Vedolizumab vs adalimumab: Which works better for biologic-naive CD patients?

Treatment with vedolizumab exhibits equivalent rates of response and mucosal healing but higher odds of drug persistence and achieving clinical remission compared with adalimumab in biologic-naïve patients with Crohn’s disease (CD), reports a study in a real-world setting.

Furthermore, “[p]atients were less likely to experience serious adverse events (AEs) and serious infections with vedolizumab than with adalimumab,” the investigators said.

Analysis was conducted using data from 218 vedolizumab- and 144 adalimumab-treated patients. The vedolizumab arm achieved higher adjusted cumulative rates of clinical remission than the adalimumab arm (66.3 percent vs 46.4 percent; p=0.006). [J Clin Gastroenterol 2025;59:640-647]

Treatment persistence probability was also higher with vedolizumab (89.3 percent vs 77.5 percent; p=0.024), but probabilities of clinical response (68.5 percent vs 61.1 percent; p=0.586) and mucosal healing (67.7 percent vs 56.0 percent; p=0.562) did not differ significantly.

Patients treated with vedolizumab were also less likely to experience serious AEs (hazard ratio [HR], 0.45, 95 percent confidence interval [CI], 0.22‒0.93). However, the risks for serious infections (HR, 0.27, 95 percent CI, 0.06‒1.20), CD exacerbations (HR, 0.91, 95 percent CI, 0.56‒1.47), and CD-related surgeries (HR, 1.55, 95 percent CI, 0.21‒11.15) were similar between treatment arms.

Complicated CD

“Vedolizumab and adalimumab were also shown to be effective for treating both complicated and noncomplicated CD,” the investigators said. “[F]urthermore, among patients with noncomplicated CD, achievement of effectiveness outcomes was higher with vedolizumab.”

However, no evaluations were made on outcomes relevant to specific complications, such as fistula healing, they added.

In the treatment of CD with complications, the recommended treatment is anti-TNFα therapy. Trial results showed the safety and efficacy of adalimumab in fistula healing relative to placebo. [Gastroenterology 2021;160:2496-2508; J Crohns Colitis 2019;14:4-22; Gut 2009;58:940-948; Aliment Pharmacol Ther 2013;38:1236-1247]

On the other hand, previous studies of vedolizumab for the treatment of complicated CD are scarce and have varying results. [Aliment Pharmacol Ther 2013;38:1236-1247; Aliment Pharmacol Ther 2013;38:1236-1247; Aliment Pharmacol Ther 2020;51:719-727]

“[T]hus, data from the current analysis may help to address an important gap in therapy for CD,” according to the investigators.

Guidelines

Since 1998, biologics have been used to treat moderate-to-severe CD, but guidelines recommend these advanced therapies for patients who do not respond to conventional nonbiologic treatments. [J Crohns Colitis 2017;11:3-25; Am J Gastroenterol 2018;113:481-517]

“However, given the extensive heterogeneity in the clinical presentation of CD, there is increasing emphasis on individualized approaches to management to optimize care,” the investigators said. [Lancet Gastroenterol Hepatol 2020;5:80-92]

“Furthermore, recent guidelines suggest that biologics should be introduced earlier for patients with moderate-to-severe CD to prevent further disease progression,” they added. [Aliment Pharmacol Ther 2020;51:831-842; Gastroenterology 2021;160:2496-2508]

The current findings can provide physicians and patients with more data based on a direct real-world comparison of treatments that they can use to make informed decisions, the investigators said.

This study obtained data from medical records of adult patients with CD who started treatment with adalimumab or vedolizumab between May 2014 and July 2017. Inverse probability weighting was used to perform adjusted analyses, accounting for differences in baseline characteristics.

The investigators estimated cumulative rates for clinical effectiveness outcomes and treatment persistence using Kaplan-Meier analyses. They also examined disease-related exacerbations, serious AEs, and serious infections.