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Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn’s Disease

Open access
Monteleone, Giovanni, Neurath, Markus F., Ardizzone, Sandro, Di Sabatino, Antonio, Fantini, Massimo C., Castiglione, Fabiana, Scribano, Maria L., Armuzzi, Alessandro, Caprioli, Flavio, Sturniolo, Giacomo C., Rogai, Francesca, Vecchi, Maurizio, Atreya, Raja, Bossa, Fabrizio, Onali, Sara, Fichera, Maria, Corazza, Gino R., Biancone, Livia, Savarino, Vincenzo, Pica, Roberta, Orlando, Ambrogio, Pallone, Francesco·2015·New England Journal of Medicine

Abstract

BACKGROUND: Crohn's disease-related inflammation is characterized by reduced activity of the immunosuppressive cytokine transforming growth factor β1 (TGF-β1) due to high levels of SMAD7, an inhibitor of TGF-β1 signaling. Preclinical studies and a phase 1 study have shown that an oral SMAD7 antisense oligonucleotide, mongersen, targets ileal and colonic SMAD7. METHODS: In a double-blind, placebo-controlled, phase 2 trial, we evaluated the efficacy of mongersen for the treatment of persons with active Crohn's disease. Patients were randomly assigned to receive 10, 40, or 160 mg of mongersen or placebo per day for 2 weeks. The primary outcomes were 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 2 weeks, and the safety of mongersen treatment. A secondary outcome was clinical response (defined as a reduction of 100 points or more in the CDAI score) at day 28. RESULTS: The proportions of patients who reached the primary end point were 55% and 65% for the 40-mg and 160-mg mongersen groups, respectively, as compared with 10% for the placebo group (P<0.001). There was no significant difference in the percentage of participants reaching clinical remission between the 10-mg group (12%) and the placebo group. The rate of clinical response was significantly greater among patients receiving 10 mg (37%), 40 mg (58%), or 160 mg (72%) of mongersen than among those receiving placebo (17%) (P=0.04, P<0.001, and P<0.001, respectively). Most adverse events were related to complications and symptoms of Crohn's disease. CONCLUSIONS: We found that study participants with Crohn's disease who received mongersen had significantly higher rates of remission and clinical response than those who received placebo. (Funded by Giuliani; EudraCT number, 2011-002640-27.).

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Metadata

Authors
Monteleone, G., Neurath, M. F., Ardizzone, S., Di Sabatino, A., Fantini, M. C., Castiglione, F., Scribano, M. L., Armuzzi, A., Caprioli, F., Sturniolo, G. C., Rogai, F., Vecchi, M., Atreya, R., Bossa, F., Onali, S., Fichera, M., Corazza, G. R., Biancone, L., Savarino, V., Pica, R., Orlando, A., & Pallone, F.
Venue
New England Journal of Medicine
Published
2015-03-19
Volume
372
Issue
12
Pages
1104-1113
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2112082141
Cited by
401
References
31
FWCI
47.70
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn’s Disease. https://app.cochat.ai/papers/10.1056/nejmoa1407250
The paper
Monteleone, G., Neurath, M. F., Ardizzone, S., Di Sabatino, A., Fantini, M. C., Castiglione, F., Scribano, M. L., Armuzzi, A., Caprioli, F., Sturniolo, G. C., Rogai, F., Vecchi, M., Atreya, R., Bossa, F., Onali, S., Fichera, M., Corazza, G. R., Biancone, L., Savarino, V., . . . Pallone, F. (2015). Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn’s Disease. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1407250

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.