INDIANAPOLIS, Nov. 5, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced
today that patients with moderate-to-severe rheumatoid arthritis
(RA) treated with baricitinib reported greater improvements in pain
control when compared to Humira®* (adalimumab) or
placebo. A new post-hoc analysis of the Phase 3 RA-BEAM study
disclosing outcomes of patient-reported levels of pain control will
be presented today at the American College of Rheumatology
(ACR)/Association of Rheumatology Health Professionals (ARHP)
Annual Meeting in San Diego,
Calif.
"While there are many treatments available for RA patients,
these data suggest that baricitinib, if approved, may be an
important advancement for patients suffering from RA-related pain,"
said James McGill, M.D.,
distinguished medical fellow and global brand development leader,
Lilly Bio-Medicines. "We are pleased to share these data suggesting
that baricitinib could provide a potential new option for people
living with RA. We remain committed to making life better for
people with rheumatoid arthritis and improving patient care."
RA-BEAM Post-hoc Analysis of Study Results
RA-BEAM was a 52-week trial of 1,305 patients who had active,
moderate-to-severe RA, despite ongoing treatment with methotrexate.
Patients were randomized to placebo once daily (n=488), baricitinib
4 mg once daily (n=487) or adalimumab 40 mg biweekly (n=330). All
patients received background methotrexate. This post-hoc analysis
reviewed outcomes of patient-reported levels of pain control during
the first 24 weeks of the trial as measured by a 0-100 mm visual
analog scale (VAS) during each study visit. Analyses were not
adjusted for multiplicity, were exploratory in nature and further
research should be conducted to confirm these results. Analysis of
reduction in pain included an assessment of the time required to
achieve ≥30 percent, ≥50 percent and ≥70 percent pain improvement,
including the following results:
- Patients treated with baricitinib reported 30-percent pain
improvement at a median 1.9 weeks post-baseline, compared to
adalimumab at a median 2 weeks and placebo at a median 4.6
weeks.
- Patients treated with baricitinib reported 50-percent pain
improvement at a median four weeks post-baseline, compared to
adalimumab at a median 7.9 weeks and placebo at a median 14
weeks.
- Patients treated with baricitinib reported 70-percent pain
improvement at a median 12.4 weeks post-baseline, compared to
adalimumab at a median 20 weeks and placebo at a median of greater
than 24 weeks. From Week 24, non-rescued patients in the placebo
group were switched to receive baricitinib.
For patients whose baseline pain levels were higher than the
median, treatment with baricitinib also led to faster pain
improvements than adalimumab or placebo.
"Many RA patients continue to struggle with chronic pain," said
Peter Taylor, M.A., Ph.D.,
presenting author and Professor at the University of Oxford. "These post-hoc analyses
suggest that these RA patients may derive meaningful and consistent
improvements in pain, particularly those patients with the highest
pain at baseline."
The observed safety profile in RA-BEAM was consistent with
previous trials evaluating baricitinib. The percentage of patients
stopping therapy due to adverse events through Week 24 were 3
percent in placebo, 5 percent in baricitinib and 2 percent in the
adalimumab group. Serious adverse event rates through 24 weeks were
similar with placebo and baricitinib (5 percent each) and lower
with adalimumab (2 percent). No additional safety signals were
observed during the post-hoc analysis.
Lilly plans to resubmit the New Drug Application (NDA) with the
U.S. Food and Drug Administration (FDA) for baricitinib as a
treatment for adult patients with RA before the end of January 2018. Baricitinib is approved for the
treatment of adult patients with RA in several geographies,
including the European Union and Japan.
*The brand listed is a registered trademark owned or licensed
by AbbVie, its subsidiaries or affiliates, and is not a trademark
of Eli Lilly and Company or Incyte Corporation. The maker of this
brand is not affiliated with and does not endorse Lilly, Incyte or
their products.
About Baricitinib
Baricitinib is a once-daily
oral JAK inhibitor currently in clinical studies for inflammatory
and autoimmune diseases. There are four known JAK enzymes: JAK1,
JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated
in the pathogenesis of a number of inflammatory and autoimmune
diseases, suggesting that JAK inhibitors may be useful for the
treatment of a broad range of inflammatory conditions, including
rheumatoid arthritis.
