TY - JOUR
T1 - The effects of Ustekinumab on health-related quality of life in patients with moderate to severe Crohn's disease
AU - Sands, Bruce E.
AU - Han, Chenglong
AU - Gasink, Christopher
AU - Jacobstein, Douglas
AU - Szapary, Philippe
AU - Gao, Long Long
AU - Lang, Yinghua
AU - Targan, Stephan
AU - Sandborn, William J.
AU - Feagan, Brian G.
N1 - Publisher Copyright:
© 2018 European Crohn's and Colitis Organisation (ECCO).
PY - 2018/7/30
Y1 - 2018/7/30
N2 - 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.
AB - 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.
KW - Inflammatory bowel disease questionnaire
KW - Medical outcome survey short form-36
KW - Patient-reported outcomes
UR - http://www.scopus.com/inward/record.url?scp=85055572495&partnerID=8YFLogxK
U2 - 10.1093/ecco-jcc/jjy055
DO - 10.1093/ecco-jcc/jjy055
M3 - Article
C2 - 29726939
AN - SCOPUS:85055572495
SN - 1873-9946
VL - 12
SP - 883
EP - 895
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 8
ER -