26) What condition had been reported in one patient after 12 doses of ustekinumab where the patient presented with headache, seizure and confusion in the setting of alcohol abuse and recovered with no residual CT-scan changes after 1 week and hence made it into the product monograph?

A

a. Reversible posterior leukoencephalopathy

93
Q

27) What is the age above which ustekinumab is approved for the treatment of psoriasis in Canada?

A

6 and above is approved

94
Q

28) What is the dosing and frequency of ustekinumab for a patient that weighs 120 kg?

A

90 0, 4 weeks, 12 weeks

95
Q

29) What is the dosing for a 15 year old weighing 38 kg? Stelara

A

0.75 mg/kg 0, 4 , q12

0,75 mg/kg  28.5 mg 0, 4, q12weeks

96
Q

1) What is the source and structure cosentyx

A

a. Fully human IgG1k monoclonal Ab

97
Q

2) What is the mechanism of action cosentyx

A

a. Binds and neutralizes IL-7A

98
Q

3) List 10 adverse effects cosentyx

A

injection site rxn
hypersensitivity rxn
increased risk infections
TB reactivation
headache
GI upset
nasopharyngitis*
rhinitis*
worsening or new onset IBD*
neutropenia*
MACE events*

99
Q

4) What are absolute contraindications to cosentyx? List 3

A

a. Known hypersensitivity (including latex)–> this is really the only one
b. Active or serious infection e.g. Tb
c. IBD

100
Q

Pregnancy category cosentyx

A

b

101
Q

7) List the FDA approved indications for cosentyx

A

PsO (6 yrs), PsA (2 yrs),

Ank spond, non radiographic AS, enthesitis arthritis

102
Q

8) How is it supplied? cosentyc

A

pre filled pen or refilled syringe

103
Q

Dosing for secukinumab

A

300 mg SC weekly x4 then q4 weeks

104
Q

12) What is the PASI-75 at 12 weeks? secu

PASI 90?

A

84%

55% PASI90

105
Q

How quickly secukinumab works

A

3 weeks

106
Q

bioavailability secu

A

55-75

107
Q

16) After how long are peak levels achieved? secu

A

5-6 days

108
Q

1/2 life secukinumab

A

27 days

109
Q

Source and structure ixekizumab

A

a. Humanized IgG4 monoclonal antibody

110
Q

MOA ixe

A

binds and neutralizes il 17A

111
Q

List 9 AE to ixe

A

a. URTI: Nasopharyngitis, rhinitis, pharyngitis,
b. Headache
c. GI upset-diarrhea
d. Candida
e. HSV
f. Tinea
g. Injection site reaction
h. Hypersensitivity reaction-urticaria, anaphylaxis
i. New or worsening IBD
j. Neutropenia
k. TB reactivation

No mace?

112
Q

Metabolism 17s?

A

drugs are expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.

113
Q

Indication for broadlumab

A

adult Pso

114
Q

Aboluste contraindication to 17s? Relative?

A

Absolute: hypersensitivity
Relative:

a. IBD=personal or stron fam hx
b. Pregnancy
c. Breastfeeding
d. Receiving live vaccines
e. Chronic or recurrent infections
f. Active or latent TB

115
Q

Pregnancy category secu

A

B

116
Q

FDA indications ixekizumab

A

Pso (6 yrs +)
PsA
AS
Radio negative spondylitis

117
Q

How is ixe supplied

A

pre filled syringe or autoinjetor

118
Q

Dosing for ixe

A

160 mg at week 0,
80 mg at week 2, 4, 6, 8, 10, 12 then q4

119
Q

12) What is the PASI-75 at 12 weeks? ixe
PASI 90? PASI 100

A

90%
70%
35% 100

120
Q

Bioavailability ixe

A

60-80%

121
Q

Ixe how long till peak levels

A

5 days

122
Q

Half life ixe

A

13 days

123
Q

source structure broda

A

a. Fully human IgG2

124
Q

2) What is the mechanism of action broad

A

Bind to IL-17RA –> prevents binding of IL-17 A/F, E, C

125
Q

Dosing broda

A

210 mg SC at 0, 1, 2 weeks then 210 q2 weeks

126
Q

5) PASI 75 and 90 at 12 weeks Broda

A

86% and 70%

127
Q

6) Name 2 drugs whose levels or effects would need to be monitored with blood tests in patients while being treated with IL-17 inhibitors according to the label?

A

a. Warfarin and cyclosporin although I checked all 3 product monographs for 22 and no monitoring is recommended currently?

128
Q

7) What are eight possible adverse reactions that are common to interleukin 17 inhibitors?

A

nasopharyngitis
rhinitis
h/a
gi upset
injection site rxn
allergic rxn
infections-viral urti, tinea, Hsv
candida
ibd
neutropenia
tb reactivation theoretical

129
Q

8) What are 8 relative contraindications to IL-17 inhibitors?

A

receiving live vaccines
immunocomp/predisposed to infections
active or latent tb
active or serious infections
pregnant
breasfeeding
ibd- personal
ibd- fam hx strong
Depression-broda only

130
Q

9) Which IL-17 inhibitor is more likely to have neutralizing anti-drug antibodies at 1 year?

