Digital patient-reported outcomes to evaluate treatment response to filgotinib in patients with ulcerative colitis.

OBJECTIVE

Patient-reported outcomes (PROs) are valuable tools for improving long-term patient outcomes and providing patient-centered care. PROs can be used to investigate real-world treatment effectiveness in patients with a chronic inflammatory disease.

METHODS

This was a real-world cohort study with digital patient-reported data collection by patients with ulcerative colitis (UC) using TrueColours-IBD, a web-based platform for prospective monitoring of symptoms, quality of life, and outcomes in Oxford. Effectiveness of filgotinib was compared between advanced therapy-naïve (ATN, i.e. filgotinib 1st line, n = 44) and advanced therapy-experienced (ATE, i.e. prior biological/small-molecule therapy, n = 56) patients using the following outcomes, evaluated post-induction (8-12 weeks) and at 6 and 12 months: clinical remission (Simple Clinical Colitis Activity Index (SCCAI) ≤2), clinical response (≥2 point SCCAI reduction from baseline), corticosteroid-free remission (defined as clinical remission without any prednisolone or budesonide in the 12 weeks preceding that time point), and treatment discontinuation (defined as stopped prescription of the medication).

RESULTS

There were no significant differences between the ATN and ATE groups regarding clinical remission, response, and corticosteroid-free remission at any time point, with P values > 0.1. More than half of the patients in each group achieved clinical remission and response at all time points. Filgotinib discontinuation rates within 12 months were comparable (P = 0.095).

CONCLUSION

This study shows that PROs can serve as an important tool in evaluating real-world treatment outcomes in patients with UC using filgotinib. The results demonstrate good subjective clinical effectiveness, regardless of prior advanced therapy exposure.