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The ppt is made for undergraduate students to have a basic understanding on Corticosteroids and its role in all feilds of medicine. This is also useful to Postgraduate students
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2. • Immunosuppressant drugs are a class of drugs that suppress, or
reduce, the strength of the body’s immune system.
• Immunomodulatory drugs modify the response of the immune
system by increasing (immunostimulators) or decreasing
(immunosuppressives) the production of serum antibodies.
3.
4. SYSTEMIC STEROIDS
• Most commonly used immunosuppressive and anti-
inflammatory drug.
Mechanism of action :
• There is passive diffusion of the glucocorticoids through the
cell membrane, followed by binding to soluble receptor
proteins in the cytoplasm.
• This hormone-receptor complex then moves to the nucleus
and regulates the transcription of a limited number of target
genes
9. SIDE EFFECTS OF LONG TERM STEROID THERAPY:
• Osteoporosis And Osteonecrosis
• Gastrointestinal Side Effects
• Endocrine Side Effects-diabetes,hpa Axis
Suprression,cushing Syndrome
• Corticosteroid And Immunity Including Vaccinations
• Ophtalmologic Side Effects
• Cutaneous Side Effects
• Cardiovascular Side Effects
• Steroid Induced Myopathy
• Cognitive And Mood Side Effects
10. Monitoring
• BP (at 1 month and atleast every 2-3 months)
• Height and weight in children
• Ophthalmological examination for cataracts
and glaucoma
• Potassium, glucose and triglyceride levels (at 1
month and atleast every 2-3 months)
• Near time of cessation ( am cortisol levels)
11. METHOTREXATE-
• Methotrexate (4-amino-N10methyl pteroylglutamic acid) is
a potent competitive inhibitor of the enzyme dihydrofolate
reductase.
• First used by Gubner et al in 1951 for psoriasis , got USFDA
approval to be used in psoriasis in 1971.
Availability-
• Oral, IM, IV preparations available
• 2.5, 5, 7.5, 10, 15 mg tabs
• 15mg/ml, 25mg/ml injections
• IV MTX more tolerable due to high renal clearance
Regimes-
• Once weekly dose
• Three divided dose over 24 hour period
• MTX inhibits cell division at S phase (DNA synthesis) of the
normal cell cycle.
12. Structure- Dose-
• 0.3mg/kg/week
• Max benefit at 10-25mg
/week
• Max dose 30mg/week
Response-
• Initial response 1-4 weeks
• Therapeutic benefit in 2-3
months.
• Antineoplastic dosage
range;30-40mg/m2/week
to 100-
12000mg/m2/week
13. Mechanism of action - • MTX affect the proliferation of
lymphocytes & blocks migration of
activated T cells
• Because of inhibition of DNA
synthesis in immunologically
competent cells , suppression of
primary and secondary antibody
responses occurs. There is no
significant effect on delayed-type
hypersensitivity.
• anti-inflammatory effects are
mediated by excess accumulation
of adenosine due to AICAR
transformylase and ecto 5′
nucleotidase interaction
• Adenosine binds to A2A receptor
in endothelial cells, inhibiting
apoptosis, neutrophil chemotaxis,
and release of TNFα, IFNγ, IL-12,
IL-6
15. Indications of MTX use in psoriasis-
• Erythrodermic psoriasis
• Psoriatic arthritis: not responsive to conventional
therapy
• Pustular psoriasis: generalized or
debilitating localized disease
• Psoriasis that adversely affects ability to maintain
employment
• Extensive, severe plaque psoriasis: not responsive
to conventional therapy (usually > 20% surface
involvement)
• Lack of response to phototherapy (PUVA and UVB) or
systemic retinoids
16. Contraindications-
Absolute
• Pregnancy
• Lactation
Relative
• Unreliable patient – including excessive alcohol intake
(>100 g/week)
• Decreased renal function (dosage must be reduced, avoid
in patients on dialysis)
• Metabolic: diabetes mellitus or obesity
• Hepatic disease: abnormal liver function tests, active
hepatitis; NASH, cirrhosis
• Severe hematologic abnormalities Active infectious disease
or history of serious infection (eg-TB)
• Immunodeficiency syndrome: hereditary or acquired
