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Etanercept an Effective Monotherapy for Psoriasis: Presented at AAAAI
By Paula Moyer
DENVER, CO -- March 13, 2003 -- A phase II study shows that etanercept (Enbrel) is an effective monotherapy for chronic plaque psoriasis, according to Anjuli S. Nayak, MD.
"We found that 30% of the patients in our study group had at least a 75% improvement in their psoriatic lesions at 12 weeks and at 24 weeks, more than half had this level of improvement," said Dr. Nayak, professor of paediatric allergy and immunology at Peoria School of Medicine in Peoria, Ill. She presented these findings here March 10th at the 60th Annual Meeting of the American Academy of Allergy, Asthma, and Immunology.
Dr. Nayak and colleagues sought to assess the efficacy of etanercept, a tumour necrosis factor-alpha (TNF-alpha) blocker, because TNF-alpha plays a role in the pathogenesis of psoriasis, and etanercept is.
Etanercept is indicated for the treatment of psoriatic arthritis, so the investigators wanted to know whether it would result in clinical and pathologic improvement in patients with chronic plaque psoriasis.
The multicenter, randomised, 24-week study randomised 57 patients to twice-weekly subcutaneous injections of etanercept 25 mg and 55 to placebo.
The investigators wanted to see how many patients had at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) at 12 weeks and at 24 weeks. The investigators also performed skin biopsies on a subgroup of patients to assess for expression of the genes Ki67, keratin 16 and ICAM-1, for CD3 count and for epidermal thickness at baseline and at week 12.
Dr. Nayak reported that 30% of the etanercept group and 2% of the placebo group achieved a 75% reduction in PASI scores at week 12 (p<0.0001). By the 24th week, 56% of the treatment arm and 5% of the placebo arm had this level of improvement (p<0.0001).
There was also significant improvement in patient and physician global assessments, in target lesion assessments, and the Dermatology Life Quality Index, Dr. Nayak said. The reduction in epidermal thickness was significantly greater in the etanercept group than in the placebo group (p=0.01). The investigators also saw greater reductions in the expression of Ki67, CD3, ICAM-1 and keratin 16 in the treatment arm.
Preliminary data from an ongoing phase III study are consistent with these findings, Dr. Nayak said.
[Study title: Etanercept Monotherapy in Patients with Psoriasis: Clinical and Pathologic Improvements. Abstract 819]
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