Predictors of health-related quality of life in patients with Crohn’s disease receiving biological therapy

Abstract

Background and Aim

Health-related quality of life (HRQoL) is impaired in patients with Crohn’s disease (CD). This study aimed to identify the impact of clinical disease activity on HRQoL in CD patients treated with biological agents.

Methods

Patients with moderate to severe active CD treated with biological agents in Denmark were included from 2016–2018. Disease related symptoms were assessed via the Harvey Bradshaw Index. HRQoL was measured on the Short Health Scale (SHS). Multivariable linear regression models were conducted separately for each SHS item and average SHS score stratified for sex, adjusting for clinical manifestation and age.

Results

In total, 1,181 CD patients were included. The mean age was 33 years and 56% were women. Abdominal pain (range of regression coefficients 1.18–1.42), number of liquid stools (0.33–0.58), and the appearance of a new rectal fistula (0.91–1.32) affected all domains in the SHS negatively for men and women. Arthralgia (0.47–0.67) and abdominal mass (0.54–0.62) affected 4 out of 5 items on SHS negatively for women and men, respectively. Female sex was found a predictor of lower HRQoL across all SHS items, whereas age and fistulizing disease, as phenotype, were not associated with lower HRQoL.

Conclusions

Abdominal pain, number of liquid stools, a new rectal fistula, arthralgia for women, clinically assessed abdominal mass for men as well as female sex, were all found to be predictors of decreased HRQoL.

Keywords:

• Health-related quality of life
• Crohn’s disease
• biological treatment
• Harvey Bradshaw index
• short health scale
• clinical activity indices
• epidemiology

Acknowledgements

The authors thank all clinical staff involved in the process of collecting data at the hospitals as well as staff from the Danish National Registry for Biological Therapy of Inflammatory Bowel Diseases enabling us to make this study.

Ethical approval

Complying with European data protection rules, the University of Southern Denmark approved the data processing activities regarding this project and registered the project (journal no. 18/1353). According to Danish law, review by an ethics board or patient consent is not required for purely register-based studies.

We are according to the EU and Danish data protection legislation not allowed to submit the data or give access to the data used for the analyses.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The authors of this article are, by Danish law, not permitted to share individual-level data. Researchers can apply for data access through the Danish National Clinical Registries [33].

Additional information

Funding

This study was funded by the Research Unit of General Practice, Odense, Denmark.