P779 COMPARATIVE EFFECTIVENESS AND SAFETY OF VEDOLIZUMAB VS ANTI-TNFs IN ULCERATIVE COLITIS BIO-NAÏVE PATIENTS AND PATIENTS WITH FAILURE OF ONE PREVIOUS ANTI-TNFα (EVOLVE-IBERIA STUDY)
Casellas Jorda, F.(1)*;Rodríguez, C.(2);Gisbert, J.P.(3);Bernardo, S.(4);Aparicio, J.(5);Tagarro, I.(5);Muñoz, F.(6);
(1)Hospital Universitari Vall d'Hebron, Crohn-Colitis Care Unit UACC, Barcelona, Spain;(2)Complejo Hospitalario de Navarra, Gastroenterology Unit, Pamplona, Spain;(3)Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa IIS-Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd., Madrid, Spain;(4)Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, Serviço de Gastrenterologia e Hepatologia, Lisbon, Portugal;(5)Takeda Farmacéutica España, Medical Department, Madrid, Spain;(6)Complejo Asistencial Universitario de Salamanca, Digestive Service, Salamanca, Spain;
Vedolizumab (VDZ) is a gut-selective, anti-lymphocyte trafficking drug inhibiting α4β7-integrin approved for treatment of moderately to severely Crohn's disease (CD) and ulcerative colitis (UC).
This was a retrospective cohort study based on review of patients charts from sites in Spain and Portugal. The primary objectives are to compare real-world clinical effectiveness and treatment patterns data on the use VDZ vs. anti-TNFα in UC patients, either as the first biologic or after failure to a single anti-TNFα. Inverse probability treatment weights (IPTW) were used to balance both cohorts on the baseline demographic and clinical characteristics.
199 UC patients were included with a median follow-up of 24 months. One hundred and two (51%) patients started treatment with VDZ, and 44% of them were bio-naïve. In the anti-TNFα cohort, 77% of patients were bio-naïve. Clinical response rates were similar in both groups at week 14, 81% in VDZ cohort vs. 80% in anti-TNFα cohort (p=0.91) and at week 52, 76% in VDZ treated patients vs. 73% anti-TNFα treated patients (p=0.72). Clinical remission rates at week 14 were 52% for VDZ group vs. 55% in anti-TNFα group (p=0.76). At week 52, clinical remission rates were 57% for VDZ vs. 62% for anti-TNFα (p=0.49). Treatment intensification was needed in 44% of VDZ treated patients vs. 40% in the anti-TNFα group (p=0.58), and median time (months) to first treatment intensification was 6.4 in the VDZ group vs 5.8 in the anti-TNFα group (p=0.96). Discontinuation rates during the follow up were 40% for VDZ treated patients vs. 50% for anti-TNFα treated patients (p=0.17) (Fig.1). Among patients with endoscopic assessments available at week 52, endoscopic remission rates were 36% in VDZ cohort (n=9/25) vs. 36% in anti-TNFα cohort (n=9/25) (p=0.95). And among those patients with biochemical assessment available, biochemical remission (fecal calprotectin <250 μg/mg) occurred in 59% of patients in VDZ group (n=41/69) vs. 54% in anti-TNFα group (n=29/54) (p=0.54) at week 52. VDZ treated patients showed a significant lower rate of treatment related adverse events vs. anti-TNFα cohort: 0.23 vs. 1.10 per 100 patients-year, respectively (p=0.037). Adverse events of special interest (infections, serious infections, and malignancies) were also less frequent in the VDZ than in the anti-TNFα cohort: 0.75 vs. 2.42 per 100 patients-year (p=0.008) (Fig.2).
Overall, these findings show similar effectiveness with VDZ and anti-TNFα when used as the first or second biologic for UC patients after 1 year, but a safety advantage in favor of VDZ, supporting a favorable benefit-risk ratio in favor of VDZ.