The Effects of Ustekinumab on Health-Related Quality of Life in Patients with Moderate to Severe Crohn’s Disease.
J Crohns Colitis. 2018 May 03;:
Authors: Sands BE, Han C, Gasink C, Jacobstein D, Szapary P, Gao LL, Lang Y, Targan S, Sandborn WJ, Feagan BG
Background and Aims: We assessed the effect of ustekinumab on health-related quality of life (HRQOL) in adults with Crohn’s disease (CD).
Methods: Patients with moderately-to-severely active CD and inadequate response or intolerance to tumor necrosis factor antagonists (UNITI1, N=741), or conventional therapy (UNITI-2, N=627) were randomized to placebo, ustekinumab 130 mg, or 6 mg/kg intravenous induction therapy. At Week 8, ustekinumab-treated responders (CDAI reduction≥100 or CDAI<150 points) were re-randomized to subcutaneous maintenance therapy (IM-UNITI, N=388) with placebo, ustekinumab 90mg q12w, or q8w for 44 additional weeks. Inflammatory Bowel Disease Questionnaire (IBDQ) and 36item Short Form Health Survey (SF36) PCS and MCS scores were completed at induction baseline and Week 8, and maintenance Weeks 20 and 44. Clinically-meaningful improvement in IBDQ, and PCS and MCS scores were evaluated. For all HRQOL outcomes, each ustekinumab dose and placebo were compared with placebo.
Results: Induction baseline mean values of IBDQ, PCS and MCS were similar across groups, but impaired relative to general population norms. At Week 8 ustekinumab induced greater improvement than placebo in both HRQOL scores. Significantly greater proportions of patients receiving ustekinumab 6 mg/kg or 130 mg had clinically-meaningful IBDQ improvement (UNITI-1: 54.8%, 46.9% versus 36.5%, respectively; UNITI-2: 68.1%, 58.7% versus 41.1%, respectively; p<0.05, all comparisons). Similarly, greater proportions of ustekinumab-treated patients in both studies had clinically-meaningful improvements in PCS and MCS as compared with placebo. At Week 44, improvements in IBDQ, PCS, and MCS scores were maintained with ustekinumab.
Conclusion: Ustekinumab improved HRQOL in patients with moderately-to-severely active CD.
Clinical Trail: ClinicalTrials.gov, NCT 01369329 [UNITI1]; ClinicalTrials.gov, NCT 01369342 [UNITI-2]; ClinicalTrials.gov, NCT 01369355 [IM-UNITI].
PMID: 29726939 [PubMed – as supplied by publisher]