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Biologics, small molecules, steroids, biosimilars, approvals, and treatment access updates.

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NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
ClinicalTrials.gov

NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease

People with Crohn's disease who develop symptomatic intestinal strictures currently often need endoscopic dilation or surgery. This trial tests an investigational oral drug (ontunisertib) aiming to improve...

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A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
ClinicalTrials.gov

A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis

A pediatric Phase 2 trial testing etrasimod could expand treatment options for children with moderately to severely active ulcerative colitis if later shown safe and effective. Families of affected children and their...

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Longitudinal visceral adipose heterogeneity supports digital health stratification of infliximab response loss in Crohn disease
Springer Science and Business Media LLC

Longitudinal visceral adipose heterogeneity supports digital health stratification of infliximab response loss in Crohn disease

If validated, an imaging-derived adipose heterogeneity biomarker could help predict who will lose response to infliximab after induction, potentially guiding earlier treatment decisions and personalized monitoring for...

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Efficacy and Safety of Upadacitinib in Refractory Very-Early-Onset Ulcerative Colitis: A Case Report.
Journal of paediatrics and child health

Efficacy and Safety of Upadacitinib in Refractory Very-Early-Onset Ulcerative Colitis: A Case Report.

Cure8 found this source from Journal of paediatrics and child health, but the page could not be read reliably yet. It is tagged for Ulcerative colitis, Inflammatory bowel disease, and Upadacitinib. Open the original...

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Clinical trajectories after preoperative traditional Chinese medicine in biologic-refractory surgery- intended acute severe ulcerative colitis: an exploratory retrospective case series
Frontiers in Immunology

Clinical trajectories after preoperative traditional Chinese medicine in biologic-refractory surgery- intended acute severe ulcerative colitis: an exploratory retrospective case series

This paper explores whether individualized integrative management including traditional Chinese medicine might influence outcomes in patients with biologic‑refractory, surgery‑intended acute severe ulcerative colitis — a...

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Rosuvastatin and Engeletin Ameliorate Acetic Acid-Induced Ulcerative Colitis through Modulation of TXNIP/NLRP3-Related Inflammatory Signaling pathway.
Immunopharmacology and immunotoxicology

Rosuvastatin and Engeletin Ameliorate Acetic Acid-Induced Ulcerative Colitis through Modulation of TXNIP/NLRP3-Related Inflammatory Signaling pathway.

The study links TXNIP/NLRP3 inflammatory signaling to disease features in an animal UC model and tests engeletin and rosuvastatin as interventions that lowered inflammatory markers—information relevant to researchers...

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Polysaccharide-based colon targeting drug delivery systems: Overview on challenges, opportunities and prospects
International Journal of Polymeric Materials

Polysaccharide-based colon targeting drug delivery systems: Overview on challenges, opportunities and prospects

Colon-targeted delivery systems aim to concentrate drugs in the colon, which could improve effectiveness and reduce systemic side effects for IBD and colorectal cancer treatments. Understanding these approaches helps...

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Adjunctive nutraceutical strategies in ulcerative colitis: From molecular pathways to clinical outcomes.
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Adjunctive nutraceutical strategies in ulcerative colitis: From molecular pathways to clinical outcomes.

People with UC often look for dietary supplements or ‘‘natural’’ add-ons. This review explains which nutraceutical approaches have the most and least clinical support, helping patients and clinicians weigh potential...

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Pharmacokinetics of IL-23p19 Inhibitors: A Systematic Review Across Immune-Mediated Inflammatory Diseases.
Clinical pharmacokinetics

Pharmacokinetics of IL-23p19 Inhibitors: A Systematic Review Across Immune-Mediated Inflammatory Diseases.

Pharmacokinetics affect how well biologic drugs work for IBD. Better PK data could help explain why many patients have inadequate responses and could inform personalized dosing for IL-23p19 inhibitors used in Crohn’s...

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Mesalazine enteric-coated tablets combined with retention enema for symptom alleviation in mild to moderate E2-type active ulcerative colitis: A retrospective comparative cohort study
Pakistan Journal of Pharmaceutical Sciences

Mesalazine enteric-coated tablets combined with retention enema for symptom alleviation in mild to moderate E2-type active ulcerative colitis: A retrospective comparative cohort study

Adding a mesalazine retention enema to oral mesalazine improved short-term symptom relief and endoscopic signs of mucosal healing in mild-to-moderate left-sided ulcerative colitis in this retrospective study. That could...

