MOA
Vipokibart is a monoclonal antibody that binds to this pro-inflammatory cytokine implicated in UC pathogenesis
What is TL1A
Typical storage conditions required for most marketed monoclonal antibodies to preserve stability.
What is refrigeration at 2–8°C?
This disease is the most common form of IBD
What is Ulcerative Colitis
To obtain a BLA, the sponsor must show clinical benefit in this UC population.
Who are patients with moderate-to-severe active UC?
Biologics like vipokibart are often dispensed through this distribution channel that manages specialty handling and reimbursement.
What is a specialty pharmacy?
TL1A binds to this receptor, activating inflammatory pathways in ulcerative colitis.
What is DR3 (Death Receptor 3)?
True or False: Vopikibart is a small molecule.
What is False? (It’s a biologic monoclonal antibody.)
The three anatomic classifications of UC are based on disease extent. Name one
What is proctitis, left-sided colitis, or extensive colitis.
Vipokibart’s IND approval allows initiation of this first in human study phase.
What is Phase 1?
Mention one strategy that pharmacy teams can use to improve access and adherence for high-cost biologics.
What are copay assistance, patient support programs, education/counseling, and specialty pharmacy coordination?
By blocking TL1A–DR3 interactions, Vopikibart helps reduce both of these inflammatory processes.
By blocking TL1A–DR3 interactions, Vopikibart helps reduce both of these inflammatory processes.
Bonus Point
Bonus Point
This class of drugs, often used first-line in mild UC
What are 5-aminosalicylates (5-ASA)?
The ultimate regulatory submission to seek FDA approval for vipokibart as a UC treatment.
What is a Biologics License Application (BLA)?
These agents are commonly used short-term to induce remission in UC patients but are not suitable for maintenance due to systemic side effects.
What are corticosteroids?
True or False: TL1A signaling is involved only in the intestinal tract.
What is False?
Diagnosis of UC is confirmed through this procedure, considered the gold standard for determining disease extent and severity
What is a colonoscopy?
Long-term UC is associated with increased risk of this form of cancer.
What is colorectal cancer?
Before FDA approval, Vopikibart was tested for ulcerative colitis in this large, confirmatory stage of clinical trials.
What are Phase 3 clinical trials?
Before a patient can start Vopikibart or another biologic, insurance approval of this type is often required.
What is prior authorization?
TL1A-DR3 signaling intersects with these types of immune responses that are key to mucosal homeostasis.
What are innate and adaptive immune responses?
An important laboratory test or screening required before starting many biologics to mitigate infectious risk.
What is screening for latent tuberculosis and hepatitis B virus?
UC is diagnosed most frequently in this race
What is White Americans
A commonly used primary efficacy endpoint in UC trials
What is clinical remission?
Patients with moderate-to-severe UC often require escalation to these biologic classes. Name one
What are TNF-α inhibitors, anti-integrins, IL-12/23 or IL-23 inhibitors, JAK inhibitors?