* Simponi tested at two dosing levels vs placebo
* Clinical response 55 pct, 52 pct vs 29.7 for placebo
* Clinical remission 17.8 pct, 18.7 pct vs 6.3 placebo
* Mucosal healing 45.3 pct, 43.2 pct vs 28.5 on placebo
By Bill Berkrot
May 21 (Reuters) – More than one-half of patients taking
Johnson & Johnson’s drug Simponi for moderate to severe
ulcerative colitis showed a significant improvement in symptoms
and bowel healing, according to data from a late-stage clinical
trial.
The J&J; drug, which is sold by Merck & Co Inc in
Europe, is approved to treat rheumatoid arthritis. It was tested
in 774 patients with ulcerative colitis, a debilitating
condition that affects roughly 700,000 Americans, and often
strikes younger, active people.
Patients taking the drug in the trial showed highly
statistically significant improvements in clinical response at
six weeks, as well as clinical remission and bowel healing
compared with a placebo, meeting the study’s primary and
secondary goals.
“I think this will be very welcomed by physicians and
patients,” said Dr. William Sandborn, the study’s lead
investigator, noting that more treatment options are needed for
the disease.
Sandborn, who called the data “quite exciting,” presented
the results on Monday at the Digestive Disease Week meeting in
San Diego.
Ulcerative colitis is a chronic condition caused by an
overactive inflammatory response in the gastrointestinal tract.
Common symptoms include diarrhea, rectal bleeding, incontinence,
abdominal pain, fever, fatigue and weight loss.
The study tested two dosing levels of Simponi, delivered by
injection under the skin, against a placebo. The patients had
either failed to respond to, or could not tolerate, other
conventional therapies such as steroids.
Patients received either 200 milligrams (mg) of Simponi at
the start of the study and 100 mg at week two; 400 mg of Simponi
to start and 200 mg at week two; or a placebo.
After six weeks, 55 percent of those who got the higher dose
and 52 percent who received the lower dose showed a clinical
response, compared with 29.7 percent of placebo patients.
Clinical response was defined as a decrease of at least 30
percent and 3 points on the 12-point Mayo scale used to assess
disease activity, and a significant decrease in rectal bleeding.
SIMPLER TO USE
The ulcerative colitis market is expected grow nearly 6
percent annually to about $3 billion by 2020, according to a
recent report from Decision Resources, which provides analysis
of biopharmaceutical industry data.
Remicade, an older J&J; drug very similar to Simponi, is
already approved for ulcerative colitis. It is administered
intravenously. The formulation of Simponi tested in the Phase
III study is self-administered via injections under the skin,
making it potentially much more convenient for patients.
About three times as many patients who got Simponi, known
chemically as golimumab, achieved clinical remission at 6 weeks
as those in the placebo group. Remission was defined as a Mayo
score of 2 points or less. Patients began the study with a score
of 6 to 12 on the Mayo scale.
The remission rate was 18.7 percent on the lower dose of
Simponi, 17.8 percent for the higher dose and 6.3 percent for
placebo, researchers said.
Results after a year on the drug, known as a maintenance
study, are expected to be available later this year, Sandborn
said.
Nearly one-half of all Simponi patients also experienced
significant bowel improvement, or mucosal healing, revealed
through endoscopic examination — 45.3 percent on the high dose
and 43.2 percent on the lower dose. That compared with 28.5
percent in the placebo group.
Side effects were similar in the drug and placebo groups in
the 6-week study, researchers said.
Simponi belongs to a class of medicines called anti-TNF
(tumor necrosis factor) drugs that work by suppressing the
immune system. They can lead to infections and other sometimes
serious ailments, such as tuberculosis.
One patient experienced a reversible neurologic event
similar to multiple sclerosis that Sandborn said was not
surprising with this class of drug.
Three patients in the study died, although one was in the
placebo group and another died from cancer that had been present
prior to the study, Sandborn said. He said the safety profile
would become much more clear once the one-year maintenance study
results were available.
(Editing by Michele Gershberg and Jeffrey Benkoe)
