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PHRM 864 Module 4 > Inflammatory Bowel Disease > Flashcards

Inflammatory Bowel Disease Flashcards

1
Q

Inflammatory bowel disease (IBD)

A

mucosal inflammatory conditions with chronic or recurring immune response and inflammation of the GI tract

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2
Q

Two types of IBD:

A

ulcerative colitis (UC) and crohn’s disease (CD)

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3
Q

Ulcerative colitis

A

mucosal inflammation confined to rectum and colon
smoking is a protective factor
more superficical, less likely to see strictures/fistulas

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4
Q

Crohn’s disease

A

transmural inflammation of GI tract that can affect any part from the mouth to the anus
smoking worsens
not just confined to mucosa, anywhere in GI tract, strictures/fistulas

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5
Q

Etiology

A

complex multifactorial immune dysfunction

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6
Q

Etiology - drug related causes

A

NSAIDs: may trigger disease occurrence or lead to flares; unclear whether COX-2 selective agents are associated with a decreased risk
generally avoid NSAIDs in pts with IBD
antibiotics: potential association, however causal relationship unclear

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7
Q

UC pathophysiology

A

confined to rectum + colon; superficial
biggest sx: substantial diarrhea and bleeding

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8
Q

CD pathophysiology

A

anywhere in the GI tract (anywhere from mouth to anus)

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9
Q

S/S of UC

A

abdominal cramping, frequent BMs +/- blood +/- mucous, weight loss, paradoxical constipation, fever/tachycardia, extraintestinal: blurred vision/ocular signs, arthritis, dermatologic manifestations

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10
Q

Lab tests UC/CD

A

fecal calprotectin (correlates with degree of inflammation) and fecal lactoferrin
more sensitive and specific than serum markers

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11
Q

Diagnosis of UC confirmed by

A

endoscopy and biopsy

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12
Q

S/S of CD

A

malaise, fever, abdominal pain, frequent BMs, hematochezia, fistula, weight loss/malnutrition, arthritis

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13
Q

CD sites of inflammation

A

transmural inflammation - spans entire gut wall

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14
Q

UC sites of inflammation

A

mucosal inflammation - mucosa or submucosa only

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15
Q

IBD treatment overview

A

pharmacologic therapy: induction, maintenance
surgical therapy
nutrition support
treatment of complications
avoiding drugs that may exacerbate IBD

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16
Q

Goals of therapy

A

highly individualized, may include: resolve acute inflammation/treatment of disease flare; resolve and/or prevent complications; maintain remission; alleviate extraintestinal manifestations; avoid need for surgical palliation/cure; surgical palliation/cure; maintain QOL; inducing + maintaining remission

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17
Q

Nonpharmacologic therapy

A

nutrition support: no specific diet shown to be beneficial; address nutritional deficiencies, impaired absorption: enteral supplementation if necessary, PN (avoid unless absolutely necessary), supplement vitamin/mineral deficiencies (calcium, vit D, folate)

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18
Q

Pharmacologic therapy

A

no agents are curative!
ASAs (aminosalicylates), corticosteroids, immunomodulators, biologics

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19
Q

ASA meds

A

sulfasalazine, mesalamine (5-ASA)

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20
Q

Immunomodulator meds

A

azathioprine, mercaptopurine, cyclosporine, methotrexate

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21
Q

Biologic meds

A

anti-TNF-alpha agents: infliximab, adalimumab, certolizumab, golimumab
other anti-inflammatory: natalizumab, vedolizumab, ustekinumab

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22
Q

ASA agent - sulfasalazine

A

sulfapyridine (inactive) + 5-ASA (active ingredient)
5-ASA MOA: anti-inflammatory effects, free radical scavenging

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23
Q

ASA agent - mesalamine

A

can administer alone
formulation important to deliver to affected area: topical - left sided disease; suppository - proctitis; oral - delayed/controlled release (do NOT crush/chew)
generally topical more effective than oral; can use oral and topical together

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24
Q

Oral mesalamine agents

A

fairly ineffective in crohn’s
apriso, lialda, pentasa, asacol HD and delzicol, olsalazine, balsalazide (prodrug)

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25
Q

ASA agents - sulfasalazine AEs

A

sulfapryridine associated with AEs
N/V, HA, anorexia, rash, anemia, hepatotoxicity, thrombocytopenia, hypersensitivity rxns in sulfonamide allergy
drug interactions: antiplatelet/anticoagulants/NSAIDs –> may increase bleeding risk

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26
Q

ASA agents - sulfasalazine monitoring

A

CBC and LFTs at baseline, every other week for 3mo, monthly for 3mo, periodically thereafter
BUN/Scr periodically

