Abbott Announces Results of Analysis Exploring the Use of HUMIRA® (Adalimumab) in Simultaneously Achieving Three Key Treatment

Abbott Announces Results of Analysis Exploring the Use of HUMIRA® (Adalimumab)
in Simultaneously Achieving Three Key Treatment Goals for Rheumatoid Arthritis

  PR Newswire

  ABBOTT PARK, Illinois, Nov. 12, 2012

- Reduction of disease activity, prevention of further joint damage and
preservation of physical function were the three goals evaluated

- Data analysis for long-standing RA patients showed 19 percent of patients
taking HUMIRA plus methotrexate (MTX) simultaneously achieved all three goals
at one year, versus 5 percent of patients treated with placebo plus MTX

- Data analysis for early RA patients —those who received open label HUMIRA
plus MTX following inadequate response to 26 weeks of MTX monotherapy— showed
29 percent simultaneously achieved all three goals at one year

ABBOTT PARK, Illinois, Nov. 12, 2012 /PRNewswire/ --Abbott today announced
results from a post-hoc analysis of HUMIRA® (adalimumab) data in early and
long-standing moderate-to-severe rheumatoid arthritis (RA) patients from three
randomized, controlled trials — DE019, OPTIMA and PREMIER. The analysis
evaluated the simultaneous achievement of three key treatment goals: low
disease activity, normal physical function and the absence of radiographic
progression at one year. These results are being presented at the American
College of Rheumatology Annual Scientific Meeting (ACR) in Washington, D.C.

In the analysis, low disease activity was measured by the Disease Activity
Score 28 based on C reactive protein [DAS28 (CRP)], less than 3.2; normal
function was measured by the Health Assessment Questionnaire for RA Disability
Index [HAQ-DI], less than 0.5; and the absence of radiographic progression was
demonstrated by a change in modified Total Sharp Score [mTSS], less than or
equal to 0.5 at one year.

Study Results For long-standing RA patients in the DE019 trial, 19 percent
(40/207) of patients taking HUMIRA plus methotrexate (MTX) simultaneously
achieved all three key treatment goals at one year, versus 5 percent (10/200)
of placebo plus MTX-treated patients in the study. DE019 enrolled patients
with long-standing moderate-to-severe RA (mean=11 years) and an inadequate
response to MTX.

For early RA patients in the OPTIMA trial – those who were given open label
HUMIRA plus MTX following inadequate response to 26 weeks of MTX monotherapy –
29 percent (102/348) of patients simultaneously achieved all three key
treatment goals at one year. This rate was comparable to what was observed in
the PREMIER trial with MTX-naïve early RA patients who were treated with
HUMIRA plus MTX (32 percent; 87/268). OPTIMA and PREMIER enrolled early
moderate-to-severe RA (mean=0.4 and 0.7 years, respectively) and MTX-naïve
patients.

According to treatment guidelines from the ACR and the European League Against
Rheumatism (EULAR), the primary target of RA treatment should be clinical
remission, defined as the absence of signs and symptoms of significant
inflammatory disease activity. For patients with long-standing disease, ACR
and EULAR recommend low disease activity as an appropriate alternative
measure.

"In recent years, we have been discussing the need for a broader approach to
treatment — such as in addition to measuring disease activity, measuring
structural changes and functional impairment — which may help physicians and
patients mitigate further irreversible effects of the disease," said Dr.
Edward Keystone, Professor of Medicine, University of Toronto, Canada. "This
analysis evaluates whether or not this is a realistic treatment goal for RA
patients, and sheds light on HUMIRA's potential to help patients
simultaneously achieve all three key treatment goals. It also supports that
the response rates are likely to be higher in patients diagnosed and treated
earlier."

All studies in this analysis–DE019, OPTIMA and PREMIER–included a comparison
of the use of HUMIRA plus MTX versus placebo plus MTX. The results are based
on a post-hoc analysis and are hypothesis-generating only.

"Advances in the last decade offer new treatment options to better manage RA,
including reducing signs and symptoms, improving physical function and
inhibiting progression of further joint damage," said John R. Medich, Ph.D.,
divisional vice president, Immunology Clinical Development, Global
Pharmaceutical Research and Development, Abbott. "We believe that the
potential effects of RA need to be addressed in a comprehensive manner that
addresses not only symptom improvement but also other important treatment
goals. Through 15 years of clinical experience and ongoing HUMIRA studies,
Abbott is committed to this effort."

About Rheumatoid Arthritis RA is a chronic inflammatory disease that can start
in any joint of the body, but most commonly begins in the smaller joints in
the fingers, hands and wrists. Unlike osteoarthritis, the "wear and tear"
arthritis and most common form of arthritis, RA is an autoimmune disease and
occurs when the body's immune system malfunctions, attacking healthy joints.
Major symptoms include joint pain, stiffness and swelling. RA affects
approximately 1.3 million people in the U.S. and 1 percent of the adult
population worldwide.

