PARIS, June 13 /PRNewswire-FirstCall/ -- Abbott announced new data from
the open-label extension of the ATLAS (Adalimumab Trial Evaluating Long-Term
Efficacy and Safety in AS) phase III clinical trial, which showed HUMIRA(R)
(adalimumab) reduced the signs and symptoms of ankylosing spondylitis (AS) for
up to three years of treatment among 74 percent of patients tested. AS is a
type of arthritis that primarily causes inflammation of the spine and the
spinal joints. These data were presented at the European League Against
Rheumatism (EULAR) annual meeting in Paris.
"There is no cure for ankylosing spondylitis and the goal of therapy is to
relieve back and joint pain," said Desiree van der Heijde, M.D., co-lead
investigator of ATLAS and Professor of Rheumatology at Leiden University
Medical Center, The Netherlands. "Even partial remission of AS can have a
considerable positive impact on a patient's symptoms. These data are
reassuring for patients because they demonstrate that adalimumab can be an
effective treatment for ankylosing spondylitis."
Three-Year ATLAS Data Summary
ATLAS was a randomized, placebo-controlled, double-blind, Phase III study
conducted in the U.S. and Europe. The study involved 315 patients with active
AS who had an inadequate response to at least one non-steroidal
anti-inflammatory drug (NSAID) or disease modifying anti-rheumatic drug
(DMARD). Patients received HUMIRA 40mg subcutaneously or placebo every other
week (EOW). Results at 12 and 24 weeks showed HUMIRA patients experienced a
statistically significant reduction in signs and symptoms according to the
Assessment in SpondyloArthritis International Society (ASAS) measure, or
ASAS20 compared to placebo. ASAS20 represents at least a 20 percent
improvement in at least three of the four assessments to measure patient
improvement and response to therapy. At 24 weeks, all patients were switched
to an open-label HUMIRA 40mg EOW dose trial for an additional 236 weeks.
Improvement was observed through three years of treatment.
Efficacy
-- After three years, 74 percent (174/234) of patients achieved ASAS20.
-- After three years, 42 percent (97/234) of patients achieved ASAS
partial remission.
Physicians measure the severity of AS on a scale of 0-100 for level of
pain, function, inflammation and a general overall assessment by the patient.
Partial remission of the disease is classified as a score of less than 20 on a
0-100 scale in each of those four assessments.
Safety
-- The most common adverse experiences occurring in greater than or equal
to five percent of patients during three years of exposure were
nasopharyngitis, upper respiratory tract infection and headache.
-- There were no cases of tuberculosis or demyelinating disorders. There
was one death caused by malignancy.
About Ankylosing Spondylitis (AS)
AS is a rheumatic condition that affects young adults, and is more common
in men than in women. Ankylosis means "fusion" and spondylitis means
"inflammation of the spine." Advanced AS can lead to new bone formation on the
spine causing it to fuse in a fixed position. It commonly begins before the
age of 35. It is estimated that nearly three million people in Europe and at
least half a million people in the United States are affected by AS or a
related spondyloarthropathy. However, there are likely more people affected
by AS because it is under-recognized and under-diagnosed.
Important Safety Information
Globally, prescribing information varies; refer to the individual country
product label for complete information.
Serious infections, sepsis, rare cases of tuberculosis (TB), and
opportunistic infections, including fatalities, have been reported with the
use of TNF antagonists, including HUMIRA. Many of the serious infections have
occurred in patients on concomitant immunosuppressive therapy that, in
addition to their underlying disease could predispose them to infections.
Patients must be monitored closely for infections, including tuberculosis,
before, during and after treatment with HUMIRA. Treatment should not be
initiated in patients with active infections until infections are controlled.
HUMIRA should not be used by patients with active TB or other severe
infections such as sepsis and opportunistic infections. Patients who develop
new infections while using HUMIRA should be monitored closely. 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-blocking agents have been associated with reactivation of hepatitis B
(HBV) in patients who are chronic carriers of the virus. Some cases have been
fatal. Patients at risk for HBV infection should be evaluated for prior
evidence of HBV infection before initiating HUMIRA.
The combinations of HUMIRA and anakinra as well as HUMIRA and abatacept is
not recommended.
