QUOTIENT Trial: Treat-to-Target Endoscopic Remission in IBD on Advanced Therapies
The QUality Outcomes Treating IBD to Target (QUOTIENT) trial is a significant, pragmatic, open-label, multicentre randomised controlled study that addresses a critical question in the management of inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis. It focuses on the "treat-to-target" approach, specifically targeting endoscopic or radiological remission in patients who are already on advanced therapies.
Objective:
The trial investigates whether switching advanced therapies in asymptomatic patients with persistent subclinical inflammation (as seen on endoscopy or radiology) improves long-term outcomes. Persistent inflammation in these patients is linked to higher risks of disease relapse, complications, increased healthcare utilisation, and reduced quality of life. The study compares two treatment strategies:
Continuing the current advanced therapy (index therapy).
Switching to an alternative advanced therapy.
The trial's overarching goal is to determine if switching therapies can help achieve endoscopic or radiological remission and improve patient outcomes in the long term, without adding harm or treatment burden.
Study Design:
- Type of Study: Pragmatic, open-label, multicentre randomised controlled trial.
- Participants: Approximately 250 adult patients with Crohn’s disease or ulcerative colitis across the USA and Canada.
- Inclusion criteria: Patients must be in corticosteroid-free symptomatic remission but have moderate-to-severe endoscopic or radiological inflammation.
- Randomisation: Participants are randomised 1:1 to either continue their current advanced therapy or switch to an alternative advanced therapy.
- Duration: Follow-up for 104 weeks in routine clinical practice.
Primary Endpoint:
The primary endpoint is time to treatment failure, which is a composite outcome including:
- Symptomatic relapse requiring treatment escalation.
- Corticosteroid use.
- IBD-related hospitalisation or surgery.
- Development of structural complications.
- Treatment-emergent adverse events leading to discontinuation of therapy.
Secondary Outcomes:
The trial also evaluates several secondary outcomes, focusing on patient-centred measures:
- Quality of life: Assessing how the disease and its treatment impact the patient’s overall well-being.
- Treatment burden: Evaluating the effort, time, and resources required for treatment.
- Patient satisfaction: Measuring how satisfied patients are with their treatment approach.
- Patient costs: Understanding the financial impact of treatment strategies.
- Safety: Monitoring adverse events and complications from treatments.
Significance:
The QUOTIENT trial is designed to reflect real-world clinical practice, moving beyond procedural or laboratory-driven targets to emphasise patient-reported outcomes and practical effectiveness. It aims to answer a key clinical question: should asymptomatic IBD patients with ongoing subclinical inflammation switch therapies to achieve deeper remission, or should they continue their current therapy?
This study is expected to directly influence clinical guidelines, shared decision-making between patients and physicians, and patient education about treat-to-target strategies in IBD. By prioritising long-term outcomes and real-world applicability, QUOTIENT has the potential to significantly improve the standard of care for IBD patients on advanced therapies.
