Impact of Biological Therapies and Tofacitinib on Real-world Work Impairment in Inflammatory Bowel Disease Patients: A Prospective Study

Abstract

Background: There are limited real-world data on the change in total work impairment (TWI) in biological-treated patients with inflammatory bowel disease (IBD). This study aimed to evaluate the real-world effects of initiating biological therapy or tofacitinib on change in TWI in IBD patients.

Methods: This multicenter prospective cohort study enrolled IBD patients who started treatment with biological therapy or tofacitinib. Subjects completed the work productivity and activity impairment (WPAI) questionnaire and short inflammatory bowel disease questionnaire at therapy initiation and at week 26. Total work impairment comprises working hours missed due to sick leave and impact of disease during working hours (range 0%-100%). Clinical disease activity was assessed using the Harvey-Bradshaw Index and Simple Clinical Colitis Activity Index (SCCAI).

Results: We included 137 IBD patients for analyses (median age 38 years, 58% Crohn's disease [CD]). The median baseline TWI was 50% and decreased by a median of 10%-points of points after 26 weeks. Patients with continued biological therapy or tofacitinib use, clinical disease activity at baseline, and clinical response or remission at week 26 showed a greater median TWI reduction (22%-points) than the remaining study patients (7%-points; P = .014). Ulcerative colitis (UC) and IBD-unclassified (IBD-U) patients showed a greater median TWI reduction (26%-points) than CD patients (6%-points); P = .041. Correlations were observed between decrease in TWI and decrease in SCCAI, decrease in fatigue and increase in quality of life.

Conclusions: Work impairment in IBD patients decreased following biological therapy or tofacitinib initiation. Patients achieving clinical remission or response showed the greatest improvement, especially UC and IBD-U patients.

Keywords: biologicals; inflammatory bowel disease; patient-reported outcomes; quality of life; work impairment.

Figure 1.

Violin plots for total work impairment stratified for patients with clinical disease activity at baseline (Harvey-Bradshaw Index (HBI) ≥5 or Simple Clinical Colitis Activity Index (SCCAI) ≥3) and clinical response (HBI reduction ≥3 or SCCAI reduction ≥2) or clinical remission (HBI < 5 or SCCAI < 3) at week 26, and continued use of the of biological therapy or tofacitinib at week 26 (n = 57) compared with the remaining patients in the study population (n = 80). The thick dotted line represents the median value and the thin dotted lines represent the 25^th and 75^th percentiles.

Figure 2.

Violin plots for total work impairment stratified for patients diagnosed with ulcerative colitis and inflammatory bowel disease-unclassified (n = 57) vs Crohn’s disease (n = 80). The thick dotted line represents the median value, and the thin dotted lines represent the 25th and 75th percentiles. Abbreviations: UC, ulcerative colitis; IBD-U, inflammatory bowel disease-unclassified.