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27
Q

ASA agents - mesalamine AEs

A

much better tolerated than sulfasalazine
N/V, HA, diarrhea (olsalazine), diarrhea, rash/pruritis, constipation, anemia, hepatitis/abnormal LFTs, UC exacerbation
drug interactions: antiplatelet/anticoagulants/NSAIDs –> may increase bleeding risk
agents affecting gastric pH (PPIs, H2RAs, antacids) -> influence release of drug in pH dependent dosage forms (asacol HD, delzicol)

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28
Q

Corticosteroids

A

MOA: anti-inflammatory
use for induction of remission but not for maintenance

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29
Q

Corticosteroids - rectal hydrocortisone

A

suppositories, foam, enema

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30
Q

Corticosteroids - budesonide

A

PO in CR formulation
extensive first pass metabolism –> minimal systemic exposure
enterocort: dissolves at pH>5.5 (ileum)
uceris: dissolves at pH>/=7 (colon), also available as foam

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31
Q

Corticosteroids - budesonide AEs

A

possible, but generally well tolerated
drug interactions: CYP3A inhibitors (ketoconazole, grapefruit juice) –> may increase systemic exposure

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32
Q

Systemic corticosteroids

A

oral prednisone or prednisolone
IV methylprednisolone or hydrocortisone (for very severe disease flare)
may be used for disease flares/induction of remission

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33
Q

Systemic corticosteroids AEs

A

give calcium and vit D while on steroids; may consider bisphosphonate in pts with risks of osteoporosis, pts using >3mo, or recurrent users
monitor: BP, BG, at baseline and q3-6mo, consider occasional bone mineral density scan (DEXA)

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34
Q

Short and long term systemic corticosteroid AEs

A

short term: hyperglycemia, gastritis, mood changes, increased BP
long term: aseptic necrosis, cataracts, obesity, growth failure, HPA suppression, osteoporosis

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35
Q

Azathioprine and mercaptopurine

A

can be effective in long term tx of UC and CD - generally reserved for pts who fail 5-ASA tx and/or pts refractory/dependent on steroids
can maintain remission, steroid sparing, limited role in induction of remission
can be used with otehr drugs (5-ASAs, steroids, TNF-alpha)
AZA is a prodrug rapidly converted to 6-MP

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36
Q

Azathioprine and mercaptopurine AEs

A

N/V/D, anorexia, stomatitis, bone marrow suppression, hepatotoxicity, fever, rash, arthralgia, pancreatitis

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37
Q

Azathioprine and mercaptopurine monitoring

A

TPMT (pharmacogenomic testing); CBC qwk for 1st month, q1-2wks after dose change, q1-3mo after; LFTs

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38
Q

Cyclosporine

A

can be effective inducing remission in pts with refractory IBD (not recommended for CD)
not an option long term
IV infusion –> PO

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39
Q

Cyclosporine AEs

A

nephrotoxicity, neurotoxicity, metabolic (HTN, hyperlipidemia, hyperglycemia), GI upset, gingival hyperplasia, hirsutism

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40
Q

Cyclosporine monitoring

A

BP qvisit; BUN/SCr q2wks until stable, then periodically; LFTs q2wks until stable, then periodically; cya tr. conc goal ~200-400ng/ml

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41
Q

Cyclosporine drug interactions

A

substrate for CYP3A and P-glycoprotein
increase cyclosporine conc: azole anti-fungals, macrolide antibiotics, CCB, grapefruit
decrease cyclosporine conc: phenytoin, rifampin

42
Q

Tacrolimus

A

used in refractory disease, role less defined

43
Q

Methotrexate

A

used in CD for tx and maintenance - steroid sparing effects, assist in inducing remission, allow steroid-tapering
SC/IM

44
Q

Methotrexate AEs

A

bone marrow suppression (add folic acid 1mg/day), N/V/D, stomatitis, mucositis, cirrhosis, hepatitis, fibrosis, hypersensitivity, pneumonitis, rash, urticaria, alopecia, teratogenic*

45
Q

Methotrexate monitoring

A

CXR, CBC, SCr, LFTs
maintenance q4-8wks

46
Q

Methotrexate contraindications

A

pregnancy, pleural effusions, chronic liver disease/EtOH abuse, immunodeficiency, preexisting blood dyscrasias, leukopenia/t.cytopenia; CrCl < 40 ml/min

