A real-world observational study of second-line anti-TNFα treatment in patients with ulcerative colitis who received vedolizumab as a first-line biologic.

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. Conclusions: 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.