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HUMIRA Pediatric Clinical Study Demonstrated Promising Results in Juvenile Rheumatoid Arthritis

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Abbott Seeks U.S. and E.U. Regulatory Approvals for HUMIRA® (Adalimumab)

as a Treatment for Juvenile Rheumatoid Arthritis & STORY=/www/story/05-07-2007/00045\

81995 & EDATE

HUMIRA Pediatric Clinical Study Demonstrated Promising Results in Juvenile

Rheumatoid Arthritis

Abbott announced it has simultaneously submitted a supplemental

Biologics License

Application (sBLA) with the U.S. Food and Drug Administration (FDA) and a

Type II Variation to the European Medicines Agency (EMEA) seeking approval

to market HUMIRA® (adalimumab) as a treatment for juvenile rheumatoid

arthritis (JRA) in the U.S. and juvenile idiopathic arthritis (JIA) in the

European Union (EU). This filing marks the first pediatric indication

sought for HUMIRA.

JRA, commonly referred to as JIA in the EU, is the most common form of

arthritis in children and normally begins before the age of 16. Typical

symptoms include persistent joint pain and stiffness that are usually worse

in the morning or after a nap. The pain may limit movement of the affected

joint, although many children will not complain of the pain. Walking with a

limp is an early sign of JRA due to an affected knee. Depending on the

severity of disease, JRA may affect bone development or cause growth

abnormalities, such as one leg or arm growing longer than the other. The

goal of treatment for JRA is to control inflammation, relieve pain, and

preserve mobility and joint function, and ultimately prevent disease


" If left untreated, JRA may slow a child's growth and cause disability

into adulthood, " said J. Lovell, MD, MPH, associate director,

Special Treatment Center for Juvenile Arthritis, Cincinnati Children's

Hospital Medical Center, Cincinnati. " HUMIRA may offer hope to children

suffering with this unpredictable disease. "

About HUMIRA JRA Clinical Study

The global filing is based on the results of a Phase III, 48-week study

that included 171 children (4 to 17 years old) with polyarticular JRA, a

form of arthritis affecting five or more joints, usually the same joints on

both sides of the body. Additional data will be submitted from an ongoing

open label extension study evaluating the long-term efficacy and safety of


In the first part of the study, two groups of patients -- those taking

methotrexate (MTX) and not taking MTX -- received HUMIRA subcutaneously

every other week (EOW) for 16 weeks. Patient responses were measured using

the American College of Rheumatology (ACR) Pediatric 30 score, which

represents a 30 percent improvement in JRA signs and symptoms, such as the

number of swollen joints with loss of motion, assessment of pain and level

of disability. Children who showed a positive clinical response (n=133)

entered the second part of the study and were randomized to receive HUMIRA

or placebo for an additional 32 weeks or until disease flare. A flare was

defined as a worsening of 30 percent or more in three of the six ACR Ped

response variables, a minimum of two active joints, and no more than one

indicator improving by 30 percent.

Children receiving HUMIRA, in the second part of the study, had

significantly fewer disease flares than children on placebo, both without

MTX (43 percent vs. 71 percent) and with MTX (37 percent vs. 65 percent).

Additionally, twice as many children on HUMIRA achieved ACR Ped 70 compared

to those on placebo (56 percent vs. 28 percent, respectively) at Week 48.

The most common adverse events were infections (mostly mild upper

respiratory) and injection site reactions. No tuberculosis or opportunistic

infections were reported during this study. The adverse events observed in

children were similar to those observed in adults in previous rheumatoid

arthritis (RA) studies with HUMIRA.

HUMIRA is approved to treat adult patients with moderately to severely

active rheumatoid arthritis. More than 180,000 patients worldwide are

currently being treated with HUMIRA. HUMIRA is currently being studied in

pediatric Crohn's disease, and Abbott plans to initiate trials for

pediatric and adolescent psoriasis later this year.

" We are pleased by the submission of our first pediatric indication for

HUMIRA, " said Eugene Sun, M.D., vice president, Global Pharmaceutical

Clinical Development at Abbott. " HUMIRA has already benefited thousands of

adults suffering with RA, and this trial shows promise for children and

families who are impacted by JRA. "

Important Safety Information

Globally, prescribing information varies; refer to the individual

country product label for complete information.

