Gastroenterology Month in Review: June 2024

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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.

Coming on the heels of a busy May with a plethora of new gastroenterological research from Digestive Disease Week (DDW) 2024, June kept the excitement rolling into the new month and was a fitting conclusion to what was a bustling first half of 2024 in the field of gastroenterology. HCPLive’s June 2024 month in review spotlights some of the top news from the past few weeks, ranging from the US Food and Drug Administration (FDA) approval of risankizumab-rzaa (Skyrizi) in ulcerative colitis (UC) to other phase 3 data for therapeutics progressing through the pipeline, also highlighting the publication of the sixth edition of Qazi Corner.

FDA News

FDA Approves Risankizumab (Skyrizi) for Ulcerative Colitis

On June 18, AbbVie announced the FDA approval of risankizumab-rzaa (Skyrizi) for adults with moderately to severely active UC. The decision, supported by data from a pair of phase 3 clinical trials demonstrating clinical remission and endoscopic improvement, makes risankizumab the first interleukin (IL)-23 specific inhibitor approved for both moderate to severe UC and moderate to severe Crohn disease (CD). Along with being approved in UC and CD, risankizumab is approved for plaque psoriasis and psoriatic arthritis.

In the Pipeline

Bruce Sands, MD: Phase 3 Treat-Through Data for Mirikizumab in Crohn’s Disease

Data from the phase 3 VIVID-1 study of mirikizumab in patients with moderately to severely active CD with or without previous biologic failure support the selective IL-23p19 monoclonal antibody’s ability to induce clinical remission and endoscopic response in this patient population. Of note, the data mark the first phase 3 treat-through data reported for an IL-23p19 antibody and showed nearly half of patients on mirikizumab achieved endoscopic response at 52 weeks, most of whom were also in clinical remission.

In this Q&A, HCPLive sat down with Bruce Sands, MD, Dr Burrill B. Crohn Professor of Medicine at Mount Sinai, for further insight into the results and what they may mean for the future of mirikizumab in CD.

GRAVITI: Positive Topline Results for Guselkumab SC Induction in Crohn’s Disease

Another notable CD pipeline development was seen with Johnson & Johnson’s announcement of positive topline results from the phase 3 GRAVITI investigational study of guselkumab (Tremfya) subcutaneous (SC) induction therapy in adult patients with moderately to severely active CD. According to a press release, the study met all primary and secondary endpoints, including statistically significant and clinically meaningful outcomes for clinical remission and endoscopic response at week 12 and multiplicity-controlled secondary endpoints at weeks 12, 24, and 48.

"The Phase 3 GRAVITI study showed promising results with SC induction and provides similar clinical benefit to what was seen with IV induction in the GALAXI studies," David Lee, MD, PhD, Global Therapeutic Area Head Immunology, Johnson & Johnson Innovative Medicine, said in a press release. "Having both SC and IV induction options provides choice and versatility for patients and providers. TREMFYA is poised to be the only IL-23 inhibitor to offer a full SC therapy for both induction and maintenance in Crohn's disease."

Ozanimod Effective, Durable in Patients with Ulcerative Colitis Naive to Advanced Therapy

Ozanimod may be an effective and durable treatment option for patients with UC who are naive to advanced therapy and whose UC is inadequately controlled by conventional therapies, according to findings from a post hoc analysis of the phase 3 True North study and its open-label extension.

Results showed the highly selective sphingosine 1-phosphate receptor modulator’s rapid onset of action, with symptomatic response and remission in numerically greater proportions of patients versus placebo as early as 2 weeks after treatment initiation. Compared with findings in the total population, the advanced therapy-naive subgroup experienced significant improvements with ozanimod numerically similar or slightly greater across all clinical and mucosal efficacy endpoints at weeks 10 and 52.

Installment 6 of Qazi Corner

Qazi Corner, Edition 6: Bariatric Surgery in Liver Disease, Glucagon, and Cuffitis Outcomes

The sixth installment of Qazi Corner, a collaborative quarterly newsletter on gastroenterology research, news, and trends between HCPLive and editor-in-chief Taha Qazi, MD, a gastroenterologist at Cleveland Clinic, was published in June. It featured a trio of articles from Cleveland Clinic experts, including a piece on glucagon in foreign body impaction and cuffitis outcomes after pouch creation, as well as interviews with Qazi regarding the significance of their work.

Glucagon’s Role in Esophageal Foreign Body Impaction

Cuff Inflammation Following Pouch Creation and Future Stricture, Fistula Development