TNF antagonists, including HUMIRA, have been associated in rare cases with
demyelinating disease and serious allergic reactions. Rare reports of
pancytopenia including aplastic anemia have been reported with TNF-blocking
agents. Adverse events of the haematologic system, including medically
significant cytopenia have been infrequently reported with HUMIRA.
More cases of malignancies including lymphoma have been observed among
patients receiving a TNF antagonist compared with control patients in clinical
trials. The size of the control group and limited duration of the controlled
portions of studies precludes the ability to draw firm conclusions.
Furthermore, there is an increased background lymphoma risk in rheumatoid
arthritis patients with long-standing, highly active, inflammatory disease,
which complicates the risk estimation. During the long-term open-label trials
with HUMIRA, the overall rate of malignancies was similar to what would be
expected for an age, gender and race matched general population. With the
current knowledge, a possible risk for the development of lymphomas or other
malignancies in patients treated with a TNF antagonist cannot be excluded.
All patients, and in particular patients with a medical history of extensive
immunosuppressant therapy or psoriasis patients with a history of Psoralen
Ultra-Violet A (PUVA) treatment, should be examined for the presence of
non-melanoma skin cancer prior to and during treatment with HUMIRA.
In clinical studies with another TNF antagonist, a higher rate of serious
congestive heart failure (CHF) related adverse events including worsening CHF
and new onset CHF have been reported. Cases of worsening CHF have also been
reported in patients receiving HUMIRA. Physicians should exercise caution
when using HUMIRA in patients who have heart failure and monitor them
carefully. HUMIRA should not be used in patients with moderate or severe
heart failure.
The most frequently reported adverse event (>1/10 patients) at least
possibly causally related to HUMIRA is injection site reaction (including
pain, swelling, redness or pruritus). Other common adverse events (reported
by >1/100 patients) at least possibly causally related to HUMIRA include lower
respiratory infections (including pneumonia, bronchitis), viral infections
(including influenza, herpes infections), candidiasis, bacterial infection
(including urinary tract infections), upper respiratory infection, dizziness
(including vertigo), headache, neurologic sensation disorders (including
paraesthesias), cough, nasopharyngeal pain, diarrhea, abdominal pain,
stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash,
pruritus, musculoskeletal pain, pyrexia, fatigue (including asthenia and
malaise).
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved for the
treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque
psoriasis, ankylosing spondylitis (AS) and Crohn's disease in the United
States and Europe. 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. To date, HUMIRA has been approved in 75
countries and more than 250,000 people worldwide are currently being treated
with HUMIRA. Clinical trials are also under way evaluating the potential of
HUMIRA in ulcerative colitis.
In Europe, HUMIRA in combination with methotrexate, is indicated for the
treatment of moderate to severe, active rheumatoid arthritis in adult patients
when the response to disease-modifying anti-rheumatic drugs including
methotrexate has been inadequate.
HUMIRA is also indicated for the treatment of severe, active and
progressive rheumatoid arthritis in adults not previously treated with
methotrexate. HUMIRA can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment with methotrexate 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 methotrexate. In the United States, HUMIRA is also approved for the
treatment of juvenile idiopathic arthritis (JIA).
HUMIRA is indicated for the treatment of active and progressive psoriatic
arthritis in adults when the response to previous disease-modifying
anti-rheumatic drug therapy has been inadequate. HUMIRA has been shown to
reduce the rate of progression of peripheral joint damage as measured by X-ray
in patients with polyarticular symmetrical subtypes of the disease and to
improve physical function.
HUMIRA is indicated for the treatment of adults with severe, active
ankylosing spondylitis who have had an inadequate response to conventional
therapy.
HUMIRA is indicated for treatment of severe, active Crohn's disease, in
patients who have not responded despite a full and adequate course of therapy
with a corticosteroid and/or an immunosuppressant; or who are intolerant to or
have medical contraindications for such therapies. For induction treatment,
HUMIRA should be given in combination with corticosteroids. HUMIRA can be
given as monotherapy in case of intolerance to corticosteroids or when
continued treatment with corticosteroids is inappropriate.
HUMIRA is indicated for the treatment of moderate-to-severe chronic plaque
psoriasis in adult patients who failed to respond to or who have a
contraindication to, or are intolerant to other systemic therapy including
cyclosporine, methotrexate or PUVA.
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.
About Abbott
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 more than 68,000 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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