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 The J&J biologic medicine, guselkumab, achieved the
main goal of the Phase II study at all five dosing regimens tested
by clearing or reducing the psoriasis to a minimal measure after 16
weeks of treatment in a far greater percentage of patients than in
the group that received a placebo. It also appeared to be as good as
or more effective than AbbVie's big selling Humira at four of the
tested doses.
"The efficacy of guselkumab in the treatment of moderate to severe
plaque psoriasis looks promising according to these Phase IIb study
results," Dr. Kristina Callis Duffin, one of the study's
investigators, said in a statement.
Results were determined using Physician Global Assessment (PGA)
scores — a zero to 5 scale in which 0 indicates the disease has been
cleared, 1 represents minimal disease and 5 indicates the most
severe symptoms.
Guselkumab led to scores of 0 or 1 in as high as 86 percent of
patients who received 100 milligrams of the drug every eight weeks,
and in 83 percent of patients who were injected with 200 mg of the
J&J medicine at the start of the trial and at week 4 and then every
12 weeks.
At the lower end, 34 percent of patients who got 5 mg of the drug to
start and at week 4 and then every 12 weeks achieved PGA scores of 0
or 1. That was still deemed to be statistically significant compared
with 7 percent for those who got a placebo.
In the Humira (adalimumab) group, 58 percent had scores of 0 or 1
after 16 weeks of treatment.
Results of the 293-patient trial, dubbed X-Plore, were presented at
the American Academy of Dermatology (AAD) meeting in Denver. J&J has
not yet said which of the treatment regimens would be advanced to
larger, pivotal Phase III trials.
Guselkumab, which would be a follow-up treatment to J&J's Stelara,
works by blocking interleukin-23, or IL-23, a protein that has been
associated with chronic inflammation and is believed to play a role
in psoriasis.
Morningstar analyst Damien Conover said the drug "is really under
the radar right now." He currently sees sales reaching about $500
million several years after approval, but said estimates could
change if later Phase III data were impressive.
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In addition to the primary goal, significantly higher proportions
of guselkumab patients achieved at least a 75 percent improvement in
psoriasis as measured by the Psoriasis Area Severity Index (PASI 75)
at week 16. Those results ranged from 44 percent of patients taking
the lowest dose up to 81 percent at higher dosing regimens. That
compared with 5 percent for placebo and 70 percent for Humira.
A 90 percent improvement was seen in as high as 62 percent of
patients who got 100 mg of guselkumab every eight weeks.
The results remained consistent or showed additional improvement
after 40 weeks of treatment, the company said.
After a year of treatment, serious adverse side effects were
reported in 3 percent of those treated with guselkumab and 5 percent
for Humira.
There were no cases of tuberculosis or opportunistic infections. One
guselkumab patient reported a malignancy and there were three major
adverse heart events, including one fatal heart attack, in patients
with pre-existing cardiovascular risk factors, the company said.
Psoriasis, an immune-system related disease that causes an
overproduction of skin cells resulting in patches of thick inflamed
skin covered with silvery scales, affects 125 million people
worldwide and about 7.5 million Americans, according to the National
Psoriasis Foundation.
(Reporting by Bill Berkrot; editing by Steve Orlofsky)
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