A Real-World Observational Study of Second-Line Anti-TNFα Treatment in Patients with Ulcerative Colitis who Received Vedolizumab as a First-Line Biologic

Abstract Background Many patients with ulcerative colitis (UC) require treatment with more than one biologic during their lifetime. This real-world observational study assessed the effectiveness of second-line anti-tumor necrosis factor α (anti-TNFα) treatment in patients with UC who had previously received vedolizumab as a first-line biologic. Methods This retrospective study included biologic-naive adult patients with UC who were treated with vedolizumab as a first-line biologic at a large, multicenter, private gastroenterology practice in Texas, United States, between January 1, 2018, and December 31, 2020. Outcomes were assessed by partial Mayo score, not including endoscopic data. Results In total, 260 patients received vedolizumab. Treatment was discontinued in 53 patients who then received a second-line anti-TNFα treatment. Of all patients treated with a second-line anti-TNFα treatment, 14/53 (26.4%) had a clinical response and 11/53 (20.8%) had clinical remission at 12 months. Accounting for anti-TNFα treatment discontinuations, 14/26 patients (53.8%) had a clinical response and 11/26 patients (42.3%) had clinical remission at 12 months, respectively. In an exploratory analysis of the patients who received vedolizumab as a first-line biologic, 188/260 (72.3%) remained on treatment at 12 months and 149/188 (79.3%) of them had clinical remission. For those with a partial Mayo score ≥ 5 at baseline, onset of vedolizumab action was observed in 49.6% by week 2 and in 87.2% by week 6. Conclusion Second-line anti-TNFα treatments were effective following vedolizumab as a first-line biologic. Most patients had onset of action of vedolizumab within 6 weeks and had clinical remission at 12 months.