P597 The effects of infliximab treatment failure on health-related quality of life and work productivity in patients with Crohn's disease
C. Steenholdt*1, J. Brynskov1, O.Ø. Thomsen1, L.K. Munck2, L.A. Christensen3, G. Pedersen4, J. Kjeldsen5, M.A. Ainsworth1
1Herlev Hospital, Dept of Gastroenterology, Herlev, Denmark, 2Køge Hospital, Dept. of Medical Gastroenterology, Køge, Denmark, 3Aarhus Hospital, Dept. of Hepatology and Gastroenterology V, Aarhus, Denmark, 4Hvidovre Hospital, Dept. of Gastroenterology, Hvidovre, Denmark, 5Odense Hospital, Dept. of Medical Gastroenterology S, Odense, Denmark
A notable proportion of patients with Crohn's disease experience relapse of disease activity despite ongoing infliximab (IFX) therapy. While handling IFX treatment failure is clinically and financially demanding, little is known about the impact on health-related quality of life (HRQOL) and work productivity in this situation.
Pre-defined analysis of a 20-week randomized controlled clinical trial where 69 Crohn's disease patients (55 luminal, 7 fistulizing, 7 both) with IFX treatment failure (CDAI ≥220 or ≥1 draining perianal fistula) had been randomized to intensified IFX regimen or personalized therapy defined by IFX and anti-IFX antibody levels.(1) HRQOL was assessed using the Short Inflammatory Bowel Disease Questionnaire (IBDQ). Productivity was assessed by the Work Productivity and Activity Impairment Questionnaire for Crohn's disease (WPAI:CD). NCT00851565.
The IBDQ score at manifestation of IFX treatment failure was median 40, and this concurred with impaired HRQOL. Patients with clinical response (CDAI decrease of ≥70 or ≥50% reduction of active fistulas) had significant improvement in IBDQ scores at all study visits: IBDQ score increased median 11 at week 4 and 8, and 13 at week 12 and 20 (p<0.001). In contrast, non-responders had a very modest increase in IBDQ scores and only at week 12 and 20 (median 4, p< 0.05). Among employed patients (55%), missed time on work due to Crohn's disease was very low both at time of manifestation of IFX treatment failure (median 0%) and throughout all subsequent study visits (all medians 0%, p >0.05). Furthermore, absenteeism was not significantly influence by clinical outcomes (p>0.05). On the other hand, impairment while working was relatively high at time of IFX failure (median 40%), and this figure decreased only among responders at subsequent study visits (week 4 median 10%, p< 0.05; week 8 30%, p >0.05; week 12 30%, p<0.01; week 20 10%, p<0.01). The overall daily activity impairment, irrespectively of employment status, was high at IFX treatment failure (median 70%), and decreased over time in responders (median at week 4, 8, 12, 20 was 20%, 30%, 30%, and 20%; p<0.001), and to a lesser extent also in non-responders (50%, p< 0.01; 55%, p >0.05; 30%, p<0.05; and 40%, p<0.05).
Therapeutic failure of IFX immediately causes major impairment of HRQOL and daily activity status, but patients who regain clinical response recover rapidly. Even though employed patients comprise a robust subgroup with a high threshold for absenteeism, IFX failure results in substantially lowered work productivity. Indirect disease related costs should be taken into account when evaluating consequences of IFX failure.
(1) Steenholdt et al. Gut 2014; 63:919-27