A

a. Ixekizumab

secukinumab 50% neutralizing but only 1% overall,
ixe 22% developed Ab’s with 9% being neutralizing= 2% neutralizing)

131
Q

GUSELKUMAB 1) What is the source? What is the structure?

A

a. Human IgG1lamba

132
Q

2) What is the MOA guselkumab

A

a. Binds to and neutralizes P19 subunit of IL-23

133
Q

3) What is the half life guselkumab
Brodalumab

A

17 days for Guselkumab
11 Days broadlumab

134
Q

4) List 7 adverse effects guselkumab

A

a. Hypersensitivity
b. Injection site reaction
c. TB reacrtivation
d. Infections
i. Viral URTI* most common
ii. Candida
iii. HSV/VZV
iv. Tinea
v. Gastroenteritis
e. H/A/migraine
f. Diarrhea
g. Arthralgias

135
Q

5) What are some drug interactions? with guselkumab

A

Live vaccines
CYP 450 substrates - e.g. metoprolol
Tremfya
other immune suppressants

136
Q

6) List 3 contraindications: guselkumab

A

hypersensitivity
active serious infection e.g. TB
Live vaccines

137
Q

7) What is the FDA approved indication? guselkumab

A

adult pso and spa

138
Q

How is tremfua supplied

A

profiled syringe or auto injector

139
Q

Dosing guselkumab

A

100 mg SC 0, week 4, then q 8 weeks

140
Q

11) What is the PASI 75, 90 and 100 at week 16? guselkumab

A

87%,, 70%, 35%

141
Q

PASI 90 guslekumab at week 24

A

77%

142
Q

1) What is the source and structure dupilumab

A

fully human IgG4

143
Q

2) What is the MOA of Dupilumab?

A

Bind to IL-4R alpha subunit on IL-4 and 13 receptors (blocks recptor), blocks 4/13 signallong

144
Q

3) What is the bioavailability of Dupilumab?

A

66%

145
Q

4) List 7 side effects of Dupilumab:

A

Dry eye
Ulcers-HSV
Peripheral Eos
Injection site rxn-MC
Like reaction-serum sickness
U-?
MF worsening
Alopecia areata
Blepharitis, keratitis

146
Q

List 2 contraindications dupilumab

A

Hypersensitivity
Pregnant/BF
Pre-existing eye diseases
Parasitic infections

147
Q

How is dupixent supplied

A

profiled syringes

148
Q

Dosing for dupixent for adults

A

Adults:
600 mg SC day 0, 300 q 2weeks

149
Q

Dosing dupixent 6-18

A

> 60 same as adults
30-60 kg: 400 SC then 200 q2 weeks
15-30 kg: 600 SC then 300 q 4 weeks

150
Q

Dosing dupixent 6 mo-5 yrs

A

15-30 kg: NO LOAD, 300 q 4 weeks
5-15 kg: NO LOAD< 200 q 4 weeks

151
Q

8) What baseline blood work would you do for dupixent

A

none required,

152
Q

9) List the name of 3 studies where Dupilumab was tested:

A

SOLO1, SOLO2, chronos (+ steroids)

153
Q

10) What was the EASI 75 and 90 in the SOLO 1, 2 and Chronos?

A

a. SOLO1: EASI75- 51% EASI90- 35%
b. SOLO2: EASI75- 44% EASI90- 30%
c. CHRONOS: EASI75-69% EASI90- 40%

154
Q

11) What are components of the EASI? Max sore?

A

Body surface area
erythema
lichenification
excoriation
edema/papules

Max score 72

155
Q

12) What are components of the PASI? Max score?

A

a. Max score 72
b. BSA + erythema, induration/thickness, scale

156
Q

Compare and contrast time of onset:

A

Etanercept 6.3 weeks
Ustekinumab 4 weeks (just over)
Guselkumab 4 weeks
Adalimumab and infliximab 4 weeks (just under)
Secukinumnab 3
Ixe and broda 2

157
Q

Drug interactions tnfs

A

Etan: Abatacept, Anakinra, ?cyclophosphamide

In: Abatacept, Anakinra, CYP450 substrates

ada: Abatacept, Anakinra, CYP450 substrates, MTX

158
Q

Certoloziumab structure

A

Recombinant humianized antibody Fab fragment conjugated to polyethyelen glycol

159
Q

eta percept Peds dosing

A

“25-50mg SC twice weekly x 12 wks
Rotate injection sites ≥1 inch apart

Peds dosage (recent RCT > 6y/o) = 0.8mg/kg/dose SC
Approved over the age of 4 “

160
Q

Skyrizi indications

A

Adult Pso
Adult PsA
Chrons -new!

161
Q

Tildrakizumab indications

A

Adults with Pso

162
Q

How many and which biologics can treat kids with psoriasis and psA

A

Adalimumab 4+ -> JIA, not psoriasis.

Etanercept 4+ PsO and poly JIA
Ustekinumab 6+ PsO and PsA
Cosentyx 2+ PsA, 4+ ERA, 6+ PsO
Ixekizumab Pso only 6+

163
Q

Which biologics can be used for PsA in adults

A

All TNFs
Ustekinumab
Guselkumab
Rizankizumab
Secukinumab
Ixekizumab

(basically not Tildra, not Broda)

MyDermatology-Bolognia (31 decks)

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