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Serum leucine-rich α-2-glycoprotein and monocyte chemoattractant protein-1 as novel biomarkers for predicting vedolizumab response in patients with ulcerative colitis.
Crohn's & colitis 360

Serum leucine-rich α-2-glycoprotein and monocyte chemoattractant protein-1 as novel biomarkers for predicting vedolizumab response in patients with ulcerative colitis.

Blood biomarkers that predict vedolizumab response could help patients and clinicians choose the most effective therapy sooner and avoid ineffective treatments. The study suggests LRG and MCP‑1 may differentiate...

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Comparative Effectiveness and Safety of Risankizumab vs Ustekinumab in Crohn's Disease: A Real-World Retrospective Cohort Study from Taiwan.
Journal of inflammation research

Comparative Effectiveness and Safety of Risankizumab vs Ustekinumab in Crohn's Disease: A Real-World Retrospective Cohort Study from Taiwan.

Comparative real-world data may help patients and clinicians weigh expected benefits and risks of risankizumab versus ustekinumab in Crohn’s disease, including effects on steroid-free remission and fistula healing.

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Aminosalicylate use Increases Corticosteroid Exposure and Decreases Biologic Durability in Pediatric Crohn's Disease.
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

Aminosalicylate use Increases Corticosteroid Exposure and Decreases Biologic Durability in Pediatric Crohn's Disease.

This study suggests that using 5‑ASA drugs early in children with Crohn’s disease was common but linked to more steroid use, delayed biologic treatment, and lower biologic durability — outcomes that matter for long‑term...

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NUDT15 c.415C>T (rs116855232) Allele Frequency and Estimated Thiopurine Metabolizer Phenotype Distribution in the Iranian Population: A Study Based on Public Genomic Data
Europe PMC

NUDT15 c.415C>T (rs116855232) Allele Frequency and Estimated Thiopurine Metabolizer Phenotype Distribution in the Iranian Population: A Study Based on Public Genomic Data

NUDT15 variants strongly affect how people metabolize thiopurine drugs used in IBD; knowing variant frequency helps decide whether routine pre-treatment genotyping is useful in Iran and among specific ethnic groups.

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Living with Primary Immunodeficiencies: CVID—Enteropathy from the Perspective of a Gastroenterologist
Journal of Human Immunity

Living with Primary Immunodeficiencies: CVID—Enteropathy from the Perspective of a Gastroenterologist

CVID-related enteropathy can resemble celiac disease or IBD, carries high morbidity and mortality, and often does not respond to standard immunoglobulin therapy — patients and clinicians need awareness of its distinct...

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Clinical and endoscopic features of checkpoint inhibitor-induced colitis and their association with selective immunosuppressive therapy use.
Inflammatory bowel diseases

Clinical and endoscopic features of checkpoint inhibitor-induced colitis and their association with selective immunosuppressive therapy use.

People receiving immune checkpoint inhibitors who develop colitis may face different risks of needing stronger immunosuppression depending on the ICI drug class. Understanding which features predict escalation could...

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GLP-1 receptor agonist therapy is associated with increased symptomatic remission in ulcerative colitis: a matched cohort study.
Inflammatory bowel diseases

GLP-1 receptor agonist therapy is associated with increased symptomatic remission in ulcerative colitis: a matched cohort study.

This study suggests commonly used GLP-1 receptor agonists (semaglutide, liraglutide) were associated with higher symptomatic and endoscopic remission in ulcerative colitis compared with matched controls. If validated,...

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Inflammatory bowel disease treatment: Mechanisms to clinical translation (Review).
International journal of molecular medicine

Inflammatory bowel disease treatment: Mechanisms to clinical translation (Review).

The article reviews current and emerging IBD treatments and the biological reasons they may work — useful for patients wanting to understand treatment options and future directions. It highlights therapies beyond...

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Evaluation of the immunomodulatory effects of novel phosphinic acid derivatives in vitro and in a murine colitis model.
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Evaluation of the immunomodulatory effects of novel phosphinic acid derivatives in vitro and in a murine colitis model.

Researchers are exploring new small molecules that might modulate T cells in IBD. This study found lab evidence of T‑cell inhibition for several compounds but no therapeutic benefit in a mouse colitis model, so these...

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Modulating immune toxicity in ulcerative colitis using a small molecule RAB27A inhibitor
Inflammatory Bowel Diseases

Modulating immune toxicity in ulcerative colitis using a small molecule RAB27A inhibitor

The report describes a novel small-molecule inhibitor (IMYX-3) targeting RAB27A to reduce neutrophil-mediated damage in ulcerative colitis models, which could point to a new therapeutic approach if later validated in...