17. Adverse effects-
• Gastrointestinal- nausea, anorexia, diarrhoea, vomiting
• Hematological- pancytopenia (more with dapsone ,
sulfonamides)
• Hepatotoxicity- risk increased with alcohol and retinoids
• Teratogenic and abortifacient
• Cutaneous- hyperpigmentation, alopecia
• Renal toxicity- only in high doses (with sulfonamides,
phenytoin , tetracyclines, chloremphenicol, probenecid)
• Erythema recall phenomenon
• MTX osteopathy
• Pulmonary- pneumonitis
• Lymphoma rarely
18. Monitoring guidelines-
• CBC & LFT every week for 4 weeks and then decrease frequency to
every 4 weeks
• RFT once or twice yearly
• Chest X ray annually
• Liver biopsy-first biopsy at 3.5 to 4 g total dose of mtx and
subsequent after 1.5-2 g accumulated dosage in low risk patients,
• consider baseline biopsy in high risk patients and After every 1g
dosage accumulation and every 6 months grade III A liver biopsy
changes
• To be stopped if
-TLC <3500 cumm
-platelet counts- <100000 cumm
-liver transaminase increases twice the upper limit
19. Acute methotrexate toxicity-
Causes
• Accidental overdose
• Drugs causing increased concentration in body
• Acute renal failure
• Hypoalbunimea
Clinical features-
• long standing chronic plaque psoriasis,
• Sudden onset of erosions on plaques and oral ulcers
Management-
• Folinic acid 10 mg/m2 according to BSA every 6 hourly
Leucovorin or(N5formyl-tetrahydrofolate: folinic acid) a fully reduced,
functional folate coenzyme bypasses the inhibition of dihydrofolate
reductase enzyme.
• Alkalization of urine by NaHCO3
• Myelosuppression – G-CSF
20. AZATHIOPRINE-
• Azathioprine was synthesized in 1959 from its parent
drug 6-mercaptopurine (6-MP), and became drug of
choice for organ transplantation during the 1970s
• Peak levels 1–2 h
• Bioavailable 88%
• Half-life 5 hours
• Therapeutic effect take 2-3 month to develop
• Metabolism
-Thiopurine methyltransferase -inactive metabolites
-Xanthine oxidase - inactive metabolites
-HGPRT - active purine analogue
21. • Azathioprime dosage after pre TPMT testing
-low values- not used to prevent severe
myelosuppression
-intermediate values- 1mg/kg
-high values- 2-2.5mg/kg
22. Mechanism of action-
-6-TG’s structural similarity to the
endogenous purines allows it to
be incorporated into DNA and
RNA,
-Hence inhibiting purine
metabolism and cell division.
-Azathioprine also affects T- and
B-cell function and antigen-
presenting cell function and
numbers.
-T-cell-mediated function is
depressed, and antibody
production is diminished in the B
cell.
26. Monitoring guidelines-
• Clinical evaluation
• Discuss the risk/benefit profile and adverse effects with patient.
• Discuss birth control/abstinence if women of child bearing potential
• Elicit history of prior alkylating agents or current use of allopurinol
• Laboratory
-Pregnancy test
-Complete blood count (CBC)
-Serum chemistry profile
-Urine analysis
-Tuberculin skin test
• Special tests- TPMT assay dose according to enzyme activity.
Follow-up
• Clinical evaluation – Annual complete physical examination for lymphoma
and SCC
• Laboratory - CBC
- LFT
biweekly for the first 2 months, every 2–3 months thereafter
27. CYCLOPHOSPHAMIDE-
• Alkylating agent Derived from nitrogen mustard
• Causes cross-linking of DNA, leading to cell death by
apoptosis
• Cell cycle non specific
• Metabolism in liver by cytochrome P450
• Bioavailability- 75%
• Peak levels in 1-2 hours and half life is 5-9 hr
• Therapeutic effect evident after 4-6 weeks
• Dose 1-1.5mg/kg (adjuvant)
• Parenteral pulse dose – 10-15 mg in 200 ml of 5% dextrose
infused over an hour.
• Advised to drink 3 litres of water and void frequently.
28. Mechanism of action-
-prodrug is biologically
inactive
-the primary metabolites
form covalent bonds
with the nucleophilic
centers of DNA.
-alkylation causes DNA
cross-linking, abnormal
basepair formation,
-Damage overwhelms
cellular repair
mechanisms, and
mutagenesis,
carcinogenesis, and cell
death result.
