WebMD Medical News
Daniel J. DeNoon
Laura J. Martin, MD
April 14, 2010 -- Patients with moderate to severe Crohn's disease are most likely
to get better if treated with a combination of biologic and immune-suppressing
therapies, a clinical trial suggests.
It's a "landmark trial," says gastroenterologist David Kerman, MD, assistant
professor of clinical medicine at the University of Miami Miller School of
Medicine, who was not involved in the study.
"This is very important news," Kerman tells WebMD. "It says that combination
therapy is actually better in these patients at an earlier point in the disease
than previously thought."
The findings already have changed clinical practice, says study researcher
William Sandborn, MD, vice chair of gastroenterology at the Mayo Clinic in
The trial enrolled 508
patients. It tested a combination of Remicade and azathioprine, an immunosuppressive drug, against each
drug by itself. Remicade is one of three approved "biologic" Crohn's treatments
that block TNF, a major player in the
immune responses that inflame the intestines of Crohn's
After 26 weeks of treatment, patients getting the combination had a 57%
chance of disease remission, compared to 44% of those getting Remicade alone
and to 30% of those getting azathioprine alone. Similar results were seen after
50 weeks of treatment.
The combination treatment worked even better in patients with
colonoscopy-confirmed disease and blood-test evidence of inflammation. Among
these patients, 69% achieved
remission with the combination treatment compared to 57% of those on Remicade
alone and to 28% of those on azathioprine alone.
"For patients who don't initially respond to corticosteroids, or who don't
continue to respond when we taper down corticosteroids, those patients are best
treated with a combination of anti-TNF and immune-suppressive drugs, Sandborn tells WebMD. "That will give patients
their best chance of being off steroids and having a healthy bowel."
Some specialists are skipping steroids and going straight to the
combination, Kerman says.
"Some patients require corticosteroids, but I think that more and more we
are realizing that corticosteroids may change the natural history of Crohn's
disease for a worse outcome," he says. "Using biological therapies and immune
modulators may preclude the need for ever needing corticosteroids."
The treatment is not without risk. Remicade and other anti-TNF drugs (Humira
and Cimzia) increase a patient's risk of life-threatening infections and
cancers. So do immune-suppressing drugs, although the Remicade trial suggested
that combination therapy is not more risky than azathioprine or Remicade
In the study, 4% of patients receiving the Remicade/azathioprine combination
developed serious infections, as did 5% of those in the Remicade-only group and
5.6% of those in the azathioprine-only group.
And the treatment is expensive. A
155-pound patient would need about 350 milligrams of Remicade per treatment.
Four 100-milligram vials of Remicade cost $2,763, according to
Other anti-TNF drugs, which Sandborn and Kerman say should work as well as
Remicade, cost about as much. But Kerman notes that anti-TNF therapy for
Crohn's disease is actually cost-effective, as the drugs prevent
hospitalizations, loss of work, and other expenses.
"I'd like for Crohn's patients to ask their doctors to consider combination
treatment with these biologics and immune modulators as an early therapy,"
Kerman says. "It has been shown that treating much earlier gives them a much
better chance of responding, rather than getting the treatment after damage
already has been done."
The combination therapy does not cure Crohn's disease. Treatment must
continue indefinitely. However, Sandborn says that some of the patients in the
earliest clinical trials are still doing well after 12 years of treatment.
Sandborn serves as a consultant to Centocor, which makes Remicade, and to
Abbott, which makes Humira. Fees for this consultation go to Mayo Clinic and
not directly to him. Kerman is on the speakers bureau for UCB, which makes the
anti-TNF drug Cimzia.
Sandborn and colleagues report the finding of their trial in the April 15
issue of the New England Journal of Medicine.
SOURCES:Colombel, J.F. New England Journal of Medicine, April 15, 2010; vol
362: pp 1383-1395.William Sandborn, MD, vice chair, division of gastroenterology and
hepatology, Mayo Clinic, Rochester, Minn.David H. Kerman, MD, assistant professor of clinical medicine, division of
gastroenterology, University of Miami Miller School of Medicine.
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