About DE019 DE019 was a Phase 3, randomized, placebo-controlled trial in which
patients with long-standing RA and an inadequate response to MTX were
randomized to one year of HUMIRA 40 mg every other week (ADA-40), HUMIRA 20 mg
weekly (ADA-20) or placebo injections; all received concomitant MTX. The
primary endpoints were ACR 20 response rate at 6 months, change in HAQ and
change in mTSS at week 52. Results of this trial demonstrated the clinical,
functional and radiographic superiority of HUMIRA plus MTX over placebo plus
MTX.

About OPTIMA OPTIMA was a multicenter, randomized, double-blind, 78-week
two-period study that enrolled 1,032 MTX-naïve patients age 18 or older with
early (less than one year) moderate to severe RA. In period 1, patients were
randomized to receive the combination of HUMIRA 40 mg every other week (eow)
and MTX or placebo and MTX for 26 weeks. Patients in the combination therapy
arm who achieved the target (defined as LDAS, DAS28<3.2) at week 22 and 26
were blindly re-randomized to receive either MTX alone (treatment arm 1) or
continued combination therapy (treatment arm 2) in period 2. Patients in the
initial placebo plus MTX group who achieved the target at weeks 22 and 26
continued to receive MTX monotherapy (treatment arm 4) in a blinded fashion in
period 2. Patients failing to achieve the target at weeks 22 and 26 received
open-label combination therapy regardless of initial treatment assignment
(treatment arms 3 and 5).

The primary endpoint of the study was a composite response of LDAS (DAS28<3.2)
and no radiographic progression (change in mTSS < or = to 0.5) at week 78 in
patients who continued the combination of HUMIRA and MTX versus those who
continued on MTX monotherapy (arms 2 and 4). Significantly more patients who
achieved the initial target response in period 1 and who continued on HUMIRA +
MTX achieved the composite outcome of a LDAS and no radiographic progression
at week 78 compared with those that achieved the initial target with placebo
and MTX in period 1 and continued to receive placebo + MTX.

About PREMIER PREMIER was a Phase 3, randomized, controlled trial in MTX-naïve
patients with early moderate to severe RA. Patients received MTX, HUMIRA 40
mg eow or HUMIRA 40 mg eow plus MTX for two years of blinded treatment. The
co-primary endpoints were ACR 50 response and mean change from baseline in
mTSS at week 52 for the HUMIRA + MTX combination therapy arm versus the MTX
monotherapy. Results of this trial demonstrated the radiographic, clinical and
functional superiority of initial combination therapy over the individual
monotherapies.

About HUMIRA® (adalimumab)

Uses HUMIRA (adalimumab) is a prescription medicine used alone, with
methotrexate, or with certain other medicines to reduce the signs and symptoms
of moderate to severe rheumatoid arthritis in adults. It may prevent future
damage to bones and joints and may help with the ability to perform daily
activities.

Important Safety Information HUMIRA is a TNF blocker medicine that affects the
immune system and can lower the ability to fight infections. Serious
infections have happened in people taking HUMIRA. These serious infections
include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria
that have spread throughout the body. Some people have died from these
infections. People should be tested for TB before HUMIRA use and monitored for
signs and symptoms of TB during therapy. People at risk of TB may be treated
with medicine for TB. Treatment with HUMIRA should not be started in a person
with an active infection, unless approved by a doctor. HUMIRA should be
stopped if a person develops a serious infection. People should tell their
doctor if they live in or have been to a region where certain fungal
infections are common, have had TB, hepatitis B, are prone to infections, or
have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including HUMIRA, the chance of getting
lymphoma or other cancers may increase. Some people have developed a rare type
of cancer called hepatosplenic T-cell lymphoma. This type of cancer often
results in death. If using TNF blockers including HUMIRA, the chance of
getting two types of skin cancer (basal cell and squamous cell) may increase.
These types are generally not lifethreatening if treated.

Other possible serious side effects with HUMIRA include hepatitis B infection
in carriers of the virus, allergic reactions, nervous system problems, blood
problems, certain immune reactions, including a lupus-like syndrome, liver
problems, and new or worsening heart failure or psoriasis. The use of HUMIRA
with anakinra or abatacept is not recommended. People using HUMIRA should not
receive live vaccines.

Common side effects of HUMIRA include injection site reactions (redness, rash,
swelling, itching, or bruising), upper respiratory infections (including sinus
infections), headaches, rash, and nausea.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before
starting therapy.

This is not a complete list of the Important Safety Information for HUMIRA.
For additional important safety information, please click for the Full
Prescribing Information and Medication Guide .

About Abbott Abbott is a global, broad-based health care company devoted to
the discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The company
employs approximately 91,000 people and markets its products in more than 130
countries.

Abbott's news releases and other information are available on the company's
Web site at www.abbott.com .

Website: http://www.abbott.com
Contact: Elizabeth Hoff, +1-847-935-4236, Javier Boix, +1-847-393-5065;
Financial: Elizabeth Shea, +1-847-935-2211
 
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