Johnson & Johnson unveiled Thursday results of a
late-stage trial that showed its psoriasis drug, ustekinumab, was more
effective than rival Enbrel sold by Wyeth and Amgen.
The results of the study were presented at a dermatologists’
medical meeting in Paris.
The study involved 903 patients with moderate to severe psoriasis. Psoriasis, a
skin disorder that causes scaly red patches, affects an estimated 7.5 million
Americans.
The 12-week study showed that ustekinumab, also called
Stelara, decreased the severity of the psoriasis by 68 percent in patients
taking a 45-milligram dose and 74 percent in patients taking a 90-milligram
dose, while patients taking 50 milligrams of Enbrel only saw a 57 percent
reduction in their condition. Both Enbrel and Stelara are given through
injections, but the later would be administered less frequently. Stelara
injections work by blocking an inflammation-causing protein called tumor
necrosis factor (TNF).
“These findings reinforce the promise of Stelara as an
infrequently administered and highly effective biologic therapy for the
treatment of adults with moderate to severe psoriasis,” Bruce Strober, one of
the trial investigators, said.
The drug also proved more efficient than Enbrel in reducing
the severity of psoriasis by 90 percent. To be more specific, 36 percent of
patients on low-dose ustekinumab and 45 percent on the higher dose saw such an
improvement compared with 23 percent of those receiving Enbrel.
“We’ve never seen clearance along the lines of what we’ve
been seeing with ustekinumab. This is pretty dramatic,” Dr. Alan Menter, a Baylor University
dermatologist who helped lead the study, said.
Also, patients given ustekinumab had fewer side effects
comparable to patient given Enbrel. There were fewer cases of redness or
irritation at the injection site in ustekinumab patients.
Wyeth questioned ustekinumab trial’s results saying they
were based on a short-term study, whereas psoriasis is a systemic, chronic
disease that requires long-term treatment.
“This is a short-term study with no longer efficacy
conclusions” or long-term safety data, Wyeth said in a statement.
A US Food and Drug Administration panel unanimously voted in
June in favor of ustekinumab. However, seven of the panel’s 11 members showed
their concern about the self-administration of the injections and recommended
that the drug be given by a physician.
“This recommendation takes away from the convenience
advantage of the product,” Raymond James analysts Jayson Bedford, said.
J&J has already applied for US approval of the drug and
expects a decision before the end of the year. If approved, analysts expect the
drug to generate hundreds of millions of dollars in sales within a few years
considering Enbrel’s sales last year that reached $5.3 billion, being one of
the best-selling drugs in the world, according to IMS Health. Enbrel was
introduced in 1998 for rheumatoid arthritis but soon after received regulatory
approval for psoriasis too. Ustekinumab global market is expected to worth
about 1.1 billion dollars in 2008 and almost 3 billion in 2010, Mike Weinstein,
analyst of JPMorgan Chase, said.