J&J psoriasis drug posts mixed results in trial
Wed Feb 7, 2007 7:42 PM ET
By Ransdell Pierson
NEW YORK, Feb 7 (Reuters) - Johnson & Johnson <JNJ.N> said on Wednesday its new type of treatment for psoriasis was highly effective in a mid-stage trial, but was linked to an increased risk of serious adverse events, including heart attacks.
The mixed results were seen in a Phase II study of CNTO 1275, an injectable medicine designed to block two immune system proteins believed to contribute to inflammation that causes the patchy skin condition.
The naturally occurring proteins -- interleukin-12 and interleukin-23 -- are new targets of treatment for psoriasis. Many of the most widely used current drugs, including J&J's Remicade, work instead by blocking an inflammatory protein called tumor necrosis factor (TNF).
The trial of CNTO 1275, a monoclonal antibody, involved 320 patients with moderate-to-severe psoriasis. Patients were equally divided into groups that took one of four different dosages of the medicine or placebos.
After the first 12 weeks of treatment, there was at least a 75 percent improvement in psoriasis for 81 percent of patients in the highest dosage group -- those who received four weekly 90-milligram doses of the experimental medicine. That magnitude of relief was only seen among two percent of the patients who received placebos.
At least a 75 percent improvement was also seen in two thirds of those who received four weekly 45-mg doses of CNTO 1275, in 59 percent of those receiving a single weekly 90-mg dose, and in 52 percent of patients receiving a single weekly 45-mg dose.
"Based upon these Phase II results, the efficacy of CNTO 1275 seems very comparable to what we've seen with Remicade" in separate trials of that older J&J treatment, said Michael Parks, a spokesman for J&J's Centocor division.
Serious adverse events leading to hospitalization were seen in 4 percent of those receiving CNTO 1275 in the trial, compared with 1 percent of those receiving placebos.
J&J said the most common serious adverse event was heart attacks, seen in two patients treated with CNTO 1275 but none among the far smaller group of patients taking placebos.
Moreover, a greater proportion of patients taking the J&J drug developed elevated levels of blood sugar, compared with those taking placebos, although the difference was not statistically significant. Increased levels of blood sugar, or glucose, are associated with higher risk of developing diabetes.
Parks said that far larger Phase III trials would be needed to better assess the safety and effectiveness of CNTO 1275.
If eventually approved, Parks said it would not be used in combination with Remicade or similar anti-TNF medicines, but would be available as an alternative to such injectable treatments.
"Patients need other treatment options," he said.
Anti-TNF drugs, including Remicade, have been associated with higher risk of infections. A significantly higher infection risk, compared with placebo, was not noted in the trial of CNTO 1275.
Psoriasis affects an estimated 2 percent of the U.S. population, almost a third of whom have cases that are considered moderate to severe, J&J said. |
