Health related quality of life results through week 22 from the CERTIFI study, a multicenter, randomized, double-blind, placebo-controlled phase2b study of Ustekinumab in patients with moderately to severely active Crohnʼs disease

In the Phase 2b CERTIFI study, ustekinumab (UST) has been shown to induce and maintain clinical response in patients with moderate-to-severe Crohn's disease (CD) who had previously failed (lack of initial response or subsequent loss of response) or did not tolerate TNF antagonist(s). This analysis examines the impact of UST on health-related quality of life (HRQOL) in CD over the course of induction and maintenance through 22wks of treatment. Patients with a CDAI score ≥ 220 and ≤ 450 who had previously failed or been intolerant of ≥1 TNF antagonists were randomized (1:1:1:1) to receive IV PBO or UST (1-, 3-, or 6-mg/kg) at wk0. At wk8 patients who received IV UST induction and were either responders (≥100 CDAI decrease) or non-responders at wk6 were re-randomized separately to SC maintenance therapy with 90mg UST or PBO at wks8 and 16, and assessed for maintenance efficacy at wk22. The inflammatory bowel disease questionnaire (IBDQ), assessing the 4 dimensions of bowel symptoms, emotional function, systemic symptoms, and social function, was administered at wks0 (baseline), 6 and 22. Mean change from baseline in IBDQ and each dimension of the IBDQ, as well as the proportion of patients achieving a minimal clinically important difference (MCID), defined as a ≥16 point improvement from baseline in IBDQ, were assessed at wk6 and wk22. In CERTIFI (N=526), median age was 38 years and 58.7% of patients were female. In the induction phase, among the 500 patients analyzable for IBDQ, the combined patients randomized to IV UST had a baseline mean (SD) IBDQ score of 115.5(28.64) vs 119.5(26.69) for IV PBO. For the 1-, 3-, and 6-mg/kg IV UST doses, mean improvement from baseline in IBDQ at wk6 (19.9, 22.7, and 24.8, respectively) was statistically significant vs that seen with PBO (11.8), (p<0.05 for all comparisons). The proportion of patients with a MCID at wk6 was 33.1% on PBO vs. 45.0% on IV UST 1 mg/kg (p=.057), 47.7% on 3 mg/kg (p=.018), and 54.7%among those randomized to 6 mg/kg (p<0.001). Changes in IBDQ dimension scores from baseline to wk6 (bowel symptoms, emotional function, systemic symptoms, and social function) were each significantly improved in combined IV UST vs. IV PBO patients, (p<0.05 for all comparisons). Of the 145 responders to IV UST induction therapy who were re-randomized in the maintenance phase, the mean(SD) IBDQ score at wk22 was 158.8(38.58) among those who continued to receive SC UST, vs 138.5(39.71) of patients rerandomized to SC PBO (p<0.001). The proportion of patients with a MCID was 68.1% (47/69) among those who continued to receive SC UST vs 44.9% (31/69) of patients re-randomized to SC PBO (p=0.005). At wk22, mean IBDQ dimension scores in wk6 UST responders remained significantly higher with SC UST compared to SC PBO maintenance, (p<0.05 for all comparisons). In patients with moderate-to-severe CD who had failed previous TNF antagonist(s), IV UST induction therapy significantly improved HRQOL compared to PBO. During maintenance with SC UST, significant improvement in HRQOL in responders to induction was maintained through wk22.

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