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intercellular adhesion molecule (ICAM)-1 found on APCs, which bind with

lymphocyte function-associated antigen expressed on the surface of T cells; ICAM-1

and ICAM-3 on APCs with CD2 on T cells; B7 (now called CD80 and CD86) on

APCs with either CD28 or CTLA4 on T cells; and CD40 on APC with CD40 ligand

(now called CD154) on T cells. The binding of costimulatory molecules is critical to

T-cell activation. Without this costimulation, T cells undergo abortive activation or

programmed T-cell death (apoptosis).

Once recognition and costimulatory binding occurs, T-cell activation and

proliferation are initiated. After interacting with class II antigens and stimulation

from IL-1 secreted from macrophages, TH cells produce and secrete cytokines (e.g.,

interleukin [IL]-2 and interferon [INF]-γ). TH cells are classified according to their

cytokine-secretion pattern into either TH1 or TH2 cells. TH1 cells secrete IL-2, INF,

and tumor necrosis factor (TNF), which stimulate cytotoxic T cells (TC). TH2 cells

secrete IL-4, IL-5, IL-6, IL-10, and IL-13, which stimulate B-cells. TH cells, along

with TC cells, are stimulated to express cell-surface IL-2 receptors (IL-2R) and other

cytokines. Once the TC cells express IL-2R, they bind to IL-2 and other cytokines,

which leads to signal transduction that results in proliferation, division, and

stimulation of T cells (signal 3). These committed TC cells bind directly to

allogeneic cells and produce cell lysis. TH-secreted cytokines recruit other T cells,

which results in further cytotoxicity. During this process, TH cells also produce

cytokines that trigger a cascade of events involving B cells and antibody production,

complement fixation, increased macrophage infiltration, neutrophil involvement,

fibrin deposition, platelet activation and release, prostaglandin release, and

inflammatory response at the graft site. These delayed-type hypersensitivity and

humoral responses occur in conjunction with one another and are not mutually

exclusive. This results in cellular and tissue injury and graft destruction

The antibodies produced by plasma cells, which are transformed B cells under the

influence of cytokines, bind to the target antigenic cells. This leads to local

deposition of complement and results in immune complexation and injury to the graft

(complement-mediated cell lysis). The newly formed antibodies cause a series of

interactions to occur with T cells, which lead to cytotoxicity (antibody-dependent,

cell-mediated cytotoxicity). These cell-mediated and humoral immunologic events

can impair organ function so significantly that without therapeutic intervention,

complete organ graft dysfunction may occur. Under certain circumstances, which are

not clear, certain TC cells, known as suppressor T cells, downregulate the immune

response to alloantigen.

6

Human Leukocyte Antigen Typing

The genetic compatibility between donor and recipient can have a major impact on

acute rejection, graft function, graft survival, and patient survival. For example, in

kidney transplantation, the closer the HLA matching is between recipient and donor,

the better the outcome, particularly over the long term. To determine this

compatibility, a number of laboratory tests, including serologic, flow cytometric,

genetic-DNA-based, and cellular assessments of donor and recipient serum and

lymphocytes, are performed before organ transplantation. This process is referred to

as tissue typing. Lymphocytes are typed for HLA-A, HLA-B, and HLA-DR. Typing

for HLA is performed using the donor and recipient lymphocytes for serology-based

techniques or tissue or fluid containing nucleated cells.

7

The panel-reactive antibody (PRA) test is commonly used to assess organ

compatibility because recipients may have HLA antibodies from previous exposure

to antigenic stimuli (e.g., blood transfusions, previous transplantation, and

pregnancy). In this test, the recipient’s serum is tested against a cell panel of known

HLA specificities that are representative of possible donors in the general

population. The percentage of cell reactions (recipient with potential donor)

determines a recipient’s PRA. It is done periodically on patients on the waiting list to

determine their immunologic reactivity. The potential recipient with a higher

percentage of PRA (>20%–50%) is at higher risk for rejection and will generally a

have longer wait time for a kidney than patients with PRA less than 20%. With recent

changes (December 2014) to kidney allocation systems, this wait time may change

for these patients.

A cytotoxic and/or flow cytometry lymphocyte cross-match is also performed

prior to transplantation. In this case, the potential recipient’s serum is cross-matched

to determine whether preformed antibodies to the donor’s lymphocytes are present. A

positive cross-match indicates the presence of recipient cytotoxic IgG antibodies to

the donor. In kidney transplantation, a positive cross-match is usually considered a

contraindication. Recently, a number of transplant programs have utilized

desensitization strategies to reduce the level of HLA antibodies present in potential

recipients as a mechanism to reduce likelihood of a positive cross-match with either

identified living donors or future potential deceased donors. Common strategies to

reduce these preformed HLA antibodies include serial delivery of plasmapheresis

coupled with IVIG, rituximab, and bortezomib.

