Three post-hoc analyses of two phase 3 studies showed
improvements in rheumatoid arthritis symptoms in patients
irrespective of age, BMI and number of previously used conventional
synthetic DMARDs
INDIANAPOLIS, Nov. 14, 2016 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today
announced new data analyses of two phase 3 trials, RA-BUILD and
RA-BEAM, showing that baricitinib treatment resulted in
improvements in rheumatoid arthritis (RA) symptoms across a diverse
population of patients with RA regardless of age, body mass index
(BMI) and previous treatment with conventional synthetic
disease-modifying antirheumatic drugs (csDMARDs). 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.
"Multiple patient characteristics may impact the effectiveness
of rheumatoid arthritis treatment," said James McGill, M.D., distinguished medical fellow
and global brand development leader, Lilly Bio-Medicines. "What
these data showed is that regardless of a patient's age, body mass
index or previous experience with conventional synthetic DMARDs,
treatment with baricitinib resulted in improvement in rheumatoid
arthritis symptoms. This gives us tremendous hope for how this oral
medication may work in a real-world setting, if approved."
Key findings include:
- Results from a post-hoc analysis of the phase 3 RA-BUILD and
RA-BEAM studies evaluating elderly patients found that age did not
affect baricitinib's efficacy as measured by ACR20, Health
Assessment Questionnaire-Disability Index (HAQ-DI), Disease
Activity Score 28 C-Reactive Protein (DAS28-CRP) and Simplified
Disease Activity Index (SDAI).
- At week 12, in the baricitinib 4 mg group, 67 percent of
patients younger than 65 years and 68 percent of patients 65 years
or older achieved an ACR20 response, meaning a 20 percent
improvement across various aspects of RA. In the group that
received placebo, 40 percent of patients younger than 65 years and
43 percent of patients 65 years or older achieved an ACR20
response.
- The percentage of patients reporting an adverse event (AE) was
higher in patients 65 years or older. The overall rates of AEs,
serious adverse events (SAEs), and serious infections were similar
between patients treated with placebo and baricitinib in patients
younger than 65 years and patients 65 years or older. Additional
safety information regarding RA-BUILD and RA-BEAM are provided in
the study description below.
- Results from a post-hoc analysis of the phase 3 RA-BUILD and
RA-BEAM studies evaluating the effect of baseline BMI on the
response to baricitinib in patients who had insufficient response
to previous csDMARDs found that baricitinib improved clinical
outcomes compared to placebo regardless of baseline BMI as measured
by ACR20, ACR50, ACR70, DAS28-CRP, SDAI and Clinical Disease
Activity Index (CDAI). The proportion of patients who reached low
disease activity or remission, including progression in structural
joint damage, improved compared to placebo across the different BMI
groups.
- Proportion of patients in the low, middle and high BMI groups
who achieved an ACR20 response were 68.4 percent, 68 percent and
64.7 percent, respectively. ACR50 and ACR70 responses (meaning a 50
percent and 70 percent improvement across various aspects of RA,
respectively) were also improved compared to placebo across the BMI
groups. As has been shown for other DMARDs, baricitinib
treatment effect for patients with higher BMI was numerically
smaller than for patients with lower BMI.
- Additional safety information regarding RA-BUILD and RA-BEAM
are provided in the study description below.
- Results from a post-hoc analysis of the phase 3 RA-BUILD and
RA-BEAM studies evaluating whether the number of previous csDMARD
failures altered patients' response to baricitinib found that
baricitinib demonstrated improvement in RA symptoms irrespective of
the number of previous csDMARDs used or the present use of oral
corticosteroids as measured by ACR20, ACR50, ACR70, radiographic
progression, SDAI and DAS28-ESR.
- At week 12, in the baricitinib 4 mg groups that previously used
methotrexate alone, methotrexate + 1 csDMARD and methotrexate + ≥2
csDMARDs, 67.9 percent, 67.3 percent and 66.9 percent of patients
achieved an ACR20 response, respectively. ACR50 responses were also
similar across the groups (42.5 percent, 42.9 percent and 39.2
percent, respectively) and ACR70 responses were 21.4 percent, 19.5
percent and 13.3 percent respectively.
- The rates of SAEs and discontinuation due to AEs were
comparable regardless of the number of csDMARDs used and
corticosteroid use. Additional safety information regarding
RA-BUILD and RA-BEAM are provided in the study description
below.
"These data add to the breadth of evidence supporting
baricitinib's efficacy profile across a wide range of patient
populations," said Steven Stein,
M.D., chief medical officer, Incyte Corporation. "If approved, we
believe that baricitinib has the potential to become an effective
once-daily oral treatment option for patients with rheumatoid
arthritis who may not respond well to other treatments — age, BMI
or previous csDMARDs use notwithstanding."
RA-BUILD
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 csDMARD and had not received a
biologic disease-modifying antirheumatic drug (bDMARD). Patients
received either once-daily baricitinib (2 mg or 4 mg) or placebo,
in addition to their background therapy.
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.
RA-BEAM
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.
In RA BEAM, compared to placebo, serious adverse events 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.
About Baricitinib
Baricitinib is a once-daily oral
selective JAK 1 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.
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-BUILD and RA-BEAM
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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