March 19, 2015
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Mongersen appears to induce remission in Crohn's disease

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Patients with Crohn’s disease achieved remission and clinical response in greater proportions with mongersen, a novel oral SMAD7 antisense oligonucleotide, compared with placebo, according to recent study data.

Researchers performed a phase 2, multicenter, double blind, placebo-controlled trial to assess the safety and efficacy of mongersen (Celgene) for treatment of active Crohn’s disease. From September 2011 to June 2013, patients aged 18 to 75 years (n = 166) were randomly assigned to 10 mg, 40 mg or 160 mg mongersen or placebo daily for 2 weeks. Treatment was completed by 96.4% of patients and 84-day follow-up was completed by 83.1%.

Of the patients who received 40 mg and 160 mg mongersen, respectively, 55% and 65% safely achieved clinical remission by day 15 and remained in remission for at least 2 weeks, compared with 10% who received placebo (P < .001). The difference between the placebo group and the 10-mg group (12%) was not significant. The rate of clinical response was 17% for the placebo group compared with 37% for the 10-mg group (P = .04), 58% for the 40-mg group (P < .001) and 72% for the 160-mg group (P < .001). The majority of adverse events were not related to treatment.

“In conclusion, the data from this phase 2 study provide evidence of the efficacy and adverse-effect profile of mongersen in active Crohn’s disease,” the researchers wrote. “Our results support earlier work showing that SMAD7 has a role in the inflammatory reaction of Crohn’s disease.”

Séverine Vermeire

Séverine Vermeire, MD, PhD, from the University Hospitals in Leuven, Belgium, wrote in an accompanying editorial, “The remission rates of between 55% and 65% are unprecedented when compared with those reported in the large pivotal induction studies of infliximab ([Remicade, Janssen Biotech] 32.5% glucocorticoid-free clinical remission at week 6 in the SONIC trial), adalimumab ([Humira, AbbVie] 36% clinical remission at week 4 in the CLASSIC-I trial), and more recently, vedolizumab ([Entyvio, Takeda]14.5% clinical remission at week 6 and 39% at week 54 in the GEMINI 2 trial), all of which also involved patients with moderate-to-severe active Crohn’s disease.” However, she said not requiring endoscopic confirmation of active disease in its inclusion criteria was a limitation of the study. “In conclusion, the impressive clinical effects of mongersen beg for follow-up studies to confirm that we have indeed entered a new phase of Crohn’s disease treatment.” – by Adam Leitenberger

 

Disclosure: This study was funded by Giuliani, an Italian pharmaceutical company, acting under contract to Nogra Pharma, Milan. Monteleone reports a financial relationship with Giuliani SpA. Vermeire reports financial relationships with AbbVie, Genentech/Roche, Merck Sharp & Dohme, Pfizer and Takeda. Please see the study for a list of all other authors’ relevant financial disclosures.