Nearly one-half of patients on mirikizumab
achieved endoscopic response at 52 weeks; most of these patients
were also in clinical remission
INDIANAPOLIS, May 21, 2024 /PRNewswire/ -- In Eli Lilly
and Company's (NYSE: LLY) pivotal Phase 3 VIVID-1 study,
patients with moderately to severely active Crohn's disease, with
or without previous biologic failure, achieved statistically
significant and clinically meaningful improvements across multiple
clinical and endoscopic endpoints at one year with mirikizumab
compared to placebo. Data from this study – the first Phase 3
treat-through data reported for an IL23p19 antibody – will be
presented at Digestive Disease Week® (DDW), held in
Washington, D.C. from May 18-21.
"Crohn's disease is a complex condition that, if untreated, may
result in irreversible damage to the digestive tract. Mirikizumab
patients achieved high rates of combined clinical remission and
endoscopic response, two important treatment targets that are
difficult to achieve in the same patient, at one year. This is
particularly impressive for patients with previous biologic failure
who are generally considered hard-to-treat," said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn
Professor of Medicine and Chief of the Dr. Henry D. Janowitz
Division of Gastroenterology, Icahn School of Medicine at Mount
Sinai.* "Consistent results across patient populations underscore
the potential impact of mirikizumab in individuals living with this
condition."
Crohn's disease is a chronic, inflammatory bowel disease
associated with progressive bowel damage, disability and decreased
health-related quality of life. If not adequately controlled, it
may lead to complications that require hospitalization and surgical
intervention. A substantial proportion of patients do not
experience adequate treatment outcomes, have secondary loss of
response to maintenance therapy or do not tolerate existing
therapies, including biologic agents. Patients with previous
biologic failure may be more difficult to treat.
As previously reported, mirikizumab achieved both co-primary
endpoints and all major secondary endpoints at Week 52 compared to
placebo (p<0.000001), including:
- Proportion of participants achieving clinical response by
patient reported outcomes (PRO)** at Week 12 and clinical remission
(defined as a Crohn's Disease Activity Index [CDAI] Total
Score <150) at Week 52 compared to placebo
- Proportion of participants achieving clinical response by PRO
at Week 12 and endoscopic response (defined as ≥50% reduction
from baseline in Simple Endoscopic Score – Crohn's Disease [SES-CD]
Total Score) at Week 52 compared to placebo
Consistent response rates and treatment effects were observed in
patients with no prior biologic failure (bio-naïve) and
harder-to-treat patients with previous biologic failure:
- 39.3% of bio-naïve and 36.7% of bio-failed patients
taking mirikizumab achieved composite Week 12 PRO clinical
response and Week 52 endoscopic response compared to 11.8% and 6.2%
of placebo, respectively
- 47.3% of bio-naïve and 43.4% of bio-failed patients
taking mirikizumab achieved composite Week 12 PRO clinical
response and Week 52 clinical remission by CDAI, compared to 26.5%
and 12.4% of placebo, respectively
At one year, clinical remission and endoscopic response were
achieved by 54.1% and 48.4% of patients on mirikizumab,
respectively. Notably, of the patients who received mirikizumab,
56.7% of bio-naïve and 51.2% of bio-failed patients achieved
clinical remission at Week 52.
Patients taking mirikizumab achieved combined Week 52 clinical
remission and endoscopic response at nominally statistically
significant higher rates compared to patients on ustekinumab (34.4%
versus 27.9%), with greater difference among those patients with
previous biologic failure. At multiple time points, including Week
52, mirikizumab also achieved nominal statistical significance
compared to ustekinumab in decreasing fecal calprotectin and
C-reactive protein, two key biomarkers for inflammation.
Superiority to ustekinumab was not achieved for endoscopic
response.
Additionally, in the population with previous biologic failure,
numerically greater rates were observed with mirikizumab compared
to ustekinumab for endoscopic response, endoscopic remission
(SES-CD total score ≤4, a ≥2-point reduction from baseline and no
subscore >1 in any individual variable), and corticosteroid-free
CDAI clinical remission at Week 52. These observed differences were
not statistically significant.
