ABBOTT PARK, Illinois, March 13 /PRNewswire/ --
- Two Sub Analyses from the CHARM Trial Evaluated Fistula Closure and
Quality Of Life in Patients with Fistulas from Crohn's Disease
Abbott announced today the first two-year data for Crohn's disease
patients with fistulas, which show that more than half of patients receiving
HUMIRA(R) (adalimumab) had continued fistula healing. These data were
presented at the European Crohn's and Colitis Organization (ECCO) Annual
Meeting in Lyon, France. Fistulas are tunnels that form between the intestine
and other parts of the body and are considered one of the most painful
complications of Crohn's disease. Fistula healing in these studies was
defined as complete cessation of fistula drainage.
"Fistulas are a serious complication of Crohn's disease that can lead to
invasive surgery," said Jean-Frederic Colombel, M.D., professor,
Gastroenterology, Hopital Huriez, Lille, France. "Medical treatments that can
promote fistula healing are important for gastroenterologists and patients
suffering from fistulizing Crohn's disease -- a very difficult-to-treat
patient population."
The results were taken from two sub-analyses of fistula patients from
Abbott's 854-patient, one-year Phase III CHARM trial for HUMIRA. Patients
were followed through a second year of therapy into a non-placebo controlled,
ongoing open-label extension (OLE) trial. Results showed:
-- Fistula healing was sustained with HUMIRA treatment. More than half of
patients (60 percent) experienced fistula healing at one year with
HUMIRA treatment, and 76 percent had continued fistula healing one
more year.
-- Seventy-one percent (50 of 70 patients) had at least a 50 percent
reduction in the number of draining fistulas after treatment with
HUMIRA.
-- Adverse event rates among patients with fistulas were consistent with
those seen in previous trials of HUMIRA in rheumatoid arthritis and
Crohn's disease.
-- More than half had a high quality-of-life score that correlates
clinical remission over two years. This was measured with an
Inflammatory Bowel Disease Questionnaire (IBDQ), a quality-of-life
tool that assesses the impact of chronic medical illness on physical,
emotional, and social well-being. Specifically, 54 percent had IBDQ
scores greater than 170 at 56 weeks (26 of 48 patients) and 60 percent
at 116 weeks (29 of 48 patients).
-- An IBDQ score greater than 170 correlates with clinician remission,
which is measured by the Crohn's Disease Activity Index (CDAI) and
defined as a CDAI score of less than 150.
"HUMIRA's ability to heal, and keep healed, a majority of fistulas among
patients studied reinforces that HUMIRA is an effective and convenient
treatment option for severe and active Crohn's disease," said Rebecca
Hoffman, M.D., divisional vice president, HUMIRA clinical development,
Abbott.
About the CHARM Trial
CHARM was a 56-week trial that enrolled 854 patients with moderate to
severe Crohn's disease and evaluated HUMIRA for the maintenance of clinical
remission. Following a four-week open label induction period, the 778
patients still participating in the trial were randomized to either HUMIRA
(40 mg every other week or weekly), or placebo. The co-primary endpoints
evaluated the maintenance of clinical remission at weeks 26 and 56 for the
HUMIRA 40mg every other week and 40mg every week groups compared to those on
placebo. A significantly greater percentage of patients treated with HUMIRA
maintained clinical remission at one year compared to placebo.
The data presented at ECCO included patients from CHARM who were followed
through one year in an ongoing open-label extension trial (OLE) and one
additional year. The analyses pooled data from both HUMIRA doses and
evaluated the subgroup of patients from CHARM who had fistulas at baseline
and enrolled into the OLE for further evaluation. Patients were analyzed for
the percentage of healed fistulas and percentage with greater than or equal
to 50 percent fistula response at 12, 18, and 24 months. Quality of life
measures evaluated included IBDQ at weeks 56, 96, and 116.
In each trial, clinical remission was measured by a CDAI score of less
than 150. CDAI is a weighted composite score of eight clinical factors that
evaluate patient wellness, including daily number of liquid or very soft
stools, severity of abdominal pain, levels of general well-being and other
measures. In these sub-analyses, fistula healing was defined as a closure of
all fistulas that were draining at baseline at 6, 12, 18 and 24 months.
Fistula response was defined as a decrease from baseline in the number of
draining fistulas of more than 50 percent over these time periods.
About Crohn's Disease
Crohn's disease is a chronic autoimmune disease characterized by
inflammation in the gastrointestinal tract. It affects people of all ages but
it is primarily a disease of young adults, with onset typically before age
40. Common symptoms of the disease include diarrhea, cramping, abdominal
pain, weight loss and fever. Complications include intestinal obstruction,
fistulas (ulcers that form tunnels to surrounding tissues), and malnutrition.
Over the course of their disease, at least 75 percent of patients with
Crohn's will undergo surgery at least once for complications or disease
resistant to treatment. Of those who undergo surgery to remove a portion of
their intestines (resection), half will experience a relapse within five
years.
HUMIRA for Crohn's Disease
Three pivotal trials have studied the effect of HUMIRA, the only fully
human monoclonal antibody for the treatment of Crohn's disease, in more than
1,400 adult patients with moderately to severely active Crohn's disease. The
CLASSIC I, CHARM and GAIN trials supporting the indication for Crohn's
disease evaluated the efficacy and safety of HUMIRA in a diverse group of
adult Crohn's disease patients, from those who were naive to anti-tumor
necrosis factor (TNF) therapy, to patients who had previously lost response
to or were unable to tolerate infliximab, another anti-TNF agent for
treatment of Crohn's disease.
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 combination of HUMIRA and anakinra and/or abatacept are 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 anaemia 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 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 (greater than 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 than1/100 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,
diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic
enzymes increased, rash, pruritus, musculoskeletal pain, pyrexia and 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), 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-α), 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 73 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.
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 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 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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