J&J's Stelara effective in psoriatic arthritis trial

June 11 Tue Jun 11, 2013 6:00pm EDT

June 11 (Reuters) - 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 and Europe.

"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.

FILED UNDER: