Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA

Simon Travis, Brian G Feagan, Laurent Peyrin-Biroulet, Remo Panaccione, Silvio Danese, Andreas Lazar, Anne M Robinson, Joel Petersson, Brandee L Pappalardo, Mareike Bereswill, Naijun Chen, Song Wang, Martha Skup, Roopal B Thakkar, Jingdong Chao

Research output: Contribution to journalArticle

Abstract

Background and Aims: Randomised trials have described the benefits of adalimumab [ADA] for ulcerative colitis [UC]; however, few data are available on health-related quality of life [HRQL] and health care costs in clinical practice.

Methods: InspirADA, a multicentre, prospective study, evaluated the effect of ADA in patients with moderate to severe UC treated according to usual clinical practice. Outcomes assessed were: Simple Clinical Colitis Activity Index [SCCAI] response/remission rates; changes in HRQL; all-cause direct costs; and UC-related direct and indirect costs from baseline to Week 26.

Results: Data from 463 patients were analysed. At Week 26, 67% (95% confidence interval [CI]: 62%, 71%) of patients achieved response; 48% [95% CI: 44%, 53%] were in remission. For the overall population, significant [all p < 0.001] improvements from baseline to Week 26 were observed for the Short Inflammatory Bowel Disease Questionnaire [SIBDQ] (mean change ± standard deviation [SD]: 17.4 ± 14.5) and the European Quality of Life-5 Dimensions-5 Level [EQ-5D-5L] (index: 0.1 ± 0.2; visual analogue scale [VAS]: 19.5 ± 25.8). Parallel improvements were seen in work productivity [11% absolute decrease in absenteeism; 25% absolute decrease in impairment while working; and 27% absolute decrease in impairment of ability to perform daily activities, all p < 0.001]. Among study completers, cumulative all-cause medical costs and UC-related medical costs were significantly [both p < 0.001] reduced by 59% and 77%, respectively, 6 months after initiation of therapy compared with the preceding 6 months. The safety profile of ADA was consistent with that observed in previous clinical trials.

Conclusions: ADA therapy in usual clinical practice is effective at improving and maintaining symptomatic control, improving HRQL, and decreasing costs of medical care among patients with UC.

Original languageEnglish
Pages (from-to)1317-1325
Number of pages9
JournalJournal of Crohn's & colitis
Volume11
Issue number11
DOIs
Publication statusPublished - Oct 27 2017

Keywords

  • Journal Article

Fingerprint Dive into the research topics of 'Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA'. Together they form a unique fingerprint.

  • Cite this

    Travis, S., Feagan, B. G., Peyrin-Biroulet, L., Panaccione, R., Danese, S., Lazar, A., Robinson, A. M., Petersson, J., Pappalardo, B. L., Bereswill, M., Chen, N., Wang, S., Skup, M., Thakkar, R. B., & Chao, J. (2017). Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA. Journal of Crohn's & colitis, 11(11), 1317-1325. https://doi.org/10.1093/ecco-jcc/jjx093