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Abbott Laboratories

Abbott Announces Regulatory Submissions for Use of HUMIRA(R) (adalimumab) as First-Line Treatment for Rheumatoid Arthritis

Abbott Park, Illinois (ots/PRNewswire)

- HUMIRA Data Shows Slowed Joint Damage in Pivotal Study
Abbott (NYSE: ABT) announced it has simultaneously submitted a
Type II Variation to the European Medicines Agency (EMEA) and a
supplemental Biologics License Application (sBLA) with the U.S. Food
and Drug Administration (FDA) seeking approval to market HUMIRA(R)
(adalimumab) for the first-line treatment of moderately to severely
active rheumatoid arthritis (RA). Currently, HUMIRA is indicated for
the treatment of patients with moderately to severely active RA who
have had insufficient response to one or more disease-modifying
antirheumatic drugs (DMARDs).
The submission is based on results of the two-year, Phase III
PREMIER Study, which found that patients with early RA (RA of less
than three years' duration) experienced significant improvement in
signs and symptoms while taking HUMIRA in combination with
methotrexate (MTX). Results from patients receiving the combination
therapy showed:
    -- Sixty-two percent of the patients achieved ACR50, one of the study's
       primary endpoints, at one year. ACR50 is a measure used by the
       American College of Rheumatology indicating 50 percent or greater
       improvement in symptoms, including pain, number of swollen joints and
       physical function.
    -- Sixty-one percent of the patients experienced inhibition of
       radiographic progression, as measured by total Sharp score (TSS) - a
       secondary endpoint of the study. TSS assesses bone erosion and
       joint-space narrowing on X-rays.
    -- One out of every two patients achieved remission as defined by DAS
       28<2.6.  DAS 28 (Disease Activity Score 28) measures disease activity
       responses for RA by assessing tender and swollen joint count, general
       health status and an inflammatory marker in the blood.
"In as little as one year, RA can cause measurable joint damage in
patients taking traditional DMARDs such as methotrexate," said
Alejandro Aruffo, Ph.D., president, Abbott Bioresearch Center and
Immunoscience Development Center, Abbott. "While HUMIRA has already
provided benefit to more than 83,000 patients worldwide, we are
hopeful that once approved as a first-line treatment it could help
many more. We are continually investigating new uses for HUMIRA and
other treatments and compounds, in keeping with Abbott's commitment
to develop innovative medicines and to address major unmet medical
needs."
PREMIER, a two-year, double-blind, controlled study, compared the
effectiveness of HUMIRA, MTX and the two drugs combined in treating
early RA. Also, it was the first trial of a TNF antagonist (a
treatment that targets TNF, a protein implicated in RA) to set ACR50
as a primary endpoint and achieve it.
Researchers compared ACR50 responses (a measure used by the
American College of Rheumatology indicating 50 percent or greater
improvement in symptoms, including pain, number of swollen and tender
joints and physical function) and radiographic progression in 799
adult patients with recent-onset RA who had not previously used MTX.
Patients, separated into three groups, received either HUMIRA (40 mg
every other week subcutaneously) combined with MTX (rapidly escalated
to 20 mg weekly); MTX alone; or HUMIRA alone.
Results showed that HUMIRA in combination with MTX significantly
improved signs and symptoms of early RA patients. Sixty-two percent
of patients receiving the combination therapy achieved the primary
endpoint of ACR50 at one year, compared to only 46 percent in the
MTX-only group.
In addition, after two years, one out of every two patients with
early RA who received a combination of HUMIRA and methotrexate
achieved clinical remission (as defined by DAS 28<2.6) compared to
only 25 percent of patients receiving methotrexate alone. DAS 28
(Disease Activity Score 28) measures disease activity responses for
RA by assessing tender and swollen joint count, general health status
and an inflammatory marker in the blood.
PREMIER's secondary endpoint, inhibition of radiographic
progression, was measured by the change in total Sharp score (TSS).
The HUMIRA-MTX combination was significantly more effective at
inhibiting radiographic progression with nearly twice as many