47
Q

Biologics: TNF-alpha antagonists

A

infliximab: CD + UC
adalimumab: CD + UC
golimumab: UC
certolizumab: CD

48
Q

Biologics: other - natalizumab

A

natalizumab: anti-alpha-subunit of integrin’s (prevents leukocyte adhesion/migration); CD

49
Q

Biologics: other - vedolizumab

A

anti-alpha4beta7 integrin antibody; CD + UC

50
Q

Biologics: other - IL inhibitors

A

ustekinumab: IL-12 and IL-23 antagonist; CD + UC
risankizumab-rzaa: IL-23 antagonist; CD + UC
mirikizumab-mrkz: IL-23 p19 antagonist; UC

51
Q

New small molecule drugs: JAK inhibitors

A

tofacitinib: UC
upadacitinib: CD + UC

52
Q

New small molecule drugs: S1P receptor modulators

A

ozanimod: UC
estrasimod: UC

53
Q

TNF-alpha inhibitors AEs

A

increase risk of serious infections - tuberculin test, CXR, Hep B/C prior to therapy and ensure vaccines up to date (live vaccines contraindicated); injection site rxns and infusion related rxns; risk of malignancy (lymphoma); hepatosplenic T-cell lymphoma risk; risk of demyelinating disease; may exacerbate CHF

54
Q

TNF-alpha inhibitors monitoring

A

CXR, PPD, s/sx of infection, UA, CBC, SCr, lytes, LFTs, Hep B/C
maintenance q8-12wks

55
Q

TNF-alpha inhibitor: infliximab

A

CD + UC - induction and maintenance therapy, can be used for fistulizing disease
IV infusion
development of antibodies to infliximab - combining with immunosuppressive (azathioprine) may be of value (and may increase risks of AEs)

56
Q

Infliximab AEs/monitoring

A

hepatosplenic T-cell lymphoma risk
infusion related rxns
monitor: s/sx of infection, vitals (each dose), infusion rxns (each dose), therapeutic drug monitoring (TDM)

57
Q

TNF-alpha inhibitor: adalimumab

A

CD + UC
use for pts with poor response to infliximab
induction + maintenance therapy
SQ injection - self administered

58
Q

Adalimumab AEs/monitoring

A

development of ADAs (antidrug antibodies)
TDM possible

59
Q

TNF-alpha inhibitor: golimumab

A

UC
induction and maintenance therapy
SQ injection - self administered

60
Q

Golimumab AEs/monitoring

A

development of ADAs
TDM possible

61
Q

TNF-alpha inhibitor: certolizumab pegol

A

CD
induction and maintenance therapy
SQ injection - self administered

62
Q

Certolizumab AEs/monitoring

A

development of ADAs
TDM possible

63
Q

Natalizumab

A

anti-alpha subunit of integrin’s (prevent leukocyte adhesion/migration)
non-specific MOA, does it at other sites in body (i.e. CNS)
CD - inducing and maintaining remission
can use in pts who fail/don’t toelrate TNF-alpha inhibitors; NOT to be used in combo with immunosuppressants, TNF-alpha inhibitors
IV

64
Q

Natalizumab AEs/monitoring

A

associated with progressive multifocal leukoencephalopathy (PML) - able to test for JC antibody; increased risk with: longer duration of therapy, prior immunosuppressant use, JC antibody +; monitor closely for neurological events
hypersensitivity rxns, ADAs

65
Q

Vedolizumab

A

anti-alpha4beta7 integrin antibody - gut specific
CD + UC - inducing and maintaining remission, decreasing steroid dependence
IV

66
Q

Vedolizumab AEs/monitoring

A

hypersensitivity rxns, ADAs, infection, PML monitoring bc of similar MOA to natalizumab
TDM possible

67
Q

Ustekinumab

A

IL-12 and IL-23 antagonist
CD + UC
IV induction, SQ maintenance

68
Q

Ustekinumab AEs

A

hypersensitivity (anaphylaxis and angioedema); ADAs; rapidly developing cutaneous cell carcinoma in pt with risk factors; neurotoxicity (reversible posterior leukoencephalopathy syndrome, posterior reversible encephalopathy syndrome)
TDM possible

69
Q

Ustekinumab monitoring

A

CXR, PPD, Hep B/C, lipids 1-2mo after start then periodically, LFTs 1-2mo after start then periodically, renal fx, s/sx of infection, skin

70
Q

Risankizumab-rzaa

A

selective IL-23 antagonist
CD + UC - induction (IV) and maintenance (SQ)
use lowest dose possible

71
Q

Risankizumab AEs

A

HA, nasopharyngitis, arthralgia, abdominal pain, anemia, nausea, infections/latent infections (TB) (vaccines necessary, avoid live ones), hypersensitivity, ADAs, hepatotoxicity, increase in lipids