8

In liver transplantation, a positive

cross-match is not an absolute contraindication because the need is urgent and

because the liver appears to be more resistant immunologically to this type of

reaction. These liver transplant recipients can, however, experience significant

complications and early graft dysfunction. In kidney transplantation, organ allocation

and matching now utilize a virtual cross-match in which potential recipients are

listed with known unacceptable HLA antigens (those that have been pre-identified in

the patient). If a potential donor is identified with a specific HLA antigen that the

recipient has known antibodies directed against, they will be skipped on the list.

ABO blood typing is one of the most critical of all evaluations when determining

the genetic compatibility for all solid organ transplants. Transplantation of an organ

with ABO incompatibility typically results in a hyperacute rejection and destruction

of the graft, although in kidney transplant, newer therapeutic approaches to overcome

ABO incompatibility have been successful.

7

IMMUNOSUPPRESSIVE AGENTS

Immunosuppressives, based on an improved understanding of their mechanisms of

action and the mechanisms of rejection, have had the most significant impact on

patient and graft survival. The currently used immunosuppressives are shown in

Table 34-1. These agents can be categorized as induction or maintenance therapy.

9

Sites of action and role of the currently used agents are discussed below.

MAINTENANCE

Azathioprine

Azathioprine is a prodrug of 6-mercaptopurine (6-MP). Azathioprine and 6-MP are

purine antagonist antimetabolites. The introduction of cyclosporine, tacrolimus,

mycophenolate, and sirolimus has led to a significant reduction of azathioprine use or

its elimination altogether in immunosuppressive protocols. It can be useful in some

cases, because it is inexpensive, or in patients who cannot tolerate other agents. It

continues to be used in other countries.

9

p. 718

p. 719

Table 34-1

Currently Used Immunosuppressive Agents

Drug (Brand Name)

Usual Dose/Route

(How Supplied) Therapeutic Use(s) Major Adverse Effects

Alemtuzumab (CampathH1)

IV 0.3 mg/kg or 30 mg × 1

dose (30-mg vial for

injection)

Prevention and treatment

of acute cellular and

antibody-mediated

rejection; steroid-free

protocols

Lymphopenia, leukopenia,

infection

Azathioprine (Imuran)

a IV or Oral 1–3 mg/kg/day

(50-mg tablet; 100-mg vial

for injection)

As maintenance agent to

prevent acute rejection

Leukopenia,

thrombocytopenia,

hepatotoxicity, nausea and

vomiting, diarrhea,

pancreatitis, infection

Antithymocyte globulin,

equine (Atgam)

IV 10–20 mg/kg/day (250

mg/5 mL ampule for

injection)

Treat acute rejection

(including severe or

steroid-resistant forms); as

induction agent in high-risk

patient to prevent acute

rejection

Anemia, leukopenia,

thrombocytopenia,

arthralgia, myalgias,

nausea and vomiting,

diarrhea, fevers, chills,

hypotension, tachycardia,

anaphylaxis, infection

Antithymocyte globulin,

rabbit (Thymoglobulin)

IV 1.5 mg/kg/day given

daily for 4–10 days (25

mg/5 mL vial for injection)

Treat acute rejection

(including severe or

steroid-resistant forms); as

induction agent in high-risk

patient to prevent acute

rejection

Fever, chills, nausea and

vomiting, hypotension,

neutropenia, flushing, rash,

itching, joint pain,

myalgias,

thrombocytopenia,

infection

Basiliximab (Simulect) IV 20 mg × 2 doses

10 mg; 2 doses for

children if <35 kg (10- and

20-mg vial for injection)

As induction agent to

prevent acute rejection

Abdominal pain, dizziness,

insomnia, hypersensitivity

reaction (rare)

Belatacept

(Nulojix)

IV

Initial Maintenance:

10 mg/kg on days 0, 4, 14,

28 and week 8 and12 and

monthly thereafter

Conversion from CNI:

5 mg/kg q 2 weeks for 5

doses, then every 4 weeks

thereafter

As maintenance agent to

prevent acute rejection;

conversion agent from

CNIs in patients with

intolerances.

