Treat-to-Target in Inflammatory Bowel Diseases: Lessons from Screening in a Pragmatic Clinical Trial.

Introduction: Treat-to-target (TTT) for patients with inflammatory bowel disease (IBD) involves treating to clinical and endoscopic remission. Despite control of clinical symptoms, many patients may not achieve endoscopic remission. Real-world prevalence and patient acceptance of staying on current advanced therapy vs switching in this scenario is not well defined. The aim of this study are to report real-world prevalence of symptomatic and endoscopic/radiologic discordance and patient and provider preferences regarding stay or switch advanced therapy in this setting. Methods: In the QUOTIENT trial, we performed screening exercises to estimate the prevalence of symptomatic and endoscopic/radiologic discordance using detailed screening logs for eligible patients. Sites completed screening exercises to identify what proportion of patients are eligible to participate in the QUOTIENT trial and willingness to participate. Results: A total of 761 patients were screened for QUOTIENT with complete data. Of patients in corticosteroid-free symptomatic remission on an advanced therapy, 12% had moderate-to-severe endoscopic inflammation. The most common reason for declining to participate was patients' preference to stay on current advanced therapy (39%). Only 11% preferred switching to advanced therapy as a reason to decline participation. Conclusions: Among patients with IBD who have achieved corticosteroid-free symptomatic remission on advanced therapies, real-world rates of achieving endoscopic remission or mild endoscopic activity are significantly higher than suggested by clinical trials. We observed a strong patient preference to stay on their current advanced therapy, rather than switching to an alternative agent, which contrasts with the providers' framework for treat-to-target.