Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2022 May;55(9):1151-1159.
doi: 10.1111/apt.16805. Epub 2022 Feb 15.

Resolution of dominant patient-reported outcome at end of induction predicts clinical and endoscopic remission in Crohn's disease

Emily C L Wong  1 , Parambir S Dulai  2 , John K Marshall  1 , Vipul Jairath  3 , Walter Reinisch  4 , Neeraj Narula  1
Affiliations
Clinical Trial

Resolution of dominant patient-reported outcome at end of induction predicts clinical and endoscopic remission in Crohn's disease

Emily C L Wong et al. Aliment Pharmacol Ther. 2022 May.

Abstract

Background: It is unclear whether improvement in patient-reported outcomes (PROs) relative to baseline symptom burden in Crohn's disease (CD) is associated with subsequent endoscopic remission.

Aim: To evaluate the relationship between dominant PRO resolution post-induction and achievement of clinical and endoscopic remission.

Methods: This post-hoc analysis of clinical trial data from 251 participants evaluated the relationship between the resolution of the dominant PRO (most severely elevated baseline PRO) or clinical response (CDAI ≥100 reduction) after induction therapy with biologics (post-induction) and 1-year clinical remission (CDAI <150) and/or endoscopic remission (SES-CD <3). Multivariate logistic regression models evaluated the relationship between post-induction-dominant PRO resolution and 1-year outcomes adjusted for confounders.

Results: Participants with dominant PRO resolution post-induction had higher odds of combined endoscopic and clinical remission compared to those without resolution (aOR: 1.94 [95% CI: 1.01-3.74], P = 0.047). Combining dominant PRO resolution with post-induction endoscopic response (SES-CD ≥50% reduction) was associated with higher odds of 1-year endoscopic and clinical remission (aOR: 6.89 [95% CI: 1.65-28.72], P = 0.008). Clinical and PRO2 response (≥30% decrease in stool frequency and/or ≥30% decrease in abdominal pain score and both not worse than baseline) at post-induction did not predict these outcomes. No significant differences were observed with 1-year endoscopic remission for post-induction-dominant PRO resolution, clinical or PRO2 response.

Conclusions: Post-induction resolution of dominant PRO, but not clinical or PRO2 response, was strongly associated with 1-year endoscopic and clinical remission. Resolution of dominant baseline PRO after induction therapy may be informative for 1-year outcomes. Further validation is required.

Keywords: Crohn’s disease; inflammatory bowel disease; patient-reported outcomes.

PubMed Disclaimer

Comment in

References

REFERENCES

    1. Baumgart DC, Sandborn WJ. Crohn’s disease. Lancet. 2012;380(9853):1590-1605.
    1. De Cruz P, Kamm MA, Prideaux L, Allen PB, Moore G. Mucosal healing in Crohn’s disease: a systematic review. Inflamm Bowel Dis. 2013;19(2):429-444.
    1. Khanna R, Zou G, D'Haens G, et al. A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn’s disease activity. Aliment Pharmacol Ther. 2015;41(1):77-86.
    1. Schoepfer AM, Beglinger C, Straumann A, et al. Fecal calprotectin correlates more closely with the simple endoscopic score for Crohn’s disease (SES-CD) than CRP, blood leukocytes, and the CDAI. Am J Gastroenterol. 2010;105(1):162-169.
    1. Cellier C, Sahmoud T, Froguel E, et al. Correlations between clinical activity, endoscopic severity, and biological parameters in colonic or ileocolonic Crohn’s disease. A prospective multicentre study of 121 cases. The Groupe d’Etudes Therapeutiques Des Affections Inflammatoires Digestives. Gut. 1994;35(2):231-235.

Publication types

Substances

LinkOut - more resources