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P698 Persistence, clinical effectiveness and safety of vedolizumab in the post-marketing real clinical practice in Italy: a double-centre, 2-year experience in Crohn’s disease and ulcerative colitis patients

A. Sartini*1, R. Solimando2, A. Curatolo1, M. C. Verga1, A. Bertani1, M. Di Girolamo3, A. Merighi2, E. Villa1

1Struttura Complessa di Gastroenterologia Azienda Ospedaliero - Universitaria di Modena, Policlinico, Modena, Italy, 2Gastroenterologia Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna, Ferrara, Italy, 3Azienda USL Modena, Modena, Italy

Background

Data on clinical effectiveness of vedolizumab (VDZ) for the treatment of refractory Cronh’s disease (CD) and ulcerative colitis (UC) in real clinical practice in Italy are still limited. Our aim was to evaluate VDZ treatment persistence and safety in the post-marketing era.

Methods

This retrospective study included adult patients with CD and UC treated with VDZ as first and second–line therapy, from June 2016 to October 2018. The Kaplan–Meier method was used to calculate the cumulative probability of treatment persistence and the bivariate Cox proportional hazard model was used to find predictors of treatment withdrawal. Biochemical parameters at baseline and 12 months were compared by the Wilcoxon-signed rank test. Adverse events (AEs) were reported as number per patients-year (PY) of exposition.

Results

We included 58 patients, 36 CD and 22 UC, of which 10/58 (17.2%) were first-line treatments. At the observation, 16/58 patients (27.4%) discontinued VDZ, 11 CD and 5 UC; only 1 patient (CD) withdrew because of remission, 11 (9 CD and 2 UC) withdrew because of failure and 4 (1 CD and 3 UC) because of AEs. Median VDZ persistence was 12.5 (IQR 10.8) and 12.4 (IQR 10.9) months in CD and UC patients, respectively. The cumulative probability of treatment persistence was 91.4%, 73.6%, 63.2% and 55.3% at 6, 12, 18 and 24 months in CD patients and 81.3%, 75.5% and 75.5% at 6, 12 and 18 months in UC patients.

Kaplan–Meyer curves showing the cumulative probability of vedolizumab treatment persistence in Crohn's disease and ulcerative colitis patients.

Baseline C-reactive protein significantly increased the risk of withdrawal (HR 1.2, 95% CI 1.1 – 1.3, p = 0.01). At Week 14, 54/58 patients persisted in therapy: 32/54 patients (59.3%) were steroid-free and 35/54 (64.8%) reached a clinical response; the clinical remission rate was low (22.2%), but it increased up to 41.7% and 50% at 6 and 12 months. Overall, 18 patients completed a colonoscopy/magnetic resonance at 12 months and 5/18 (27.8%) reached a deep remission. The median White blood cells and platelets count significantly decreased from baseline to month 12 (p = 0.01). The incidence rate of AEs and severe AEs was 28/100 PY and 3.3/100 PY, respectively. The majority of them were delayed reactions (88.2%); joint pain (13.5/100 PY) and acute diarrhoea (3/100 PY) were the most common AEs and severe AEs, respectively.

Conclusion

More than half of CD and 2/3 of UC patients treated with VDZ were persistent over 24 and 18 months, respectively; safety was fairly good. Nevertheless, the low rate of clinical remission at Week 14 could be explained by its gut-selective mechanism of action, which requires more time to reach deep remission.