Biologic medicines for organ transplantation MCQs With Answer

Introduction: This quiz set focuses on biologic medicines used in organ transplantation, tailored for M.Pharm students studying Biological Evaluation of Drug Therapy. It covers mechanisms of action, pharmacokinetics, pharmacodynamics, clinical indications (induction, maintenance, desensitization), adverse effects, monitoring, immunogenicity, biosimilar considerations and methods used in transplantation immunology. The questions are designed to deepen understanding beyond basic facts, emphasizing how biologics modulate immune responses, practical therapeutic choices, safety concerns such as infection and post-transplant lymphoproliferative disorder, and laboratory assessments used to guide therapy. Use these MCQs to test and reinforce applied knowledge required for postgraduate pharmacy practice and examinations.

Q1. Which description best characterizes the mechanism of action of basiliximab in transplant immunosuppression?

• Monoclonal antibody binding CD20 to deplete B cells
• Monoclonal antibody targeting IL-2 receptor alpha (CD25)
• CTLA-4 Ig fusion protein blocking CD80/86
• Complement C5 inhibitor preventing membrane attack complex

Correct Answer: Monoclonal antibody targeting IL-2 receptor alpha (CD25)

Q2. What is the primary pharmacological distinction between anti-thymocyte globulin (ATG) and therapeutic monoclonal antibodies used in transplantation?

• ATG is a small molecule immunosuppressant while mAbs are proteins
• ATG is a polyclonal antibody preparation causing broad T-cell depletion
• ATG selectively blocks IL-2 signaling without cell depletion
• ATG only acts on B cells and spares T cells

Correct Answer: ATG is a polyclonal antibody preparation causing broad T-cell depletion

Q3. How does the neonatal Fc receptor (FcRn) influence the pharmacokinetics of IgG-based biologics?

• FcRn mediates renal excretion of IgG, shortening half-life
• FcRn degrades IgG in lysosomes, reducing systemic exposure
• FcRn recycles IgG back to circulation, prolonging half-life
• FcRn blocks FcγR binding, preventing ADCC

Correct Answer: FcRn recycles IgG back to circulation, prolonging half-life

Q4. Belatacept is best described as which of the following?

• Anti-CD20 monoclonal antibody depleting B cells
• CTLA-4 Ig fusion protein blocking CD28-mediated costimulation
• Anti-C5 monoclonal antibody inhibiting complement activation
• IL-6 receptor antagonist reducing cytokine release

Correct Answer: CTLA-4 Ig fusion protein blocking CD28-mediated costimulation

Q5. Which biologic agent acts by binding complement protein C5 and preventing formation of the membrane attack complex?

• Rituximab
• Eculizumab
• Basiliximab
• Belatacept

Correct Answer: Eculizumab

Q6. Which clinical risk is most characteristically associated with rituximab therapy in transplant or desensitization protocols?

• Prolonged neutrophil recovery due to bone marrow stromal toxicity
• B-cell depletion with risk of hepatitis B reactivation and infusion reactions
• Direct complement activation causing hemolysis
• Selective T-cell depletion leading to severe acute cellular rejection

Correct Answer: B-cell depletion with risk of hepatitis B reactivation and infusion reactions

Q7. Which statement best describes hyperacute rejection in organ transplantation?

• It is mediated primarily by recipient T cells recognizing donor MHC
• It occurs weeks to months after transplant and involves chronic vascular changes
• It is caused by preformed recipient anti-donor antibodies activating complement
• It is driven by donor-derived immune cells causing graft-versus-host disease

Correct Answer: It is caused by preformed recipient anti-donor antibodies activating complement

Q8. What are anti-drug antibodies (ADAs) and how do they affect biologic therapies?

• Drug metabolites that block therapeutic action and increase potency
• Endogenous antiviral antibodies that enhance biologic half-life
• Host antibodies against the biologic that can be neutralizing or non-neutralizing and alter PK/PD
• Monoclonal antibodies engineered to reduce immunogenicity

Correct Answer: Host antibodies against the biologic that can be neutralizing or non-neutralizing and alter PK/PD

Q9. What is the usual route of administration for most monoclonal antibody biologics used in transplantation?

• Oral tablet formulations for daily dosing
• Intramuscular injection into the deltoid
• Intravenous infusion (with some formulations available subcutaneously)
• Topical application at the graft site

Correct Answer: Intravenous infusion (with some formulations available subcutaneously)

Q10. Which set of monitoring parameters is most appropriate after initiating biologic immunosuppression in a transplant recipient?

