| June 11
June 11 Johnson & Johnson's Stelara
produced significant improvement in signs and symptoms of
psoriatic arthritis through 52 weeks of treatment in a late
stage study, according to data being presented at a medical
meeting in Europe.
The Phase III trial tested Stelara at two doses against a
placebo in 312 patients with active psoriatic arthritis, and
included both subjects who had previously been treated with
widely used biotech drugs from a class known as anti-TNF
medicines and those who had not.
At week 52, 46.8 percent of those who received the 45
milligram dose of Stelara and 48.4 percent of those to got 90 mg
had at lease a 20 percent reduction in arthritis symptoms, such
as swollen and tender joints - a measure known as ACR 20.
The company had previously reported results through 24 weeks
of treatment in which nearly 44 percent of those who received
Stelara at either dose achieved ACR 20 versus 20.2 percent who
reached ACR 20 in the placebo group. The result was deemed to be
highly statistically significant.
Nearly 56 percent of the placebo patients who crossed over
and began taking 45 mg Stelara at week 24 had achieved ACR 20 by
week 52, researchers said.
The data was being presented at the European League Against
Rheumatism meeting in Madrid this week.
Psoriatic arthritis is a chronic inflammatory condition in
which joint pain is caused by the immune system attacking
healthy tissues. It affects about 30 percent of those who suffer
from the painful and unsightly skin condition psoriasis. Many
patients are treated with anti-TNF drugs such as AbbVie's
Humira and J&J's own Remicade.
Researchers also measured ACR 50 and ACR 70 scores,
representing 50 and 70 percent improvement in symptoms.
For those who received 45 mg of Stelara, 27.7 percent
reached ACR 50 and 12.8 percent hit 70 percent improvement after
52 weeks. At 90 mg, 26.3 percent achieved ACR 50 and nearly 18
percent hit ACR 70.
For those patients who started on placebo and took Stelara
from week 24 through week 52, 28.6 percent achieved ACR 50 and
15.6 percent reached ACR 70, researchers said.
Stelara, known chemically as ustekinumab, is already
approved to treat psoriasis. The medicine is currently under
review for a psoriatic arthritis approval in the United States
"One of the major unmet needs in psoriatic arthritis is for
patients who have an inadequate response to anti-TNF agents or
who for whatever reason cannot take anti-TNFs who really don't
have good alternatives," Dr. Christopher Ritchlin, the study's
lead investigator, said in a telephone interview.
"Those of us who treat large numbers of these patients have
been struggling with options," said Ritchlin, who will present
the study results on Wednesday.
"Now we have another agent besides anti-TNF agents that can
provide relief for the skin and joints. These data add a new
option that we didn't have before," he said.
Stelara proved more effective in patients who did not
receive prior treatment with anti-TNF drugs, researchers said.
However, they noted that previously treated patients had more
active disease at the start of the trial.
The drug was well tolerated with no deaths or cases of
tuberculosis reported, researchers said. Serious adverse events
were reported in 5.8 percent of Stelara patients, they said.