Natural History and Longitudinal Disease Outcomes
Background and aims: Crohn’s disease (CD) is a progressive disease that often leads to complications requiring pharmaceutical and surgical interventions. There is no standard definition of disease progression. The Crohn’s & Colitis Foundation IBD Plexus program formed a Workgroup to address unmet need for CD patients who progress despite treatment. The study aimed to develop a CD progression score using longitudinal, registry data linked to claims and assess if real world data allows for categorizing CD patients with progression.
Methods: CD patients in the IBD Plexus and HealthVerity® dataset were observed from diagnosis (index) until disease progression or endpoint, defined as three or more CD surgeries or total colectomy. A progression score was developed utilizing clinical factors, and patients were categorized into low, moderate, or high progression on index. Progression criteria were weighted based on expected relative impact on progression. Kaplan Meier estimation was used to examine time to endpoint and confirm that patients in each category had distinct survival curves. The categorization and potential utility of the score was evaluated using an extended Cox proportional hazards model.
Results: 2,229 CD patients were categorized on index and each time they progressed to a new category or endpoint. Survival analysis confirmed that progression score categories created were distinct. Model results further demonstrated the score’s utility, as each subsequent progression category was increasingly associated with progression or endpoint.
Conclusion: The authors hope development of this score will help clinicians better understand the progression journey of patients and encourage future research to reduce disease burden by halting or slowing disease progression.