patients (61 percent) experiencing disease inhibition compared to
patients who exhibited disease inhibition with MTX only (34 percent).
After two years, patients in the MTX-only group experienced five
times the radiographic progression of patients in the HUMIRA-MTX
combination group, with TSS increases averaging 10.4 and 1.9,
respectively. The differences between the combination group and the
MTX group were statistically significant (p<0.001).
"Early and aggressive treatment can help slow the progression of
joint deformity and disability caused by rheumatoid arthritis," said
Ferdinand Breedveld, M.D., Leiden University Medical Center, Leiden,
the Netherlands and an investigator for the PREMIER trial. "Studies
have shown that people who receive early treatment for RA are less
likely to experience the type of joint damage that leads to joint
replacement."
About RA
More than 5 million people worldwide suffer from RA, a chronic
autoimmune disease that causes pain, swelling and stiffness in the
joints of the hands, feet and wrists, and often leads to the
destruction of joints. Unlike osteoarthritis, the most common form of
arthritis, RA is an autoimmune disease where joints are inflamed,
resulting in eventual destruction of the joints' interior and the
surrounding bone.
More information on RA and current treatment options can be found
at http://www.RA.com .
Important Safety Information
Common adverse events (>1/100 and less than or equal to 1/10) at
least possibly causally related to HUMIRA include headache,
dizziness, respiratory tract and urinary tract infection, nausea,
diarrhea, sore throat, herpes simplex, abdominal pain, rash, pruritis
and anemia. Injection site pain was reported by >1/10 patients.
Patients must be monitored closely for infections, including
tuberculosis (TB), before, during and after treatment with HUMIRA.
Treatment should not be initiated in patients with active infections
until infections are controlled. Patients who develop new infections
while using HUMIRA should be monitored closely. HUMIRA should not be
used by patients with active TB or other severe infections such as
sepsis and opportunistic infections. HUMIRA should be discontinued if
a patient develops a new serious infection until infections are
controlled. Physicians should exercise caution when considering use
of HUMIRA in patients with a history of recurring infection or with
underlying conditions that may predispose patients to infections.
TNF-antagonists, including HUMIRA, have been associated in rare
cases with exacerbation of clinical symptoms and/or radiographic
evidence of demyelinating disease. Prescribers should exercise
caution in considering the use of HUMIRA in patients with
pre-existing or recent-onset central nervous system demyelinating
disorders.
HUMIRA should be used with caution in patients with mild heart
failure, and is contraindicated in patients with moderate or severe
heart failure. HUMIRA must be discontinued in patients who develop
new or worsening symptoms of congestive heart failure.
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved by the
FDA and EMEA for reducing the signs and symptoms, inhibiting the
progression of structural damage and improving physical function in
adults with moderately to severely active RA who have had
insufficient response to one or more DMARDs. HUMIRA can be used alone
or in combination with methotrexate or other DMARDs. HUMIRA offers
convenient every-other-week dosing by subcutaneous injection (shot
beneath the skin) via a specially designed, pre-filled syringe.
Clinical trials are currently underway evaluating the potential of
HUMIRA in other autoimmune diseases, including juvenile rheumatoid
arthritis (JRA), psoriasis, psoriatic arthritis, Crohn's disease and
ankylosing spondylitis. In addition to filing for HUMIRA as a
treatment for early RA, Abbott also filed an sBLA in the U.S. and a
Marketing Authorization Application (MAA) in the E.U. for HUMIRA for
the treatment of psoriatic arthritis.
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 more than 55,000 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 http://www.abbott.com .
Web site: http://www.abbott.com

Contact:

International Media, Rand Walton, +1-847-938-8848, or U.S. Media, Jim
Bozikis, +1-847-937-6844, or Financial Community, Larry Peepo,
+1-847-935-6722, all of Abbott
Company News On-Call: http://www.prnewswire.com/comp/110328.html

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