Ulcerative Colitis

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.

There were no new safety signals identified from the COMMAND trial.

In the maintenance period, 86% of patients treated icanbelimod completed and 67% achieved clinical remission through week 48.

The median exposure of vedolizumab was 1.93 years and lower incidence rates were found for infliximab or adalimumab.

For the maintenance trial, 42% and 55% of patients treated with upadacitinib 15 mg and 30 mg achieved clinical remission at week 52, compared to 14% of the placebo group.

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.

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.

Patients in long-remission also presented with fecal bacterial composition that was similar to what was found in the healthy control group and there was a positive correlation between Akkermansia muciniphila abundance and time in remission.

Disease activity and treatment with a small-molecule or an investigation drug were independently linked to an exclusion diet, while a history of stenosis and active disease were associated with fasting.

The results show 52.5% of patients achieved clinical remission at week 96, while 59.0% saw endoscopic improvement, 35.9% achieved endoscopic remission, and 70.5% achieved a clinical response.

There are many reasons why biosimilars are not utilized in gastroenterology, mainly patients present younger and treatments can lose efficacy over time.

Some traditional sarcopenia assessment techniques included direct measurements on cross sectional imaging, but cross sectional imaging also comes with increased time, cost, and radiation exposure.

Using the bidirectional Montreal classification system, which accounts for disease regression, showed that 90% of patients exhibited inflammatory disease behavior at 5 years, compared to 58% if the hierarchical, unidirectional Montreal classification system was implemented.

The FDA cited manufacturing concerns in their letter for the potential ulcerative colitis treatment.

The incidence of mPDAI-defined remission at week 14 was 31% in the vedolizumab group, compared to 10% in the placebo group.

At the 6 month follow-up visit, all participants had stable folic acid levels without macrocytic anemia and the monthly questionnaires showed no increase in symptoms or adverse events reported.

Patients at a risk of malnutrition had a significantly lower mean of albumin, as well as significantly increased proportion of patients with CRP >5 mg/L.

The results show 83% of patients in the combination group achieved clinical response at week 12, compared to 61% of the golimumab monotherapy group and 75% of the guselkumab group.

The 2 groups had similar data for any endoscopic recurrence and severe endoscopic recurrence at the first endoscopic evaluation.

Acute severe ulcerative colitis and a greater number of biologics precoloectomy were linked to an increased probability of acute pouchitis, while older age at colectomy was associated with a decreased probability of acute pouchitis.

The results from the INSPIRE trial show risankizumab met all primary and secondary endpoints in treating adult patients with moderately to severely active ulcerative colitis.

Clinical remission and clinical response odds, in both induction and maintenance periods, have been consistent over time.

In the infliximab reference group, the persistence at month 12 was 94% for Crohn’s disease and 92.8% for ulcerative colitis.

The results show concomitant recurrent CDI was associated with an IBD flare in 54% of participants. Of this group, 63% received IBD remission-induction therapy before FMT.

Recent data during ECCO 23 show ustekinumab results in higher rates of clinical remission and clinical response in patients with inflammatory bowel disease.

There was a 0.9% increase in the first dispensation of infliximab, either the biosimilar or originator during the first year of follow-up, as well as a 16.2% increase in infliximab dose escalation, a 2.4% decrease in the dispensation of antibiotics, and a 2.6% decrease in the new use of prednisone.

The results show 58% of patients treated with ustekinumab were in clinical remission, while 80% were in clinical response.

Much of the recent focus on drug development in IBD has centered on the IL-23 pathway.

The patients that did not undergo colectomy in the infliximab group were more often re-hospitalized because to the need for intravenous corticosteroids at the two-year follow-up compared to the cyclosporine group.

Individuals that did not respond had a lower percentage of naïve T cells compared to responders, while responders had a lower percentage of Th2 and CD4 central memory subsets before vaccination.