Lilly's IL-23p19 Inhibitor Mirikizumab Demonstrates Sustained Improvement in Fatigue Symptoms in Crohn’s Disease Patients

May 24, 2021 /BioonBIOON/ --Eli Lilly(Eli Lilly) recently announced new data from the Phase 2 SERENITY study evaluating the novel anti-inflammatory drug mirikizumab for the treatment of moderate-to-severe Crohn's disease (CD). In a prespecified analysis, as measured by the mean change in FACIT-Fatigue scores,At week 12 of treatment, mirikizumab improved patient fatigue compared with placebo, and this improvement was sustained for one year.These data were presented at the recently held Digestive Disease Week 2020 (DDW 2020).

Mirikizumab is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23), and is currently under development for the treatment of various immune-mediated diseases, including ulcerative colitis (UC) and Crohn's disease (CD).UC and CD are two types of inflammatory bowel disease that may cause severe and debilitating symptoms and interfere with daily life.

At DDW, in another real-world data analysis of the prospective adult research cohort study for inflammatory bowel disease (SPARC IBD),Over 40% of UC patients (n=181) and nearly half (47.7%, n=431) of CD patients reported fatigue in daily life.Additionally, UC patients reporting fatigue also exhibited higher disease activity levels, more days absent from work or school, and reduced overall well-being. CD patients reporting fatigue had a longer disease duration, higher disease activity levels, more days absent from work or school, and reduced overall well-being.

Inflammatory Bowel Disease (UC, CD, Image source: tahminahaqmd.com)

First author of these analyses and Chair of the Department of Gastroenterology, Hepatology and Nutrition at Cleveland Clinic Miguel Regueiro said: “DDWMeetingThe latest data indicate that fatigue is not merely a symptom of UC and CD; it can also serve as a significant predictor of disease severity and its potential impact on patients' quality of life. Data from the Phase 2 study suggest that mirikizumab may help improve fatigue in patients with moderate-to-severe active CD, further underscoring the importance of evaluating mirikizumab as a potential therapeutic agent for CD patients.”

Eli Lilly# ImmunologyPrentice C. Stovall, Head of Global Development, stated: "Fatigue is a key symptom that requires monitoring in patients with UC and CD, as it is prevalent in both conditions and is associated with increased disease activity, reduced work productivity, and decreased quality of life."Eli Lilly“I am pleased to provide gastroenterologists with important insights into the treatment of patients with UC and CD, underscoring the need for additional treatment options that can deliver meaningful improvement for the burdensome symptoms of these diseases.”

In the SERENITY study, as measured by the mean change from baseline in the FACT-Fatigue score,During the 12-week induction period, patients treated with mirikizumab showed improvement in fatigue compared with placebo.(mirikizumab 200 mg: 10.81±1.73, p < 0.001; 600 mg: 9.09±1.72, p = 0.004; 1000 mg: 9.62±1.22, p < 0.001; placebo: 2.90±1.21). The FACIT-Fatigue scale is a validated 13-item questionnaire used to assess the impact of fatigue on the daily activities of patients with chronic disease.

At the end of the 12-week induction period, patients receiving mirikizumab who achieved an improvement of ≥1 point in the Simple Endoscopic Score for Crohn's Disease (SES-CD) were re-randomized 1:1 to continue receiving once-monthly intravenous treatment or once-monthly subcutaneous mirikizumab 300 mg through Week 52. Patients receiving mirikizumab who had no improvement in SES-CD at Week 12, as well as patients receiving placebo during the induction period, received once-monthly intravenous mirikizumab 1000 mg through Week 52.

Sustained improvement in fatigue at one year in patients treated with mirikizumab. In addition to these data, previously reported results evaluating the 52-week efficacy and safety of mirikizumab were also presented at this year's DDW. In this study, the safety results were consistent with those of mirikizumab in UC studies. (Bioon.com)

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