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<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 which assesses the impact of fatigue on daily
activities in patients with chronic illnesses.
At the end of the 12-week induction period, patients treated
with mirikizumab who achieved ≥1 point improvement in Simple
Endoscopic Score for Crohn's Disease (SES-CD) were re-randomized
1:1 to continue to receive the same, once-monthly IV treatment or
once-monthly mirikizumab 300 mg, administered subcutaneously, up to
52 weeks. Patients who received mirikizumab and did not have SES-CD
improvement at 12 weeks and those who received placebo during
induction received once-monthly mirikizumab 1000 mg, administered
intravenously, up to one year.
At one year, improvements in fatigue were sustained among those
treated with mirikizumab. For methodology, see "About the Analyses"
section below.
In addition to these data, previously-presented results
evaluating the efficacy and safety of mirikizumab through 52 weeks
will also be presented virtually at DDW this year. In this study,
the safety results were consistent with that of mirikizumab in UC
and with the class.
Fatigue Among Patients with UC or CD is Associated with
Higher Levels of Disease Activity,
Decreased Work Productivity and Reduced Well-Being
In a real-world data analysis of the Study of a Prospective
Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD),
more than 40% of patients with UC (n=181) and nearly half of
patients living with CD (47.7%, n=431) reported living with
fatigue, as measured by those who indicated whether they had
experienced fatigue within the last week.
Patients with UC who reported fatigue (n=184) also had higher
levels of disease activity, (2.1 [1.86] vs. 0.7 [1.21], p<0.01),
missed more days of work or school (6.1 days [33.21] vs. 0.2 days
[1.32], p=0.05) and reported reduced general well-being (those who
ranked general well-being as "poor to terrible" or "slightly under
par": 111 [61.6%] vs. 52 [20%], p<0.01) compared to patients
with UC who did not report fatigue (n=265). No statistically
significant differences were seen in disease duration (11.6 years
[10.27] vs. 11.6 years [9.94], p=0.99).
Patients with CD who reported fatigue (n=431) had longer disease
duration (15.4 years [11.13] vs. 13.8 years [9.64], p=0.03), higher
levels of disease activity (157.7 [97.57] vs. 83.8 [55.26],
p<0.01), missed more days of work or school (6.1 days
[26.69] vs. 0.4 days [2.11], p<0.01) and reported reduced
general well-being (those who ranked general well-being as "poor to
terrible" or "slightly under par": 271 [62.9%] vs. 97 [20.6%],
p<0.01) compared to those with CD who did not report fatigue
(n=472). For methodology, see "About the Analyses" section
below.
Results from two analyses of a cross-sectional survey were also
presented at DDW, which evaluated the burden of fatigue and rectal
urgency, respectively, among 1,057 patients with UC and 1,228
patients with CD.
"Fatigue is a key symptom to monitor in people living with
ulcerative colitis and Crohn's disease, as it is prevalent in both
conditions and associated with higher levels of disease activity,
decreased work productivity and worse quality of life," said
Prentice C. Stovall, Jr., Global Development Leader, Immunology at
Lilly. "Lilly is excited to present data that offer important
insights for gastroenterologists when treating patients with UC and
CD, and they reinforce the need for additional treatment options
that can offer meaningful improvements for the burdensome symptoms
of these diseases."
About The Analyses
- Mirikizumab Therapy is Associated with Improved Fatigue in
Patients with Moderately to Severely Active Crohn's Disease
At baseline, 191 patients from the Phase 2 SERENITY trial were
randomized 2:1:1:2 to once-monthly placebo, mirikizumab 200 mg,
mirikizumab 600 mg or mirikizumab 1000 mg, administered
intravenously. At 12 weeks, patients treated with mirikizumab who
achieved ≥1 point improvement in Simple Endoscopic Score for
Crohn's Disease (SES-CD) from baseline were re-randomized 1:1 to
continue to receive the same, once-monthly IV treatment assignment
or to once-monthly mirikizumab 300 mg, administered subcutaneously,
up to 52 weeks. Patients who received mirikizumab and did not have
any SES-CD improvement at 12 weeks and those who received placebo
during induction received once-monthly mirikizumab 1000 mg,
administered intravenously, up to 52 weeks. Fatigue was measured
using the FACIT–Fatigue scale, a validated 13-item questionnaire
which assesses the impact of fatigue on daily activities. Change
from baseline to 12 weeks and 52 weeks in FACIT-Fatigue were
calculated. P-values shown above are not adjusted for multiplicity.