• Serum cholesterol and liver enzymes only
• Complete blood count, viral loads (CMV, BK), and renal function
• Fasting glucose and HbA1c only
• Daily therapeutic drug monitoring of calcineurin inhibitor levels only

Correct Answer: Complete blood count, viral loads (CMV, BK), and renal function

Q11. Which agent is correctly matched as a costimulation blocker used in transplantation?

• Rituximab — CD28 pathway blocker
• Belatacept — CTLA-4 Ig blocking CD80/86
• Eculizumab — CD40 ligand antagonist
• Basiliximab — CD80/86 fusion protein

Correct Answer: Belatacept — CTLA-4 Ig blocking CD80/86

Q12. For regulatory approval of a biosimilar to a transplant biologic, which is the central requirement?

• Complete independent Phase III trials for every indication without extrapolation
• Demonstration of high similarity with no clinically meaningful differences in quality, safety, and efficacy
• Only identical primary amino acid sequence is required regardless of glycosylation
• Approval based solely on lower cost compared to originator biologic

Correct Answer: Demonstration of high similarity with no clinically meaningful differences in quality, safety, and efficacy

Q13. How can Fc engineering enhance antibody-dependent cellular cytotoxicity (ADCC) of therapeutic antibodies?

• By removing the Fc domain to reduce immune activation
• By altering Fc glycosylation to increase FcγRIIIa binding affinity
• By increasing complement binding to promote CDC exclusively
• By shortening the IgG half-life through FcRn affinity reduction

Correct Answer: By altering Fc glycosylation to increase FcγRIIIa binding affinity

Q14. Which procedure is primarily used to acutely remove circulating alloantibodies in a desensitization protocol before transplant?

• High-dose corticosteroid bolus
• Intravenous immunoglobulin infusion
• Plasmapheresis (plasma exchange)
• Oral tacrolimus dose escalation

Correct Answer: Plasmapheresis (plasma exchange)

Q15. Alemtuzumab targets which antigen and produces what principal effect relevant to transplantation?

• CD20 on B cells causing transient antibody suppression
• CD3 on T cells causing selective signalling blockade without depletion
• CD52 on lymphocytes causing profound and prolonged lymphocyte depletion
• IL-6 receptor causing cytokine storm prevention

Correct Answer: CD52 on lymphocytes causing profound and prolonged lymphocyte depletion

Q16. Which transplant immunosuppressive strategy is most strongly associated with increased risk of EBV-driven post-transplant lymphoproliferative disorder (PTLD)?

• Switching from tacrolimus to cyclosporine for maintenance
• Use of T-cell depleting agents such as ATG or alemtuzumab
• Administering low-dose aspirin prophylaxis
• Using belatacept with minimal induction therapy

Correct Answer: Use of T-cell depleting agents such as ATG or alemtuzumab

Q17. Which laboratory crossmatch technique detects complement-dependent cytotoxicity when testing recipient serum against donor lymphocytes?

• Flow cytometric crossmatch (FCXM)
• Solid-phase single antigen bead assay
• Complement-dependent cytotoxicity (CDC) crossmatch
• ELISA for anti-HLA IgM

Correct Answer: Complement-dependent cytotoxicity (CDC) crossmatch

Q18. In clinical development for biosimilars of transplant biologics, what is typically the primary focus of equivalence studies?

• Demonstrating identical manufacturing processes
• Pharmacokinetic and pharmacodynamic comparability plus no clinically meaningful differences in efficacy and safety
• Only in vitro binding assays without human studies
• Cost-effectiveness compared to the reference product

Correct Answer: Pharmacokinetic and pharmacodynamic comparability plus no clinically meaningful differences in efficacy and safety

Q19. Which mechanism is part of how intravenous immunoglobulin (IVIG) can ameliorate antibody-mediated rejection?

• Direct blockade of IL-2 receptors on T cells only
• Multiple mechanisms including Fc receptor blockade, neutralization of alloantibodies, and complement modulation
• Selective depletion of donor B cells via ADCC exclusively
• Enhancement of complement activation to clear immune complexes

Correct Answer: Multiple mechanisms including Fc receptor blockade, neutralization of alloantibodies, and complement modulation

Q20. Which laboratory finding would most strongly indicate increased infection risk related to biologic immunosuppression after transplantation?

• Elevated hemoglobin concentration above baseline
• Lymphopenia/low absolute lymphocyte count
• Mild isolated elevation of alkaline phosphatase
• Low serum creatinine indicating improved graft function

Correct Answer: Lymphopenia/low absolute lymphocyte count

Download