The HCPLive Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for C difficile, IBS and IBD, Crohn's disease, and more.
November 22nd 2024
The supplemental Biologics License Application is supported by the phase 3 ASTRO study of guselkumab SC induction therapy in ulcerative colitis.
Mirikizumab Bests Placebo in Treating Patients With Ulcerative Colitis
There were higher percentages of patients treated with mirikizumab that had clinical remission at week 12 of the induction trial compared to the placebo group. This was also true at week 40 of the maintenance trial.
IBD Trials Re-Randomizing Patients Had Higher Remission Rates
In recent years trial designs have evolved to become increasingly complex and sophisticated with new endpoints that could include patient-reported outcomes, biomarkers, mucosal, and histological healing, central endoscopy reading, and trials that examine both induction and maintenance of remission within the same study.
Intercept Cancels Plans For NASH Treatment After CRL
The treatment, developed by Intercept Pharmaceuticals, could not be approved in its present form, according to the CRL and any resubmission of the treatment for patients with NASH would require at least the successful completion of the long-term outcomes phase of the REGENERATE study.
Patients With Hepatitis Delta Virus More Likely to Experience Rapid Liver Fibrosis Progression
Patients with anti-HDV antibodies had a significantly higher prevalence of liver cirrhosis, significantly lower prothrombin time, and a higher prevalence of HIV co-infection compared to patients who demonstrated serum anti-HDV antibody negatively.