The overall safety profile of mirikizumab in patients with
moderately to severely active Crohn's disease was consistent with
the known safety profile in patients with ulcerative colitis. The
frequency of serious adverse events was greater in placebo than
mirikizumab. The most common adverse events were COVID-19, anemia,
arthralgia, headache, upper respiratory tract infection,
nasopharyngitis and injection site reaction.
"After one year of treatment, more than one-half of patients
treated with mirikizumab achieved clinical remission and nearly
one-half achieved endoscopic response. Remarkably, the majority of
patients who achieved either of these endpoints, achieved both
together," said Mark Genovese, M.D.,
senior vice president of Lilly Immunology development. "Lilly is
committed to developing innovative treatments, like mirikizumab,
that may improve upon the standard of care for people impacted by
inflammatory bowel disease and immune-mediated diseases."
Lilly submitted a supplemental Biologics License Application for
mirikizumab in Crohn's disease to the U.S. Food and Drug
Administration and European Medicines Agency this year. Additional
global regulatory submissions are planned.
Lilly is committed to finding solutions to elevate care and
improve treatment outcomes for people living with inflammatory
bowel diseases. Lilly has ongoing studies to evaluate the efficacy
and safety of mirikizumab in other populations with Crohn's
disease, including a Phase 3 study in pediatric patients
(NCT05509777) and a long-term extension study of patients with
moderately to severely active Crohn's disease (NCT04232553).
Omvoh™ (mirikizumab-mrkz) is approved for the treatment
of moderately to severely active ulcerative colitis (UC) in adults
and has additional ongoing trials in UC, including a study in
pediatric patients (NCT05784246) and a study to evaluate the
long-term efficacy and safety of mirikizumab in adults
(NCT03519945). Lilly is continuing to lead the science with an
open-label UC trial studying two new endpoints in the assessment of
bowel urgency with frequency and deferral time, both of which
impact the quality of life for patients (NCT05767021).
* Disclosure: Dr. Sands is a paid consultant for Lilly. He
has not been compensated for any media work.
About the VIVID-1 Clinical Trial Program
VIVID-1 was a Phase 3, randomized, double-blind, treat-through
study that evaluated the safety and efficacy of mirikizumab
compared with placebo and an active control (ustekinumab) in adults
with moderately to severely active Crohn's disease. Patients
randomized to mirikizumab were administered 900 mg of mirikizumab
intravenously every four weeks from Week 0-12, then 300 mg
subcutaneously every four weeks from Weeks 12-52. In this study,
49% of patients taking mirikizumab or placebo had experienced a
prior biologic failure.
** Clinical response by PRO is defined as ≥30% decrease in stool
frequency and/or abdominal pain, and neither score worse than
baseline.
Indications and Usage for Omvoh™ (mirikizumab-mrkz) (in
the United States)
Omvoh™ is indicated for the treatment of moderately to severely
active ulcerative colitis in adults.
Important Safety Information for Omvoh
(mirikizumab-mrkz)
CONTRAINDICATIONS - Omvoh is contraindicated in patients
with a history of serious hypersensitivity reaction to
mirikizumab-mrkz or any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis during
intravenous infusion, have been reported with Omvoh administration.
Infusion-related hypersensitivity reactions, including
mucocutaneous erythema and pruritus, were reported during
induction. If a severe hypersensitivity reaction occurs,
discontinue Omvoh immediately and initiate appropriate
treatment.
Infections
Omvoh may increase the risk of infection. Do not initiate
treatment with Omvoh in patients with a clinically important active
infection until the infection resolves or is adequately treated. In
patients with a chronic infection or a history of recurrent
infection, consider the risks and benefits prior to prescribing
Omvoh. Instruct patients to seek medical advice if signs or
symptoms of clinically important acute or chronic infection occur.
If a serious infection develops or an infection is not responding
to standard therapy, monitor the patient closely and do not
administer Omvoh until the infection resolves.
Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to
initiating treatment with Omvoh. Do not administer Omvoh to
patients with active TB infection. Initiate treatment of latent TB
prior to administering Omvoh. Consider anti-TB therapy prior to
initiation of Omvoh in patients with a history of latent or active
TB in whom an adequate course of treatment cannot be confirmed.
