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Digestive Disease Week (DDW) - 2024 | News | Updates | iPharmaCenter

Updated: May 26

More than half of the Crohn's disease patients treated with Lilly's mirikizumab achieved clinical remission after one year, including those with previous biological treatment failures

Almost half of the patients on mirikizumab demonstrated an endoscopic response at 52 weeks, with the majority also achieving clinical remission.

Eli Lilly presented findings from the pivotal Phase 3 VIVID-1 study, which involved patients with moderately to severely active Crohn's disease, both with and without previous biological failures. The study showed statistically significant and clinically meaningful improvements in several clinical and endoscopic measures at one year with mirikizumab compared to a placebo.

Crohn's disease is a chronic inflammatory bowel condition that can cause progressive bowel damage, disability, and reduced quality of life. Without proper management, it can lead to severe complications requiring hospitalization and surgery. Many patients do not experience sufficient treatment outcomes, lose response to ongoing maintenance therapy, or cannot tolerate current treatments, including biologics. Those with previous biological failures often face greater treatment challenges.

Earlier reports indicated that mirikizumab met both primary endpoints and all major secondary endpoints at Week 52 compared to placebo. These included:

  • The percentage of participants achieving a clinical response based on patient-reported outcomes (PRO) at Week 12 and clinical remission (defined as a Crohn's Disease Activity Index [CDAI] Total Score <150) at Week 52 compared to placebo.

  • The percentage of participants achieving a clinical response by PRO at Week 12 and endoscopic response (defined as a ≥50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease [SES-CD] Total Score) at Week 52 compared to placebo.

Response rates and treatment effects were consistent in both patients with no prior biologic failure (bio-naïve) and those who were more challenging to treat due to previous biologic failure:

  • 39.3% of bio-naïve and 36.7% of bio-failed patients taking mirikizumab achieved a combined Week 12 PRO clinical response and Week 52 endoscopic response, compared to 11.8% and 6.2% of those on placebo, respectively.

  • 47.3% of bio-naïve and 43.4% of bio-failed patients on mirikizumab achieved a combined Week 12 PRO clinical response and Week 52 clinical remission by CDAI, compared to 26.5% and 12.4% of those on placebo, respectively.

At the one-year mark, 54.1% of patients on mirikizumab reached clinical remission, and 48.4% showed an endoscopic response. Notably, 56.7% of bio-naïve and 51.2% of bio-failed patients achieved clinical remission at Week 52.

Patients treated with mirikizumab achieved combined Week 52 clinical remission and endoscopic response at significantly higher rates compared to those on ustekinumab (34.4% versus 27.9%), with the difference being more pronounced among patients with previous biologic failures. Mirikizumab also showed significant reductions in fecal calprotectin and C-reactive protein, key inflammation biomarkers, at various time points, including Week 52, compared to ustekinumab. However, it did not surpass ustekinumab in terms of endoscopic response.

In patients with previous biologic failures, mirikizumab showed numerically higher rates for endoscopic response, endoscopic remission (SES-CD total score ≤4, a ≥2-point reduction from baseline, and no subscore >1 in any variable), and corticosteroid-free CDAI clinical remission at Week 52 compared to ustekinumab. These differences were not statistically significant.

The overall safety profile of mirikizumab in patients with moderately to severely active Crohn's disease was consistent with its known safety profile in ulcerative colitis patients. Serious adverse events were more frequent in the placebo group than in those treated with mirikizumab. The most common adverse events included COVID-19, anemia, joint pain, headache, upper respiratory tract infection, nasopharyngitis, and injection site reactions.


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