Biologic medicines for autoimmune diseases MCQs With Answer

Introduction

This blog provides an advanced set of multiple-choice questions focused on biologic medicines used in autoimmune diseases, tailored for M.Pharm students specializing in Biological Evaluation of Drug Therapy. It emphasizes mechanisms of action, pharmacokinetics, immunogenicity, laboratory monitoring, safety considerations, regulatory principles for biosimilars, and therapeutic drug monitoring. Questions are designed to deepen understanding beyond definitions — addressing assay selection for anti‑drug antibodies, FcRn recycling, Fc effector functions (ADCC/CDC), infection risk screening, and practical issues like storage and vaccination guidance. Use these MCQs to test critical thinking, prepare for exams, and reinforce application of concepts to clinical and regulatory scenarios.

Q1. Which of the following best describes the primary mechanism of action of anti‑TNF biologic agents used in autoimmune diseases?

• Neutralization of soluble and membrane‑bound tumor necrosis factor alpha (TNF‑α)
• Inhibition of Janus kinase (JAK) signaling pathways
• Depletion of CD20+ B cells via complement activation
• Blocking CD28‑mediated T‑cell co‑stimulation

Correct Answer: Neutralization of soluble and membrane‑bound tumor‑necrosis factor alpha (TNF‑α)

Q2. Rituximab exerts its therapeutic effect in autoimmune diseases primarily by targeting which molecule?

• CD3 on T lymphocytes
• CD20 on B lymphocytes
• IL‑6 receptor on inflammatory cells
• CTLA‑4 pathway on antigen presenting cells

Correct Answer: CD20 on B lymphocytes

Q3. Abatacept is a fusion protein used in autoimmune disease; its main immunomodulatory action is:

• Binding TNF‑α and preventing receptor interaction
• Blocking IL‑1 signaling by acting as a decoy receptor
• Binding CD80/CD86 to inhibit CD28‑mediated T‑cell co‑stimulation
• Depleting plasma cells through ADCC

Correct Answer: Binding CD80/CD86 to inhibit CD28‑mediated T‑cell co‑stimulation

Q4. Which laboratory assay format is most commonly used as a first‑line screening method to detect anti‑drug antibodies (ADAs) against therapeutic monoclonal antibodies?

• Bridging ELISA
• Flow cytometry cell‑binding assay
• Western blot for drug fragments
• Mass spectrometry peptide mapping

Correct Answer: Bridging ELISA

Q5. In monoclonal antibody nomenclature, the suffix “‑ximab” most commonly indicates what type of antibody?

• Fully human monoclonal antibody
• Humanized monoclonal antibody
• Chimeric monoclonal antibody
• Peptidic fusion protein

Correct Answer: Chimeric monoclonal antibody

Q6. The neonatal Fc receptor (FcRn) contributes to the long serum half‑life of IgG‑based biologics primarily by:

• Enhancing hepatic metabolism of IgG molecules
• Facilitating transcytosis into tissues for rapid clearance
• Recycling IgG and protecting it from lysosomal degradation
• Activating complement to extend circulatory time

Correct Answer: Recycling IgG and protecting it from lysosomal degradation

Q7. Which infectious risk is most classically associated with initiation of anti‑TNF therapy and therefore requires screening prior to treatment?

• Reactivation of latent tuberculosis
• Opportunistic fungal infections only in neutropenia
• Primary Epstein‑Barr virus infection
• Infection with cytomegalovirus (CMV) in immunocompetent hosts

Correct Answer: Reactivation of latent tuberculosis

Q8. Antibody‑dependent cell‑mediated cytotoxicity (ADCC) involves which primary cellular interaction?

• Macrophage FcγRI binding to IgE leading to histamine release
• Natural killer (NK) cell FcγRIII (CD16) binding to IgG Fc on target cells
• Complement C3b opsonization enabling neutrophil phagocytosis
• T‑cell TCR recognition of antibody variable regions

Correct Answer: Natural killer (NK) cell FcγRIII (CD16) binding to IgG Fc on target cells

Q9. The regulatory approval pathway for a biosimilar is based primarily on which principle?

• Requiring full, de novo clinical development identical to the reference product
• Demonstrating a totality of evidence showing no clinically meaningful differences from the reference product
• Approval only if the biosimilar is produced in the same cell line as the originator
• Limiting approval to a single indication without extrapolation

Correct Answer: Demonstrating a totality of evidence showing no clinically meaningful differences from the reference product

Q10. Which laboratory biomarker change is most commonly monitored to assess therapeutic response in rheumatoid arthritis patients treated with biologics?