72
Q

Risankizumab monitoring

A

CXR, PPD, Hep B/C, lipids 1-2mo after start then periodically, LFTs 1-2mo after start then periodically, renal fx, s/sx of infection

73
Q

Mirikizumab-mrkz

A

IL-23p19 antagonist
UC - induction (IV) and maintenance (SQ)

74
Q

Mirikizumab AEs

A

HA, arthralgia, rash, injection site rxn, infections/latent infections (TB) (vaccines necessary, avoid live ones), upper respiratory tract infections*, hypersensitivity possible, ADAs, hepatotoxicity

75
Q

Mirikizumab monitoring

A

CXR, PPD, Hep B/C, lipids 1-2mo after start then periodically, LFTs 1-2mo after start then periodically, renal fx, s/sx of infection

76
Q

TDM of biologics

A

potential for determining concentrations of drugs and ADAs
consider if loss of treatment response (use reactively, not proactively)
check ADA concurrently; optimal trough concentrations not clear

77
Q

Detectable/undetectable ADAs

A

subtherapeutic drug levels - detectable ADAs: change to alternate drug, within same class; if no ADAs: dose escalate
therapeutic drug levels - detectable ADAs: switch to out of class biologic agent; no ADAs: switch to out of class biologic agent

78
Q

JAK inhibitor - tofacitinib

A

approved for UC only - who have had an inadequate response or who are intolerant to TNF blockers; option for pts who fail biologics
use lowest effective dose to maintain response
rapid onset; do NOT use with immunosuppressants or biologics

79
Q

Tofacitinib AEs

A

diarrhea, elevated cholesterol, HA, herpes zoster, increased creatine phosphokinase, nasopharyngitis, rash, URI; increased risk of infections (vaccines, no live ones)
rare: malignancy, serious infection, neutropenia, hypersensitivity (angioedema, urticaria)
black box warning: increase mortality in RA pts with at least one CV risk factor; thrombosis –> increased risk in RA pts with at least one CV risk factor

80
Q

Tofacitinib monitoring

A

CXR, PPD, Hep B/C, ANC q3mo, CBC q1-2mo then q3mo, lipids 1-2 months after start then periodically, LFTs 1-2mo after start then periodically, s/sx of infection, skin exam

81
Q

JAK1 inhibitor: upadacitinib

A

oral selective JAK1 inhibitor
CD + UC - who have had inadequate response or who are intolerant to TNF blockers; pts who fail biologics; should NOT be used with immunosuppressants or biologics
rapid onset

82
Q

Upadacitinib AEs

A

black box warning similar to tofacitinib; increased risk of serious infection (vaccines, no live ones); upper respiratory tract infection, acne, increased creatine phosphokinase, elevated cholesterol, HA, herpes zoster
rare: malignancy (lymphoma), serious infection, increased LFTs, anemia, neutropenia, lymphopenia, hypersensitivity (angioedema, urticaria), teratogenic*

83
Q

Upadacitinib monitoring

A

CXR, PPD, Hep B/C, ANC/ALC q3mo, CBC q1-2mo then q3mo, lipids 1-2wks after start then periodically, LFTs 1-2wks after start then periodically, s/sx of infection, skin exam

84
Q

S1P receptor modulator: ozanimod

A

oral selective spingosine-1-phosphate recpetor modulator: prevents lympocyte mobilization to inflammatory sites
UC only - if dose missed in 1st 2wks of tx, reinitiate titration regimen
do NOT use with non-corticosteroid immunosuppressive or immune modulating drugs

85
Q

Ozanimod contraindications

A

if in last 6mo experienced: MI, unstable angina, stroke, TIA, decompensated HF, class III or IV HF, type II 2nd or 3rd degree AV block, sick sinus syndrome, or SA block (unless functioning pacemaker), severe untreated sleep apnea, taking MAO inhibitor

86
Q

Ozanimod AEs

A

increased risk of infections (PML) - vaccinate against varicella, no live vaccines; bradycardia/AV conduction delays; liver injury/elevated transaminases (not recommended in pts with LFTs >5fold upper limit of normal); increase in systolic BP; respiratory effects; macular edema; reversible posterior leukoencephalopathy syndrome/posterior reversible encephalopathy syndrome

87
Q

Ozanimod drug interactions

A

adrenergic and serotonergic drugs
combo beta blocker and CCB
foods high in tyramine
MAO inhibitors

