Global pharma powerhouse Eli Lilly and Company has released new long-term data suggesting its drug Omvoh (mirikizumab-mrkz) may set a new benchmark in treating moderate to severe ulcerative colitis, a chronic inflammatory bowel disease.

 

The company says patients who achieved “disease clearance” after one year of treatment maintained those results for up to four years in the LUCENT-3 extension study. Among those patients, 63.5% sustained disease clearance at year four with continuous treatment.

 

The findings mark the first time an interleukin-23p19 (IL-23p19) inhibitor has demonstrated durable disease clearance over four years in ulcerative colitis.

 

Disease clearance in this context is a stringent outcome requiring simultaneous symptomatic, endoscopic and histologic remission.

 

“Ulcerative colitis is a lifelong disease, and every person living with the condition deserves a treatment that can deliver strong and durable disease control, not just symptom relief,” said Adrienne Brown, executive vice president and president of Lilly Immunology. 

 

“Disease clearance sets that bar higher, and these data show Omvoh-treated patients achieved and sustained it over four years with consistent monthly dosing.”

 

The LUCENT-3 analysis followed patients who responded to Omvoh in earlier studies and continued long-term treatment. Researchers reported that 63.5% of patients who reached disease clearance at one year maintained it through four years. Even under a stricter definition requiring complete endoscopic normalization, 61.3% maintained remission over the same period.

 

“What makes these data so compelling is that they go beyond individual measures of improvement to show that patients treated with Omvoh achieved disease clearance, with simultaneous symptomatic, endoscopic and histologic remission, maintained over four years,” said Jean-Frédéric Colombel, director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai. 

 

“Until now, disease clearance has not been demonstrated for this length of time for any IL-23p19 therapy in ulcerative colitis. For a progressive disease like ulcerative colitis, that level of durable remission has the potential to change the long-term course of the disease for patients.”

 

Lilly reported no new safety signals in the long-term data. Among patients continuing into the extension study, 12% reported a serious adverse event and 7% discontinued treatment due to side effects. The most common reactions included upper respiratory infections, injection site reactions, joint pain, rash, headache, and herpes viral infections.