P611 COMPARATIVE EFFECTIVENESS AND SAFETY OF VEDOLIZUMAB VS. ANTI-TNFs IN CROHN’S DISEASE BIO-NAÏVE PATIENTS AND PATIENTS WITH FAILURE OF ONE PREVIOUS ANTI-TNFα (EVOLVE-IBERIA STUDY)
Muñoz Nuñez, J.F.(1)*;Rodríguez, C.(2);Gisbert, J.P.(3);Bernardo, S.(4);Aparicio, J.(5);Tagarro, I.(5);Casellas, F.(6);
(1)Complejo Asistencial Universitario de Salamanca, Digestive Service, Salamanca, 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, Spain;(5)Takeda Farmacéutica España, Medical Department, Madrid, Spain;(6)Hospital Universitari Vall d'Hebron, Crohn-Colitis Care Unit UACC, Barcelona, Spain;
Background
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).
Methods
Medical charts from CD patients were retrospectively reviewed in sites from 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 CD patients, either as the first biologic or after failure to a single anti-TNFα. Inverse probability of treatment weights (IPTW) were used to balance both study cohorts for the baseline demographic and clinical patient characteristics.
Results
210 CD patients were included with a median follow-up of 26.0 months. Eighty-three (40%) patients started treatment with VDZ, being 57% of them bio-naïve. In the anti-TNFα cohort, 76% of patients were bio-naïve. Clinical response rates at week 14 were higher for anti-TNFα group (88%) vs. VDZ group (68%) (p=0.007). However, at week 52, clinical response rates were comparable with 75% in the VDZ group and 70% in the anti-TNFα group (p=0.48). Clinical remission rates at week 14 were higher for anti-TNFα group (79%) vs. VDZ group (56%) (p=0.005). However, at week 52, clinical remission rates were comparable among VDZ and anti-TNFα cohorts, 51% vs. 67%, respectively (p=0.07). The rate of treatment intensification was 31% in VDZ vs. 42% in the anti-TNFα group (p=0.13). Median time (months) to first treatment intensification was 8.8 in the VDZ group vs. 6.3 in the anti-TNFα group (p=0.83). The overall discontinuation rates were 39% with VDZ vs 49% with anti-TNFα (p=0.16) (Fig.1). Among patients with endoscopic assessments available, endoscopic remission occurred in 47% of patients in the VDZ group (n=7/15), and in 42% of patients in the anti-TNFα arm (n=10/24) (p=0.86) at week 52. And among those patients with biochemical assessment available, biochemical remission (CRP<5mg/L) was achieved by 70% of patients in VDZ cohort (n=49/70) vs. 75% patients in anti-TNFα cohort (n=88/118) (p=0.45) at week 14, and by 74% of patients in both arms (n=45/61 and 78/106, respectively) at week 52. VDZ treated patients showed a significant lower rate of treatment related adverse events vs. anti-TNFα cohort: 1.15 vs. 2.7 per 100 patients-year, respectively (p=0.024). Infections, serious infections, and malignancies were also less frequent in the VDZ than in the anti-TNFα cohort: 0.48 vs. 1.75 per 100 patients-year, respectively (p=0.015) (Fig.2).
Conclusion
This real-world study supports the long-term use of VDZ as the first or second biologic for CD patients, showing similar effectiveness than anti-TNFα after 1 year, but better safety outcomes.