-greater effect upon B
lymphocytes than T
lymphocytes.
30. Contraindications-
Absolute
• Drug allergy (conflicting reports of cross-reaction
with clorambucil)
• Depressed bone marrow function
• Lactation
• Pregnancy (teratogenic) category D
• Prior history of bladder cancer
Relative
• Active infection
• Impaired hepatic metabolism
• Impaired renal function
31. Side effects-
• Genitourinary- Bladder fibrosis, contracture,
vesicoureteral reflux, Dysuria, urgency, microscopic
hematuria ,Hemorrhagic cystitis (5–41%) by acrolein
• Carcinogenesis- Bladder carcinoma, Leukemia,
Lymphoma, SCC
• Gastrointestinal - Anorexia, stomatitis, hepatotoxicity,
hemorrhagic colitis ,Nausea, vomiting, diarrhea
• Hematologic- pancytopenia
• Reproductive- Amenorrhea, Azoospermia (improved
with testosterone) ,Ovarian failure
• Dermatologic- Alopecia (anagen effluvium),
Pigmentation of skin and nails Pigmented band on
teeth (irreversible) ,Urticaria or bullous eruptions
32. Monitoring guidelines-
• CBC and urine analysis
-weekly for a month
-every 2 weeks for 2 months
-monthly with stable dose
• discontinue if WBC<4000 ,platelets<100000 and
RBC in urine
• LFT-
-Every month for 6 months
-every 3 months
33. CYCLOSPORINE-
• isolated from the soil fungus Tolypocladium inflatum gams
• Neutral cyclic peptide (11 amino acids)
• family of calcineurin inhibitors and it was initially approved
by the FDA in 1983 to reduce the risk of organ transplant
rejection
• Bioavailability- 30-35%
• peak concentration levels- 2 to 4 hours
• metabolized in the liver by cytochrome P450 3A4
• main route of excretion bile.
• 2 formulations sandimmune and neooral.
• Starting Dose 5mg/kg in recalcitrant psoriasis
• 2.5-3 mg/kg in atopic dermatitis
• Duration of therapy 3-6 months
34. • -Inhibit production of IL-2
by inhibiting calcineurin
• -Calcineurin inhibition
leads to reduced activity
of the transcription factor
-NFAT-1
• -Inhibits T-cell
proliferation
• -Inhibits IFN-γ production
• -Reduced HLA DR-
positivity
• -reduced keratinocyte
proliferation
• -Binds to steroid receptor
associated heat-shock
protein 56
• -Inhibits transcription of
proinflammatory cytokines
such as GM-CSF, IL-1, IL-3,
IL-4, IL-5, IL-6, IL-8, TNF-α
35. Uses-
US FDA-approved indications
• Psoriasis
• Severe Recalcitrant psoriasis
• Disabling psoriasis (including localized versions such as hand and foot psoriasis)
• Atopic dermatitis (in other countries)
Other dermatologic uses
• Papulosquamous dermatoses- Lichen planus
• Bullous dermatoses- Pemphigus, Pemphigoid, Epidermolysis bullosa acquisita
• Autoimmune connective tissue diseases- Dermatomyositis, Lupus erythematosus,
Scleroderma
• Neutrophilic dermatoses- Behçet’s disease, Pyoderma gangrenosum
• Atopic dermatitis
• Alopecia areata ,Lichen planopilaris
• Granulomatous dermatoses- Granuloma annulare, Sarcoidosis
• Disorders of keratinization- Pityriasis rubra pilaris
• Photosensitivity dermatoses - Chronic actinic dermatitis
• Persistent papular acantholytic dermatosis- Purpura pigmentosa chronica, Reiter’s
syndrome
• Urticaria- Chronic urticaria, Cold urticaria, Solar urticaria
36. Contraindications-
Absolute
• Significantly decreased renal function
• Uncontrolled hypertension
• Hypersensitivity to CsA or any ingredients in formulation
• Clinically cured or persistent malignancy
• Cutaneous T-cell lymphoma
Relative
• Age <18 years or >64 years Controlled hypertension
• Planning to receive a live attenuated vaccination
• On medications that potentiate renal dysfunction
• Active infection or evidence of immunodeficiency
• receiving , methotrexate, or other immunosuppressive
agents
• Pregnancy or lactation Pregnancy– Category C
38. Monitoring guidelines-
• Blood pressure
• CBC
• LFT
• S.creatinine
• Fasting lipid profile
Every 2 weeks for 2 months
Then every 4 weeks
• S.creatinine if >30% baseline repeat in 2 weeks if not
normalised stop drug
• Blood pressure if >140/90 ,repeat in 2 weeks ,if not
normalised , reduce the dose by 30% or treat with calcium
channel blockers.
