P573 Change in fatigue in patients with Ulcerative Colitis or Crohn’s disease initiating vedolizumab or other biologic therapy: Data from Belgian registry patients
Louis, E.(1)*;Bossuyt, P.(2);Colard, A.(3);Caenepeel, P.(4);Baert, F.(5);Hantson, A.(6);Van Gassen, G.(6);Zhou, J.(7);Vermeire, S.(8);
(1)University Hospital CHU of Liège, Department of Gastroenterology, Liège, Belgium;(2)Imelda General Hospital, Imelda GI Clinical Research Center, Bonheiden, Belgium;(3)Hospital CHC, Department of Gastroenterology, Liège, Belgium;(4)Ziekenhuis Oost Limburg, Department of Gastroenterology, Genk, Belgium;(5)AZ Delta, Department of Gastroenterology, Roeselare, Belgium;(6)Takeda, Gastroenterology, Brussels, Belgium;(7)Takeda, Gastroenterology, Cambridge- MA, United States;(8)University Hospitals Leuven, Department of Gastroenterology, Leuven, Belgium;
Background
Fatigue in patients (pts) with ulcerative colitis (UC) and Crohn’s disease (CD) is associated with decreased quality of life. This analysis aimed to describe fatigue evolution and identify factors associated with time to fatigue disappearance or fatigue persistence at 1 year among pts initiating vedolizumab (VDZ) or other biologic treatment (tx).
Methods
Post-hoc analysis of fatigue registry data of Belgian pts being followed in a prospective real-world safety study (PASS; NCT02674308). Pts ≥18 years with UC or CD initiating VDZ or other biologics with no prior VDZ exposure were included. Pts completed the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and physicians collected disease characteristics at baseline and 6-month intervals (4.5-year follow-up). Fatigue persistence was defined by 2 consecutive FACIT-F scores of <40, and fatigue disappearance (in pts with baseline fatigue) by a FACIT-F score of >40. Factors associated with time to fatigue disappearance and fatigue persistence at 1 year were assessed using multivariate regression.
Results
This analysis included 465 pts with UC (n=174) or CD (n=291) who initiated VDZ (n=259) or other biologic tx (n=206) at registry enrolment (Table 1 for baseline characteristics). Change in FACIT-F scores among all pts (Figure 1) showed an improvement in fatigue in the first 6-months following tx initiation before stabilising for the remainder of the study. The Kaplan-Meier estimate for time to fatigue disappearance (Figure 2) indicated fatigue disappearance occurred in 2.1%, 6.2% and 14.2% of pts with baseline fatigue at 6, 12 and 24-months respectively. In pts with baseline fatigue, lower likelihood of fatigue persistence was associated with achieving clinical remission (OR 0.31 [0.16, 0.60]). Probability of fatigue disappearance per unit of time was estimated to be higher in pts with UC vs CD (HR 1.53 [1.07, 2.21]) and in pts achieving vs not achieving clinical remission (HR 2.02 [1.18, 3.48]) and lower in pts with vs without extra-intestinal manifestations at baseline (HR 0.62 [0.39, 0.99]). No associations were observed between fatigue persistence/disappearance and tx group, demographics, disease duration, tx history, use of other medication, history of or active fistula, IBD surgery or clinical response.
Conclusion
These real-world findings suggest fatigue in pts initiating VDZ or other biologic therapy for UC or CD improves in the first 6 months of treatment before stabilising over time. Clinical remission was associated with a lower likelihood of fatigue persistence and shorter time to fatigue disappearance.