Abbott Presents Data Exploring Relationship of Physical Function to Inflammation and Structural Damage in RA

By Abbott, PRNE
Sunday, November 7, 2010

ABBOTT PARK, Illinois, November 8, 2010 - Today, Abbott (NYSE: ABT) presents results from a pooled analysis of two
pivotal HUMIRA(R) (adalimumab) studies, which look at patients with early and
long-standing moderate to severe rheumatoid arthritis (RA), at the American
College of Rheumatology meeting in Atlanta.

The study looked at inflammation and structural damage of the joints in
early and long-standing RA and their relationship with deteriorating physical
function in each stage of the disease. In patients with early RA (less than
three years), inflammation was more strongly correlated to worsening physical
function than in patients with long-standing RA. Structural damage showed
stronger correlation to worsening physical function in long-standing RA
compared to early RA.

"We know that RA is a progressive disease, and for years we've
hypothesized about what is driving these changes in physical function," said
Primary Investigator Martin Bergman, M.D., clinical associate professor of
medicine, Drexel University College of Medicine and chief of the division of
rheumatology at Taylor Hospital. "These data are important because they can
help advance our understanding of how RA changes over time."

RA is a chronic autoimmune disease that affects approximately 1.3 million
people in the U.S. Typically, RA is characterized by pain, swelling and
stiffness in the joints of hands, feet and wrists and often leads to the
erosion of joints.

"These data and analyses provide additional insights into RA which we
hope will inform better patient care in the future," said Eugene Sun, M.D.,
vice president, Global Pharmaceutical Development, Abbott.

Analysis Methodology

Specifically, the analysis evaluated data from two HUMIRA trials -
PREMIER (patients with early RA) and DE019 (patients with long-standing RA).
There were 908 patients with disease duration three years or less and 507
patients with disease duration of more than three years. The study assessed
the relationship of physical functioning with inflammation and structural
damage.

Commonly used methods of patient reported measures calculated physical
functioning. The measures include the 20 question Health Assessment
Questionnaire (HAQ) and two components of the well-known, health-related
quality of life questionnaire SF-36: the physical function scale (PF) and the
physical component summary (PCS).

Inflammation was measured by C-Reactive Protein (CRP) levels and
structural damage was measured by modified total Sharp scores (mTSS), a
well-established method of assessing structural joint damage.

In the early RA disease group, all indicators of physical function were
significantly correlated to CRP readings measuring inflammation (HAQ, PCS,
and PF correlation co-efficients of 0.395, -0.288 and -0.357, respectively [p
value = <0.05 for all]), but none correlated to mTSS scores measuring
structural damage. In the long-standing RA disease group, mTSS was
significantly correlated with physical functioning measures (HAQ, PCS, and PF
correlation co-efficients of 0.238, -0.119, and -0.137, respectively [p value
= <0.01]). The inflammation CRP levels were also correlated to physical
functioning in the long-standing RA group, but this correlation was weaker
than in the early RA group. Additionally, a linear regression analysis, a
second analysis of the data, showed that mTSS affects HAQ in long-standing
disease, but not early RA.

HUMIRA RA Indication

HUMIRA is used to reduce the signs and symptoms of moderate to severe
rheumatoid arthritis in adults, may prevent further damage to bones and
joints, and may help the ability to perform daily activities. HUMIRA can be
used alone or with methotrexate or with certain other medicines. HUMIRA is
taken by injection and is available by prescription only.

HUMIRA Important Safety Information

HUMIRA is a TNF blocker that affects the immune system, and can lower the
ability to fight infections. Patients treated with HUMIRA are at an increased
risk for developing serious infections that may lead to hospitalization or
death. Most patients who developed these infections were also taking other
medicines that suppress the immune system, such as methotrexate or
corticosteroids. Reported infections include tuberculosis (TB), and
infections caused by viruses, fungi or bacteria that have spread throughout
the body. Patients should be tested for TB before HUMIRA use and during
therapy, and treatment for latent infection should be initiated prior to
HUMIRA use. Treatment with HUMIRA should not be started in patients with
active infections. HUMIRA should be stopped if a patient develops a serious
infection. There have been cases of lymphoma and other cancers, some fatal,
in children and adolescents receiving TNF blockers. For children and adults
taking TNF blockers, including HUMIRA, the chances of getting lymphoma or
other cancers may increase. Other possible serious side effects with HUMIRA
include: allergic reactions, reactivation of hepatitis B in patients who are
chronic carriers (some fatal), nervous system problems, blood problems, new
or worsening heart failure or psoriasis and immune reactions including a
lupus-like syndrome. The combination of HUMIRA and anakinra is not
recommended. Patients using HUMIRA should not receive live vaccines.

The most common side effects in HUMIRA clinical trials, reported at a
rate of greater than 10 percent, were: infections (e.g. upper respiratory,
sinusitis), injections site reactions, headache and rash. As with any
treatment program, the benefits and risks of HUMIRA should be carefully
considered before starting therapy. Full Prescribing Information for HUMIRA
is available at www.rxabbott.com/pdf/humira.pdf.

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 nearly 90,000 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.

Media, DeAnna DuBose, +1-630-347-2510, or Financial, Larry Peepo, +1-847-935-6722, both of Abbott

Clinical Trials / Medical Discoveries News

November 8 News

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