Crohn's patients respond to J&J's Stelara in study

Sun May 8, 2011 5:45pm EDT

 * 39.7 pct respond to Stelara vs 23.5 pct for placebo
 * Stelara remission rate 41.7 pct at week 22
 * Adverse events similar to placebo group
 By Bill Berkrot
 NEW YORK, May 8 (Reuters) - Johnson & Johnson's (JNJ.N)
Stelara helped a significantly higher percentage of Crohn's
disease sufferers than those who received a placebo, according
to a study of patients who had not been helped by other
commonly used drugs.
 In addition, nearly 70 percent of patients who stayed on
Stelara beyond the initial six weeks of the mid-stage study
continued to respond to the drug and there was a significantly
higher rate of remission at 22 weeks than in a placebo group.
 Stelara, known chemically as ustekinumab, is already
approved to treat the skin condition plaque psoriasis and is in
late-stage testing for psoriatic arthritis. An approval for
Crohn's would give the drug entry into an estimated $1.3
billion U.S. market and $2.7 billion market worldwide.
 The intravenous biotech drug met the primary goal of the
study as almost 40 percent of patients who received the 6
milligrams per kilogram of weight dose of Stelara achieved a
clinical response -- defined as a 100-point reduction in the
Crohn's Disease Activity Index (CDAI) -- after six weeks of
treatment.
 That compared with a response rate of 23.5 percent of
patients who received a placebo.
 Two lower doses of Stelara were also tested in the study of
526 patients with moderate to severe Crohn's disease who were
not helped by, or could not tolerate, treatment with a widely
used class of drugs known as TNF antagonists, such as Abbott
Laboratories' (ABT.N) Humira.
 Those who received 1 mg/kg had a 36.6 percent response rate
and the 3 mg/kg dose led to a 34.1 percent response rate.
 "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, the study's lead
investigator, who presented the data at the Digestive Disease
Week meeting in Chicago on Sunday.
 "It's effective in the patient population that has the
greatest unmet need at this point in time," Sandborn said of
patients who do not respond to anti-TNF drugs.
 He said a 100-point drop in the CDAI was clinically
meaningful to patients. "They'll feel measurably better."
 "The patient population was really quite ill and had very
high disease activity, and despite that we saw nice response
rates," Sandborn said.
 In a second phase of the study, those who responded to
Stelara after six weeks of treatment were given either a 90-mg
injection of Stelara at week eight and week 16 or a placebo.
 After 22 weeks, 69.4 percent of the Stelara patients
maintained a clinical response and 41.7 percent were deemed to
be in clinical remission. That compared with 42.5 percent who
maintained a clinical response and a 27.4 percent remission
rate in the placebo group.
 Clinical remission was defined as a CDAI score down to 150.
Patients in the study on average started at 320 or 325 on the
CDAI scale, researchers said.
 Crohn's is a chronic autoimmune disorder of the
gastrointestinal tract that affects an estimated 700,000
Americans. Common symptoms are abdominal pain and diarrhea, and
it can lead to bowel perforations. Many Crohn's patients
require surgery when medicines no longer control symptoms.
 The rate of infections and other serious side effects was
similar in the Stelara and placebo groups, researchers said.
 "We'll need more patients and longer-term data to really
fully characterize the safety profile in Crohn's disease, but
so far so good," Sandborn said.
 (Reporting by Bill Berkrot; Editing by Tim Dobbyn and Dale
Hudson)


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