Combination Therapy Treats Crohn's Disease
Study Shows Combination of Biologic and Immune-Suppressing Drugs Is Best Treatment for Crohn's
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."
Combination Treatment for Crohn's: Risk, Cost
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