Abbott (ticker: ABT, exchange: New York Stock Exchange (.N))
News Release -
HUMIRA(R) (Adalimumab) Shows Promise in Treating Patients With Rheumatoid Arthritis Who Previously Failed Anti-TNF Treatment- One-Third of Patients Taking HUMIRA Experienced a 50 Percent or Greater Improvement in the Signs and Symptoms of Rheumatoid Arthritis After 12 Weeks -
SAN DIEGO, Nov 13, 2005 /PRNewswire-FirstCall via COMTEX News Network/ -- New data from a subgroup
analysis at 12 weeks of the Research in Active Rheumatoid Arthritis (ReAct)
study in more than 800 patients show HUMIRA(R) (adalimumab) was promising in
treating those battling rheumatoid arthritis (RA) who failed previous therapy
with other anti-tumor necrosis factor (TNF) treatment. Failure of previous
therapy was defined as no response, loss of response, or intolerance to
therapy. Of those who previously failed anti-TNF therapy on etanercept and/or
infliximab, a majority (61 percent) showed a clinical response with HUMIRA.
The data, being presented tomorrow at the annual American College of
Rheumatology meeting, provides evidence indicating that patients failing one
anti-TNF therapy may have a favorable clinical response to HUMIRA.
Anti-TNF therapies are targeted therapies that work to inhibit and block
the activity of inflammatory cytokines including TNF-alpha. TNF-alpha is a
molecule directly involved in the pathogenesis of RA. These therapies are
designed specifically to target and bind to TNF-alpha, ultimately reducing
inflammation and slowing the progression of joint damage. Anti-TNF therapies
have an established clinical record of efficacy and safety with approximately
12 years of post-marketing experience and clinical data. HUMIRA has clinical
experience into the seventh year.
HUMIRA was first approved in 2002 for the treatment of patients with
moderately to severely active RA who had insufficient response to one or more
disease-modifying antirheumatic drugs (DMARDs). In October 2005, Abbott
received FDA approval to market HUMIRA as a first-line treatment for recent
onset moderate to severe RA.
"This study showed that failure on one anti-TNF may not indicate failure
with another TNF blocker," said Stefano Bombardieri, M.D., ReAct study
investigator and Professor of Rheumatology, Department of Internal Medicine,
University of Pisa, Pisa, Italy. "These findings are encouraging for patients
who have been battling RA for years and have had to discontinue anti-TNF
therapy due to lack of response or intolerance."
ReAct Study Results
ReAct was an open label study of 6,610 patients with moderate to severe RA
who had an insufficient response to standard anti-rheumatic therapies.
Patients were treated with HUMIRA 40 mg every other week (eow) in addition to
or as a replacement for their pre-existing therapy. Patients were observed at
weeks 2, 6, 12, 28, 36 and 52 to evaluate ACR responses and mean change in DAS
28. American College of Rheumatology (ACR) scores measure the percentage of
improvement in tender and swollen joint count and several other clinical
measures. The Disease Activity Score (DAS) measures disease activity
responses in RA by assessing tender and swollen joint counts, general health
status and an inflammatory marker. Outcomes from this study were analyzed at
week 12 for the subgroup of patients who previously failed anti-TNF therapy.
Of the 819 patients who had previously failed etanercept and/or
infliximab, nearly two-thirds of patients (61 percent) achieved ACR 20 and
one-third (33 percent) achieved ACR 50 after 12 weeks of HUMIRA 40 mg eow. Of
this group, 14 patients had previously been treated unsuccessfully with both
etanercept and infliximab, three of which had ACR 50 responses to HUMIRA at
Thirteen percent of the 819 patients who previously failed etanercept
and/or infliximab achieved clinical remission after 12 weeks of HUMIRA 40 mg
eow, as measured by DAS28<2.6. The mean improvement in health-related quality
of life from baseline for patients with previous anti-TNF failure was similar
to patients naive to TNF therapy (- 0.49 and - 0.55 respectively).
Health-related quality of life is measured by the Health Assessment
Questionnaire Disability Index (HAQ DI), which is designed to capture
patients' assessment of the ability to carry out activities of daily living
such as grooming, dressing and walking. HAQ DI scores range from 0-3, with
lower scores indicating higher levels of physical function.
Among the 819 patients with previous anti-TNF failure the most frequent
severe adverse events were musculoskeletal disorders (2 percent), infections
(1 percent) and skin disorders (0.6 percent). Of the 160 etanercept and/or
infliximab intolerant patients, eight discontinued HUMIRA due to adverse
events, one of them due to hypersensitivity.
"In the ReAct study the majority (61 percent) of patients who previously
failed other anti-TNF therapies showed a clinical response with HUMIRA," said
Alejandro Aruffo, Ph.D., vice president, Global Pharmaceutical Development,
Abbott. "These results, along with the recent approval of HUMIRA as a
first-line treatment for moderate to severe RA, provide rheumatologists an
effective treatment option for recent-onset as well as established RA
The ReAct study provides potentially useful information to practitioners
because a wide spectrum of adult patients with moderate-to-severe RA were
included, with varying disease durations and treatment backgrounds. ReAct
captured data from a broad patient population representing individuals from
450 sites in 11 European countries and Australia.
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
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.
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 rheumatoid arthritis. HUMIRA can
be used alone or in combination with methotrexate (MTX) or other DMARDS
(disease-modifying anti-rheumatic drugs).
HUMIRA is indicated for reducing the signs and symptoms of active
arthritis in patients with psoriatic arthritis. HUMIRA can be used alone or
in combination with DMARDS.
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
Abbott (NYSE: ABT) 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 60,000 people and markets its products in more than 130
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