New Phase III Data Shows Abbott's HUMIRA(R) (Adalimumab) Induced Clinical Remission In Patients With Crohn's Disease Who Lost Re
23 Ottobre 2006 - 3:00PM
PR Newswire (US)
- Study Demonstrates Promising Results in Tough-to-Treat Crohn's
Disease Patients - ABBOTT PARK, Ill., Oct. 23
/PRNewswire-FirstCall/ -- Abbott today announced results from a
study showing HUMIRA(R) (adalimumab) induced significantly higher
rates of clinical remission compared to placebo in patients with
moderately to severely active Crohn's disease who lost response to,
or were intolerant to, infliximab therapy. The data is being
presented simultaneously at the American College of
Gastroenterology (ACG) annual meeting in Las Vegas and the United
European Gastroenterology Week (UEGW) in Berlin. Crohn's disease is
a serious, chronic inflammatory disease of the gastrointestinal
(GI) tract that may affect more than one million people in North
America and Europe. There is no medical or surgical cure for
Crohn's disease and few options for patients suffering with this
chronic condition. Data from GAIN, Gauging Adalimumab effectiveness
in Infliximab Non- Responders, showed three times the percentage of
patients with moderately to severely active Crohn's disease (CDAI
220-450) who had lost response to, or were intolerant to,
infliximab achieved clinical remission with HUMIRA versus placebo
at week four. Clinical remission was measured by a decrease in the
Crohn's Disease Activity Index (CDAI) to less than 150 points. 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, level of general
well-being and other measures. HUMIRA met the primary endpoint in
GAIN, which was the proportion of patients achieving clinical
remission (CDAI < 150) at week four compared to placebo.
Significantly higher rates of clinical remission were observed for
patients receiving HUMIRA compared to those receiving placebo at
week four, 21 percent versus seven percent respectively (p less
than or equal to 0.001). "The results of the GAIN study suggest the
potential of HUMIRA to help patients who lost response or were
intolerant to infliximab therapy and positively impact both their
disease and quality of life," said Stephen Hanauer, M.D., professor
of medicine and clinical pharmacology chief, Section of
Gastroenterology and Nutrition, University of Chicago. "These data
are encouraging for patients and physicians dealing with this
debilitating disease." The GAIN Study GAIN, a randomized,
double-blind, placebo-controlled study of 325 patients who lost
previous response to, or were intolerant to, infliximab, was
designed to assess the efficacy and safety of HUMIRA versus placebo
for induction of clinical remission in moderately to severely
active Crohn's disease (CDAI 220- 450), measured at four weeks. Of
the 325 patients included in the trial, 159 received initiating
treatment with HUMIRA, 160 mg at week zero followed by 80 mg at
week two, and the remaining 166 patients received placebo. Results
were also significant in the study's secondary endpoints, clinical
response 70 (CR-70) defined as a decrease from baseline CDAI of
greater than or equal to 70 points, and clinical response 100
(CR-100), defined as a decrease from baseline CDAI of greater than
or equal to 100 points. More than half (52 percent) of patients
receiving HUMIRA achieved CR-70 at week four, compared to one in
three (34 percent) receiving placebo (p less than or equal to
0.001). At week four, 38 percent of patients taking HUMIRA, versus
25 percent of patients receiving placebo, achieved CR-100 (p less
than or equal to 0.01). In addition, 52 percent of patients
receiving HUMIRA achieved CR-70 at week two, compared to 33 percent
of patients receiving placebo (p less than or equal to 0.01). The
safety profile in the GAIN study was consistent with previous
reports in Crohn's disease and rheumatoid arthritis studies of
HUMIRA. The most frequently reported treatment emergent adverse
events (greater than or equal to 5 percent) for patients in the
HUMIRA arm included abdominal pain, joint pain, headache, and
injection site irritation. "The findings of the GAIN study are
significant, because they provide data showing that HUMIRA induced
clinical remission and response in this difficult to treat Crohn's
disease patient population," said Eugene Sun, M.D., vice president,
Global Pharmaceutical Clinical Development, Abbott. About Crohn's
Disease Crohn's disease is typically diagnosed before age 40. It
can have a devastating impact on the lifestyles of patients, many
of whom are young and active. Common symptoms of the disease
include diarrhea, cramping, abdominal pain, weight loss, fever, and
in some cases, rectal bleeding. Over the course of their disease,
at least 50 percent of patients with Crohn's will undergo surgery
at least once for complications or disease refractory to treatment
and up to 70 percent of those patients will require a second
surgery. HUMIRA Regulatory Filings in Crohn's Disease In September
2006, Abbott announced it had simultaneously submitted a
supplemental Biologics License Application (sBLA) with the FDA and
a Type II Variation to the European Medicines Agency (EMEA) seeking
approval to market HUMIRA as a treatment for moderately to severely
active Crohn's disease. The global filings are based on the results
of three randomized, double-blind, placebo-controlled, multi-center
trials of HUMIRA - CLASSIC I (CLinical assessment of Adalimumab
Safety and efficacy Studied as an Induction therapy in Crohn's
disease), CHARM (Crohn's trial of the fully Human antibody
Adalimumab for Remission Maintenance) and GAIN. Crohn's disease is
the fourth of seven diseases Abbott is studying for HUMIRA therapy.
Important Safety Information Serious infections, sepsis,
tuberculosis (TB) and rare cases of 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. 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. 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. In
HUMIRA clinical trials for ankylosing spondylitis and psoriatic
arthritis, the safety profile for patients treated with HUMIRA was
similar to the safety profile seen in patients with rheumatoid
arthritis. About HUMIRA 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. HUMIRA resembles antibodies normally found in the
body. It works by blocking tumor necrosis factor alpha (TNF-a), a
protein that plays a central role in the inflammatory responses of
autoimmune diseases. To date, HUMIRA has been approved in 67
countries and more than 160,000 people worldwide are currently
being treated with HUMIRA. 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 structural damage, and improving physical function
in adult patients with moderately to severely active RA. HUMIRA is
also indicated for reducing the signs and symptoms of active
arthritis in patients with PsA. HUMIRA can be used alone or in
combination with methotrexate or other disease-modifying
anti-rheumatic drugs (DMARDs). HUMIRA was also approved on July 28,
2006 for reducing signs and symptoms in patients with active AS. In
Europe, HUMIRA, in combination with methotrexate, is indicated for
the treatment of moderate to severe, active RA in adult patients
when the response to DMARDs including methotrexate (MTX) has been
inadequate. HUMIRA is also indicated for the treatment of severe,
active and progressive RA in adults not previously treated with
MTX. Additionally, HUMIRA is indicated for the treatment of active
and progressive PsA and severe, active AS in adults when the
response to previous DMARD-therapy has been inadequate. 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 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
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 countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com/. DATASOURCE: Abbott
CONTACT: U.S. Media, Elizabeth Shea, +1-847-935-2211, or Media
Outside the U.S., Kellie Harris, +1-847-937-9789, or Financial
Community, John Thomas +1-847-938-2655, all for Abbott Web site:
http://www.abbott.com/ Company News On-Call:
http://www.prnewswire.com/comp/110328.html
Copyright