Abbott Announces First Long-term Patient-reported Health Outcomes Data for Investigational Use of HUMIRA® (Adalimumab) in

  Abbott Announces First Long-term Patient-reported Health Outcomes Data for
     Investigational Use of HUMIRA® (Adalimumab) in Patients with Active
             Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

  PR Newswire

  ABBOTT PARK, Illinois, Nov. 12, 2012

-In the Phase 3 ABILITY-1 trial, HUMIRA patients experienced a statistically
significant improvement in select measures of physical function and
health-related quality of life (HRQOL) at 12 weeks

-Post-hoc analysis of data showed that nr-axSpA patients taking HUMIRA
continued to experience improvement in physical function and HRQOL measures at
52 weeks

ABBOTT PARK, Illinois, Nov. 12, 2012 /PRNewswire/ -- Abbott (NYSE: ABT)today
announced the first long-term patient-reported health outcomes data from an
open-label analysis of the ongoing, Phase 3 ABILITY-1 trial of HUMIRA®
(adalimumab). The study evaluated improvements in physical function and
health-related quality of life (HRQOL) after 52 weeks in patients with active
non-radiographic axial spondyloarthritis (nr-axSpA). These results are being
presented at the American College of Rheumatology Annual Scientific Meeting
(ACR) in Washington, D.C.

"There are many adults, especially younger, with nr-axSpA whose disease can be
as painful, and have similar adverse impact on the ability to function, as
those with more classic ankylosing spondylitis," said Professor Philip Mease,
University of Washington and Swedish Medical Center, Seattle, Washington.
"This study evaluated adalimumab treatment on reduction of signs and symptoms
in nr-axSpA patients and the improvement of important patient-reported
outcomes including physical function and health-related quality of life, goals
we all want for this often inadequately recognized and treated patient group."

Study Results An exploratory, post-hoc analysis of data from the open-label
extension showed that nr-axSpA patients taking HUMIRA continued to experience
improvement in physical function and HRQOL measures at week 52. In both the
double-blind and open-label phases of the study, physical function was
assessed using the disability index of the Health Assessment Questionnaire for
Spondyloarthropathies (HAQ-S). Approximately 62 percent of patients met the
minimum important difference (MID) for the HAQ-S of 0.26 at week 52.

The HRQOL was assessed using the Short Form 36 Health Survey (SF-36) score. 77
percent of patients met the MID for SF-36 Physical Component Summary (PCS)
score of 3.0 at week 52. Placebo patients who switched to open-label HUMIRA
experienced improvements in HRQOL comparable to patients who received HUMIRA
through week 52. By week 52, patients in both groups achieved SF-36 scores
(42.8 and 44.1, respectively), expressed on a scale of 0-100, where higher
scores indicate better health and well-being.

AxSpA can be a debilitating disease most often seen in younger individuals in
their most productive time of life, and can go unrecognized for years. AxSpA,
which includes ankylosing spondylitis (AS) and nr-axSpA, primarily presents
with chronic back pain and stiffness, and can be accompanied by the presence
of arthritis, inflammation in the eye and/or gastrointestinal tract. People
with nr-axSpA can have similar signs and symptoms as AS – including
inflammation that can lead to chronic pain and loss of function – but do not
have X-ray evidence of structural damage.

"Patient-reported outcomes data focusing on physical function and
health-related quality of life help measure the impact treatment has on
patients in their day-to-day life," said John R. Medich, Ph.D., divisional
vice president, Immunology Clinical Development, Global Pharmaceutical
Research and Development, Abbott. "Because there are currently so few
treatment options available to help patients with non-radiographic axSpA,
Abbott remains committed to exploring ways HUMIRA can help improve the care
and outlook for this patient population."

In the open-label extension, both the investigator and patient knew that
patients were receiving HUMIRA. Additionally, open-label extension data may be
enriched as patients who remain in the study long-term tend to do better than
those who drop out. Physical function and SF-36 PCS were two of nine secondary
endpoints evaluated in the double-blind portion of the study, all of which
were statistically significant for HUMIRA versus placebo.

Additional results from the double-blind period showed that nr-axSpA patients
taking HUMIRA experienced a statistically significantly greater improvement in
HAQ-S as compared to placebo (-0.3 versus -0.1 respectively; P=0.025.) at week
12, as well as a statistically significantly greater improvement in SF-36 PCS
(5.5 versus 2.0, respectively; p<0.001) at week 12. Patients were then entered
into an open-label period, in which all participants (n=179) could receive
HUMIRA, and were asked to again complete the health assessment questionnaires
at week 52.

In July 2012, the European Commission approved HUMIRA for the treatment of
adults with severe nr-axSpA, making it the first biologic and only approved
medication available for this disease in Europe. In the U.S., HUMIRA is being
investigated for the treatment of nr-axSpA and is not approved for the
treatment of spondyloarthritides other than AS and psoriatic arthritis.

About SpA Spondyloarthritis (SpA) is a group of diseases that share common
clinical, radiographic and genetic features. SpA can be categorized according
to which part of the body is mainly affected – axial or peripheral. Assessment
of SpondyloArthritis International Society (ASAS) developed improved
classification criteria for axial and peripheral SpA designed to facilitate
identification and classification of people with SpA who share similar
symptoms. Criteria for axial SpA incorporate the use of magnetic resonance
imaging (MRI), in addition to traditional X-rays, for visualizing sacroiliitis
(inflammation of the sacroiliac joint which connects the lower spine and
pelvis), one of the hallmarks of axial spondyloarthritis. While worldwide
epidemiologic data does not exist for axSpA, studies have shown it is
estimated that axSpA affects up to 1 percent of adults in the United States.

About ABILITY-1 ABILITY-1 is the first large, pivotal study to use the ASAS
criteria to classify nr-axSpA patients, and to evaluate an anti-tumor necrosis
factor medication (anti-TNF) in treating patients with nr-axSpA. It is an
ongoing, multi-country, Phase 3 study designed to evaluate the efficacy and
safety of HUMIRA in nr-axSpA patients.

Eligible patients were randomized 1:1 to receive either HUMIRA (40 mg every
other week, n=91) or placebo (n=94) for 12 weeks. The primary endpoint results
from this double-blind, placebo-controlled study showed that a significantly
higher percentage of HUMIRA patients, compared to those receiving placebo,
achieved ASAS 40 at week 12 (36.3 percent versus 14.9 percent; p<0.001). ASAS
40 is defined as at least a 40 percent improvement from baseline in the
Assessment of SpondyloArthritis International Society (ASAS) response
criteria.

The double-blind period was followed by the open-label extension phase in
which all patients could receive HUMIRA (40 mg every other week) for up to an
additional 144 weeks (n=179). During the open-label extension phase of the
study, both the investigator and the patient knew that the patient was
receiving HUMIRA. Baseline demographics and disease characteristics were
comparable between patients who entered the open-label period and those of
patients who were initially randomized.

About HUMIRA® (adalimumab)

Uses HUMIRA (adalimumab) is a prescription used to reduce the signs and
symptoms of ankylosing spondylitis in adults.

HUMIRA is used alone or with certain other medicines to reduce the signs and
symptoms of psoriatic arthritis in adults. It may prevent further 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 life threatening 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.

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Web site at www.abbott.com .

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