Monitor patients for signs and symptoms of active TB during and
after Omvoh treatment. In clinical trials, subjects were excluded
if they had evidence of active TB, a history of active TB, or were
diagnosed with latent TB at screening.
Hepatotoxicity
Drug-induced liver injury in conjunction with pruritus was
reported in a clinical trial patient following a longer than
recommended induction regimen. Omvoh was discontinued. Liver test
abnormalities eventually returned to baseline. Evaluate liver
enzymes and bilirubin at baseline and for at least 24 weeks of
treatment. Monitor thereafter according to routine patient
management. Consider other treatment options in patients with
evidence of liver cirrhosis. Prompt investigation of the cause of
liver enzyme elevation is recommended to identify potential cases
of drug-induced liver injury. Interrupt treatment if drug-induced
liver injury is suspected, until this diagnosis is excluded.
Instruct patients to seek immediate medical attention if they
experience symptoms suggestive of hepatic dysfunction.
Immunizations
Avoid use of live vaccines in patients treated with Omvoh.
Medications that interact with the immune system may increase the
risk of infection following administration of live vaccines. Prior
to initiating therapy, complete all age-appropriate vaccinations
according to current immunization guidelines. No data are available
on the response to live or non-live vaccines in patients treated
with Omvoh.
ADVERSE REACTIONS
Most common adverse reactions (≥2%) associated with Omvoh
treatment are upper respiratory tract infections and arthralgia
during induction, and upper respiratory tract infections, injection
site reactions, arthralgia, rash, headache, and herpes viral
infection during maintenance.
MR HCP ISI UC APP
Please click for Prescribing
Information and Medication Guide for
Omvoh. Please click for Instructions for
Use included with the device.
About Omvoh™
Omvoh (mirikizumab-mrkz) is an interleukin-23p19 antagonist
indicated for the treatment of moderately to severely active
ulcerative colitis in adults. Omvoh selectively targets the p19
subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due
to over-activation of the IL-23 pathway plays a critical role in
the pathogenesis of ulcerative colitis. Treatment of ulcerative
colitis with Omvoh starts with 300-mg IV infusions, once every four
weeks for a total of three infusions, and transitions to two,
100-mg subcutaneous injections every four weeks during maintenance
treatment.
Omvoh™ and its delivery device base are trademarks owned by Eli
Lilly and Company.
About Lilly
Lilly is a medicine company turning science into healing to make
life better for people around the world. We've been pioneering
life-changing discoveries for nearly 150 years, and today our
medicines help more than 51 million people across the globe.
Harnessing the power of biotechnology, chemistry and genetic
medicine, our scientists are urgently advancing new discoveries to
solve some of the world's most significant health challenges:
redefining diabetes care; treating obesity and curtailing its most
devastating long-term effects; advancing the fight against
Alzheimer's disease; providing solutions to some of the most
debilitating immune system disorders; and transforming the most
difficult-to-treat cancers into manageable diseases. With each step
toward a healthier world, we're motivated by one thing: making life
better for millions more people. That includes delivering
innovative clinical trials that reflect the diversity of our world
and working to ensure our medicines are accessible and affordable.
To learn more, visit Lilly.com and Lilly.com/news, or follow
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About Digestive Disease Week®
Digestive Disease Week® (DDW) is the largest
international gathering of physicians, researchers and academics in
the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American
Association for the Study of Liver Diseases (AASLD), the American
Gastroenterological Association (AGA), the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW is an in-person and online meeting
from May 18-21, 2024. The meeting
showcases more than 5,600 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org.
Cautionary Statement Regarding Forward-Looking
Statements
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 people with
moderately to severely active 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 is no guarantee that
planned or ongoing studies will be completed as planned, that
future study results will be consistent with study results to date,
or that mirikizumab will receive FDA and other additional
regulatory approvals, or that it will be commercially successful.
For further discussion of these and other risks and uncertainties
that could cause actual results to differ from Lilly's
expectations, see Lilly's 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.
© Lilly USA, LLC 2024. All rights reserved.
Refer to:
|
Carla Cox;
cox_carla@lilly.com; +1-317-750-3923; (Lilly media)
|
|
Joe Fletcher;
jfletcher@lilly.com; +1-317-296-2884; (Lilly investors)
|
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