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Cardiovascular and Thromboembolic Risk With Upadacitinib in Spondyloarthritis and Inflammatory Bowel Disease: A Meta-Analysis of Randomized Controlled Trials.
Journal of cardiovascular pharmacology

Cardiovascular and Thromboembolic Risk With Upadacitinib in Spondyloarthritis and Inflammatory Bowel Disease: A Meta-Analysis of Randomized Controlled Trials.

People with IBD or Crohn's disease considering or taking upadacitinib may worry about rare but serious risks such as heart attacks, strokes, or blood clots. This meta-analysis found no clear increase in those events...

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Outcomes of risankizumab use in adults with Crohn's disease in a real-world setting (ARISE-CD): a multicentre, retrospective cohort study.
BMJ open gastroenterology

Outcomes of risankizumab use in adults with Crohn's disease in a real-world setting (ARISE-CD): a multicentre, retrospective cohort study.

This real-world multicentre study evaluates risankizumab effectiveness and short-term persistence in adults with Crohn's disease, including those previously treated with ustekinumab — information that can help patients...

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A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
ClinicalTrials.gov

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

The trial could show whether a smart-label app plus clinician alerts improves medication adherence and downstream clinical outcomes for people with Crohn's disease or ulcerative colitis starting oral or subcutaneous...

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Coccidioidomycosis in patients with inflammatory bowel disease receiving advanced therapy: An observational study from an endemic tertiary center.
Inflammatory bowel diseases

Coccidioidomycosis in patients with inflammatory bowel disease receiving advanced therapy: An observational study from an endemic tertiary center.

People with IBD on biologics or small molecules who live in or travel to areas where Coccidioides is endemic face a measurable risk of coccidioidomycosis. How the infection is classified (proven/probable/possible)...

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Recombinant human Thymosin β4 ameliorates experimental colitis and intestinal fibrosis through suppression of mineralocorticoid receptor signaling
PubMed Central

Recombinant human Thymosin β4 ameliorates experimental colitis and intestinal fibrosis through suppression of mineralocorticoid receptor signaling

The work identifies an endogenous peptide (Tβ4) that is reduced in IBD and shows that replacing it in mice lessens colitis and intestinal fibrosis, pointing to a new potential treatment target for inflammation and...

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Efficacy, Safety, and Pharmacokinetics of Upadacitinib Among Patients in East Asia With Moderately to Severely Active Ulcerative Colitis: A Post Hoc Subanalysis of Randomized Phase 3 Studies
Journal of Gastroenterology and Hepatology

Efficacy, Safety, and Pharmacokinetics of Upadacitinib Among Patients in East Asia With Moderately to Severely Active Ulcerative Colitis: A Post Hoc Subanalysis of Randomized Phase 3 Studies

This analysis suggests upadacitinib works and has a similar safety and pharmacokinetic profile in East Asian patients with moderately to severely active ulcerative colitis as in the global trials, which may reassure...

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Continued concomitant antibiotic or immunosuppression therapies reduce the risk of pouchitis among patients with ileal pouch-anal anastomosis and primary sclerosing cholangitis.
Crohn's & colitis 360

Continued concomitant antibiotic or immunosuppression therapies reduce the risk of pouchitis among patients with ileal pouch-anal anastomosis and primary sclerosing cholangitis.

Patients with ulcerative colitis and PSC face higher risk of pouch inflammation after IPAA. The study reports fewer pouchitis events among the small group who received antibiotics or immunosuppression, which could...

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The impact of ustekinumab and tumor necrosis factor antagonists on extraintestinal manifestations of Crohn's disease: a systematic review and meta-analysis.
Frontiers in pharmacology

The impact of ustekinumab and tumor necrosis factor antagonists on extraintestinal manifestations of Crohn's disease: a systematic review and meta-analysis.

Extraintestinal symptoms such as fatigue and joint pain significantly affect quality of life in Crohn's disease. This review suggests ustekinumab may help reduce fatigue and arthritis/arthralgia more than TNF antagonists...

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Upadacitinib effectively suppresses IL13RA2 expression in primary human intestinal fibroblasts derived from Crohn's disease tissue.
Biochemical pharmacology

Upadacitinib effectively suppresses IL13RA2 expression in primary human intestinal fibroblasts derived from Crohn's disease tissue.

The study identifies a cellular mechanism (JAK1-STAT6 pathway) by which upadacitinib can lower IL13RA2 — a molecule tied to inflammation and anti-TNF resistance — which could help explain how JAK inhibitors work in IBD...

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