Triple combination therapy ‘superior to monotherapy,’ improves remission in Crohn’s
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Key takeaways:
- Results showed 54.5% and 34.5% of patients achieved clinical and endoscopic remission, respectively, at week 26.
- No new safety concerns were reported.
A combination of vedolizumab, adalimumab and methotrexate resulted in endoscopic remission at week 26 in more than a third of patients with Crohn’s disease, according to data in Clinical Gastroenterology and Hepatology.
In the phase 4, single-arm, open-label EXPLORER study, researchers aimed to “try and overcome the therapeutic ceiling of CD,” Jean-Frederic Colombel, MD, professor and director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Center at Mount Sinai, told Healio.
Colombel and colleagues enrolled 55 biologic-naive patients with newly diagnosed moderate- to high-risk CD, who received 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 weekly methotrexate 15 mg.
The primary endpoint was endoscopic remission, defined as Simple Endoscopic Score for Crohn’s Disease (SES-CD) of no more than 2 at week 26, while secondary outcomes included clinical remission, defined as Crohn’s Disease Activity Index (CDAI) of less than 150 at weeks 10 and 26, and adverse events.
The cohort’s mean CD duration was 0.4 years, and baseline SES-CD and CDAI were 12.6 and 265.5, respectively, researchers reported.
Results showed 34.5% of patients achieved endoscopic remission at week 26, and more than half (54.5%) achieved clinical remission at that time. According to post-hoc Bayesian analysis, the probabilities that triple combination therapy yielded higher rates of endoscopic remission (33.5%; 95% CI, 22.4-24.7) compared with placebo (14%), vedolizumab monotherapy (27%) or adalimumab monotherapy (30%) were greater than 99.9%, 86.3% and 71.4%, respectively.
Serious adverse events were reported in six patients.
“Combination therapy was safe and, based on post-hoc Bayesian analysis, superior to monotherapy,” Colombel said. “Combination therapies should be ideally designed using orthogonal therapies. New combinations should be explored using rational approach.”
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