Ulcerative Colitis

Results showed patients treated with vedolizumab experienced less dose escalation and were at a decreased risk of requiring dose escalation compared to patients treated with adalimumab and infliximab.

This phase 3 program was advised to discontinue given that cobitolimod was shown to be less likely to meet its primary endpoint.

New data from ACG 2023 shows etrasimod-treated patients were able to achieve UC remission, with or without concomitant steroid treatment at baseline.

Eli Lilly and Company announced the FDA approval of mirikizumab (Omvoh) for moderately and severely active ulcerative colitis in adults on October 26, 2023.

Induction treatment with guselkumab resulted in a rapid onset of efficacy, beginning at week 1 and increasing over time to week 12, for patients with refractory moderately to severely active ulcerative colitis.

Etrasimod demonstrated rapid and significant symptomatic improvement, with differences compared to placebo evident as early as 2 days after initiation of treatment in patients with ulcerative colitis.

The approval of infliximab-dyyb as a maintenance therapy following IV infliximab for patients with moderately to severely active ulcerative colitis and Crohn disease was announced on October 22, 2023.

The approval of oral, once-daily etrasimod 2 mg was based on positive data from the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials.

An analysis of the Phoenix cohort provides insight into responder rates and treatment persistence with infliximab biosimilars among those with no previous exposure to biologics, a previous failure to respond to biologics, or those switching from reference infliximab.

Investigators observed higher rates of clinical and endoscopic remission among patients with UC treated with FMT compared to those on control treatments, further noting comparable rates of adverse reactions between the groups.

Findings from cross-sectional and predictive analyses of patients with UC treated with upadacitinib revealed HEMR and HEMI are associated with positive long-term clinical outcomes.

AbbVie submitted regulatory applications to the FDA and EMA for rizankizumab 1200 mg intravenous induction dose and 180 mg and 360 mg subcutaneous maintenance dose following successful Phase 3 trials INSPIRE and COMMAND.

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.

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.

Both the incidence and prevalence of inflammatory bowel disease is growing among the older population.

There is no additional risk of developing new cancers for patients treated with IBD medications.

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.