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Human Anti-IL12p40 Shows Promise in Plaque Psoriasis: Presented at EADV

By Jill Stein

RHODES, GREECE -- October 6, 2006 -- Human anti-IL12p40 (CNTO 1275), administered subcutaneously, seems to be an effective psoriasis treatment, according to phase 2 results released here at the 15^th Congress of the European Academy of Dermatology and Venereology (EADV).

The investigational compound is an antagonist to the heterodimeric cytokines IL-12 and -23, 2 key cytokines in type 1 immune responses.

Gerald. C. Krueger, MD, professor, dermatology division, University of Utah Health Science Center, Salt Lake City, Utah, United States, and colleagues randomised 320 patients to subcutaneously injections of human anti-IL12p40 or placebo. The active treatment subjects received 1 of 4 regimens: 1 injection of 50 mg or 100 mg, or 4 weekly 50-mg 100-mg injections.

The primary study endpoint was the proportion of patients who achieve at least 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline at week 12.

Patients assigned to the active treatment received an additional dose at week 16 if they did not have an excellent or complete response, defined as at least 75% clearing by Physician's Global Assessment (PGA). The placebo cohort received 100 mg of human anti-IL12p40 at week 20.

Participants in the trial had moderate-to-severe plaque psoriasis and were candidates for phototherapy or systemic psoriasis treatment. The trial excluded patients who were on systemic and topical psoriasis medications.

At week 12, the primary endpoint was achieved in 52%, 59%, 67%, and 81% of patients treated with each human anti-IL12p40 regimen, respectively, compared with 2% of subjects in the placebo arm (P < .001 for each vs placebo).

At least a 90% improvement in PASI scores was observed in 23%, 30%, 44%, and 52% of patients in the respective human anti-IL12p40 groups compared with 2% of placebo (P < .001 for each vs placebo).

Eighty-seven patients were retreated with human anti-IL12p40 at week 16. Although fewer than half of patients needed to be retreated, the overall percentages of patients with > 50%, > 75%, and > 90% improvement in PASI score or who had an excellent response remained relatively stable through week 24.

Results also show a correlation between clinical and quality-of-life improvements, according to the researchers.

Human anti-IL-12p40 was generally well tolerated.

Many patients reported that psoriasis had no detectable adverse effect on their quality of life after active treatment.

Beyond demonstrating the effectiveness of human anti-IL12p40 in the management of psoriasis, the results support the role of the p40 family of cytokines in the pathogenesis of this condition, Dr. Kruger said.

The study was sponsored by Centocor.


[Presentation title: Results of a Phase II Study of CNTO 1275 in the Treatment of Psoriasis. Abstract P035.75]

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