88
Q

Ozanimod monitoring

A

CXR, PPD, Hep B/C, CBC periodically, LFTs periodically, s/sx of infection, BP each visit, spirometry, ECG, optho

89
Q

S1P receptor modulator: estrasimod

A

oral selective spingosine-1-phosphate receptor modulator - prevents lymphocyte mobilization to inflammatory sites
UC
do NOT use with non-corticosteroid immunosuppressive or immune-modulating drugs

90
Q

Estrasimod contraindications

A

in last 6mo experienced: MI, unstable angina, stroke, TIA, decompensated HF, class III or IV HF, various cardiac conduction abnormalities
no same warnings regarding MAO inhibitors as oxanimod

91
Q

Estrasimod AEs

A

increased risk of infections (PML) - vaccinate against varicella (no live vaccines); bradycardia/AV conduction delays; liver injury/elevated transaminases; increase in systolic BP; macular edema; reversible posterior leukoencephalopathy syndrome/posterior reversible encephalopathy syndrome; respiratory effects

92
Q

Estradimod monitoring

A

CXR, PPD, Hep B/C, CBC periodically, LFTs periodically, s/sx of infection, spirometry, ECG, optho

93
Q

Mild-moderate active UC tx overview

A

left sided disease: enemas
proctitis: suppositories
extensive disease, pancolitis: systemic tx

94
Q

Mild-moderate active UC: oral/topical ASAs

A

extensive disease: oral 5-ASA
left sided disease: topical mesalamine enema
proctitis: mesalamine suppository
combo of oral + topical in left-sided/extensive disease
if unresponsive to 5-ASA can change formulation or increase dose/combo therapy

95
Q

Mild-moderate active UC: alternatives

A

CR budesonide when nonresponsive to oral or topical 5-ASA
PO corticosteroids (prednisone) in pts refractory to ASAs (not for maintenance!)
topical corticosteroids effective for distal disease
remember: combo oral and topical mesalamine can be more effective

96
Q

Moderate-severe UC tx overview

A

4-6 stools/day, +/- blood in stool, some systemic sx
5-ASA therapy possible for moderate, not severe
systemic corticosteroids (PO prednisone), for moderate can use oral budesonide
consider TNF-alpha inhibitors/biologics in pts unresponsive to ASAs/other therapy or who fail steroids
use methotrexate for induction or maintenance
thiopurine monotherapy only for maintenance
combine TNF-antagonists, vedolizumab, or ustekinumab with thiopurines or MTX rather than monotherapy
suggest early use of biologics

97
Q

Severe-fulminant UC tx overview

A

inpatient tx; consider NPO
parenteral corticosteroids: methylprednisolone or hydrocortisone for 3-7 days, then transition to PO
TNF-alpha inhibitors (infliximab) or cyclosporine in pts unresponsive to IV steroids

98
Q

UC maintenance of remission tx overview

A

use ASA, TNF-alpha antagonist (infliximab and adalimumab), azathioprine, or 6-MP
no role for corticosteroids!
ASAs: mesalamine better tolerated than sulfasalazine
if unresponsive to ASA, use azathioprine or 6-MP
TNF-alpha antagonist for pts who required one for induction or fail azathioprine

99
Q

Mild-moderate active CD tx overview

A

sulfasalazine (not great efficacy)
do NOT use mesalamine
controlled release budesonide for ilealeocecal or right-sided disease

100
Q

Moderate-severe active CD tx overview

A

failed tx for mild-mod disease or having systemic sx
systemic corticosteroids (PO prednisone) - treat until resolution of sx; hospitalized pts may receive IV corticosteroids (methylprednisolone, hydrocortisone)
early biologic therapy - TNF-alpha antagonists (inflizimab + AZA; adalimumab), also use the other biologics
immunomodulator (AZA and 6-MP) monotherapy not recommended to induce remission, can be used for maintenance of remission; MTX for induction and maintenance
do NOT use cyclosporine, 5-ASA, sulfasalazine

101
Q

Severe-fulminant CD tx overview

A

inpatient tx; consider NPO; supportive care
parenteral corticosteroids (methylprednisolone or hydrocortisone, treat 3-7 days, then transition PO)
infliximab may be preferred if fulminant

102
Q

CD maintenance of remission

A

sulfasalazine and PO mesalamine (not for mod-severe)
NO role for systemic corticosteroids
budesonide minimal long-term efficacy, don’t use for >4mo
AZA and 6-MP are effective; MTX alternative to AZA and 6-MP
TNF-alpha antagonists are options: use of infliximab or adalimumab in combo with AZA or 6-MP

PHRM 864 Module 4 (7 decks)

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