Pregnant women with celiac disease were not only at a higher risk of several pregnancy and delivery related complications, but also less likely to have a full-term uncomplicated delivery compared to the cohort without celiac disease.
In the induction trial, guselkumab resulted in a higher rate of clinical remission, as well as symptomatic remission, clinical response, endoscopic improvement, and histo-endoscopic mucosal improvement at week 12.
Guselkumab induction treatment resulted in significantly greater proportions of patients achieving symptomatic remission, clinical response, endoscopy improvement, and histo-endoscopic mucosal improvement at week 12 and symptomatic remission at week 4 compared to placebo.
The lowest screening completion rate was in the colonoscopy invitation group at 14.5% and the patients offered a choice were more likely to complete screening of any kind, compared to either group of patients offered only 1 screening modality.
The mean number of required reinterventions was significantly lower in the patients who received a direct endoscopic necrosectomy at index session when compared with patients who received the step-up treatment approach.
There was a significant reduction in severity score for diarrhea, constipation, abdominal pain, epigastric pain, bloating, vomiting, and acid reflux in participants who reported digestive problem improvements followed by SIM01 treatment.
Patients with IBD who were treated with advanced therapies who obtained clinical remission had 1.6 times more likely to maintain remission when compared with those who achieved clinical response without remission.
A proportion of patients reported triggering or worsening symptoms after a meal, with the largest proportion experiencing bloating or distention, followed by abdominal pain or discomfort, and epigastric pain.
No statistically significant differences in infusion reaction, serious reaction, or immunogenicity rates were identified between patients switching to an infliximab biosimilar and those who continued treatment on the originator.