Background and Aim
Normalizing healthârelated quality of life (QoL) and fatigue are important longâterm treatment targets in inflammatory bowel disease (IBD). We examined their evolution in relation to changes in disease activity during vedolizumab therapy.
Methods
Cohort study of biologically refractory IBD patients treated with vedolizumab. Patients were prospectively evaluated at all infusions by Short Health Scale (SHS) (QoL questionnaire covering four health dimensions) (n = 79), visual analogous scale for fatigue (VASâF) (n = 30), and clinical disease activity. Objective disease assessment was carried out after 1 year or at treatment failure.
Results
Patients in steroidâfree clinical remission at end of induction improved significantly in all SHS items already from week 2 with full implementation by week 14 (âSymptomsâ 59% improvement, PÂ <Â 0.001; âFunctionâ 63%, PÂ <Â 0.001; âWorriesâ 59%, PÂ <Â 0.001; âWellâbeingâ 40%, PÂ <Â 0.01). Then, SHS remained stable at background levels (<Â 20) for 1Â year (improvements 67%; 65%; 62%; 57%; PÂ <Â 0.001). Combined clinicalâobjective remission at 1Â year was associated with highest SHS improvements (64â72%; PÂ <Â 0.001). Of note, early SHS improvements preceded manifestation of clinical remission in most patients (22 of 33; 67%). Clinical response materialized into late (week 6 or later) and minor SHS improvements (31â46%, PÂ <Â 0.001). Fatigue improved steadily over 6Â months to background levels (VASâFÂ <Â 4) among patients in clinical remission (45% decrease) or clinicalâobjective remission (41%). SHS and VASâF impairment remained elevated in patients without effect of therapy.
Conclusion
QoL rapidly improves and predicts later significant clinicalâobjective efficacies of vedolizumab at end of induction and 1Â year. Fatigue improves slowly after remission is attained.