Better results for vedolizumab in early CD

Prospective data of an interim analysis on vedolizumab comparing achievement of remission in early versus late Crohn’s disease (CD) were clearly in favour of the early group. A combined clinical and endoscopic remission was reached by 47% of those with under 2 years of CD in contrast with 16% of those in the late CD study arm.

In the treatment of CD, vedolizumab has demonstrated efficacy both as induction and maintenance therapy [1,2]. “We know also that for other treatments, mainly anti-TNF where we have the most data, higher efficacy is observed in patients with a shorter disease duration, but we do not have prospective data on whether the same would be observed with vedolizumab in early CD,” Prof. Geert D’Haens (Amsterdam UMC, the Netherlands) explained the reason for the investigator-initiated LOVE-CD trial (NCT02646683) [1].

The multicentre, international, open-label study compared the remission rates in patients with early and late moderate-to-severe CD who were treated with intravenous vedolizumab at a dose of 300 mg every 8 weeks up to week 52, after induction until week 14. Included early CD patients had their diagnosis <2 years ago and their treatment history only showed corticosteroids and/or immunomodulators. Late CD was defined as over 2 years of disease duration and prior therapy with immunomodulators and anti-TNF plus corticosteroids.

Prof. D’Haens underlined that a hard primary endpoint was chosen for LOVE-CD that combined steroid-free clinical remission and endoscopic remission, expressed in a Crohn's Disease Activity Index (CDAI) <150 and a Simple Endoscopic Score for Crohn´s Disease (SES-CD) ≤3.

The intention-to-treat population of the presented interim analysis, after the second endoscopy at 6 months, consisted of 47 participants with early CD and 110 with late CD. Baseline demographics in these 2 groups were a median age of 29 and 35.5 years, a median CDAI of 252 and 257, and a SES-CD of 9 and 11, respectively. In the late group, disease duration varied between 3–41 years and anti-TNF-exposure was 80% for adalimumab and 77.3% for infliximab.

The combined primary endpoint was reached by a significantly higher proportion of the early CD group (47%), compared with 16% of the late CD group (P=0.0001). Also, secondary endpoints led to significantly superior results for the early CD arm: SES-CD=0 in 45% versus 15% (P=0.0001) and SES-CD ≤3 in 66% versus 34% (P=0.0002). As the trial is still ongoing, the results at week 52 will be available at a later stage.

Overall, 21 serious adverse events were observed within LOVE-CD, among them were exacerbation of disease, perianal abscess, and tibial plateau fracture, with 2 cases each. Prof. D’Haens confirmed that there were no strong signals towards new adverse events that were unknown with this mechanism of action.

“We can conclude that in moderate-to-severe CD, vedolizumab treatment in early CD was significantly better than in late CD, to obtain steroid-free clinical remission and endoscopic remission,” Prof. D’Haens ended his talk.

1. D’Haens GR, et al. Higher endoscopic and clinical remission rates with vedolizumab in early than in late Crohn’s disease: results from the LOVE-CD study (low countries vedolizumab n CD study). OP130, UEG Week 2022, Vienna, Austria, 8-11 October.
2. Sandborn WJ, et al. N Engl J Med. 2013;369(8):711–21.

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Posted on 1 December, 20228 April, 2024