Serious infections, sepsis, tuberculosis (TB) and opportunistic

infections, including fatalities, have been reported with the use of TNF-

blocking agents, including HUMIRA. Many of these serious infections have

occurred in patients also taking other immunosuppressive agents that in

addition to their underlying disease could predispose them to infections.

Infections have also been reported in patients receiving HUMIRA alone.

Treatment with HUMIRA should not be initiated in patients with active

infections. TNF-blocking agents, including HUMIRA, have been associated

with reactivation of hepatitis B (HBV) in patients who are chronic carriers

of this virus. Some cases have been fatal. Patients at risk for HBV

infections should be evaluated for prior evidence of HBV infections before

initiating HUMIRA. The combination of HUMIRA and anakinra is not

recommended and patients using HUMIRA should not receive live vaccines.

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 3.5 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. 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.

Worsening congestive heart failure (CHF) has been observed with TNF-

blocking agents, including HUMIRA, and new onset CHF has been reported with

TNF-blocking agents. Treatment with HUMIRA may result in the formation of

autoantibodies and rarely, in development of a lupus-like syndrome.

The most frequent adverse events seen in the placebo-controlled

clinical trials in adults with 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.

In HUMIRA clinical trials for ankylosing spondylitis, psoriatic

arthritis and Crohn's disease, the safety profile for adult patients

treated with HUMIRA was similar to the safety profile seen in adult

patients with rheumatoid arthritis.


HUMIRA is the only fully human monoclonal antibody approved for the

treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and

ankylosing spondylitis (AS) in the U.S. and Europe and Crohn's disease in

the U.S. HUMIRA resembles antibodies normally found in the body. It works

by blocking tumor necrosis factor alpha (TNF-alpha), a protein that when

produced in excess, plays a central role in the inflammatory responses of

many immune- mediated diseases. Clinical trials are currently under way

evaluating the potential of HUMIRA in other autoimmune diseases.

In the U.S., HUMIRA is approved by the FDA for reducing signs and

symptoms, inducing major clinical response, inhibiting the progression of

joint structural damage, and improving physical function in adult patients

with moderately to severely active RA. HUMIRA is indicated for reducing the

signs and symptoms of active arthritis, inhibiting the progression of

structural damage and improving physical function in patients with

psoriatic arthritis. HUMIRA can be used alone or in combination with

methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).

HUMIRA is also approved for reducing signs and symptoms in patients with

active AS. Earlier this year, HUMIRA was approved for reducing the signs

and symptoms and inducing and maintaining clinical remission in adults with

moderately to severely active Crohn's disease who have had an inadequate

response to conventional therapy, and reducing the signs and symptoms and

inducing clinical remission in these patients if they have also lost

response to or are intolerant to infliximab.

In Europe, HUMIRA, in combination with methotrexate (MTX), is indicated

for the treatment of moderate to severe, active RA in adult patients when

the response to disease-modifying anti-rheumatic drugs (DMARDs) including

MTX has been inadequate, and for the treatment of severe, active and

progressive RA in adults not previously treated with MTX. HUMIRA can be

given as monotherapy in case of intolerance to MTX or when continued

treatment with MTX is inappropriate. HUMIRA has been shown to reduce the

rate of progression of joint damage as measured by x-ray and to improve

physical function, when given in combination with MTX.

Additionally, HUMIRA is indicated for the treatment of active and

progressive PsA in adults when the response to previous DMARD-therapy has

been inadequate and for the treatment of severe, active AS in adults who

have had an inadequate response to conventional therapy.

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 immune-

mediated diseases.

In April 2007, Abbott announced the opening of Abbott Biotechnology

Limited (ABL), its new state-of-the-art biologics manufacturing facility in

Puerto Rico to support the long-term supply of HUMIRA. The new facility is

the main manufacturing site for supplying HUMIRA to patients in the U.S.

More information about HUMIRA, including full prescribing information,

is available on the Web site or in the United States


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 65,000 people and markets its products in more than 130


Abbott's news releases and other information are available on the

company's Web site at

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