Stelara, a medication currently approved for the treatment of plaque psoriasis, has shown promising results in the treatment of moderate to severe Crohn's disease, according to findings from a new study presented at the Digestive Disease Week meeting in Chicago on May 8, 2011.
When compared to a placebo, Stelara (ustekinumab) helped to ease difficult-to-treat symptoms of the digestive condition Crohn's disease in patients who had not experienced success with other drugs. Stelara is approved for the skin condition plaque psoriasis and is currently in development as a treatment for psoriatic arthritis.
In the new study, 40 percent of patients taking Stelara achieved a clinical response at the conclusion of the six-week study, as compared with 23.5 percent of patients who took a placebo. A clinical response was defined as a 100-point reduction in a patient's score on the Crohn's Disease Activity Index, which takes into account many symptoms associated with Crohn's.
Additionally, 70 percent of patients who continued to take Stelara beyond the six-week study continued to see results from the medication, with a higher rate of disease remission in those who remained on Stelara treatment versus those who took a placebo.
"To see these kind of outcomes, where you have high response rates in the short term and then good remission rates out toward five or six months of therapy, it shows unequivocally that the drug is effective for treating Crohn's disease," said Dr. William Sandborn, lead investigator of the study.
Researchers said that a 100-point drop in the Crohn's Disease Activity Index can mean a significantly better quality of life for patients with the disease. Factors that play a role in the calculation of a patient's score on the index include frequency of soft stools, frequency of abdominal pain, changes in weight, low hematocrit levels, presence of abdominal mass, use of medications for diarrhea and the presence of any complications such as joint pain, fever or anal fissures.
The 526 patients involved in the study had not experienced previous success with tumor necrosis factor (TNF) antagonist medications such as adalimumab (Humira), etanercept (Enbrel) or infliximab (Remicade).
Sandborn and other study researchers will continue to study the drug's effectiveness in long-term studies to determine its effectiveness and safety in the treatment of Crohn's disease.
by
Akshaya Srikanth
Pharm.D Internee
When compared to a placebo, Stelara (ustekinumab) helped to ease difficult-to-treat symptoms of the digestive condition Crohn's disease in patients who had not experienced success with other drugs. Stelara is approved for the skin condition plaque psoriasis and is currently in development as a treatment for psoriatic arthritis.
In the new study, 40 percent of patients taking Stelara achieved a clinical response at the conclusion of the six-week study, as compared with 23.5 percent of patients who took a placebo. A clinical response was defined as a 100-point reduction in a patient's score on the Crohn's Disease Activity Index, which takes into account many symptoms associated with Crohn's.
Additionally, 70 percent of patients who continued to take Stelara beyond the six-week study continued to see results from the medication, with a higher rate of disease remission in those who remained on Stelara treatment versus those who took a placebo.
"To see these kind of outcomes, where you have high response rates in the short term and then good remission rates out toward five or six months of therapy, it shows unequivocally that the drug is effective for treating Crohn's disease," said Dr. William Sandborn, lead investigator of the study.
Researchers said that a 100-point drop in the Crohn's Disease Activity Index can mean a significantly better quality of life for patients with the disease. Factors that play a role in the calculation of a patient's score on the index include frequency of soft stools, frequency of abdominal pain, changes in weight, low hematocrit levels, presence of abdominal mass, use of medications for diarrhea and the presence of any complications such as joint pain, fever or anal fissures.
The 526 patients involved in the study had not experienced previous success with tumor necrosis factor (TNF) antagonist medications such as adalimumab (Humira), etanercept (Enbrel) or infliximab (Remicade).
Sandborn and other study researchers will continue to study the drug's effectiveness in long-term studies to determine its effectiveness and safety in the treatment of Crohn's disease.
by
Akshaya Srikanth
Pharm.D Internee
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