January 08, 2019
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Entyvio, Corticosteroid Combination may Improve Crohn’s Induction Response

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Bruce Sands, MD
Bruce E. Sands

Using a combination of Entyvio and stable doses of corticosteroids as a baseline therapy may help induce remission or clinical response in patients with moderately to severely active Crohn’s disease, according to research published in Inflammatory Bowel Diseases.

“Guidelines provide only weak recommendations regarding combination induction therapy for CD,” Bruce E. Sands, MD, of the Icahn School of Medicine at Mount Sinai, and colleagues wrote. “Given the limited evidence available to date, further data are needed about therapies that provide benefits when combined with conventional corticosteroid treatment.”

Researchers conducted a post hoc exploratory analysis using data from the GEMINI 2 and GEMINI 3 trials, which evaluated outcomes following induction therapy over 6- and 10-week periods, respectively. They stratified patients based on corticosteroid use at baseline and assessed for clinical remission — CD Activity Index (CDAI) of at least 150 points — and enhanced clinical response — decrease of greater than 100 points in CDAI score from baseline.

Researchers found that Entyvio (vedolizumab, Takeda) plus corticosteroids resulted in higher clinical remission rates at week 6 of the GEMINI 2 trial (19% vs. 4.6%), as well as week 6 and week 10 of the GEMINI 3 trial (19.8% vs. 10.2%; 34.2% vs. 11.1%) compared with corticosteroids plus placebo. Patients who received the combination therapy also experienced more clinical remission than patients who received vedolizumab alone.

Combination therapy also resulted in higher enhanced clinical response at each time point compared with corticosteroid and placebo (GEMINI 2 week 6, 36% vs. 18.5%; GEMINI 3 week 6, 38.7% vs. 22.2%; GEMINI 3 week 10, 53.2% vs. 22.2%), and compared with vedolizumab and placebo.

Incidence of adverse events was similar across all groups.

Sands and colleagues wrote that their findings suggest that this combination therapy may improve induction of clinical response or remission without any additional safety or tolerability concerns.

“In patients who have responded to treatment with vedolizumab, corticosteroids may then be reduced and/or discontinued in accordance with the standard of care,” they wrote. “Additional data could confirm whether the favorable outcomes observed during induction continue after patients have tapered corticosteroids and are receiving maintenance therapy.” – by Alex Young

Disclosures: Sands reports receiving consulting fees and research grants from 4D Pharma, AbbVie, Allergan, Amgen, Arena Pharmaceuticals, Boehringer-Ingelheim, Capella Biosciences, Celgene, EnGene, Ferring, Gilead, Janssen, Lilly, Lyndra, MedImmune, Oppilan Pharma, Otsuka, Palatin Technologies, Pfizer, Progenity, Rheos Pharmaceuticals, Seres Therapeutics, Synergy Pharmaceuticals, Takeda, Target PharmaSolutions, Theravance Biopharma R&D, TiGenix, and Vivelix Pharmaceuticals; consulting fees and research grants from Celgene, Janssen, Takeda; and honoraria for speaking in a CME program from Vindico Medical and WebMD. Please see the full study for all other authors’ relevant financial disclosures.