Biologic medicines for digestive disorders MCQs With Answer

Biologic medicines for digestive disorders MCQs With Answer

This quiz set is designed for M.Pharm students studying Biological Evaluation of Drug Therapy. It focuses on biologic therapeutics used in gastrointestinal diseases — primarily inflammatory bowel disease (IBD) — covering mechanisms of action, immune targets (TNF, integrins, IL‑12/23), pharmacokinetics, immunogenicity, therapeutic drug monitoring, biosimilars, safety concerns (infections, infusion reactions, PML risk) and clinical application. Questions range from molecular details (Fab/Fc roles, chimeric vs humanized antibodies) to practical considerations (screening for latent TB, dosing routes, trough level interpretation). Use these MCQs to test and deepen your conceptual and applied knowledge of biologics in digestive disorders.

Q1. Which mechanism best describes how infliximab treats Crohn’s disease?

• Blockade of IL-17 receptor signaling
• Neutralization of tumor necrosis factor-alpha (TNF-α)
• Inhibition of JAK-STAT intracellular signaling
• Antagonism of α4β7 integrin on lymphocytes

Correct Answer: Neutralization of tumor necrosis factor-alpha (TNF-α)

Q2. Which characteristic distinguishes certolizumab pegol from other anti-TNF monoclonal antibodies?

• It is a fully human IgG1 monoclonal antibody
• It is a PEGylated Fab’ fragment lacking an Fc region
• It selectively blocks α4 integrins
• It targets the p40 subunit of IL-12/23

Correct Answer: It is a PEGylated Fab’ fragment lacking an Fc region

Q3. Vedolizumab differs from natalizumab primarily by what clinical advantage in IBD therapy?

• Vedolizumab provides systemic immunosuppression reducing lung infections
• Vedolizumab selectively blocks gut-homing lymphocytes, lowering PML risk
• Vedolizumab inhibits TNF-α more potently than natalizumab
• Vedolizumab is an oral small molecule with better CNS penetration

Correct Answer: Vedolizumab selectively blocks gut-homing lymphocytes, lowering PML risk

Q4. Ustekinumab exerts its therapeutic effect in Crohn’s disease by targeting which cytokine subunit?

• IL-6 receptor alpha chain
• TNF-α soluble receptor
• IL-12/23 p40 subunit
• IL-17A cytokine

Correct Answer: IL-12/23 p40 subunit

Q5. Which monitoring strategy is most important to reduce loss of response to anti-TNF therapy?

• Periodic measurement of serum creatinine only
• Therapeutic drug monitoring of trough drug levels and anti-drug antibodies
• Routine colonoscopy every 2 weeks
• Measuring serum complement levels monthly

Correct Answer: Therapeutic drug monitoring of trough drug levels and anti-drug antibodies

Q6. Why is screening for latent tuberculosis recommended before initiating anti-TNF biologics?

• Anti-TNF agents cause direct TB bacteria proliferation
• Anti-TNF therapy impairs granuloma maintenance, increasing TB reactivation risk
• Anti-TNF agents neutralize isoniazid activity
• Latent TB screening reduces the risk of infusion reactions

Correct Answer: Anti-TNF therapy impairs granuloma maintenance, increasing TB reactivation risk

Q7. Which pharmacokinetic property is most influenced by the neonatal Fc receptor (FcRn) for IgG-based biologics?

• Oral bioavailability
• Distribution to bile
• Extended plasma half-life through recycling of IgG
• Renal tubular secretion

Correct Answer: Extended plasma half-life through recycling of IgG

Q8. A patient on infliximab develops anti-drug antibodies leading to infusion reactions. What is a common management option?

• Switch to a small-molecule JAK inhibitor immediately without evaluation
• Add immunomodulator (e.g., azathioprine) or switch to a different biologic class
• Increase infliximab infusion rate to overcome antibodies
• Discontinue all treatments and observe only

Correct Answer: Add immunomodulator (e.g., azathioprine) or switch to a different biologic class

Q9. Which statement about biosimilars for biologic therapies in IBD is correct?

