Vedolizumab useful, safe for long-term treatment of inflammatory bowel disease

Most patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) on vedolizumab (VDZ) persist with their treatment for up to 5 years, according to a posthoc analysis of the phase III GEMINI long-term safety (LTS) study presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2019 Annual Meeting.

“These findings … support the longer-term effectiveness and safety of VDZ in patients with moderately to severely active UC and CD,” according to the researchers.

The analysis included 190 patients with UC (mean disease duration, 8.7 years) and 231 with CD (mean disease duration, 10.6 years) from GEMINI LTS who had received VDZ every 4 weeks. These patients had no previous exposure to the drug (de novo cohort). Majority of the population—61 percent in the UC group and 74 percent in the CD groups—had prior antitumour necrosis factor (anti-TNF) inhibitor failure.

Over a 5-year follow-up, 276 patients (66 percent) discontinued VDZ. Commonly endorsed reasons were lack of efficacy (24 percent and 33 percent, respectively) and adverse events (AEs; 16 percent of patients in the group; 17 percent in the CD group). [AIBD 2019, abstract P055]

On Kaplan-Meier survival analysis, treatment persistence rates at month 54 were 53 percent in the UC group and 41 percent in the CD group. The rates were much higher among patients who did vs did not show response at week 12 (UC: 60 percent vs 26 percent; p<0.0001; CD: 42 percent vs 35 percent; p=0.001), as well as among patients without vs with prior anti-TNF failure (UC: 63 percent vs 47 percent; p=0.046; CD: 47 percent vs 42 percent; p=0.016).

Among patients with baseline anti-TNF failure, those with secondary vs primary nonresponse in the UC group had markedly higher 54-month VDZ treatment persistence rates (65 percent vs 15 percent; p<0.0001). This difference was not seen in the CD group (44 percent vs 40 percent; p=0.573).

Concomitant therapy had no impact on treatment persistence.

A gut-selective, humanized monoclonal antibody, VDZ is approved for the treatment of moderately to severely active IBD. It is available in single-use vials containing 300 mg of lyophilized VDZ.

“Although VDZ efficacy and safety are well established, there are limited publications on longer-term (>3 years) treatment persistence,” according to the researchers.