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Biologic therapy is proven to increase the quality of life in adult patients suffering from moderate-to-severe psoriasis. A recent study shows that etanercept (Enbrel, Immunex) can achieve similar positive results in children and adolescents, offering hope to this patient population.
Amy S. Paller, M.D., professor and chairman, department of dermatology, and professor of pediatrics, Northwestern University Medical School, Chicago, and colleagues conducted a randomized, double-blind, placebo-controlled, North American phase 3 study of etanercept.
The study aimed to assess health-related quality of life (HRQoL), self-esteem and family burden, as well as establish the minimally important difference (MID) for the Children's Dermatology Life Quality Index (CDLQI) in children and adolescents ages 4 to 17 years with moderate-to-severe psoriasis. The MID represents the smallest amount of change in an instrument score that can be regarded as clinically meaningful.
Study design included an escape arm in which patients could receive open-label etanercept until week 12 if, at or after week four, the PASI score increased by greater than 50 percent over baseline and 4 points or greater at one visit, or by greater than 25 percent and 4 points or greater at each of two consecutive visits.
All patients, including those who entered the escape arm, received open-label etanercept during weeks 13 to 36. Patients were assessed at day one, weeks two, four, eight and 12, and every four weeks thereafter.
Results showed that children and adolescents who received placebo during weeks one to 12 achieved a percentage improvement in total CDLQI score at week 24, after 12 weeks of etanercept therapy, that was similar to that achieved by their etanercept counterparts at week 12. These improvements were sustained through week 36 for both the placebo and etanercept groups.
Also, the results demonstrated that the negative impact on the HRQoL in pediatric patients is similar to that seen in adult psoriasis patients.
"Our results were very encouraging and showed that etanercept is a drug that can be used successfully in this patient population," Dr. Paller tells Dermatology Times.
"The clear evidence that etanercept can improve not only the symptoms of psoriasis, but also the quality of life, is a compelling reason to consider the use of the biologics in children and adolescents with moderate-to-severe psoriasis," Dr. Paller says.
Disclosure: Dr. Paller has been a consultant and investigator for Amgen.