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| |  Etanercept Shows High Efficacy and Tolerability for Pediatric Psoriasis: Presented at AAD By Bruce Sylvester SAN ANTONIO, TX -- February 6, 2008 -- Pediatric patients with psoriasis who were treated with etanercept (Enbrel) have achieved significant and sustained improvement with good tolerability, researchers reported at the American Academy of Dermatology 66th Annual Meeting (AAD). Lead investigator Amy Paller, MD, Professor of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, presented the findings at a poster session here on February 3. "We saw truly excellent results for these patients, with very high tolerability," Dr. Paller said. "Over a 48-week period, etanercept was safe and the children did very well on a low dose. So, we can use fairly low doses and still get very good results." As background, the authors noted in their poster, "Treating psoriasis (PsO) in children is challenging. Patients may not respond to or tolerate conventional agents, and neither topical nor systemic therapies have been well studied in children. Although there are published case reports on the use of biologics in children with promising results, this is the first clinical study assessing etanercept (ETN) in children with PsO." The investigators enrolled 211 children, aged 4 to 17 years, who had been diagnosed with psoriasis involving 10% or more body surface area and with a Psoriasis Area and Severity Score (PASI) score of 12 or higher. Patients were randomised in a 1:1 design to a 12-week, double-blind, placebo-controlled treatment period of once-weekly subcutaneous placebo or etanercept 0.8 mg/kg (maximum dose 50 mg), followed by 24 weeks of open-label etanercept treatment. This was followed by a 12-week randomised, double-blind withdrawal phase. Subjects who did not achieve a 50% improvement in PASI score (PASI 50) at week 24 or a 90% improvement in PASI (PASI 75) at week 36 could receive topical standard of care therapy. The primary endpoint was PASI 75 response at week 12. Other endpoints included PASI 75 at other time points, PASI 50, PASI 90, static Physician's Global Assessment (PGA), and safety measures. Baseline demographics and disease characteristics were similar in both study arms. The researchers reported that at week 12, 57% of etanercept subjects achieved PASI 75, compared with 11% of those treated with placebo (P <.001). They also found that the number of patients achieving PASI 50, PASI 90, and PGA status of "clear" or "almost clear" were significantly higher among etanercept subjects than placebo subjects. Differences in PASI 75 between treatment arms had emerged by week 4 of the study. At week 24, percentages of subjects achieving PASI 75/PGA status of "clear" or "almost clear" were 62%/56% for the original placebo arm and 69%/57% for the original etanercept arm. Subjects maintained their PASI 75 response through week 36; 56% (original placebo arm) and 53% (original etanercept arm) achieved PGA clear or almost clear. The proportions of subjects with PASI 50 and PASI 90 at weeks 24 and 36 increased in both groups compared with week 12. No serious adverse events were reported in the etanercept group. The authors concluded, "In this study, [etanercept] was well-tolerated and provided significant and sustained improvement in disease severity in children and adolescents with moderate to severe plaque PsO." Dr. Paller added, "This drug changed children's lives." Funding for the study was provided by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Pharmaceuticals.
[Presentation title: Etanercept Treatment in Children and Adolescents With Plaque Psoriasis. Poster 2300]
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