Long-term Health Outcomes in Patients With Moderate-to-Severe Ulcerative Colitis Treated With Guselkumab: a Model-based Projection
Author(s)
Elise Wu, PhD, Sumesh Kachroo, PhD;
Johnson & Johnson, Horsham, PA, USA
Johnson & Johnson, Horsham, PA, USA
Presentation Documents
OBJECTIVES: Guselkumab, a dual-acting human IgG1 interleukin (IL)-23p19 subunit inhibitor, potently neutralizes IL-23 and binds to CD64, blocking a key pathway in ulcerative colitis (UC). This study modeled long-term health outcomes in guselkumab-treated patients with moderate-to-severe UC by response to prior advanced treatment (ADT).
METHODS: A hybrid decision-analytical model, combining a decision tree for induction and a Markov cohort model for maintenance, estimated time in remission, response, active UC, and surgery over 1, 3, and 5 years for ADT non-failure and ADT-failure patients treated with guselkumab (50%: 100 mg Q8W; 50%: 200 mg Q4W). Probabilities of transition to conventional therapy for selected outcomes were derived from the QUASAR trial, network meta-analysis, and literature.
RESULTS: In the ADT non-failure population, patients spent 32.23%, 39.33%, and 37.14% of time in remission compared to 17.4%, 18.98%, and 15.25% in the ADT failure population at 1-, 3-, and 5-year time horizons, respectively. Time in the response state was numerically greater in the ADT non-failure population (27.65%, 14.86%, and 9.41%) versus the ADT failure population (26.08%, 12.7%, and 7.85% at 1-, 3-, and 5-years, respectively). UC-related surgery time was low in both groups (ADT non-failure: 0.19%, 0.95%, and 1.96% and ADT failure: 0.31%, 1.46%, and 2.86% at 1-, 3-, and 5-years, respectively). The ADT failure population spent numerically greater time in active UC compared with ADT non-failure across all times (56.4%-75.65% versus 40.04%-52.63%). Consequently, the ADT non-failure population remained on guselkumab longer due to extended response/remission periods.
CONCLUSIONS: The model predicts that guselkumab-treated patients with ADT non-failure will spend a greater proportion of time in remission and response and less time in active UC over 1-, 3-, and 5-years versus patients with ADT failure. This reduction in active disease state time may lead to lower healthcare resource utilization and improved quality of life.
METHODS: A hybrid decision-analytical model, combining a decision tree for induction and a Markov cohort model for maintenance, estimated time in remission, response, active UC, and surgery over 1, 3, and 5 years for ADT non-failure and ADT-failure patients treated with guselkumab (50%: 100 mg Q8W; 50%: 200 mg Q4W). Probabilities of transition to conventional therapy for selected outcomes were derived from the QUASAR trial, network meta-analysis, and literature.
RESULTS: In the ADT non-failure population, patients spent 32.23%, 39.33%, and 37.14% of time in remission compared to 17.4%, 18.98%, and 15.25% in the ADT failure population at 1-, 3-, and 5-year time horizons, respectively. Time in the response state was numerically greater in the ADT non-failure population (27.65%, 14.86%, and 9.41%) versus the ADT failure population (26.08%, 12.7%, and 7.85% at 1-, 3-, and 5-years, respectively). UC-related surgery time was low in both groups (ADT non-failure: 0.19%, 0.95%, and 1.96% and ADT failure: 0.31%, 1.46%, and 2.86% at 1-, 3-, and 5-years, respectively). The ADT failure population spent numerically greater time in active UC compared with ADT non-failure across all times (56.4%-75.65% versus 40.04%-52.63%). Consequently, the ADT non-failure population remained on guselkumab longer due to extended response/remission periods.
CONCLUSIONS: The model predicts that guselkumab-treated patients with ADT non-failure will spend a greater proportion of time in remission and response and less time in active UC over 1-, 3-, and 5-years versus patients with ADT failure. This reduction in active disease state time may lead to lower healthcare resource utilization and improved quality of life.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO12
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
SDC: Gastrointestinal Disorders