Benefit-risk trade-offs among patients and providers selecting advanced therapy for moderate-to-severe ulcerative colitis

Introduction: As ulcerative colitis (UC) advanced therapy (AT) options expand, understanding the benefit-risk trade-offs acceptable to patients and providers is increasingly important. Methods: A discrete choice experiment quantified preferences for six benefit-risk attributes of AT among patients with moderate-to-severe UC and providers in the US and Europe. Relative attribute importance (RAI), maximum acceptable risk (MAR), and simultaneous MAR thresholds (SMARTs) were calculated. Patient results were stratified by prior AT experience. Results: The combination of remission and corticosteroid-free remission at one year was most important to patients (N=557; RAI 40.1%) and providers (N=500; RAI 51.1%) followed by 5-year cancer risk (31.7% and 25.7%, respectively). Providers had a higher MAR for cancer than patients (4.0% vs 2.5%) and were willing to accept some higher joint risks of major adverse cardiovascular events (MACE) and cancer in exchange for increased probability of remission. Among AT-naïve patients, RAIs for remission and cancer risk were 36.0% and 35.3%, respectively, compared to 43.1% and 28.8% among AT-experienced patients. AT-experienced patients had a higher MAR for cancer versus AT-naïve patients (2.9% vs 1.8%) and were willing to accept some higher joint risks. Across all groups, when risks were considered jointly, risk tolerance decreased. Conclusions: Likelihood of remission and cancer risk were the most important to both patients and providers. Both groups were willing to make benefit-risk trade-offs, however, some differences emerged between patients and providers, and among patients by AT experience. Findings highlight the need for shared decision-making and communication about the complete benefit-risk profiles of AT options.