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Mirikizumab Improves Fatigue in Patients with Crohn's Disease in Phase 2 Trial

Published: 2021-05-22 16:16:00 ET

- At one year, improvements in fatigue were sustained among those treated with mirikizumab -

- Three separate analyses of real-world data highlight the burden of fatigue and rectal urgency among people living with ulcerative colitis or Crohn's disease -

INDIANAPOLIS, May 22, 2021 /PRNewswire/ -- In a pre-specified analysis of the Phase 2 SERENITY study, Eli Lilly and Company's (NYSE: LLY) mirikizumab improved fatigue in patients with moderately to severely active Crohn's disease (CD) at 12 weeks, as measured by the mean change in FACIT-Fatigue scores compared to placebo, with improvements that were sustained up to one year. These results are being presented virtually at Digestive Disease Week® (DDW), May 21-23, 2021.

Mirikizumab is being studied for UC and CD, two forms of inflammatory bowel disease that can cause serious and debilitating symptoms, and disruptions in daily life.

"New data at DDW show that fatigue is more than a symptom of ulcerative colitis and Crohn's disease – two chronic, inflammatory bowel diseases that can be challenging to treat. It can also be an important predictor for the severity of a person's disease and the potential impact it has on their quality of life," said Miguel Regueiro, M.D., chair of Gastroenterology, Hepatology & Nutrition at Cleveland Clinic and lead author of these analyses. "The data from Lilly's Phase 2 study show mirikizumab may help improve fatigue in patients with moderately to severely active Crohn's disease, reinforcing the importance of further study into mirikizumab as a potential treatment for those living with this disease."

Mirikizumab Demonstrated Improvements in Fatigue

In SERENITY, patients treated with mirikizumab saw improvements in fatigue during the induction period of 12 weeks, as measured by the mean change in FACIT-Fatigue scores from baseline compared to placebo (mirikizumab 200 mg: 10.81±1.73, p

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