EVOLVE-IBERIA: Real-world evidence on vedolizumab and anti-tumor necrosis factor-α as first- or second-line biologic treatment among patients with ulcerative colitis

Real-world evidence (RWE) on vedolizumab (VDZ), an anti-lymphocyte trafficking treatment that selectively targets the α4β7/MAdCAM-1 interaction on the gut, is mostly limited to patients who are repeatedly refractory to anti-tumor necrosis factor-alpha (anti-TNF-α), and other treatments. The EVOLVE-IBERIA study assessed VDZ or anti-TNF-α as first- or second-line biologic treatment, in patients with Crohn's disease or ulcerative colitis (UC); here, we present the outcomes in patients with UC. Medical records were retrospectively reviewed from 25 hospitals in Spain and Portugal. Eligible patients with UC were aged ≥18 years and had received treatment with first- or second-line VDZ or anti-TNF-α. Objectives were to evaluate clinical effectiveness, safety, and treatment patterns of VDZ and anti-TNF-α, and to characterize healthcare resource utilization. Baseline covariates were balanced in both cohorts by means of propensity scores, using the inverse probability of treatment weighting (PS-IPTW) method. A total of 199 patients with UC were included (median follow-up: 24.0 months). At Week 52, clinical response rates were 75.6% and 73.2% ( p = 0.72) and clinical remission rates were 56.6% and 62.0% ( p = 0.49), in the VDZ cohort and anti-TNF-α cohort, respectively. Treatment-related adverse event rates per 100 patient-years were 0.23 in the VDZ cohort and 1.1 in the anti-TNF-α cohort ( p = 0.037). The similar long-term effectiveness and lower incidence of adverse events of VDZ compared with anti-TNF-α in the real-world setting, confirm the favorable benefit:risk ratio of VDZ as first- or second-line biologic treatment for UC. La evidencia en práctica clínica real sobre vedolizumab (VDZ), un tratamiento antitráfico linfocitario selectivo a nivel intestinal, se limita a pacientes refractarios a tratamiento previo con inhibidores del factor de necrosis tumoral alfa (anti-TNF-α). Este estudio evaluó VDZ en comparación con anti-TNF-α como tratamiento biológico de primera o segunda línea en pacientes con enfermedad de Crohn y colitis ulcerosa (CU). Presentamos los resultados en pacientes con CU. Se revisaron retrospectivamente las historias clínicas de pacientes de 25 hospitales en España y Portugal. Los pacientes elegibles tenían ≥ 18 años y CU, habiendo recibido VDZ o anti-TNF-α como terapia biológica de primera o segunda línea. Se analizaron la efectividad clínica, la seguridad, los patrones de tratamiento y la utilización de recursos sanitarios. Para equilibrar las covariables basales, se aplicaron puntuaciones de propensión mediante el método de ponderación por probabilidad inversa de tratamiento. Se incluyeron 199 pacientes con CU (mediana de seguimiento: 24,0 meses). En la semana 52, las tasas de respuesta clínica fueron 75,6 y 73,2% (p = 0,72), y las tasas de remisión clínica fueron 56,6 y 62,0% (p = 0,49), en la cohorte de VDZ y de anti-TNF-α, respectivamente. Las tasas de eventos adversos relacionados con el tratamiento por cada 100 pacientes-año fueron 0,23 en la cohorte de VDZ y 1,1 en la de anti-TNF-α (p = 0,037). La efectividad similar a largo plazo y la menor incidencia de eventos adversos de VDZ en comparación con los anti-TNF-α respaldan el perfil beneficio-riesgo favorable de VDZ como tratamiento biológico de primera o segunda línea para el tratamiento de la CU.