Anemia, neutropenia,

diarrhea, UTIs,

headaches, peripheral

edema, PTLD

Cyclosporine

a

(Sandimmune)

Oral

5–10 mg/kg/dose BID

IV

1.5–2.5 mg/kg/dose (100

mg/mL oralsolution; 25-

and 100-mg capsule; 250

mg/5 mL ampule for

injection)

As maintenance agent to

prevent acute rejection

Nephrotoxicity,

hypertension,

neurotoxicity, hair growth,

gingival hyperplasia,

hyperglycemia,

hyperkalemia,

dyslipidemia,

hypomagnesemia,

infection, neoplasm

Cyclosporine (Neoral,

Gengraf, various others)

a

Oral 4–8 mg/kg/day BID

(100-mg solution; 25-, 50-,

and 100-mg capsule)

As maintenance agent to

prevent acute rejection;

conversion agent from

tacrolimus in patients with

intolerance

Same as above

Everolimus (Zortress) Oral 0.5–1.5 mg BID

(0.25-, 0.5-, 0.75-mg

tablets

As maintenance agent to

prevent acute rejection;

conversion agent from

CNI in patients with

intolerance or poor

response

Dyslipidemia,

thrombocytopenia,

neutropenia, impaired

healing, mouth ulcers,

proteinuria, pneumonitis

(rare)

Methylprednisolone

a

sodium succinate (SoluMedrol, various others)

10–1,000 mg/dose (40-,

125-, 250-, 500, 1,000-,

and 2,000-mg vial for

injection)

As induction and

maintenance agent to

prevent acute rejection; to

treat acute rejection

Hyperglycemia, psychosis,

euphoria, impaired wound

healing, osteoporosis,

acne, peptic ulcers,

gastritis, fluid, electrolyte

disturbances, hypertension,

dyslipidemia, leukocytosis,

cataracts, cushingoid state,

infection, insomnia,

irritability

Mycophenolate

a mofetil

(CellCept)

1.5–3.0 g/day BID IV/PO

(250-mg capsule; 500-mg

tablet; 200 mg/mL oral

suspension; 500-mg vial

for injection)

As maintenance agent to

prevent acute rejection;

conversion agent from

azathioprine and sirolimus

in patients with intolerance

or poor response

Diarrhea, nausea and

vomiting, neutropenia,

dyspepsia, ulcers,

infection,

thrombocytopenia, anemia

Mycophenolate

a

sodium

(Myfortic)

360–720 mg PO BID

(180- and 360-mg tablets)

As maintenance agent to

prevent acute rejection.

Alternative to MMF

Similar side effect profile

as MMF

p. 719

p. 720

Prednisone

a Oral 5–20 mg/day (1-, 2.5-

, 5-, 10-, 20-, 50-, and 100-

mg tablet)

As maintenance agent to

prevent acute rejection

See methylprednisolone

Sirolimus

a

(Rapamune) Oral 2–10 mg/day (0.5-, 1-

, and 2-mg tablet; 1

mg/mL oralsolution)

As maintenance agent to

prevent acute rejection;

conversion agent from

CNI or mycophenolate or

azathioprine in patients

with intolerance or poor

response

Dyslipidemia,

thrombocytopenia,

neutropenia, anemia,

diarrhea, impaired healing,

mouth ulcers, proteinuria,

pneumonitis (rare)

Tacrolimus (Prograf,

Astagraf XL, Envarsus

XR)

a

Oral

0.15–0.3 mg/kg/day BID

IV

0.025–0.05 mg/kg/day as

continuous infusion (0.5-

mg, 1-mg, and 5-mg

capsule; 5 mg/mL ampule

for injection)

Astagraf XL:

Oral

0.1–0.2 mg/kg/day

Once daily

(0.5-mg, 1-mg, and 5-mg

capsules)

Envarsus XR:

Oral

0.1–0.2 mg/kg/day once

daily

80% of total daily dose of

tacrolimus when

converting from

immediate-release

formulation (0.75-, 1-, and

4-mg tablets)

As maintenance agent to

prevent acute rejection;

conversion agent from

cyclosporine in patients

with intolerance or poor

response

Nephrotoxicity,

hypertension,

neurotoxicity, alopecia,

hyperglycemia,

hyperkalemia,

dyslipidemia,

hypomagnesemia,

infection, neoplasm

Bortezomib (Velcade) 1.3 mg/m

2 on days 1,4, 8,

and 11 IV bolus or sc (3.5

mg single use vial)

Inhibits plasma cells Bone marrow suppression,

thrombocytopenia,

neuropathy, hypotension,

gastrointestinal

Eculizumab (Soliris) 600–1,200 mg IV infusion

(300 mg single use vial [30

mL of 10 mg/mL soln])

Inhibits complement Infusion reaction,

headache, hypertension,

leukopenia, infections

Rituximab (Rituxan) 375 mg/m

2 × 1–5 doses or

500 mg/m

2

single-dose IV

infusion (100 and 500 mg

single use vial, in 10

mg/mL concentration)

Inhibits B-cell production Infusion reactions ( fever,

chills, rigors); pain at

infusion site, infections

Intravenous

Immunoglobulin (Carimune

NF, Flebogamma,

Gammagard S/D,

Gamunex, Iveegam EN,

Octagam, Polygam)

100 mg/kg–2 g/kg IV

infusion (vialsize varies

based on manufacturer,

ranging from 1, 2.5, 5, 6,

10, 12, 20, 30 and 40 g;

usually concentrations are

Immunomodulation of Tand B cells and/or

immunoglobulin

replacement

Infusion reactions (fever,

chills, rigors); pain at

infusion site, thrombosis,

hemolytic anemia, acute

renal failure, septic

meningitis

5% and 10%)

aGeneric products available.

