Source: DGNews  |  Posted 1 year ago

By Perrie Susman

MIAMI BEACH, Fla -- March 10, 2010 -- Serious adverse events occurred rarely among paediatric patients with psoriasis treated for at least 2 years with etanercept, researchers said here at the 68th Annual Meeting of the American Academy of Dermatology (AAD).

“No malignancies, opportunistic infections, tuberculosis, lymphomas, demyelinating events, or deaths were reported,” said Amy Paller, MD, Northwestern University’s Feinberg School of Medicine, Chicago, Illinois, during her poster presentation on March 8.

Of the 181 patients included in the extension study, 145 (80%) reported at least 1 adverse event during the 96-week period, with the most common being upper respiratory tract infections, nasopharyngitis, streptococcal pharyngitis, headache, and sinusitis.

Three patients reported serious adverse events, but Dr. Paller said none of those events were considered study drug-related and all were noninfectious. One patient experienced anxiety; 1 was diagnosed with an intestinal obstruction; and 1 patient reported abdominal pain, dehydration, and underwent an elective abortion.

Dr. Paller said that 2 adverse events led to study withdrawal -- Crohn’s disease and sinusitis. Neither condition was considered related to the use of etanercept, she noted.

The number of serious adverse events was similar to that reported in the 48-week primary study, in which 4 serious adverse events were reported by 3 patients, she said.

The researchers noted that exposure-adjusted analysis per 100 patient-years did not signal any increase of new adverse events due to long-term etanercept treatment.

“Long-term safety of etanercept therapy was demonstrated during the first 96 weeks of the extension study in paediatric patients with moderate to severe plaque psoriasis, and efficacy results achieved during the 48-week primary study were maintained, supporting the long-term safety and efficacy of etanercept for up to 144 weeks in the paediatric dermatology setting,” she reported.

The safety and efficacy results of the randomised, double-blind, placebo-controlled, phase 3, multicentre study of etanercept in a paediatric population with moderate to severe plaque psoriasis have been previously reported. Eligible patients were enrolled in a 264-week open-label extension study.

Funding for this study was provided by Immunex Corp and Wyeth.

Presentation title: Safety and Efficacy of Etanercept Treatment in Children and Adolescents With Plaque Psoriasis: 96-Week Results of Open-Label Extension Study. Abstract P506