Triple drug combo induces endoscopic remission in more than a third of CD patients

In the treatment of Crohn’s disease (CD), the triple combination of vedolizumab, adalimumab, and methotrexate leads to endoscopic remission in 34.5 percent of patients and clinical remission in 54.5 percent, according to data from the phase IV EXPLORER trial.

EXPLORER included 55 biologic-naïve patients with newly diagnosed, moderate- to high-risk CD. These patients received triple combination therapy with vedolizumab (300 mg on day 1, weeks 2 and 6, then every 8 weeks), adalimumab (160 mg on day 2, 80 mg at week 2, then 40 mg every 2 weeks), and methotrexate (15 mg weekly).

The mean disease duration of the patients was 0.4 years. At baseline, the mean Simple Endoscopic Score for Crohn’s Disease (SES-CD) was 12.6, and the mean Crohn’s Disease Activity Index (CDAI) was 265.5.

The primary endpoint of endoscopic remission (SES-CD ≤2) at week 26 occurred in 19 patients (34.5 percent. Clinical remission, the secondary endpoint, was reported in 34 patients (61.8 percent) at week 10 and in 30 patients (54.5 percent) at week 26.

In post hoc Bayesian analysis, the probabilities that triple combination therapy yielded a higher endoscopic remission rate (33.5 percent, 95 percent credible interval, 22.4–45.7) than placebo (14 percent), vedolizumab monotherapy (27 percent), or adalimumab monotherapy (30 percent) were ≥99.9 percent, 86.3 percent, and 71.4 percent, respectively.

Severe adverse events were documented in six patients.