The effect of mirikizumab on rectal urgency was not evaluated in
this study.
- Prevalence of Fatigue among Crohn's Disease and Ulcerative
Colitis Patients: Analyses from SPARC IBD
Real-world data from 443 people with UC and 903 people with CD were
analyzed in the Study of a Prospective Adult Research Cohort with
Inflammatory Bowel Disease (SPARC IBD). Patients indicated if they
experienced fatigue within the last week and were categorized as
either having fatigue or not having fatigue. Descriptive and
contingency table analyses were conducted to determine the overall
prevalence of fatigue. In both patients with UC and CD, disease
duration was measured by mean number of years, and number of days
of work or school missed was measured by mean number of days in the
past 12 months. For patients with UC, disease activity was measured
by a mean UC Disease Activity Index (UCDAI) 6-point score, and for
patients with CD, disease activity was measured by mean simplified
CD activity index (sCDAI) score.
About Mirikizumab
Mirikizumab is a humanized IgG4 monoclonal antibody that binds to
the p19 subunit of interleukin 23. Mirikizumab is being studied for
the treatment of immune diseases, including ulcerative colitis and
Crohn's disease.
About the Mirikizumab Phase 2 Trial in Crohn's
Disease
SERENITY, the Phase 2, multi-center, randomized, parallel-arm,
double-blind, placebo-controlled trial was designed to assess the
safety and efficacy of mirikizumab in patients with moderately to
severely active Crohn's disease. At baseline, participants were
randomized with a 2:1:1:2 allocation across four treatment arms
(placebo, mirikizumab 200 mg, mirikizumab 600 mg and mirikizumab
1000 mg). The primary endpoint was endoscopic response as
determined by the proportion of participants achieving at least 50
percent reduction from baseline on the Simple Endoscopic Score for
Crohn's Disease (SES-CD) at Week 12. In May
2019, Lilly reported Phase 2 results showing more
patients with moderate to severe Crohn's disease receiving
mirikizumab achieved clinical remission and response at 12 weeks.
Overall, the safety profile at 12 weeks was consistent with that of
mirikizumab in studies of ulcerative colitis and with the
class.
About Crohn's Disease
Crohn's disease, which is a form of inflammatory bowel disease
(IBD), is a chronic immune-mediated condition of the
gastrointestinal (GI) tract. Crohn's most commonly affects the end
of the small bowel (the ileum) and the beginning of the colon, but
it may affect any part of the GI tract, from the mouth to the anus.
IBD, which is inclusive of Crohn's disease and ulcerative colitis,
affects 10 million people worldwide.
About Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease that
affects the colon. UC occurs when the immune system sends white
blood cells into the lining of the intestines, where they produce
chronic inflammation and ulcerations. There is an unmet need
for additional treatment options for UC that provide meaningful
symptom relief, including bowel urgency, and deliver sustained
clinical remission.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring
life-changing medicines to those who need them, improve the
understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us
at lilly.com and lilly.com/newsroom. P-LLY
Lilly Forward-Looking Statement
This press release
contains forward-looking statements (as that term is defined in the
Private Securities Litigation Reform Act of 1995) about mirikizumab
as a potential treatment for patients with ulcerative colitis
and/or Crohn's disease and reflects Lilly's current beliefs
and expectations. However, as with any pharmaceutical product,
there are substantial risks and uncertainties in the process of
drug research, development, and commercialization. Among other
things, there can be no guarantee that future study results will be
consistent with study results to date, that mirikizumab will prove
to be a safe and effective treatment or that mirikizumab will
receive regulatory approvals or be commercially successful. For
further discussion of these and other risks and uncertainties,
see Lilly's most recent Form 10-K and Form 10-Q filings with
the United States Securities and Exchange Commission. Except
as required by law, Lilly undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
Refer to: Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (media)
Kevin Hern; hern_kevin_r@lilly.com;
317-277-1838 (investors)
View original content to download
multimedia:http://www.prnewswire.com/news-releases/mirikizumab-improves-fatigue-in-patients-with-crohns-disease-in-phase-2-trial-301297207.html
SOURCE Eli Lilly & Company