Download Opens New Doors for GI Patients

Opens New Doors for GI Patients
By Douglas Wolf, M.D.
Today, there are approximately 1.2
million patients in the United States
with Crohn’s disease and ulcerative
colitis (UC). Although the cause of
these conditions is unknown and
currently there is no cure, there are
many effective medical treatments,
and interest in clinical research in both
ulcerative colitis and Crohn’s disease is
increasing rapidly.
Over the last decade, the physicians
at Atlanta Gastroenterology Associates
(AGA) have played a key role in many
clinical trials and the practice is considered one of the top 10 centers in the
country offering treatment options for
patients with Crohn’s disease and UC.
As a result of some successful study
outcomes, AGA patients are reaping
the benefits. For one 33-year-old patient
in particular, the clinical trials have
resulted in a better quality of life.
“Joe’s” Story
As a young man with a wife and
15-month-old baby, “Joe” faced several
challenges. Suffering from a type of
Crohn’s disease that affected his entire
colon, surgery to remove the colon
was an option, but not a very good
one. Having been on Prednisone, an
oral corticosteroid, for seven years,
he had developed facial edema, body
swelling and fluid retention. He even
developed osteoporosis.
Over time, we tried several different medications, but he no longer
responded to the drugs and continued
to suffer from edema and osteoporosis.
When a new drug, Tysabri (generically
known as natalizumab), became available last January, we switched “Joe” to
the new medication.
12 An InsideLook
Dr. Douglas Wolf reviews clinical trial documentation
with his research coordinator, Katie Neri, RN.
For the first time in seven years, he was
able to stop taking Prednisone and stay
off of it. His swelling started to diminish
and today he is feeling better than he has
in a long time.
The clinical trial resulting in “Joe’s”
remarkable turnaround is just one of 30
studies in which I have acted as principal
investigator over the last decade. Others
include trials for infliximab (also known
as Remicade®), used both to induce
remission and maintenance of active
Crohn’s disease and to treat fistulizing
Crohn’s disease, as well as adalimumab
(Humira®), and certolizumab (Cimzia®),
which are used to treat patients with
active Crohn’s disease and patients who
have lost response or had infusion reactions to Remicade.
These drugs are known as biologics, i.e., injectable treatments created
from human or animal proteins. First
approved for use in treating Crohn’s
disease in 1998, they are given by intravenous infusion over one to two hours
or by injection. Patients often notice an
improvement in symptoms within weeks
and sometimes days of their treatment.
Despite the impressive success in
some cases, no drug keeps patients in
remission more than 30 percent of the
time. In fact, some patients can develop
antibodies against a drug after repeat
treatments, decreasing the drug’s effectiveness. As a result, other medications
are recommended to help ease their
symptoms. Finding the most effective
treatments for these debilitating diseases
is at the core of our clinical trial efforts,
and makes research a vitally important
part of our practice.
About Clinical Trials
All clinical trials at Atlanta Gastroenterology are conducted through
our research division, the Center for
Clinical Research, and every study is
FDA-approved and monitored by the
regulatory divisions of the pharmaceutical industry. In addition, the research
center is supervised by board certified
gastroenterologists and has a full-time
staff of trained and certified clinical
research coordinators.
The majority of the clinical trials
offered are Phase II and Phase III trials,
which test the safety and efficacy of new
drugs being developed for the treatment
of both Crohn’s disease and ulcerative
colitis.
By providing a broad range of treatment options through clinical trials,
patients have a real advantage, particularly those having difficulties with
current medications. Because patients
can lose responsiveness to drugs used
to treat Crohn’s disease, for example,
participating in a clinical trial may give
them the opportunity to benefit from
new medications two to five years before
they are released by the FDA. Offering our patients the opportunity to try
investigational drugs not only increases
their chances of gaining a better quality
of life, but those patients also make an
important contribution to research
efforts for Crohn’s disease and ulcerative colitis. Those research efforts are
constantly expanding.
As a physician, participating in clinical trials is extremely gratifying. Being
involved in cutting edge research of
biologic therapy for Crohn’s disease is
just one promising aspect. In addition,
AGA is currently enrolling patients in
clinical trials to study the use of stem
cell therapy and Chinese herbs to treat
Crohn’s disease. No other practice in
the Atlanta area – or the southeast – is
involved in gastrointestinal clinical trials
quite like these.
While many patients may be discouraged after trying medications that have
not worked, it is through these clinical trials that new options and a better
understanding of currently available
drugs are being discovered. With new
therapeutic options on the horizon every
day, the future is bright for patients with
ulcerative colitis and Crohn’s disease.
For more information on participating
in clinical trials or treatment options for
Crohn’s disease, make an appointment
with Dr. Wolf or contact Study Coordinator Katie Neri, RN, at 678-538-1584.
Douglas C. Wolf, M.D.
Board Certified
Internal Medicine and Gastroenterology
Dr. Wolf is a graduate of Duke University in Durham,
North Carolina. He
completed medical
school, as well as
his internship and
residency, at the
West Virginia School
of Medicine in Morgantown. Following completion of a fellowship in
gastroenterology at the Cleveland Clinic
in Ohio, Dr. Wolf joined the faculty at
Emory University Hospital in Atlanta
as senior associate of medicine in digestive diseases and was later named assistant professor of medicine for digestive
diseases. He presently serves on the
visiting faculty at the Annenberg Medical Center.
Dr. Wolf is an active member of
many professional organizations and
holds several leadership and committee
appointments. He is a member of the
American Gasroenterologic Association,
the American College of Physicians, the
American Society for Gastrointestinal
Endoscopy, the American College of
Gastroenterology, the Georgia Gastroenterologic and Endoscopic Society,
the American Federation for Clinical
Research, and the American Medical
Association. He is past president of the
Atlanta Gastroenterology Club and also
serves on the Board of Trustees for the
Georgia Crohn’s and Colitis Foundation.
Dr. Wolf joined Atlanta Gastroenterology Associates in 1994 and sees patients
at the Saint Joseph’s location.
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