The integrin receptor antagonist vedolizumab mostly works as well as the TNF-alpha inhibitor infliximab in biologic-naive patients with moderate-to-severe ulcerative colitis (UC) treated in the real-world setting, although vedolizumab slightly surpasses infliximab in terms of inducing endoscopic response and remission while having a better safety profile, according to a study.

After 52 weeks of treatment, clinical remission was reported in 82.3 percent of vedolizumab-treated patients and in 77.4 percent of those treated with infliximab, with the difference not reaching statistical significance (p=0.11). [AIBD 2024, abstract S26]

Vedolizumab and infliximab were also similar with regard to the number of patients showing steroid-free clinical remission (84.8 percent vs 83.1 percent; p=0.79), biochemical remission (42.6 percent vs 35.1 percent; p=0.93), and clinical response (90.7 percent vs 88.3 percent; p=0.80).

However, significantly more vedolizumab-treated patients achieved endoscopic remission (47.4 percent vs 33.1 percent; p=0.03) and endoscopic response (78.4 percent vs 62.7 percent; p<0.001) compared with infliximab-treated patients.

Furthermore, vedolizumab was associated with a reduced need for dose optimization (19.2 percent vs 36.7 percent; p=0.03) and a higher treatment persistence (80.8 percent vs 61.8 percent; p<0.001) compared with infliximab. Only 0.71 percent of patients who received vedolizumab required hospitalization for UC as opposed to 9.1 percent of those treated with infliximab (p<0.001).

As for safety, the incidence of adverse events was numerically lower in the vedolizumab than in the infliximab group (34.0 percent vs 46.1 percent; p=0.17), as was the secondary loss of response (15.0 percent vs 20.3 percent; p=0.24).

In this real-world study, both vedolizumab and infliximab are effective in UC patients naive to biologics, according to the investigators, led by Dr Sandro da Costa Ferreira from the Ribeirao Preto Medical School, University of Sao Paulo, Brazil.

Nevertheless, vedolizumab yields superior endoscopic outcomes, with higher treatment persistence and better safety profile compared with infliximab, da Costa Ferreira continued, adding that vedolizumab should be considered as the first-line biologic in UC.

The study included 297 patients with moderate-to-severe UC, defined as having a total Mayo score of 6-12 and an endoscopic score of at least 2. None of the patients had previously received biologics. The primary endpoints were clinical remission (partial Mayo score ≤2), endoscopic remission (endoscopic Mayo subscore 0), and steroid-free clinical remission at week 52. Secondary endpoints included clinical response, endoscopic response (endoscopic Mayo subscore 0-1), need for drug optimization, adverse events, need for hospitalization, loss of response, and biochemical remission (C-reactive protein ≤0.5 mg/dL and/or faecal calprotectin ≤150 mg/g) at week 52.