In Bio-naive IBD Patients, Does Clinical Response After Induction Therapy With Biologics Predict Treatment Failure...

We aimed to examine patients with and without disease activity after induction therapy and the association with several treatment failure endpoints within 2 years.

The efficacy of biological agents is documented for patients with Inflammatory Bowel Disease (IBD). Still, some patients may experience disease activity after induction therapy.

In this Danish cohort study, 2 bio-naive IBD populations were included: (i) the Bio-IBD population with clinical and biochemical data from 2016 to 2019, and (ii) a nationwide register population from 2005 to 2023. Patients with disease activity were compared with patients without disease activity within 120 days after the first maintenance treatment following induction therapy. We used Cox proportional hazard regression models for examining associations.

In total, 9961 patients were included, 762 from the Bio-IBD population, and 9199 from the nationwide population. Within these populations, 253 (33.2%) and 1224 (13.3%) patients had active disease, respectively. The risk for a switch of biological treatment, IBD surgery, IBD hospitalization, corticosteroid usage, or treatment failure (composite endpoint) was statistically significantly increased for patients with active disease compared with patients without disease activity in both study populations. The adjusted hazard ratio for treatment failure was 1.33 (95% CI, 1.07-1.67) and 2.69 (95% CI, 2.50-2.90) in the Bio-IBD and the nationwide population, respectively.

In 2 Danish cohorts of patients with IBD, disease activity after induction therapy with biologics was associated with adverse outcomes (switch of biological treatment, IBD surgery, hospitalization, and corticosteroid usage). Clinicians may use disease activity after induction therapy as a prognostic marker of future adverse outcomes.