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Biologics for Psoriasis: The Second Generation
A promising new treatment for psoriasis had high efficacy, few adverse effects in phase II trial.
IL-12 and IL-23 are two related cytokines that play an important role in the activation of T-lymphocytes. Both are overexpressed in psoriatic plaques, and IL-12, in particular, has been implicated in the pathogenesis of psoriasis in preclinical models.
Investigators conducted a phase II study in patients with moderate-to-severe psoriasis who were treated with subcutaneous injections of a humanized, neutralizing, monoclonal antibody directed against both IL-12 and IL-23. Patients were randomized to receive one of four dosages (one 45-mg dose, one 90-mg dose, four weekly 45-mg doses, or four weekly 90-mg doses) or placebo. They received no other treatment and were followed for 32 weeks. Patients in all treatment groups responded well. Of those who received four 90-mg doses, more than 80% achieved at least 75% improvement and 52% attained at least 90% improvement in the PASI score at 12 weeks. Patients treated at the higher dosage levels maintained this level of improvement through at least week 20. Similar degrees of improvement were found on assessments by the Physician’s Global Assessment and the Dermatology Life Quality Index. There were no significant increases in adverse effects compared with placebo. The incidence of heart disease, however, was increased slightly but not significantly.
Comment: The efficacy of IL-12/IL-23 antibody therapy compares favorably to the most effective currently available psoriasis therapies, and there were few adverse reactions. The ease of administration (a maximum of 4 injections over 3 months) makes it particularly attractive for patients. Efficacy of this antibody treatment will have to be confirmed in larger phase III studies, and its approval as psoriasis therapy will also depend on the short-term and long-term adverse effects, especially susceptibility to serious infections; predisposition to lymphoma, internal malignancies, and nonmelanoma skin cancers; and the incidence of heart disease.
— Craig A. Elmets, MD
Published in Journal Watch Dermatology February 9, 2007
Citation(s):
Krueger GG et al. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med 2007 Feb 8; 356:580-92.
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