PARIS, June 13 /CNW/ -- Seven-year rheumatoid arthritis (RA) data from
open-label extension studies show that treatment with Abbott's HUMIRA(R)
(adalimumab) resulted in clinical remission among long-standing RA patients
when used in combination with methotrexate (MTX). The percentage of patients
achieving clinical remission continued to increase after two or more years of
continuous treatment with combination therapy. These data were presented at
the European League Against Rheumatism (EULAR) annual meeting in Paris.
The seven-year HUMIRA data are a combined analysis of open-label
extensions of the ARMADA, DE019, STAR, DE005 and DE037 trials. The open-label
extension period of these studies assessed the measures of efficacy, remission
and change over time in the safety profile in patients with long-standing RA
treated for up to seven years with 40mg of HUMIRA every other week plus MTX.
"Rheumatoid arthritis is a chronic, progressive disease with no cure and
usually requires long-term management for patients, so it is reassuring that
HUMIRA has demonstrated up to seven years of efficacy in patients with this
disease," said Michael E. Weinblatt, M.D., Brigham and Women's Hospital,
Boston, and lead investigator.
Seven-Year Clinical Data Summary
A total of 1,469 patients with a history of RA who had continued on from
randomized, controlled HUMIRA trials were treated with HUMIRA and MTX for
greater than or equal to 30 days and up to seven years in open-label extension
studies. The average length of exposure to treatment was 47 months.
The randomized controlled HUMIRA study included:
* The ARMADA trial: a Phase III study to evaluate efficacy and safety
of HUMIRA in patients with moderate to severe RA who had failed at
least one disease-modifying anti-rheumatic drug (DMARD).
* DE019: a Phase III study, which evaluated the efficacy and safety of
HUMIRA in patients with moderate to severe RA with inadequate
response to MTX, including assessment of inhibition of radiographic
* The STAR trial: a Phase III study that evaluated the efficacy and
safety of HUMIRA when added to a standard treatment regimen for RA
in patients with inadequate response.
* DE005: a Phase I study evaluating the safety and efficacy of HUMIRA
in combination with methotrexate in methotrexate partial responders.
* DE037: a Phase I roll-over study that evaluated the safety,
pharmacokinetics and early signs of HUMIRA efficacy among RA
patients in the United States and Japan.
* After six months of therapy, all efficacy measures showed
significant improvements versus baseline.
* At year two, additional improvements were observed in American
College of Rheumatology (ACR) responses. ACR responses represent a
percent improvement in tender joint count, swollen joint count and
other relevant clinical measures.
* Improved response after year one was confirmed by examining
sustained clinical remission (Disease Activity Score (DAS28) of less
than 2.6) for at least three consecutive visits; sustained remission
was achieved in 42 percent of all patients after a mean of 18 +/- 17
months. DAS28 is a composite index that includes variables such as
the number of tender and swollen joints, specific laboratory values
and other measures of disease activity.
* The treatment exposure-adjusted rate of serious adverse events
(SAEs), and serious infections, declined progressively during seven
years of observation.
* Rates and types of SAEs were consistent with randomized controlled
trials, including the rate of serious infections. Two patients
reported tuberculosis, one after three months and another after 13
months of exposure.
About Rheumatoid Arthritis
Unlike osteoarthritis, the most common form of arthritis, RA is an
autoimmune disease where joints are inflamed, which may lead to damage of the
joints' interior and the surrounding bone. The joints most commonly affected
during the beginning of the disease are the smaller joints of the fingers,
feet and wrists. The elbows, knees, ankles and hips can be affected, but less
often. Although there is no cure for RA, people continue to seek treatments
that not only alleviate the pain and inflammation but also slow disease
progression, thereby inhibiting the joint damage that can hinder patients from
performing daily activities. Five million people worldwide are currently
living with RA and most of them are between the ages of 25 and 55.
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
The most frequently reported adverse event (greater than or equal to 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 greater than or equal to >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).
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
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
HUMIRA is indicated for the treatment of adults with severe, active
ankylosing spondylitis who have had an inadequate response to conventional
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
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 68,000 people and markets its products in more than
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