• Decrease in serum creatinine
• Increase in alkaline phosphatase
• Reduction in C‑reactive protein (CRP)
• Rise in plasma glucose

Correct Answer: Reduction in C‑reactive protein (CRP)

Q11. Tocilizumab, an IL‑6 receptor antagonist, is particularly associated with which laboratory adverse effects that require monitoring?

• Nephrotic‑range proteinuria and hypokalemia
• Elevation of liver transaminases and dyslipidemia
• Severe hypoglycemia and adrenal suppression
• Macrocytic anemia and hypercalcemia

Correct Answer: Elevation of liver transaminases and dyslipidemia

Q12. Neutralizing anti‑drug antibodies differ from non‑neutralizing (binding) antibodies in that neutralizing antibodies:

• Increase serum drug concentration by blocking clearance pathways
• Directly block the therapeutic activity of the drug at its binding site
• Are only detectable by mass spectrometry
• Improve drug efficacy by enhancing receptor engagement

Correct Answer: Directly block the therapeutic activity of the drug at its binding site

Q13. Which marketed biologic is a CTLA‑4‑Ig fusion protein rather than a monoclonal antibody?

• Etanercept
• Abatacept
• Infliximab
• Rituximab

Correct Answer: Abatacept

Q14. What is the recommended general storage condition for most marketed monoclonal antibody therapeutics?

• Room temperature (20–25°C) with exposure to light
• Freezing at −20°C to maintain stability
• Refrigeration at 2–8°C and protect from freezing
• Dry storage at >40°C to reduce aggregation

Correct Answer: Refrigeration at 2–8°C and protect from freezing

Q15. How does Fc glycosylation of an IgG monoclonal antibody influence its clinical properties?

• It only affects antigen specificity but not effector function
• It can modulate Fc effector functions such as ADCC and influence stability
• Glycosylation prevents FcRn binding and shortens half‑life universally
• Glycosylation eliminates immunogenicity completely

Correct Answer: It can modulate Fc effector functions such as ADCC and influence stability

Q16. Compared with a monoclonal antibody, a receptor‑Fc fusion protein typically differs because it:

• Is always administered orally rather than parenterally
• Combines an extracellular receptor or ligand domain with an Fc fragment to act as a soluble decoy
• Has intrinsic enzymatic activity that degrades cytokines
• Is synthesized chemically and not produced in mammalian cells

Correct Answer: Combines an extracellular receptor or ligand domain with an Fc fragment to act as a soluble decoy

Q17. Which vaccination policy is generally recommended for patients on active biologic immunosuppressive therapy?

• Administer live attenuated vaccines during therapy for enhanced protection
• Defer all vaccinations indefinitely while on biologics
• Prefer inactivated vaccines; avoid live vaccines during therapy
• Only give polysaccharide vaccines and avoid conjugate vaccines

Correct Answer: Prefer inactivated vaccines; avoid live vaccines during therapy

Q18. Prior to initiating anti‑TNF therapy, standard pre‑treatment screening should include which test?

• Serum hepatitis A IgM only
• Tuberculin skin test (TST) or interferon‑gamma release assay (IGRA) for latent TB
• Routine bone marrow biopsy
• Baseline brain MRI for demyelinating disease

Correct Answer: Tuberculin skin test (TST) or interferon‑gamma release assay (IGRA) for latent TB

Q19. Therapeutic drug monitoring for biologics commonly measures trough drug concentration and anti‑drug antibodies; an undetectable trough with high ADA levels most likely suggests:

• Excellent drug efficacy and no need to change therapy
• Increased drug clearance due to immunogenicity and likely loss of response
• Drug accumulation requiring dose reduction
• Laboratory error only, with no clinical implications

Correct Answer: Increased drug clearance due to immunogenicity and likely loss of response

Q20. Complement‑dependent cytotoxicity (CDC) mediated by therapeutic antibodies requires which of the following?

• Antibody subclass that poorly binds C1q, such as IgG4
• Activation of the classical complement pathway typically facilitated by IgG1 or IgG3 Fc regions
• Direct T‑cell engagement via Fc receptors independent of complement
• Only small peptide therapeutics can trigger CDC

Correct Answer: Activation of the classical complement pathway typically facilitated by IgG1 or IgG3 Fc regions

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