Markedly higher rates of remission, clinical response among those receiving mongersen versus placebo
WEDNESDAY, March 18, 2015 (HealthDay News) — For patients with Crohn’s disease, treatment with an oral SMAD7 antisense oligonucleotide, mongersen, is associated with significantly higher rates of remission and clinical response versus placebo, according to a study published in the March 19 issue of the New England Journal of Medicine.
Giovanni Monteleone, M.D., Ph.D., from the University of Tor Vergata in Rome, and colleagues conducted a double-blind, phase 2 trial involving patients with active Crohn’s disease. Participants were randomized to receive 10, 40, or 160 mg of mongersen or placebo daily for two weeks. Clinical remission at day 15, defined as a Crohn’s Disease Activity Index (CDAI) score of less than 150 with maintenance of remission for at least two weeks, was assessed as the primary outcome. Clinical response, defined as a reduction of 100 points or more in the CDAI score, at day 28 was assessed as a secondary outcome.
The researchers found that 55 and 65 percent of patients in the 40-mg and 160-mg mongersen groups, respectively, reached the primary end point, compared with 10 percent of patients in the placebo group. No significant difference was seen in the percentage of participants reaching clinical remission in the 10-mg mongersen group and placebo group (12 and 10 percent, respectively). For patients receiving 10-mg, 40-mg, or 160-mg mongersen, the rate of clinical response was significantly higher than that seen among those receiving placebo (37, 58, and 72 percent, respectively, versus 17 percent; P = 0.04, P< 0.001, and P < 0.001, respectively).
“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,” writes the author of an accompanying editorial.
The study was funded by Giuliani, acting under contract to Nogra Pharmaceuticals.
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