EVOLVE-IBERIA: Real-world evidence on vedolizumab and anti-tumour necrosis factor-α as first- and second-line biologic treatment in Crohn's disease.

OBJECTIVE

Much of the available real-world evidence on the gut-selective α4β7 integrin antibody vedolizumab comes from patients with repeated failure of anti-tumour necrosis factor-α (anti-TNFα) agents and other treatments. The EVOLVE-IBERIA study is aimed to generate additional real-world evidence for vedolizumab and anti-as first- or second-line biologic treatment, in patients with Crohn's disease or ulcerative colitis; here we present the outcomes in patients with Crohn's disease.

PATIENTS AND

METHODS

Medical charts of patients aged 18 years or older treated with vedolizumab or anti-TNFα as first- or second-line biologic in Spain and Portugal were retrospectively reviewed; both cohorts therefore included biologic-naive and biologic-exposed patients to compare the clinical effectiveness, safety and treatment patterns of vedolizumab and anti, and to characterize healthcare resource utilisation. Analyses were adjusted by means of propensity scores using inverse probability of treatment weighting.

RESULTS

A total of 210 patients with Crohn's disease were included; median follow-up was 26.0 months. At Week 52, clinical response rates were 74.8% and 69.8% (p=0.481) and clinical remission rates were 51.3% and 66.5% (p=0.065), in the vedolizumab cohort and in the anti-TNFα cohort, respectively. Treatment-related adverse event rates per 100 patient-years were 1.15 in the vedolizumab cohort and 2.70 in the anti-TNFαcohort (p=0.024).

CONCLUSION

In the real-world setting, the comparable long-term effectiveness and lower incidence of treatment-related adverse events of vedolizumab compared with anti-suggest a favourable benefit: risk ratio of vedolizumab as first- or second-line biologic treatment in patients with Crohn's disease.