New psoriasis drug is safe and effective

By Matias A. Loewy

BUENOS AIRES (Reuters Health) - A new psoriasis drug, which could be self-injected every 3 months, had "impressive" safety and efficacy results in a late-stage, multicenter clinical trial involving more than 1,200 patients with chronic plaque psoriasis, researchers announced here at the World Congress of Dermatology.

"Clinical results are hard to ignore," said Dr. Craig Leonardi, of the St. Louis University Medical School and lead investigator of the study. "It has all the characteristics of a first-line drug of choice," he told Reuters Health.

Ustekinumab (CNTO 1275; Centocor, Inc) is a monoclonal antibody that targets interleukin 12 (IL-12) and interleukin 23 (IL-23), which are produced in an inappropriate response of the body's immune system. In the trial, patients with moderate to severe plaque psoriasis received 45 or 90 milligrams of ustekinumab every 4 weeks, or placebo.

A response of at least a 75-percent reduction in psoriasis at week 12, as measured by an index of psoriasis area and severity (PASI) was achieved by 67 percent patients given the lower dose and by 76 percent given the higher dose, but by only 4 percent of patients in the placebo group.

Furthermore, 42 percent of patients treated with the 45-mg doses and 51 percent of those in the 90-mg group had a 90-percent reduction in symptoms (PASI 90) after 12 weeks, compared with 1 percent in the placebo group.

PASI 90 is considered to be an indicator of nearly complete clearance of psoriasis.

According to the clinical data released here in Buenos Aires, one additional dose given at week 16 allowed responders to maintain their response through week 28. That is consistent with a quarterly maintenance regimen, which is currently being evaluated in a 5-year extension trial.

This dosing interval "would be impressive for the convenience of patients," Leonardi said.

The drug was found to be very well tolerated, with adverse events and rates of discontinuation not different from placebo.

Leonardi said that the trial figures are impressive, but that he personally thinks that his patients had even better outcomes with ustekinumab. However, he does not discount the possibility that patients might start to lose response to the drug over time.

"We haven't seen it yet. But it happens with other biologicals, and common sense tells me that it would probably happen (with ustekinumab) as well," he said.