P0682 Effectiveness, safety and predictors of response to vedolizumab as first- or second-line biological therapy in patients with ulcerative colitis: A real-world observational multicenter study.
Authors: Ferreira S , Serafim Parra R , Yukie Sassaki L , Luz Parente J M , Kurtz de Mello M , Andrade Chebli L , Luporini R L , Tiburcio Alves Junior A J , Firmino Nóbrega F J , da Silva B C , Miranda E F , Botelho Quaresma A , Mattioli Nicollelli G , Galhardi Gasparini R , de Medeiros Dutra R , da Conceição da Silva K , Oliveira Magro D , Imbrizi M R , Kibune Nagasako C , Féres O , de Almeida Troncon L E , Kotze P G , Fonseca Chebli J M 
Published: January 2025

Background

Vedolizumab (VDZ) is an α4β7 integrin antibody used to treat moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). We aimed to assess the real-life long-term effectiveness and safety of VDZ as a first- or second-line biological therapy and identify predictors of efficacy in a large cohort of patients with refractory or difficult-to-treat UC.

Methods

This was a multicenter, retrospective observational cohort study including patients with moderately-to-severely active UC who received VDZ for at least 12 weeks. Primary endpoints were clinical remission (partial Mayo score ≤ 2), endoscopic remission (endoscopic Mayo subscore of 1 or 0), and steroid-free clinical remission at week 52. Secondary endpoints included clinical response at weeks 12, 26, and 52; endoscopic response at week 52; primary and secondary loss of response; drug discontinuation; need for dose optimization; adverse events (AEs); need for hospitalization; and colectomy. Clinical predictors of VDZ treatment success were evaluated. Univariable and multivariable analyses as well as Kaplan–Meier analyses of treatment persistence were performed.

Results

We included 206 UC patients (mean age 44.9 ± 16.2 years, 56.8% female, 56% pancolitis, 76.8% biologic-naïve, and 22.7% with previous anti-TNF failure). Clinical remission was observed in 69.2% of biologic-naïve patients and 63.8% of anti-TNF failure patients at week 52. Steroid-free clinical remission was achieved in 70.3% and 58.8% of biologic-naïve and anti-TNF failure patients, respectively. Endoscopic remission at one year was achieved in 48.9% and 42.9% of biologic-naïve and anti-TNF failure patients, respectively. Biochemical remission at one year was achieved in 77.8% and 73.9% of biologic-naïve and anti-TNF failure patients, respectively. Primary and secondary loss of response occurred in 7.5% and 13.8% of biologic-naïve patients and in 18.2% and 21.3% of anti-TNF failure patients, respectively. Treatment persistence was higher among biologic-naïve UC patients (84.9% vs. 72.3%, p = 0.048). Three patients (1.4%) required colectomy, and 14 patients (6.8%) needed hospitalization while on VDZ treatment. Clinical response at week 12 (p = 0.001) and biologic-naïve status (p = 0.006) were predictors of better VDZ response, whereas BMI &gt; 30 kg/m² (p = 0.04) and serum albumin ≤ 3.5 g/dL (p = 0.03) were predictors of poorer response.

Conclusion

In this real-world study of patients with severe UC, VDZ demonstrated effectiveness in inducing clinical remission and endoscopic improvement, even in cases of previous anti-TNF failure, with a favorable safety profile. Biologic-naïve status and early clinical response were associated with higher likelihood of one-year clinical and endoscopic remission.