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Our gastroenterology month in review highlights multiple FDA approvals, conference coverage from ACG 2023, and other top news in gastroenterology.
October was a busy month in gastroenterology, characterized by multiple FDA approvals and a plethora of data presented at the American College of Gastroenterology 2023 Annual Scientific Meeting. To celebrate the advances and other top news in the field of gastroenterology, our October 2023 Gastroenterology Month in Review spotlights 7 pieces of content examining topics ranging from FDA decisions for ulcerative colitis treatments to a new stool DNA test for detecting colorectal cancer.
Gastroenterology FDA Decisions
It was a bustling month for the FDA, kicking off with the approval of etrasimod (Velsipity) 2 mg for adults with moderately to severely active ulcerative colitis (UC). The decision was supported by data from the ELEVATE UC phase 3 registrational program, including the ELEVATE UC 52 and ELEVATE UC 12 trials, assessing the safety and efficacy of etrasimod on clinical remission in patients with UC who had previously failed or were intolerant to at least 1 conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
In ELEVATE UC 52, 27.0% and 32.0% of patients receiving etrasimod achieved clinical remission at weeks 12 and 52, respectively. In ELEVATE UC 12, clinical remission was achieved among 26.0% of patients receiving etrasimod.
Just 2 weeks later, the FDA approved another treatment for UC, mirikizumab (Omvoh), based on data from a pair of phase 3 trials within the LUCENT program. The approval marked the first IL-23p19 antagonist to receive such an indication, but it was not an easy feat. The initial Biologics License Application from Eli Lilly and Company for mirikizumab dates back to Q1 of 2022, with the road to approval delayed by a Complete Response Letter from the FDA in April 2023 expressing concerns related to the proposed manufacturing of the agent.
The editorial team of HCPLive Gastroenterology sat down with Marla Dubinsky, MD, chief of the division of pediatric gastroenterology at Mount Sinai Kravis Children’s Hospital, for further insight into the LUCENT program and its extension study assessing the safety and efficacy of mirikizumab through 104 weeks of continuous treatment.
The FDA managed to squeeze 1 last approval in on the final day of the month, ending October by approving ustekinumab-auub (Wezlana) as a biosimilar to and interchangeable with ustekinumab (Stelara) for the treatment of multiple inflammatory diseases, including Crohn disease and ulcerative colitis.
Conference Coverage: HCPLive at ACG 2023
A meta-analysis of 17 randomized controlled trials exploring various GLP-1 agonists across 22,000 adult patients with a BMI of ≥30 or ≥27 kg/m2 with obesity-related comorbidities revealed tirzepatide 15 mg was the most efficacious for obesity management. Tirzepatide 5 mg was found to induce a -13.60% reduction in weight (95% CI, -15.48 to -11.72), the 10 mg dose resulted in a mean -19.00% change in weight (95% CI, -20.88 to -17.12), and the 15 mg dose resulted in a -20.10% change in body weight (95% CI, -21.98 to -18.22). An FDA decision for tirzepatide in obesity management is expected at the end of 2023.
Consumption of sweet snacks and candy and poor access to healthy food, are risk factors for early-onset colorectal cancer mortality, according to findings from an analysis of data from the Surveillance, Epidemiology, and End Results program and the CDC: National Program of Cancer Registries. Dietary patterns and food environment were found to be significantly correlated with early-onset colorectal cancer mortality. By location, the strongest correlation was food environment index, which had a -0.46 correlation with mortality (P < .0001). Additionally, household consumption of fruits and vegetables, packaged sweet snacks, and consumption of butter, margarine, and solid fats were also strongly correlated with early-onset colorectal cancer mortality (P < .0001).
The Exact Sciences Corp’s next-generation Cologaurd test met all endpoints in the pivotal BLUE-C trial, including a demonstrated 94% sensitivity for CRC at 91% specificity, with data showing it was significantly more likely to detect both cancer (93.9% vs 67.3%) and advanced precancerous lesions (APLs; 43.4% vs 23.3%) compared to standard fecal immunochemical test. Study investigator Thomas F. Imperiale, MD, professor of medicine at Indiana University Medical Center, sat down with HCPLive at ACG 2023 to discuss topline findings from BLUE-C.