BID, 2 times daily; CNI, calcineurin inhibitor; IV, intravenous; MMF, mycophenolate mofetil; PO, orally.

Azathioprine, a nonspecific antimetabolite immunosuppressive agent, affects both

cell-mediated (i.e., T cell) and antibody-mediated (i.e., B cell) immune responses.

Because it inhibits the early stages of cell differentiation and proliferation,

azathioprine is useful for preventing rejection, but it is ineffective for the treatment of

acute rejection. 6-MP, an active metabolite, is incorporated into DNA and RNA,

thereby interfering with the intracellular formation of thioguanine nucleotides (TGN).

6-MP is intracellularly converted by hypoxanthine phosphoribosyltransferase to

thioinosinic acid and then to thioguanine nucleotides. 6-MP may have two separate

immunosuppressive effects: inhibition of cellular proliferation and cytotoxicity. A

decrease in the levels of intracellular purine ribonucleotides decreases cellular

proliferation, and incorporation of TGN into DNA mediates cytotoxicity.

The major metabolic conversion of azathioprine to 6-MP is via nucleophilic attack

by glutathione. The liver and red blood cells are thought to be major tissue sites for

this metabolic conversion. The 6-MP formed by this reaction can be metabolized

further to thiopurine ribonucleosides and ribonucleotides such as 6-thioguanine

nucleotide. These active metabolites, which have longer half-lives, are responsible

for immunosuppressive activity. Azathioprine pharmacokinetics are not affected by

renal dysfunction, but 6-TGN metabolite concentrations can accumulate in this

situation.

1

The most common adverse effect of azathioprine is bone marrow suppression.

Bone marrow suppression may be related to a genetic deficiency of the enzyme,

thiopurine methyltransferase. Low activity of this enzyme is rare but in some

individuals it

p. 720

p. 721

leads to greater availability of 6-MP, elevated 6-thioguanine levels, and

susceptibility to myelosuppression. Low levels of thiopurine methyltransferase and

specific genetic polymorphisms of this enzyme have been associated with severe

azathioprine myelotoxicity and reduced efficacy.

10,11 Testing for this polymorphism

has been advocated. However, few transplant centers perform genetic testing prior to

use.

Mycophenolate Mofetil and Mycophenolate Sodium

As a result of several multicenter comparative registry trials in kidney transplant

recipients, mycophenolate mofetil (MMF) has replaced azathioprine in many

transplant protocols. MMF is used as adjunctive therapy in combination with

cyclosporine or tacrolimus, prednisone, mammalian target of rapamycin (mTOR)

inhibitors, and monoclonal and polyclonal antibodies to prevent acute rejection and

used for calcineurin inhibitor (CNI) withdrawal and minimization. It is also used as

rescue therapy when patients have not responded to, or cannot tolerate, the side

effects of other immunosuppressive agents.

MMF is an antiproliferative antimetabolite that inhibits purine synthesis, but in a

more selective manner than azathioprine. Unlike azathioprine, MMF interferes with

the de novo pathway for purine synthesis. MMF is the morpholinoethyl ester prodrug

of mycophenolic acid (MPA), which is the active component. MPA selectively,

noncompetitively, and reversibly blocks an enzyme known as inosine monophosphate

dehydrogenase (IMPDH) found primarily in actively proliferating T- and B cells. Tand B cells rely on this enzyme and the de novo purine pathway to produce purine

nucleotides for DNA and RNA synthesis. Thus, MPA interferes with T-cell and Bcell proliferation. It is more selective than azathioprine. MPA also may affect

cytokine production. Other secondary effects include inhibition of B-lymphocyte

antibody production, decreased adhesion molecule expression, decreased smooth

muscle proliferation and recruitment, and infiltration of neutrophils

12

(MMF

pharmacokinetics are complex and discussed in detail in Case 34-7, Question 9).

Another oral formulation of MPA, enteric-coated mycophenolate sodium, is also

approved by the US Food and Drug Administration (FDA) to prevent rejection in

kidney transplantation, when used in combination with a calcineurin inhibitor (CNI)

and corticosteroids. The original purpose of designing the enteric-coated formulation

was to reduce or prevent the gastrointestinal (GI) side effects commonly seen with

MMF. However, most data suggest that the efficacy rates and side effect profiles of

MMF and mycophenolate sodium are nearly identical. These two agents are not

bioequivalent.

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