INDIANAPOLIS, Feb. 15, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced
today additional detailed results from RA-BEAM – a pivotal phase 3
study of baricitinib in the treatment of moderate-to-severe
rheumatoid arthritis (RA) – were published in the New England
Journal of Medicine.
The New England Journal of Medicine publication includes
supplementary data, which show that starting as early as week 8,
and sustained through week 52, a higher proportion of patients
taking baricitinib achieved ACR50 and ACR70 response – composite
scores that represent at least 50 percent and 70 percent
improvement, respectively, in multiple components of RA disease
activity – compared to adalimumab (Humira®*). These
improvements were statistically significant compared to adalimumab
at weeks 12, 20, 28, 32 and 40. At week 52, both ACR50 and ACR70
rates were higher in the baricitinib group compared to adalimumab,
although only ACR 50 was statistically significant.
A significantly higher proportion of patients taking baricitinib
had low disease activity, assessed by the 28-joint Disease Activity
Score (using high-sensitivity C reactive protein [DAS28-CRP]),
Simplified Disease Activity Index (SDAI) and Clinical Disease
Activity Index (CDAI) scores, compared to adalimumab at weeks 12
and 52.
Lilly and Incyte previously announced positive topline results
of RA-BEAM, stating that the study met its primary objective of
demonstrating superiority compared to placebo after 12 weeks of
treatment based on ACR20 response – a standard clinical measure
that represents at least a 20 percent improvement in RA disease
activity.
"This is an exciting time for rheumatology, with potential new
treatments for rheumatoid arthritis on the horizon. The RA-BEAM
study of baricitinib is the first phase 3 trial showing that a
once-daily, oral treatment significantly improved clinical outcomes
compared with a current standard of care, injectable adalimumab
used with background methotrexate therapy," said Peter Taylor, M.A., Ph.D., F.R.C.P., study
author and Norman Collisson chair of
Musculoskeletal Sciences in the Nuffield Department of
Orthopaedics, Rheumatology and Musculoskeletal Sciences at the
University of Oxford. "These data
demonstrate that baricitinib could provide another treatment option
for people with rheumatoid arthritis."
The 52-week RA-BEAM study included more than 1,300 patients with
inadequate response to methotrexate, all of whom continued to
receive methotrexate through the study period. Patients were
randomized to placebo once daily (n=488), baricitinib 4 mg once
daily (n=487) or adalimumab 40 mg biweekly (n=330). At week 24,
patients taking placebo were crossed over to the baricitinib
treatment group. The design of the head-to-head study and
statistical analysis plan included prespecified and controlled for
multiple testing for both non-inferiority and superiority of
baricitinib compared with adalimumab.
Detailed safety results from the trial show that 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).
Through the 52-week period, serious adverse event rates were 8
percent for baricitinib and 4 percent for adalimumab. Patients
stopping therapy due to adverse events from baseline through week
52 were 7 percent for baricitinib and 4 percent for adalimumab.
Major adverse cardiovascular events (MACE) were reported in less
than 1 percent of patients in both the baricitinib and adalimumab
groups (baseline through 52 weeks). A total of 5 deaths were
reported in the study (1 placebo, 2 baricitinib, 1 adalimumab and 1
placebo rescued to baricitinib).
Baricitinib, an investigational medicine for the treatment of
moderate-to-severe RA, is in the late stages of regulatory review
in the United States and
Japan. In February 2017, the European Commission granted
marketing authorization for baricitinib for the treatment of
moderate-to-severe RA in adult patients who have responded
inadequately to, or who are intolerant to, one or more
disease-modifying anti-rheumatic drugs (DMARDs).
About Baricitinib
Baricitinib is a once-daily oral
selective JAK1 and JAK2 inhibitor currently in late-stage 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.
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., European Union and Japan in Q1 2016, and is being studied in
phase 2 trials for atopic dermatitis and systemic lupus
erythematosus.
About Rheumatoid Arthritis
Rheumatoid arthritis is an
autoimmune disease characterized by inflammation and progressive
destruction of joints.i,ii More than 23 million
people worldwide suffer from RA.iii 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 disease-modifying antirheumatic drugs
(cDMARDs), such as methotrexate – the current standard of care –
and injectable, biological disease-modifying antirheumatic drugs
(bDMARDs) that target selected mediators implicated in the
pathogenesis of RA.iv Despite current treatment
options, many patients do not reach their therapeutic goals or
sustained remission.v,vi There remains an important
need to provide additional treatments to improve overall patient
care.
About Baricitinib Phase 3 Trials
Lilly and Incyte
conducted four pivotal phase 3 clinical trials of baricitinib in
patients with moderately-to-severely active rheumatoid arthritis to
support regulatory submission in most countries. An additional
phase 3 study was initiated 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 disease-modifying
antirheumatic drugs, or inadequate responders to TNF inhibitors.
Patients completing any of the five phase 3 studies can 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.
*The brand listed is a trademark of AbbVie and a not
trademark of Eli Lilly and Company or Incyte Corporation. The maker
of this brand is not affiliated with and does not endorse Eli Lilly
and Company or Incyte Corporation or their products.
(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
rheumatoid arthritis and the RA-BEAM trial, and reflects Lilly and
Incyte's current belief. 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 future study results will be
consistent with study findings to-date, or that baricitinib will
receive regulatory approvals or prove to be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's and Incyte's most recent Form 10-K and
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.
i American College of Rheumatology, Rheumatoid
Arthritis,
http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp (Accessed: September
15, 2016)
ii Hand Clinics, Advances in the Medical
Treatment of Rheumatoid Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf (Accessed: September
15, 2016)
iii 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 September
15, 2016)
iv 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: September
15, 2016)
v Rheumatoid arthritis, Lancet,
https://www.ncbi.nlm.nih.gov/pubmed/27156434
(Accessed: September 15, 2016)
vi Sustained rheumatoid arthritis remission is
uncommon in clinical practice, Arthritis Research &
Therapy, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/ (Accessed: September
15, 2016)
Refer to:
Scott MacGregor;
jsmacgregor@lilly.com; +1-317-440-4699 (Lilly media)
Phil Johnson;
johnson_philip_l@lilly.com; +1-317-655-6874 (Lilly investors)
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
Michael Booth, DPhil;
mbooth@incyte.com; +1-302-498-5914 (Incyte investors)
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SOURCE Eli Lilly and Company