HUMIRA(R) (adalimumab) Receives FDA Approval for First-Line Treatment of Moderate to Severe Rheumatoid Arthritis

Abbott (NYSE: ABT)
announced today that it received U.S. Food and Drug Administration (FDA)
approval to market HUMIRA(R) (adalimumab) for first-line treatment of recent
onset moderate to severe rheumatoid arthritis (RA). The approval offers RA
patients an important therapeutic option early in the course of their disease,
when there is a critical window of opportunity to intervene before the
potential crippling effects of joint destruction and long-term disability set
in. In 2002, HUMIRA was approved to treat patients with moderately to
severely active RA, who have had insufficient response to one or more
disease-modifying anti-rheumatic drugs (DMARDs).

HUMIRA Offers Proven Benefit in Early RA
The approval for the expanded indication is based on clinical and
radiographic data from the two-year PREMIER study of 799 methotrexate
(MTX)-naive patients with active recent onset moderate to severe RA (defined
as disease of less than three years duration). On average, patients had less
than nine months of disease duration from the time of diagnosis. The trial
compared three arms, HUMIRA monotherapy, MTX monotherapy, and the two drugs
combined in treating this patient population. The study showed HUMIRA in
combination with MTX was superior to MTX alone on several efficacy endpoints,
including the two primary endpoints -- inhibition of joint damage and
improvement in signs and symptoms at one year -- and a secondary endpoint,
achievement of clinical remission measure of DAS28<2.6 at one year. The
Disease Activity Score (DAS) measures disease activity responses in RA by
assessing tender and swollen joint count, general health status and an
inflammatory marker.
"Mounting evidence suggests that early and aggressive treatment of
moderate to severe RA can achieve favorable outcomes, since joint damage can
occur quickly, even in the first year," said Arthur Kavanaugh, M.D., UCSD
Center for Innovative Therapy, La Jolla, Calif., and PREMIER investigator.
"HUMIRA (adalimumab) has been shown to slow the progression of RA when
initiated in patients early in their treatment. For many patients, this means
reduction in signs and symptoms, but more importantly, significant inhibition
of joint damage."

Inhibition of Joint Damage in Early RA
The PREMIER study showed patients taking HUMIRA in combination with MTX
experienced significantly less joint damage as measured by the change in
modified Total Sharp Score, or mTSS, than those on MTX alone. Modified Total
Sharp Score assesses bone erosion and joint space narrowing on X-rays. A
smaller change in mTSS reflects less progression of joint damage. Also,
approximately twice as many patients on the HUMIRA-MTX regimen experienced no
further joint destruction compared to those on MTX alone (61 percent vs. 34
percent) after two years. No joint destruction was defined as less than or
equal to 0.5 units change from baseline in mTSS. After one year, patients on
MTX alone had four times the disease progression as those in the HUMIRA-MTX
regimen, with a mean change in mTSS of 5.7 vs. 1.3 respectively, and after two
years, patients on MTX alone had five times more disease progression than
those on the HUMIRA-MTX regimen, with a mean change in mTSS of 10.4 vs. 1.9
respectively.

Improvement in RA Signs and Symptoms
In this trial, HUMIRA in combination with MTX significantly improved the
signs and symptoms of RA. After one year, 62 percent of patients on the
HUMIRA-MTX regimen achieved ACR50 (a 50 percent or greater improvement in
signs and symptoms of RA) compared to 46 percent on MTX alone and 41 percent
on HUMIRA alone. After two years, 59 percent of patients on the HUMIRA-MTX
regimen achieved ACR50 compared to 43 percent on MTX alone and 37 percent on
HUMIRA alone. PREMIER is the first RA trial to measure ACR50 as a primary
endpoint. American College of Rheumatology (ACR) scores measure the
percentage of improvement in tender and swollen joint count and several other
clinical measures.

Major Clinical Response
Forty-three percent of patients on the HUMIRA-MTX regimen achieved a
measure of clinical remission as defined by DAS28<2.6 at one year vs. 21
percent of patients on MTX only, and nearly one in two patients on the
combination therapy achieved clinical remission at two years compared with one
in four patients on MTX alone (49 percent vs. 25 percent). Additionally,
almost half of patients on the HUMIRA-MTX regimen achieved major clinical
response, defined as achieving and maintaining an ACR70 response for six or
more continuous months, compared to MTX alone (49 percent vs. 28 percent).
Also, 27 percent of patients on the HUMIRA-MTX regimen achieved ACR90 at two
years, a 90 percent or greater improvement in signs and symptoms, compared to
13 percent on MTX alone.
"HUMIRA has been an important treatment choice for thousands of patients
with moderate to severe RA, and we're pleased that it is now available to
patients earlier in their disease, offering the potential to improve
outcomes," said Eugene Sun, M.D., vice president, Global Pharmaceutical
Clinical Development at Abbott. "The PREMIER study demonstrates treatment of
RA with HUMIRA can inhibit progression of joint destruction at an earlier
stage of the disease."
In this trial, all treatment arms had a comparable overall rate of adverse
events. Among patients taking HUMIRA, the most common adverse events were
nasopharyngitis, headache, nausea, diarrhea, joint pain, and pharyngitis.
In December 2004, Abbott simultaneously submitted applications to the FDA
and the European Medicines Agency seeking approval to market HUMIRA to treat
early RA and psoriatic arthritis. HUMIRA received European approval for early
severe RA and psoriatic arthritis on Aug. 8, 2005.

About RA
More than five 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, potentially resulting in 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
Cases of tuberculosis (TB) have been observed in patients receiving
HUMIRA. Serious infections and sepsis, including fatalities, have been
reported with the use of TNF-blocking agents, including HUMIRA. Many of these
infections occurred in patients also taking other immunosuppressive agents
that in addition to their underlying disease could predispose them to
infections. Treatment with HUMIRA should not be initiated in patients with
active infections. The combination of HUMIRA and anakinra is not recommended.
TNF-blocking agents, including HUMIRA, have been associated in rare cases
with demyelinating disease and severe allergic reactions. Infrequent reports
of serious blood disorders have been reported with TNF-blocking agents. More
cases of malignancies have been observed among patients receiving TNF
blockers, including HUMIRA, compared to control patients in clinical trials.
These malignancies, other than lymphoma and non-melanoma skin cancer, were
similar in type and number to what would be expected in the general
population. There was an approximately four fold higher rate of lymphoma in
combined controlled and uncontrolled open label portions of HUMIRA clinical
trials. The potential role of TNF-blocking therapy in the development of
malignancies is not known.
The most frequent adverse events seen in the placebo-controlled clinical
trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site
reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent
vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12
percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11
percent vs. 9 percent). Discontinuations due to adverse events were 7 percent
for HUMIRA and 4 percent for placebo. As with any treatment program, the
benefits and risks of HUMIRA should be carefully considered before initiating
therapy.
The safety profile for patients with psoriatic arthritis treated with
HUMIRA in the clinical trials has been similar to the safety profile seen in
patients with RA.

About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved by the FDA for
reducing signs and symptoms, inducing major clinical response, inhibiting the
progression of structural damage, and improving physical function in adult
patients with moderately to severely active RA. HUMIRA can be used alone or
in combination with MTX 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.

Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative
treatments for immunologic diseases. The Abbott Bioresearch Center, founded
in 1989 in Worcester, Mass., United States, is a world-class discovery and
basic research facility committed to finding new treatments for autoimmune
diseases. More information about Abbott Immunology and HUMIRA, including full
prescribing information, is available on the Web site http://www.rxabbott.com,
or in the United States by calling Abbott Medical Information at
1-800-633-9110.

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 60,000 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 .

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