• Biosimilars are identical copies of the reference biologic at molecular level
• Biosimilars require extensive comparability studies but are not exact molecular replicas
• Biosimilars are generic small molecules with the same chemical structure
• Biosimilars do not require clinical trials before approval

Correct Answer: Biosimilars require extensive comparability studies but are not exact molecular replicas

Q10. Which adverse effect is most commonly associated with anti-TNF biologics used in digestive disorders?

• Hyperthyroidism
• Serious opportunistic infections, including reactivation of tuberculosis
• Immediate hypertension
• Severe hyperglycemia

Correct Answer: Serious opportunistic infections, including reactivation of tuberculosis

Q11. Which biologic used in ulcerative colitis is a small-molecule JAK inhibitor rather than a monoclonal antibody?

• Tofacitinib
• Vedolizumab
• Ustekinumab
• Infliximab

Correct Answer: Tofacitinib

Q12. Certolizumab pegol differs in fetal transfer compared with other IgG1 biologics because:

• Its Fc region binds FcRn more strongly increasing placental transfer
• It lacks an Fc region, reducing active placental transfer of IgG
• It is actively transported by P-glycoprotein across the placenta
• It is an oral agent and not present in maternal circulation

Correct Answer: It lacks an Fc region, reducing active placental transfer of IgG

Q13. Which laboratory test is most useful to detect immunogenicity against a biologic drug?

• Serum C-reactive protein only
• Anti-drug antibody assay
• Urine protein electrophoresis
• Serum amylase

Correct Answer: Anti-drug antibody assay

Q14. Which design feature of monoclonal antibodies primarily mediates ADCC (antibody-dependent cellular cytotoxicity)?

• Fab antigen-binding fragment
• Fc region interacting with Fcγ receptors
• PEGylation of the molecule
• Complement activation by the variable region

Correct Answer: Fc region interacting with Fcγ receptors

Q15. In therapeutic drug monitoring for anti-TNF agents, a low trough concentration with high anti-drug antibody titre suggests which next step?

• Increase dose of the current biologic indefinitely without change
• Switch to an alternative biologic or add an immunosuppressant to reduce antibodies
• Stop all therapy and restart same agent after a week
• Administer an oral antibiotic to clear antibodies

Correct Answer: Switch to an alternative biologic or add an immunosuppressant to reduce antibodies

Q16. Which route of administration is most commonly used for vedolizumab in clinical practice?

• Oral tablet once daily
• Intravenous infusion
• Topical rectal gel
• Inhalation

Correct Answer: Intravenous infusion

Q17. Which clinical scenario is a relative contraindication to starting anti-TNF therapy?

• History of treated latent TB with completed prophylaxis
• Active severe bacterial infection
• Well-controlled hypertension on a single agent
• History of resolved shingles more than 5 years ago

Correct Answer: Active severe bacterial infection

Q18. How can cytokine blockade by biologics indirectly alter small-molecule drug metabolism?

• Cytokine blockade increases gastric pH altering absorption of all drugs
• Reducing inflammation can normalize CYP enzyme expression, changing metabolism of CYP substrates
• Biologics directly inhibit cytochrome P450 enzymes through binding
• Biologics cause renal failure, reducing clearance of small molecules

Correct Answer: Reducing inflammation can normalize CYP enzyme expression, changing metabolism of CYP substrates

Q19. Which statement best describes interchangeability of biosimilars in most regulatory frameworks?

• All biosimilars are fully interchangeable with the reference product without additional data
• Interchangeability may require extra evidence; policies differ by region and affect pharmacy substitution
• Biosimilars cannot be prescribed for the same indications as the reference product
• Interchangeability is based solely on lower cost, not clinical data

Correct Answer: Interchangeability may require extra evidence; policies differ by region and affect pharmacy substitution

Q20. Which long-term safety concern requires ongoing vigilance in patients receiving anti-integrin or anti-TNF therapy?

• Progressive multifocal leukoencephalopathy (PML) with some integrin inhibitors and opportunistic infections with anti-TNF
• Immediate onset diabetes mellitus within hours of the first dose
• High risk of acute myocardial infarction within days of initiation
• Guaranteed development of autoimmune hepatitis in all patients

Correct Answer: Progressive multifocal leukoencephalopathy (PML) with some integrin inhibitors and opportunistic infections with anti-TNF

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