Health-Related Quality of Life of Patients Treated with Biological Agents and New Small-Molecule Drugs for Moderate to Severe Crohn's Disease: A Systematic Review.

Crohn’s disease (CD) leads to a poor health-related quality of life (HRQoL). This review aimed to investigate the effect of biological agents and small-molecule drugs in improving the HRQoL of patients with moderate to severe CD. We adopted a systematic protocol to search PubMed and Cochrane Central Register of Controlled Trials (CENTRAL), which was supplemented with manual searches. Eligible studies were RCTs that matched the research objective based on population, intervention, comparison and outcomes. Studies in paediatric populations, reviews and conference abstracts were excluded. Covidence was used for screening and data extraction. We assessed all research findings using RoB2 and reported them narratively. We included 16 multicentre, multinational RCTs in this review. Of the 15 studies that compared the effect of an intervention to a placebo, 9 were induction studies and 6 investigated maintenance therapy. Of these, 13 studies showed a significant (p < 0.05) improvement in the HRQoL of patients with CD. One non-inferiority study compared the intervention with another active drug and favoured the intervention. This systematic review reported a substantial improvement in the HRQoL of patients with CD using biological agents and small-molecule drugs. These pharmaceutical substances have the potential to improve the HRQoL of patients with CD. However, further large clinical trials with long-term follow-up are essential to validate these findings.