Ustekinumab improved work productivity in patients with moderate to severe ulcerative colitis: Results from the phase 3 UNIFI induction and maintenance studies

INTRODUCTION:

We evaluated the effect of ustekinumab (UST) on work productivity and daily activity in patients with moderate-severe active ulcerative colitis (UC) in the UNIFI induction and maintenance studies.

METHODS:

In the induction study, patients were randomized to a single intravenous (IV) dose of placebo (PBO, n = 319), UST 130 mg (n = 320), or UST ;6 mg/kg (n = 322). Patients who were in clinical response 8 wks after receiving UST IV induction were eligible for the maintenance study and randomized to subcutaneous (SC) PBO (n = 175), UST 90 mg q12w (n = 172), or UST 90 mg q8w (n = 176). Work productivity was assessed using the Work Productivity and Activity Impairment Questionnaire (WPAI), a validated tool that assesses work time missed (absenteeism), reduced job effectiveness (presenteeism), overall work impairment, and daily activity impairment due to health over the previous week. The impact of UC on overall daily productivity at home, school, and work was assessed using a visual analog scale (VAS, 0 to 10, 0 5 no impact at all, 10 5 impacts very much).

RESULTS:

At induction baseline, patients had a mean percent work time missed ranging from 17.7% to 19.3%, impairment while working from 39.1% to 45.3%, overall work impairment from 43.7% to 49.1%, and activity impairment from 51.8% to 52.8%. At Wk 8, patients who received UST IV had significantly greater improvement in WPAI domains and daily productivity VAS compared with PBO (Table 1). In the maintenance study, UST-treated patients generally maintained or numerically improved WPAI scores, while scores for patients in the PBO group worsened. The mean changes from baseline toWk 44 in work time missed was 4.7% in the SC PBO group, -2.0% (P = 0.133) in the SC UST 90-mg-q12w group, and 2.1% (P = 0.172) in the SC UST 90-mg-q8w group, impairment while working was 7.4%, 21.6 (P = 0.017), and 26.4% (P < 0.001), respectively; overall work impairment was 7.7%, 22.2% (P = 0.013), and 26.1% (P < 0.001), respectively; and activity impairment was 9.3%, 0.8% (P = 0.002), and 24.2% (P < 0.001), respectively. Mean changes from baseline toWk 44 in daily productivity VAS scores were 1.0, 20.2 (P < 0.001), and 20.5 (P < 0.001), respectively.

CONCLUSION:

Patients who received UST IV induction reported significantly greater improvement in work productivity and daily activity compared with PBO. In patients who responded to UST IV induction, those who received UST SC maintenance through Wk 44 sustained or improved the levels of work productivity and activity that were achieved during induction. (Figure Presented).