In December 2009, Lilly and Incyte announced an
exclusive worldwide license and collaboration agreement for the
development and commercialization of baricitinib and certain
follow-on compounds for patients with inflammatory and autoimmune
diseases. Baricitinib was submitted for regulatory review seeking
marketing approval for the treatment of rheumatoid arthritis in
the U.S., the European Union and Japan in
2016. Baricitinib was approved in the EU in February
2017 and in Japan in July 2017. In April
2017, the U.S. Food and Drug Administration issued a
Complete Response Letter on the New Drug Application for
baricitinib. Baricitinib remains under review in other markets. It
is also being studied for the treatment of atopic dermatitis and
systemic lupus erythematosus. The Phase 3 program for psoriatic
arthritis is expected to begin in 2018.
About Rheumatoid Arthritis
Rheumatoid arthritis
is a systemic autoimmune disease characterized by inflammation and
progressive destruction of joints.1,2 More than 23
million people worldwide suffer from RA.3 Approximately
three times as many women as men have the disease. Current
treatment of RA includes the use of non-steroidal anti-inflammatory
drugs, oral conventional synthetic disease-modifying antirheumatic
drugs (csDMARDs), such as methotrexate, and injectable, biological
disease-modifying antirheumatic drugs (bDMARDs) that target
selected mediators implicated in the pathogenesis of
RA.4 Despite current treatment options, many
patients do not reach their therapeutic goals or sustained
remission.5,6 There remains an important need to provide
additional treatments to improve overall patient care.
About Baricitinib Phase 3 Trials
Lilly
and Incyte conducted four successful pivotal Phase 3
clinical trials of baricitinib in patients with moderate-to-severe
active rheumatoid arthritis to support regulatory submission in
most countries. Two of the four studies included pre-specified
comparisons to approved DMARDs: one to methotrexate (RA-BEGIN) and
one to adalimumab (RA-BEAM). An additional phase 3 study recently
concluded to support clinical development in China. The
clinical trial program includes a wide range of patients including
those who are methotrexate-naïve, inadequate responders to
methotrexate, inadequate responders to conventional synthetic
disease modifying antirheumatic drugs, or inadequate responders to
bDMARDs including TNF inhibitors. Patients completing any of the
Phase 3 studies were able to enroll in a long-term extension study.
For additional information on this clinical trial program, please
visit www.clinicaltrials.gov.
About Incyte
Incyte Corporation is
a Wilmington, Delaware-based biopharmaceutical company
focused on the discovery, development and commercialization of
proprietary therapeutics. For additional information
on Incyte, please visit the Company's web site
at www.incyte.com.
Follow @Incyte on Twitter
at https://twitter.com/Incyte.
About Eli Lilly and Company
Lilly is a
global healthcare leader that unites caring with discovery to 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 www.lilly.com and newsroom.lilly.com/social-channels.
P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about baricitinib as a potential treatment for patients with
rheumatoid arthritis and reflects Lilly's
and Incyte's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
Among other things, there can be no guarantee that baricitinib will
receive regulatory approval or be commercially successful.
For further discussion of these and other risks and uncertainties,
see Lilly's and Incyte's most recent respective Form 10-K
and Form 10-Q filings with the United States Securities and
Exchange Commission. Except as required by law, Lilly
and Incyte undertake no duty to update forward-looking
statements to reflect events after the date of this release.
1 American College of Rheumatology, Rheumatoid
Arthritis,
http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp.
Accessed November 1, 2017.
2 Hand Clinics, Advances in the Medical Treatment of
Rheumatoid Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf.
Accessed November 1, 2017.
3 WHO Global Burden of Disease Report, (table 7, page
32) 2004,
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
Accessed November 1, 2017.
4 Arthritis Foundation, Medications for Rheumatoid
Arthritis,
http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php.
Accessed November 1, 2017.
5 Rheumatoid arthritis, Lancet,
https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed November 1, 2017.
6 Sustained rheumatoid arthritis remission is
uncommon in clinical practice, Arthritis Research & Therapy,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed
November 1, 2017.
Refer to:
Danielle Neveles;
danielle.neveles@lilly.com; 317-796-4564 (Lilly media)
Phil Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (Lilly investors)
Catalina Loveman;
cloveman@incyte.com; 302-498-6171 (Incyte media)
Michael Booth, DPhil;
mbooth@incyte.com; 302-498-5914 (Incyte investors)
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