New Psoriasis Drug Shows Promising Results Say Johnson And Johnson

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Main Category: Eczema / Psoriasis
Also Included In: Clinical Trials / Drug Trials
Article Date: 05 Oct 2007 - 7:00 PDT

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Centocor Inc, a subsidiary of drug company Johnson & Johnson have announced that international phase 3 trials for its injectable biologic drug to treat psoriasis, CNT0 1275 (ustekinumab), have shown promising results.

According to the National Institutes of Health, some 7.5 million Americans have psoriasis, a non-contagious, lifelong skin disease.

The most common form of the ailment is plaque psoriasis which shows as red raised patches or lesions covered with a silver white crusty build up of dead skin cells called scale. It occurs mostly on the knees, elbows, lower back and scalp.

CNT0 1275 (ustekinumab) is a new type of drug known as a fully human monoclonal antibody that targets chemical messengers in the immune system involved in skin inflammation and skin cell production. The chemical messengers in this case are the cytokines interleukin-12 (IL-12) and interleukin-23 (IL- 23).

The first reported findings of the late-stage, multicentre, randomized, double-blind, placebo-controlled trial were presented at the 21st meeting of the World Congress of Dermatology in Buenos Aires, Argentina, on Wednesday this week.

More than two thirds of patients with moderate to severe plaque psoriasis who had two doses of the drug achieved at least a 75 per cent reduction in symptoms after 12 weeks, said the company in a press release.

The study used the Psoriasis Area and Severity Index (PASI 75) to measure the changes in symptom severity. The PASI index combines an assessment of lesion severity and extent of affected areas.

The results also showed that another dose at week 16 of the trial helped a substantial percentage of the patients to maintain the level of symptom reductions up to week 28.

The study covered more than 1,200 patients and showed that within the first four weeks of treatment, patients who were given ustekinumab were already experiencing significant and meaningful improvements in quality of life compared to patients who were on placebo.

The most common adverse events included sore throat, congestion and headache.

Dr Craig Leonardi, of the St Louis University Medical School and lead investigator of the study said that:

"These findings provide further evidence of the role of IL-12/23 in the pathogenesis of psoriasis and the promise that a new therapeutic approach like ustekinumab may hold for dermatologists and their patients living with this chronic, immune-related disease."

He added that the new safety and efficacy data from the trial was an exciting development for the dermatology community.

At week 12 of the trial, 67 per cent of patients given two doses of 45 mg of ustekinumab four weeks apart, and 76 per cent of patients given two 90 mg doses four weeks apart, attained a PASI 75 improvement level compared with only 4 per cent of patients on placebo. This was statistically significant to the p<0.001 level in both dosage groups.

Also, 42 per cent of patients on the 45 mg dose and 51 per cent on the 90 mg dose were nearly completely clear of psoriasis at week 12 (PASI 90) compared to 1 per cent on placebo (significance p<0.001 in both groups).

The patients in the placebo group who switched to ustekinumab also showed similar improvement after 12 weeks of treatment with the drug.

Senior vice president for Clinical Research and Development at Centocor, Dr Jerome A Boscia, said that:

"These findings show that by targeting IL-12/23 with ustekinumab, we may be able to offer dermatologists and patients a new, promising biologic therapy with an infrequent dosing regimen for the treatment of psoriasis."

"We are encouraged by the results from the Phase 3 program and look forward to collaborating with regulatory authorities around the world in an effort to bring ustekinumab to physicians and patients in need of new therapeutic options," he added.

One dermatologist's reaction reported by Reuters news agency in Buenos Aires appeared optimistic, that the drug was likely to give good results for his patients, but he wondered if the benefits would diminish over time, as happens with other biologicals.

Click here for a more detailed clinical account of this phase 3 trial (Centocor press release).

Written by: Catharine Paddock
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