* Celgene says 41 pct of patients saw 20 pct improvement
* Safety profile remains benign; mostly nausea, diarrhea
* Subgroup of patients saw significantly better results
By Toni Clarke
Nov 13 Celgene Corp's experimental
treatment for psoriatic arthritis, apremilast, proved to be
modestly effective compared with leading treatments in a
late-stage study, and it showed fewer side effects, according to
data released by the company on Tuesday,
Data released at the annual meeting of the American College
of Rheumatology showed that 41 percent of patients who took 30
milligrams of apremilast twice daily achieved a 20 percent
improvement in symptoms after 16 weeks, compared with 19.4
percent who took a placebo.
Psoriatic arthritis is a chronic, inflammatory disease that
affects the joints and causes pain, stiffness and swelling. It
is associated with psoriasis, a skin disorder.
The study, known as PALACE-1, is the first of three
late-stage trials of the drug, a pill that inhibits an enzyme
known as phosphodiesterase 4, or PDE4, and acts to damp down
inflammation. The results of the remaining trials will be
released within the next several months.
Currently, psoriatic arthritis is treated with a variety of
drugs, the most effective being injectable biologics such as
Abbott Laboratories' Humira, Amgen Inc's
Enbrel, and Johnson & Johnson's Remicade and Simponi.
The results met the main goal of the clinical trial, but
they were not as robust as the biologics.
"While these efficacy results might be acceptable in a
disease like psoriasis, we don't view them as sufficient for a
disease characterized by ongoing joint destruction and
progressive disability," said Geoffrey Porges, an analyst at
Sanford Bernstein, in a recent research report based on an
initial summary of the data.
A table compiled by Porges shows that between 50 percent and
57 percent of patients taking standard biologics achieved a 20
percent improvement in symptoms after 24 weeks in clinical
Patients in the PALACE-1 trial took apremilast with or
without a variety of other therapies. Celgene said that those
who took apremilast alone - somewhat fewer than half the 500
patients in the trial - had a much better response than those
who took the drug in combination with other treatments.
About 50.8 percent of those who took 30 milligrams of
apremilast twice daily as a monotherapy experienced a 20 percent
improvement in symptoms.
How important that figure will be to physicians remains to
be seen since it is not the number Celgene will use to file for
marketing approval with regulators.
Only 20 percent of patients taking apremilast in the study
experienced a 50 percent improvement in symptoms, and only 11
percent saw in improvement of 70 percent or more after 16 weeks.
Those figures are also lower than those seen with the biologics.
Celgene expects to file for U.S. approval of the drug in
treating psoriatic arthritis in the first half of 2013.
On the plus side, apremilast appears considerably safer than
the biologic drugs, which block a protein known as tumor
necrosis factor and can increase the risk of infections, certain
types of cancer, and tuberculosis.
The most common side effects with apremilast, which is also
being tested as a treatment for psoriasis, were gastrointestinal
disturbances such as nausea and diarrhea.
Celgene expects to begin reporting data from two late-stage
studies of the drug in psoriasis by the end of this year and to
file for marketing approval in the second half of next year.
In Europe, the company has said it plans to file for both
the psoriasis and psoriatic arthritis indications together in
the second half of the year.
(Reporting By Toni Clarke)