| March 22
March 22 An experimental Johnson & Johnson
drug for moderate to severe psoriasis proved
significantly better at clearing the scaly, uncomfortable skin
patches associated with the disease than a placebo, according to
data from a midstage study presented on Saturday.
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.
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)