Colon to Rectum
Clin Gastroenterol Hepatol. 2023;21(1):182–91.e2
Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF-experienced ulcerative colitis patients: A nationwide Dutch Registry study
Background and aims: Clinicians face difficulty in when and in what order to position biologics and Janus kinase inhibitors in patients with anti-tumor necrosis factor-alpha (TNF)-refractory ulcerative colitis (UC). The authors aimed to compare the effectiveness and safety of vedolizumab and tofacitinib in anti-TNF-exposed patients with UC in their prospective nationwide Initiative on Crohn and Colitis Registry.
Methods: Patients with UC who failed anti-TNF treatment and initiated vedolizumab or tofacitinib treatment were identified in the Initiative on Crohn and Colitis Registry in the Netherlands, and were selected with both clinical as well as biochemical or endoscopic disease activity at initiation of therapy. Patients previously treated with vedolizumab or tofacitinib were excluded. Corticosteroid-free clinical remission (Simple Clinical Colitis Activity Index ≤ 2), biochemical remission (C-reactive protein ≤ 5 mg/l or fecal calprotectin ≤ 250 μg/g), and safety outcomes were compared after 52 weeks of treatment. Inverse propensity score-weighted comparison was used to adjust for confounding and selection bias.
Results: Overall, 83 vedolizumab- and 65 tofacitinib-treated patients were included. Propensity score-weighted analysis showed that tofacitinib-treated patients were more likely to achieve corticosteroid-free clinical remission and biochemical remission at weeks 12, 24, and 52 compared with vedolizumab-treated patients (odds ratio [OR] = 6.33, 95% confidence interval [CI]: 3.81–10.50, p < 0.01; OR = 3.02, 95% CI: 1.89–4.84, p < 0.01; and OR = 1.86, 95% CI: 1.15–2.99, p = 0.01; and OR = 3.27, 95% CI: 1.96–5.45, p < 0.01; OR = 1.87, 95% CI: 1.14–3.07, p = 0.01; and OR = 1.81, 95% CI: 1.06–3.09, p = 0.03, respectively). There was no difference in infection rate or severe adverse events.
Conclusions: Tofacitinib was associated with superior effectiveness outcomes compared with vedolizumab in anti-tumor necrosis factor-experienced patients with ulcerative colitis along with comparable safety outcomes.