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

Page 13 of 26 · 1224 articles

Model‐informed dose optimization of etrasimod in ulcerative colitis across CYP2C9 genotypes and hepatic impairment
British Journal of Clinical Pharmacology

Model‐informed dose optimization of etrasimod in ulcerative colitis across CYP2C9 genotypes and hepatic impairment

People with ulcerative colitis taking etrasimod may have higher drug levels if they have certain CYP2C9 genotypes or significant liver impairment; dose adjustments could be needed to avoid increased exposure.

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Tacrolimus Bridging and Combination Therapy Following Infliximab and JAK Inhibitor Failure in Ulcerative Colitis: A Case Series.
JGH open : an open access journal of gastroenterology and hepatology

Tacrolimus Bridging and Combination Therapy Following Infliximab and JAK Inhibitor Failure in Ulcerative Colitis: A Case Series.

Patients with UC who fail both anti-TNF and JAK inhibitor therapies have limited options. This report suggests tacrolimus can be used as a short-term bridge or in combination to reach another maintenance drug, with many...

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Comprehensively validated µSPE-HPLC-MS/MS method for high-throughput clinical monitoring of Janus kinase inhibitor drugs approved for inflammatory bowel disease treatment
Scientific Reports

Comprehensively validated µSPE-HPLC-MS/MS method for high-throughput clinical monitoring of Janus kinase inhibitor drugs approved for inflammatory bowel disease treatment

Reliable, high-throughput lab methods are a prerequisite for therapeutic drug monitoring (TDM). For people with IBD on JAK inhibitors, validated assays can enable exposure measurement needed for future precision dosing...

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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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Early infliximab levels and clearance predict outcomes in acute severe ulcerative colitis.
Translational gastroenterology and hepatology

Early infliximab levels and clearance predict outcomes in acute severe ulcerative colitis.

Based on the title and source metadata, this appears to be a clinical study related to Ulcerative colitis, Inflammatory bowel disease, and Infliximab. The original article is from Translational gastroenterology and...

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Suppressing FUT8 with a Novel Small Molecule Inhibitor Ameliorates Inflammation in Murine T Cell-mediated Colitis Models.
Cellular and molecular gastroenterology and hepatology

Suppressing FUT8 with a Novel Small Molecule Inhibitor Ameliorates Inflammation in Murine T Cell-mediated Colitis Models.

This study identifies FUT8, an enzyme that adds core fucose to N-glycans, as a possible new target to reduce pro-inflammatory T-cell responses in IBD. For people with IBD, new mechanisms in preclinical research may...

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Long-Term Effectiveness and Persistence of Ustekinumab in Crohn's Disease Patients: An Observational Retrospective Study.
Journal of clinical medicine

Long-Term Effectiveness and Persistence of Ustekinumab in Crohn's Disease Patients: An Observational Retrospective Study.

Ustekinumab is already approved for moderate-to-severe Crohn's disease; this real-world study reports encouraging longer-term clinical, biological, and endoscopic outcomes up to 96 weeks and suggests good treatment...

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Exploration of novel costunolide derivatives bearing indole/indoline as anti-ulcerative colitis agents by targeting JAK2-STAT3 pathways.
Bioorganic chemistry

Exploration of novel costunolide derivatives bearing indole/indoline as anti-ulcerative colitis agents by targeting JAK2-STAT3 pathways.

This study reports early-stage lab and mouse evidence for new small molecules that target the JAK2–STAT3 immune signaling pathway, a pathway relevant to inflammation in ulcerative colitis. If findings are confirmed in...

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Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov

Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis

This registry will track how people with moderate to severe ulcerative colitis do on risankizumab in routine Japanese clinical practice, which may provide information about real-world remission rates and longer-term...

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Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries.
Paediatric drugs

Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries.

Children with IBD often wait years for medicines to be approved after adult approvals; this review shows many ongoing paediatric trials for biologics and small molecules that could improve treatment options.

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Development of Hydrophobic Tag Based HDAC6 Degrader for Ulcerative Colitis Treatment.
Journal of medicinal chemistry

Development of Hydrophobic Tag Based HDAC6 Degrader for Ulcerative Colitis Treatment.

The study introduces a novel preclinical therapeutic approach that selectively degrades HDAC6 and reduced inflammation in a mouse model of colitis, suggesting a potential new drug-discovery avenue relevant to ulcerative...

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An Open-Label, Comparative, Parallel Clinical Trial of the Safety, Pharmacokinetics and Immunogenicity of the Ustekinumab Biosimilar GNR-068 and the Originally Developed Ustekinumab as a Reference Drug After a Single Subcutaneous Administration in Healthy Male Volunteers
Antibodies

An Open-Label, Comparative, Parallel Clinical Trial of the Safety, Pharmacokinetics and Immunogenicity of the Ustekinumab Biosimilar GNR-068 and the Originally Developed Ustekinumab as a Reference Drug After a Single Subcutaneous Administration in Healthy Male Volunteers

Ustekinumab treats Crohn’s disease and ulcerative colitis; a biosimilar that shows similar pharmacokinetics and safety could expand treatment options and affect availability and cost.

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Treatment persistence after switching between anti-tumor necrosis factor agents and tofacitinib in ulcerative colitis: A nationwide claims-based cohort study in South Korea.
Therapeutic advances in gastroenterology

Treatment persistence after switching between anti-tumor necrosis factor agents and tofacitinib in ulcerative colitis: A nationwide claims-based cohort study in South Korea.

Patients and clinicians considering sequencing of advanced UC therapies may care because this study reports differences in how long patients stayed on second-line treatment depending on the order of anti-TNF agents and...

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