HUMIRA Improves Remission In Crohn’s Patients

An open-label extension study of the CHARM and GAIN studies, performed
in Abbott labs, demonstrate that patients with moderate-to-severe
Crohn’s disease who are treated with HUMIRA®
(adalimumab) actually achieved long-term clinical remission and a full
clinical response respectively. This information was presented on May
21, 2008 at Digestive Disease Week® (DDW) in San Diego. DDW is the
largest international gathering of physicians, researchers, and
academics from the fields of gastroenterology, hepatology, endoscopy
and
gastrointestinal surgery.

Crohn’s Disease (CD) is a gastrointestinal disorder which is indicated
by chronic inflammation of the wall of the digestive tract. The disease
involves constant cycles of flare-ups and remission throughout the life
of the patient. It is considered an inflammatory bowel disease (IBD),
similar to ulcerative colitis, It can affect people of all ages, but is
generally a disease of young adults, and most patients will experience
onset before age 40. It affects more than 500,000 Americans, and over
the
course of the disease, up to 75% of all Crohn’s patients will undergo
surgery for complications because the disease is resistant to
treatment. Common
symptoms include diarrhea, cramping, abdominal
pain, weight loss, fever, and occasionally rectal bleeding.

HUMIRA, or Adalimumab, works by binding Tumor Necrosis Factor α
(TNF-α),
an important part of the immune response pathway — in this way it is
related to infliximab and other TNF-α blockers.To date, it has been
approved in 75 countries, and more than 250,000 patients are presently
being administered HUMIRA. It is indicated for reducing signs and
symptoms, as well as maintaining clinical remission in adult patients
who haeve moderately to severely active CD, who have had inadequate
response to conventional therapies, or if they have lost response or
are intolerent to infliximab. HUMIRA has been approved for treatment of
many autoimmune diseases such as
CD, psoriasis, ankylosing spondylitis, and many types of arthritis
including: rheumatoid, juvenile idiopathic, psoratic, and severe
chronic plaque arthritis. Presently, clinical trials are in
progress to evaluate the potential use of HUMIRA in other
immune-mediated diseases.

The Crohn’s trial of the fully Human antibody Adalimumab for
Remission Maintenance (CHARM) examined 854 patients with moderate to
severe Crohn’s disease, in order to study HUMIRA’s efficacy in
maintaining clinical remission. After four weeks of treatment, the
778 patients were blindly randomized to a placebo, HUMIRA
dosed every week, or to the same dosage of HUMIRA administered half as
often. At or after week 12, patients without remission were given the
option of either of the non-placebo treatments for further therapy. The
study evaluated clinical remission at weeks 26 and 56 for the HUMIRA
groups compared to the placebo group. There was a significant
improvement in clinical remission rates in HUMIRA treated patients in
contrast to the placebo.

In the Gauging Adalimumab effectiveness in Infliximab
Nonresponders (GAIN) study, 325 patients who had lost repsonse or were
intolerent to infliximab were examined in a four week induction trial.
In this study, three times as many HUMIRA patients reached clinical
remission at week four in comparison to the placebo (21% versus 7%.)

The study reported at DDW was an open-label extension study (OLE) to
focus on HUMIRA’s ability to maintain remission and achieve response in
the long term follow up period. A diverse set of CD patients with
moderate to severe Crohn’s disease were included, including those
native to anti-TNF agents and those who had lost reponse or were
intolerent to infliximab. Patients at the end of CHARM and the GAIN
study were given HUMIRA every other week and the CHARM study received
their previous regimens. Based on flare or non-response, patients were
able to switch into the higher, every week, dosage. The results were
pooled for analysis.

Response was measured by a change in the Crohn’s Disease Activity Index
(CDAI), which is a weighted composite of eight clinical factors to
evaluate patients wellness, including: daily number of liquid or very
soft stools, severity of abdomincal pain, and levels of general
well-being. Clinical remission was identified as a score of less than
150, and a clinical response was measured as a decline of 70 or more
points.

The CHARM arm of the extension data showed that three quarters of
patients (77%) taking HUMIRA, in remission at the end of the study,
maintained clinical remission for an additional year. The gain GAIN
extension data showed that, in the patients with a clinical response at
four weeks, approximately 65% maintained clinical response at one year,
while 40% remained in clinical remission.

“Crohn’s disease is a life-long condition with no known cure.
One of the goals of treatment is to induce and maintain remission,
which can help patients with their chronic symptoms,” said Remo
Panaccione, M.D., Associate Professor, and Director of the Inflammatory
Bowel Disease Clinic at the University of Calgary. “In this
study, many patients taking HUMIRA during a
lengthened treatment period showed clinical response and remission,
which translates into improvement of disease symptoms. “

Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical
Development, Abbott, concludes with additional support for the drug.
“HUMIRA’s ability to effectively treat the chronic symptoms of Crohn’s
disease makes it an important option for gastroenterologists and
patients looking for improved disease management.”

About HUMIRA

More information about HUMIRA, including full prescribing information
and Medication Guide, is available on the Web site www.humira.com or in
the United States by calling Abbott Medical Information at
1-800-633-9110.

About DDW

DDW is the largest international gathering of physicians, researchers
and academics in the fields of gastroenterology, hepatology, endoscopy
and gastrointestinal surgery. Jointly sponsored by the
American Association for the Study of Liver Diseases, the American
Gastroenterological Association (AGA) Institute, the American Society

for Gastrointestinal Endoscopy and the Society for Surgery of the
Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego
Convention Center, San Diego, CA. The meeting showcases
approximately 5,000 abstracts and hundreds of lectures on the latest
advances in GI research, medicine and technology. For more
information, visit www.ddw.org.

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 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 www.abbott.com.

Written by Anna Sophia McKenney

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