mirikizumab为溃疡性结肠炎（UC）带来临床缓解以及症状改善

March 16, 2021 Eli Lilly and Company announced today that mirikizumab met the primary endpoint and all key secondary endpoints of LUCENT-1, bringing clinical remission and symptom improvement to ulcerative colitis (UC).

UC is a chronic inflammatory disease of the large intestine (also called the colon) that affects the lining of the colon and may lead to the formation of small sores or ulcers. This inflammation can cause abdominal pain, frequent and urgent trips to the bathroom, bloody stools, and incontinence.

"The results of this study provide further clinical evidence for mirikizumab to become the first anti-IL-23p19 biologic agent to treat ulcerative colitis," said Dr. William J. Sandborn, professor of medicine and chief of the division of gastroenterology at UC San Diego.

LUCENT-1 is a 12-week Phase 3 induction study evaluating the efficacy and safety of mirikizumab in patients with moderate to severe ulcerative colitis. LUCENT-2 is a multicenter, randomized, double-blind, placebo-controlled maintenance study of mirikizumab in patients who completed the 12-week LUCENT-1 induction study and is currently ongoing.

In LUCENT-1, mirikizumab met the primary endpoint of clinical response at week 12 (p<0.0001) compared with placebo. Clinical remission is achieved when inflammation in the colon is controlled or resolved, resulting in normalization or near-normalization of symptoms such as stool frequency and bleeding.

Mirikizumab also achieved all key secondary endpoints in UC patients at week 12 with highly statistically significant p-values compared to placebo, including reduction in bowel urgency, clinical response, endoscopic response, symptomatic relief, and improvement in endoscopic histological inflammation.

Additionally, mirikizumab showed rapid improvement in patients' symptoms as early as four weeks after starting treatment. Mirikizumab also reduced symptoms in patients who had previously failed to respond or stopped responding to biologics and/or Janus kinase (JAK) inhibitor therapies.

In the 12-week placebo-controlled induction study of LUCENT-1, the incidence of therapeutic adverse events (AEs) and serious adverse events in mirikizumab-treated patients was consistent with previous UC mirikizumab Phase 2 studies and anti-IL-23p19 antibody class studies. The most common adverse events with placebo and mirikizumab included nasopharyngitis, anemia, and headache.

"Patients with UC often struggle to effectively manage recurring disease attacks," said Lotus Mallbris, Ph.D., vice president of immunology development at Eli Lilly and Company. "With these positive results, we look forward to continuing the study to 52 weeks, hoping to provide a new option for UC patients."

About Mirikizumab

Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. Mirikizumab is being studied to treat immune diseases including psoriasis, ulcerative colitis and Crohn's disease.

About ulcerative colitis

Ulcerative colitis is a chronic inflammatory bowel disease that affects the colon and occurs when the immune system sends white blood cells into the lining of the intestine, producing chronic inflammation and ulcers.