When anti–tumor necrosis factor-alpha (anti-TNF) treatment fails to achieve remission for patients with ulcerative colitis (UC), tofacitinib (Xeljanz) appears more effect sooner than vedolizumab (Entyvio), suggests a Dutch registry study.
Data on nearly 150 patients with UC who had already undergone treatment with anti-TNF drugs showed that combined clinical and biochemical remission was about five times more likely with tofacitinib versus vedolizumab within 12 weeks of starting therapy.
However, the differences tailed off over subsequent weeks, such that there was no significant difference in combined remission rates at 52 weeks. There were also no notable differences in safety between the two drugs.
“These results may help in guiding clinical decisionmaking after anti-TNF failure in patients with UC,” the authors write.
The research was published online by Clinical Gastroenterology and Hepatology.
Real-world evidence
“This study offers more real-world evidence than a standard randomized controlled trial, since there was no randomization between the two study groups and no strict inclusion and exclusion criteria,” co–senior authors Tessa Straatmijer, MD, PhD candidate, and Marjolijn Duijvestein, MD, Amsterdam University Medical Center, the Netherlands, told this news organization.
They continued: “It is known that tofacitinib is more rapid of action compared to vedolizumab. We therefore expected that the odds ratio of remission rates between the two groups would be higher at weeks 12 and 24, compared to week 52.”
“We will continue with collecting data in our prospective cohort up to 10 years after initiating tofacitinib or vedolizumab,” Dr. Straatmijer and Dr. Duijvestein added. “Hopefully we can provide long-term outcomes after a couple of years.”
The authors highlight that for a “considerable proportion” of patients with UC, their condition does not respond to anti-TNF drugs, they experience adverse effects, or the response diminishes over time. Alternatives, such as vedolizumab and tofacitinib, are typically “prescribed after failure of the anti-TNF,” owing to their price and clinician experience.
While vedolizumab (an α4β7 integrin blocker) and tofacitinib (a Janus kinase inhibitor) have different mechanisms of action, head-to-head randomized controlled trials comparing their efficacy among patients with UC whose condition is refractory to anti-TNF are “lacking,” they add. “However, to guide physician decisionmaking on the most suitable drug choice after anti-TNF failure, effectiveness data comparing tofacitinib with vedolizumab is pivotal.”
To assess the comparative effectiveness and safety of the next therapeutic options, the team examined data from the Dutch Initiative on Crohn and Colitis registry.
They identified nearly 300 adult patients with clinical or biochemical disease activity who had initiated treatment with vedolizumab or tofacitinib. They excluded patients without prior anti-TNF treatment, those who had previously been treated with vedolizumab or tofacitinib, and those who did not have clinical and biochemical or endoscopic disease activity at baseline. The final analysis included 83 patients given vedolizumab and 65 treated with tofacitinib.
Patients given tofacitinib received 10 mg twice daily for the first 8 weeks, followed by maintenance treatment of 5 mg twice daily, with optional dose optimization in case of insufficient response. Vedolizumab was administered intravenously in line with the label; 300 mg was administered at weeks 0, 2, and 6, followed by 300 mg every 8 weeks, with a shortened infusion interval in cases of inadequate response.
There were few differences between the two groups at baseline, although patients given vedolizumab had been treated longer than those in the tofacitinib group (12 years vs. 7 years). Vedolizumab patients were also more likely to be receiving concomitant oral prednisone at baseline (50.6% vs. 30.8%).