Ulcerative Colitis

The June 2024 gastroenterology month in review highlights FDA news and other pipeline developments in GI as well as the publication of the latest installment of Qazi Corner.

Findings from a post hoc analysis of True North and its open-label extension highlight ozanimod’s rapid onset of action and durability in advanced therapy-naive patients with UC.

The approval is based on data from a pair of phase 3 studies and makes risankizumab-rzaa the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn’s disease.

Findings suggest cuffitis after ileal pouch-anal anastomosis is linked to long-term complications including strictures and fistulas, potentially contributing to a greater risk of pouch failure.

In honor of World Digestive Health Day, this feature examines the growth of intestinal ultrasound in IBD care in the US and how it aligns with STRIDE-II guidance.

The phase 3 QUASAR Maintenance study met its primary endpoint of clinical remission and demonstrated statistically significant endoscopic remission rates in UC treatment.

Announced on April 18, the approval is based on the VISIBLE 2 trial and comes less than 7 months after the approval of SC vedolizumab in ulcerative colitis.

Findings demonstrate a similar postoperative safety profile for both tofacitinib and biologics in patients with medically refractory ulcerative colitis undergoing colectomy.

Findings highlight the negative impact of bowel urgency and bowel urgency-related accidents on the daily lives of patients with UC and CD.

Findings from a novel study supports the JAK inhibitor tofacitinib as a potential first-line therapy for ASUC.

The submission could grant guselkumab its third indication, after being approved by the FDA for psoriasis and psoriatic arthritis.

Dubinsky discusses the importance of head-to-head trials in IBD and looks ahead to the use of combination therapy to achieve desired treatment outcomes.

A high intake of fish and vegetables at 1 year of age was associated with a lower risk of IBD, while consuming sugar-sweetened beverages was linked to a greater risk of developing IBD.

Findings from the retrospective cohort study suggest an increased prevalence of advanced kidney disease among individuals with Crohn disease and ulcerative colitis.

Patients ≥ 65 years of age experienced similar rates of remission and adverse events compared to their younger counterparts, with no significant difference in change in renal function observed between the 2 groups.

Results confirmed the long-term efficacy of ustekinumab maintenance in patients with ulcerative colitis, demonstrating consistent rates of symptomatic remission and endoscopic improvement with no new safety signals.

BLA submission was based on data from phase 3 clinical trials in which DMB-3115 showed no clinically meaningful differences compared with the reference product for the treatment of plaque psoriasis.

The guideline includes 9 conditional recommendations to support practitioners in the management of pouchitis and inflammatory pouch disorders.

The past year has seen a multitude of FDA approvals, ranging from IL-23 and JAK inhibitors to biologics and subcutaneous treatment administrations, that have helped redefine what it means to treat IBD.

The S1PR modulators are currently positioned to serve as a great treatment option for patients with moderate disease who are hesitant to escalate to a biologic treatment.

Investigators ranked ChatGPT responses to healthcare professional-oriented questions about IBD as more useful and reliable than the model’s responses to patient-oriented questions.

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.