Ustekinumab Improves Productivity and Reduces Work Limitation of Patients With Moderate to Severe Crohnʼs Disease: Results From Three Phase 3 Clinical Trials

Introduction: UNITI-1 & 2 and IM-UNITI are Phase 3 studies that evaluate ustekinumab (UST) in moderate-severe active Crohn's disease (CD). This analysis assesses effect of UST on improving work productivity with induction therapy and maintaining improvement in patients (pts) with active CD. Methods: Pts with moderate-severe active CD [defined by CD Activity Index (CDAI) score of 220-450] who had inadequate response or intolerance to anti-TNFs (UNITI-1, N=741) or conventional therapy (UNITI-2, N=639) were randomized 1:1:1 to PBO, UST 6mg/kg IV or UST 130mg SC at Wk 0. Pts who had clinical response to UST at Wk 8 (defined as reduction in CDAI score ≥ 100, or CDAI score < 150 if baseline CDAI ≤ 248) were re-randomized to PBO or UST SC 90mg q12w or q8w through Wk 44 (IMUNITI, N=388). Impact of CD on productivity at work, school or home was measured using a visual analog scale(VAS) of 0-10 (0, no impact; 10, very much impact). Presenteeism (productivity loss on the job) was assessed using Work Limitation Questionnaire(WLQ). WLQ has 4 domains (time management, and physical, mental-interpersonal and output demands); domain scores range 0-100, higher scores indicate > work limitations. Productivity VAS and WLQ outcomes were compared by treatment at baseline, Wk 8 (induction), and 22 and 44 wks after induction (maintenance). Results: At induction baseline, mean productivity VAS values ranged 6.3-6.8, indicating significant impact of CD on productivity, and were comparable across treatments. At Wk 8, UST pts had statistically significantly > improvement in productivity VAS score vs PBO inUNITI-1 & 2 (all p-values < 0.05). Reduction in productivity VAS score from baseline in UST groups combined was -1.6 (23.2% improvement) in UNITI-1 and -2.1 (33.3% improvement) in UNITI-2, compared to PBO (-0.8 [11.9% improvement] in UNITI-1 and -1.1 [17.7% improvement] in UNITI-2, p-values < 0.01). Overall, % improvement from baseline was numerically > for UST vs PBO pts in 3/4 WLQ domains at Wk 8: time management (24.1% vs 17.6%, UNITI-1; 35.1% vs 27.3%, UNIT-2), physical demand (21.2% vs 11.9%, UNIT-1; 25.6% vs 21.9%, UNIT-2), output demand (21.4% vs 20.1%, UNIT-1; 38.3% vs 21.0%, UNIT-2) and mentalinterpersonal demand (19.5% vs 20.3%, UNITI-1; 33.7% vs 24.5%, UNITI-2). Improvements in productivity VAS and WLQ scores were better maintained with UST vs PBO in IM-UNITI through Wk 44. Conclusion: UST improves productivity & reduces work limitations in pts with moderate to severe CD.

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