The effects of Ustekinumab on health-related quality of life in patients with moderate to severe Crohn's disease

Bruce E. Sands, Chenglong Han, Christopher Gasink, Douglas Jacobstein, Philippe Szapary, Long Long Gao, Yinghua Lang, Stephan Targan, William J. Sandborn, Brian G. Feagan

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

Abstract

Background and Aims: We assessed the effect of ustekinumab on health-related quality of life [HRQOL] in adults with Crohnfs disease [CD]. Methods: Patients with moderately to severely active CD and inadequate response or intolerance to tumour necrosis factor antagonists [UNITI-1, n = 741], or conventional therapy [UNITI-2, n = 627] were randomised to placebo, ustekinumab 130 mg, or 6 mg/kg intravenous induction therapy. At Week 8, ustekinumab-treated responders (Crohnfs Disease Activity Index [CDAI] reduction .100 or CDAI <150 points) were re-randomised to subcutaneous maintenance therapy [IM-UNITI, n = 388] with placebo, ustekinumab 90 mg every 12 weeks [q12w], or ustekinumab 90 mg every 8 weeks [q8w], for 44 additional weeks. Inflammatory Bowel Disease Questionnaire [IBDQ] and 36-item Short Form Health Survey [SF-36] physical component summary [PCS] and mental component summary [MCS] scores were completed at induction baseline and Week 8, and at 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. 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. Conclusions: Ustekinumab improved HRQOL in patients with moderately to severely active CD.

Original languageEnglish
Pages (from-to)883-895
Number of pages13
JournalJournal of Crohn's and Colitis
Volume12
Issue number8
DOIs
StatePublished - 30 Jul 2018

Keywords

  • Inflammatory bowel disease questionnaire
  • Medical outcome survey short form-36
  • Patient-reported outcomes

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