39. MYCOPHENATE MOFETIL-
• Prodrug to mycophenolic acid
• Derived from penicillium stoloniferum
• Morpholinoethylester of MPA
• Bioavailable 94%
• Protein bound 97%
• First peak in 1 hr second peak in 6 hrs
• Metabolised in liver by glucoronidation into MPA
• Excreted in urine in form of MPAG
• Dose 25-35mg/kg for T cell mediated diseases and 35-
55mg/kg for antibody mediated
• Induction and maintenance in lupus nephritis at 500mg
ODHS for a week.
40. Mechanism of action-
• MPA non-competitively
binds to and inhibits
inosine monophosphate
dehydrogenase
(IMPDH), the key
enzyme in the de novo
pathway.
• MMF has a much higher
affinity for the isoform
of IMPDH that is
expressed in activated
lymphocytes.
• Hence MMF is able to
target those
lymphocytes most
responsible for disease
sparing other organs and
cells
45. INTRAVENOUS IMMUNOGLOBULIN-
• Derived from human plasma pool of >1000 healthy donors
• Comprised of IgG in major amounts and traces of others
• Peak immediate
• Half life- 3-5 weeks
• Distribution- 60% intravascular
• Dose 2g/kg/cycle 3 consecutive days slow infusion over 4
hours
one cycle every 3 weeks
• Clinical control in 4-6 months -> tapering done -> at end
point 2 infusions 16 weeks apart
46. Mechanism of action-
-the suppression of antibody production by
IgG binding via its Fc fragment to surface
receptors on B lymphocytes
-binds to C3 and C5 convertases, block
complement activation hence prevent
formation of the membrane attack complex
-IVIg binds to Fc receptors on macrophages,
subsequently downregulating these
receptors.
-downregulate the expression of co-
stimulatory molecules such as lymphocyte
function-associated antigen-1 (LFA-1) on
activated T cells, interfering with T-cell
activation
-Antibodies against the extracellular matrix
protein Arg-Gly-Asp may inhibit the cellular
adhesion and subsequent cellular migration
-anti-Fas-receptor antibodies, which block
molecular Fas ligand/Fas receptor
interactions and keratinocyte apoptosis
48. Contraindications-
Absolute
• anaphylaxis secondary to previous infusions
Relative
• Congestive heart failure (increased risk fluid overload)
• Renal failure (increased risk fluid overload)
• IgA deficiency (increased risk of anaphylaxis)
• Rheumatoid arthritis (increased risk of renal failure)
• Cryoglobulinemia (increased risk of renal failure)
• Pregnancy NOT a contraindication for IVIg therapy
49. Side effects-
Infusion-related adverse effects –
• headache, myalgia,
• chills, flushing, fever,
• nausea or vomiting,
• low back pain,
• wheezing, chest pain,
• blood pressure changes, and tachycardia.
Anaphylaxis in patients with IgA deficiency having anti-IgA
antibodies.
Fluid overload and Rarely acute renal failure due to ‘osmotic
nephrosis’ in patients receiving sucrose-containing IVIg
preparations.
Hematologic disorders, such as neutropenia and hemolysis
Aseptic meningitis reported in up to 11% patients
Thromboembolic events
Infections from pooled human plasma.
50. Monitoring guidelines-
• Complete history and physical exam with emphasis on
cardiopulmonary and renal status
• Laboratory – Complete blood count (CBC)
– LFT
– RFT
– Immunoglobulin levels ( to exclude IgA deficiency
increases risk of anaphylaxis)
• Screen for rheumatoid factor and cryoglobulins (these patients are
at increased risk for renal failure from IVIg)
• Consider screening for hepatitis B and C , HIV.
• During infusions monitor blood pressure and heart rate frequently.
• Assess for signs of fluid overload – auscultate lungs and heart,
weigh the patient
• Laboratory – no specific follow-up laboratory testing required