- Significant improvement in joint pain, severity of morning
joint stiffness and tiredness with baricitinib compared to placebo,
were seen as early as day 3
- Post-hoc analysis of two phase 3 studies shows
significantly improved joint pain, severity of morning joint
stiffness and tiredness compared to adalimumab, within 3 weeks of
treatment in patients with rheumatoid arthritis who had inadequate
response to conventional synthetic DMARDs, including
methotrexate
INDIANAPOLIS, Nov. 14, 2016 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today
announced that in two phase 3 trials, RA-BEAM and RA-BUILD,
patients with rheumatoid arthritis (RA) treated with baricitinib
experienced significant improvements in patient-reported outcomes,
including joint pain, severity of morning joint stiffness and
tiredness, compared to placebo and adalimumab
(Humira®)*. These findings were presented today at the
American College of Rheumatology (ACR)/Association of Rheumatology
Health Professionals (ARHP) Annual Meeting in Washington DC, November
11-16, 2016.
"This analysis looked at important aspects of rheumatoid
arthritis such as the pain, morning joint stiffness and tiredness
that are common and debilitating symptoms for patients," said
Terence Rooney, M.D., Lilly's senior
medical director for baricitinib. "Our study results show that
treatment with baricitinib rapidly led to significantly greater
symptom improvement compared to adalimumab and placebo. The results
are very encouraging, and further support baricitinib as a
potential oral treatment for those living with RA."
Key findings include:
RA-BEAM
- In the RA-BEAM trial, once-daily baricitinib (4 mg)
significantly improved joint pain, severity of morning joint
stiffness and tiredness, compared to placebo, as early as day 3 and
significantly improved duration of morning joint stiffness by day
5. With the same dose of baricitinib, these improvements were
significantly greater than adalimumab by day 17 (joint pain), day
19 (severity of morning joint stiffness) and day 21
(tiredness).
- In RA-BEAM, compared to placebo, serious adverse events (SAEs)
rates were similar for baricitinib and lower for adalimumab;
serious infection rates were similar across groups. There were no
cases of gastrointestinal perforations. One event of tuberculosis
was reported in each of the baricitinib and adalimumab groups. The
most common adverse events observed with baricitinib were
nasopharyngitis and bronchitis. Discontinuations due to adverse
events occurred with similar frequency across treatment
groups.
- The 52-week RA-BEAM study randomized 1,307 patients who had
active, moderate-to-severe RA, despite ongoing treatment with
methotrexate. Patients were randomized to once-daily placebo
(n=488), once-daily baricitinib 4 mg (n=487) or biweekly adalimumab
40 mg (n=330). All patients received background methotrexate. At
week 24, patients taking placebo were crossed over to the
baricitinib treatment group.
RA-BUILD
- In the RA-BUILD trial, baricitinib (4 mg) significantly
improved joint pain, severity and duration of morning joint
stiffness and tiredness by days 4, 4, 10 and 3, respectively,
compared to placebo.
- In RA-BUILD, the incidence of SAEs with baricitinib treatment,
including serious infections, was similar to placebo. There were no
gastrointestinal perforations in the study. A single case of
tuberculosis was reported in a patient receiving baricitinib. The
most common adverse events observed were consistent with previous
studies of baricitinib in RA. Discontinuation rates due to adverse
events were similar between treatment groups.
- The RA-BUILD study enrolled 684 patients with
moderate-to-severe RA who previously had an inadequate response to,
or were intolerant of, at least one conventional synthetic
disease-modifying antirheumatic drug (csDMARD) and had not received
a biologic DMARD. Patients received either once-daily baricitinib
(2 mg or 4 mg) or placebo, in addition to their background
therapy.
"Across its pivotal studies, baricitinib has consistently shown
significant and rapid improvement of some of the most commonly felt
symptoms experienced by patients with RA," said Steven Stein, M.D., chief medical officer,
Incyte Corporation. "These data, especially the strong
patient-reported outcomes in patients who did not have an
acceptable response with their previous conventional synthetic
DMARD therapy, underscore previous results and the potential
benefits of baricitinib seen in patients with this devastating
disease."
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 not a
trademark of Eli Lilly and Company. The maker of this brand is
not affiliated with and does not endorse Eli Lilly and
Company or its 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
patients with rheumatoid arthritis and the RA-BEAM and RA-BUILD
trials, 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 future study results will be consistent with the
results to date or that baricitinib will achieve its primary study
endpoints or receive regulatory approvals. 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.
i American College of Rheumatology, Rheumatoid
Arthritis,
http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp.
Accessed May 16, 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 May 16, 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 May 16, 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 May 16, 2016.
v Rheumatoid arthritis, Lancet,
https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed May 19, 2016.
vi Sustained rheumatoid arthritis remission is uncommon
in clinical practice, Arthritis Research & Therapy,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed
May 19, 2016.
Refer to: Nan
Frient; frient_nan@lilly.com; +1-317-471-7040 (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