Investigating fatigue in vedolizumab-treated patients with ulcerative colitis or Crohn’s disease from a Belgian registry

Abstract

S503 social functioning; Work Productivity and Activity Impairment questionnaire (WPAI) for work productivity; State-Trait Anxiety Inventory (STAI 1,2), for psychological assessment. IBD activity was measured by Partial Mayo score. Student's t test or Wilcoxon rank sum test were used to compare continuous variables between subgroups and chi-square test to compare categorical variables. Univariate and multi-variate linear regression were used, respectively, to assess the relationship between psychosocial and disease characteristics and to compare outcomes with determinant associated results in univariate regression. Results: Univariate analysis showed a statistically significant correlation of the overall QFS score with both the level of education (0.6; 95% CI = 0.1-1.2; p = 0.028) and the unemployed status (-4.5; 95% CI =-8.9-0.1; p = 0.044). Moreover, the impairment of WPAI was greater in subjects with ulcerative colitis with severe endoscopic activity according with Partial Mayo score (15.5; 95% CI = 1.0-30.0; p = 0.038). Overall impairment in subjects with stable employment correlated with age (-0.5; 95% CI =-0.9-0.1; p = 0.010) and was greater in subjects who underwent at least one surgical operation (15.8; 95% CI = 3.0-28.6; p = 0.016). Psychological evaluation showed that state and trait anxiety correlated significantly with Partial Mayo score (re-spectively 1.8; 95% CI = 0.6-2.7; p = 0.004 and 1.3; 95% CI = 0.1-2.5; p = 0.042) and age (respectively-0.2; 95% CI =-0.3-0.1; p = 0.028 and-0.3; 95% CI =-0.5-0.1; p = 0.037). State anxiety increased in case of long-standing illness (-0.3; 95% CI =-0.5-0.1; p = 0.037), while the non-worker status correlated with trait anxiety when compared to paid employment (-7.0; 95% CI =-0.9-13.1; p = 0.026). Conclusion: Social functioning was correlated to the employment status and to the level of education. Work productivity was lower in UC patients with severe activity and who undergone at least one surgery related to IBD. The state of anxiety was related with age, duration and activity of illness, while the trait of anxiety was major in non-worker patients. Background: Vedolizumab (VDZ) has demonstrated remission in ul-cerative colitis (UC) and Crohn's disease (CD), but its impact on patient (pt) fatigue is not well understood. Herein we report interim fatigue analysis data from a Belgian registry of VDZ-treated pts. Methods: Ad-hoc analysis from the prospective observational Belgian VDZ registry (started, November 2016; data cutoff, February 2019), a sub-study of the European VDZ post-authorization safety study (ENcePP EUPAS6469) included pts aged ≥18 years with UC or CD with ongoing VDZ intravenous therapy (≥2 weeks) at recruitment. At baseline (recruitment) and every 6 months, physicians collected data (follow-up was 3 years or 1 year after last dose if VDZ was discontinued [whichever occurred first] and pts completed the 13-Item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Clinical remission was defined as Harvey-Bradshaw Index (HBI) score <5 for CD, and partial Mayo score (pMS) <2 with no individual subscore >1 for UC. This analysis explored the association (using generalized estimating equations) between all available FACIT-F total scores and baseline demographic, clinical, and treatment characteristics in the treatment analysis set (TAS; pts had ≥1 VDZ dose and ≥1 year of follow-up records). Results: The registry enrolled 202 VDZ-treated UC and CD pts from 19 Belgian centres. TAS included 141 pts (UC 47, CD 94); median follow-up was 537 days; 140/141 pts had ≥1 FACIT-F score. In the UC and CD groups, respectively, 68% and 42% of pts were male; median (IQR) age at index date was 51 (37-59) and 40 (29-52); and baseline median (IQR) FACIT-F total score was 39 (32-46) and 32 (24-40). Lower FACIT-F score (more fatigue) was associated with higher pMS in UC (p<0.001), and higher HBI score (p=0.01) and having ongoing fistulas at baseline (p=0.01) in CD (Table). Less fatigue was associated with being in remission at baseline in both UC and CD (p<0.01). Being male was associated with less fatigue in the overall population and CD (p<0.01), but not in UC alone. Baseline occurrence of extra intestinal manifestations (EIMs) was associated with more fatigue in the overall group (p=0.037); however few pts (UC 4; CD 8) had EIMs. UC pts had less fatigue than CD pts (p=0.004). From baseline to month 24, the change in median (IQR) FACIT-F total score was-3.0 (-12.0 to 5.0) points for UC and 3.5 (-1.0 to 18.0) for CD. Conclusion: These real-world data from a long-term registry study of VDZ-treated pts in Belgium demonstrate that higher pMS and HBI score, active fistulae, and EIM occurrence at baseline may be associated with more fatigue in IBD pts. Pts treated with VDZ had no significant change in FACIT-F total score over 24 months.