Trial reportAlimentary pharmacology & therapeutics2016
Impact of patient characteristics on the clinical efficacy of mongersen (GED-0301), an oral Smad7 antisense oligonucleotide, in active Crohn's disease.
Trial report in Alimentary pharmacology & therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 36 citations in OpenAlex.
- Smad7 Antisense Oligonucleotide-Based Therapy in Crohn's Disease: Is it Time to Re-Evaluate?Molecular diagnosis & therapy · 2022Trial
- A Pharmacological Batch of Mongersen that Downregulates Smad7 is Effective as Induction Therapy in Active Crohn's Disease: A Phase II, Open-Label Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Trial
- Trial
- Crohn's Disease: From Immune Dysregulation to Intestinal Damage.Inflammation · 2026Review
- Intestinal epithelial Smad7 drives purine metabolic dysregulation and ileal inflammation.Journal of biomedical science · 2026Article
- Emerging strategy towards mucosal healing in inflammatory bowel disease: what the future holds?Frontiers in immunology · 2023Review
- Smad7 Antisense Oligonucleotide in Crohn's Disease: A Re-Evaluation and Explanation for the Discordant Results of Clinical Trials.Pharmaceutics · 2022Article
- Inhomogeneous Diastereomeric Composition of Mongersen Antisense Phosphorothioate Oligonucleotide Preparations and Related Pharmacological Activity Impairment.Nucleic acid therapeutics · 2022Article
- Intestinal Regulatory T Cells.Advances in experimental medicine and biology · 2021Article
- Treatment of Intestinal Inflammation With Epicutaneous Immunotherapy Requires TGF-β and IL-10 but Not Foxp3Frontiers in immunology · 2021Article
- Controlling Gut Inflammation by Restoring Anti-Inflammatory Pathways in Inflammatory Bowel Disease.Cells · 2019Review
- Chemokines and Chemokine Receptors as Therapeutic Targets in Inflammatory Bowel Disease; Pitfalls and Promise.Journal of Crohn's & colitis · 2018Review
- Old and New Lymphocyte Players in Inflammatory Bowel Disease.Digestive diseases and sciences · 2018Review
- Emerging oral targeted therapies in inflammatory bowel diseases: opportunities and challenges.Therapeutic advances in gastroenterology · 2017Review
- TGF-β in inflammatory bowel disease: a key regulator of immune cells, epithelium, and the intestinal microbiota.Journal of gastroenterology · 2017Review
- Preclinical and Clinical Advances of GalNAc-Decorated Nucleic Acid Therapeutics.Molecular therapy. Nucleic acids · 2017Review
- Emerging biologics in inflammatory bowel disease.Journal of gastroenterology · 2017Review
- The Role of Cytokines in the Fibrotic Responses in Crohn's Disease.Frontiers in medicine · 2017Review
- Increased duodenal expression of miR-146a and -155 in pediatric Crohn's disease.World journal of gastroenterology · 2016Article
- New and Evolving Immunotherapy in Inflammatory Bowel Disease.Inflammatory intestinal diseases · 2016Review
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn a phase 2 study, mongersen, an oral antisense oligonucleotide targeting Smad7, was effective in inducing clinical remission in approximately 60% of patients with active Crohn's disease (CD).
aimIn a post hoc analysis to evaluate those patient disease characteristics that may have influenced the efficacy and safety of mongersen therapy.
methodsPatients with steroid-dependent/resistant, active CD were randomised to mongersen 10, 40 or 160 mg/day or placebo for 2 weeks; patients were followed for 10 weeks. Clinical remission [Crohn's Disease Activity Index (CDAI) score <150] and clinical response (CDAI score reduction ≥100 points) were assessed at weeks 2, 4 and 12 for these subgroups: disease duration <5/≥5 years, human serum C-reactive protein (hsCRP) <3/≥3 mg/L, and CDAI at baseline ≤260/>260. Additional patient baseline and disease characteristics were explored.
resultsClinical remission and response rates were significantly higher in patients receiving mongersen 40 and 160 mg/day but not 10 mg/day vs. placebo and independent of disease duration and hsCRP. Patients with baseline CDAI ≤260 had significantly higher remission rates with 40 and 160 mg/day. In patients with baseline CDAI >260, remission rates were statistically greater with 160 mg/day and numerically better with 40 mg/day vs. placebo. Adverse event rates were similar across treatment groups. Mongersen was safe and well tolerated.
conclusionsPatients with higher CDAI scores achieved clinical remission most frequently with the highest mongersen dose. Disease duration and baseline human serum C-reactive protein did not appear to significantly impact efficacy of mongersen in this study (EudraCT Number: 2011-002640-27.).
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