Mirikizumab, an interleukin-23p19 (IL-23p19) antagonist already approved for ulcerative colitis, has shown promising long-term efficacy and safety in both ulcerative colitis and Crohn's disease, according to recent data released by Eli Lilly. These findings suggest that mirikizumab could provide durable intestinal healing and relief from key symptoms for patients with inflammatory bowel disease (IBD).
Long-Term Remission in Ulcerative Colitis
Data from the LUCENT-2 clinical trial demonstrated that 81% of participants who achieved clinical remission with mirikizumab at one year maintained long-term clinical remission after an additional two years of treatment, totaling up to three years. This sustained benefit was observed across symptomatic, clinical, endoscopic, and histologic endpoints, regardless of prior failure to TNF inhibitors, tofacitinib, or other biologics.
According to Anabela Cardoso, MD, senior vice president for Lilly Immunology Medical Affairs, "These long-term data show mirikizumab can provide durable intestinal healing and relief from the key symptoms that matter most to patients giving health care providers the evidence needed to inform clinical decision making in treating inflammatory bowel disease."
Sustained Efficacy in Crohn's Disease
Eli Lilly also presented data from the VIVID-2 clinical trial at ACG 2024, evaluating mirikizumab in the treatment of moderately to severely active Crohn’s disease. The study showed that participants treated with mirikizumab maintained high rates of clinical and endoscopic remission for up to 5 years, with 96% having a clinical response measurable by the Crohn’s Disease Activity Index (CDAI), and 87% in clinical remission based on the CDAI.
Cardoso explained, "These findings reinforce the efficacy and safety of mirikizumab to date, and also demonstrate that people who achieve remission with mirikizumab can sustain long-term endoscopic remission for up to 5 years. These results build on the growing body of evidence for mirikizumab, which is approved in the U.S. for the treatment of moderately to severely active ulcerative colitis in adults [and] under review with the U.S. FDA for moderately to severely active Crohn’s disease."
Mechanism of Action and Clinical Significance
Mirikizumab selectively binds to the p19 subunit of the IL-23 protein, inhibiting its interaction with the IL-23 receptor and reducing its effects on inflammation. The IL-23 pathway plays a critical role in the development and persistence of ulcerative colitis and Crohn's disease.
Rudolph Bedford, MD, a board-certified gastroenterologist at Providence Saint John’s Health Center, noted the importance of new therapies like mirikizumab, stating, "Because with our old drugs, our tumor necrosis factors (TNFs), there are many times that the drug begins to wear out its welcome, so to speak, in that [in] the patients they’re no longer effective. So we need more drugs in our armamentarium to add on to what we’re utilizing at this point in time."
With approximately 10 million people globally living with IBD and no existing cure, mirikizumab represents a significant advancement in providing long-standing remission and relieving disease burden for those affected by these chronic conditions.
