FDA Approves Etanercept for Moderate-to-Severe Psoriasis in Children
The US Food and Drug Administration (FDA) has approved the the use of etanercept (Enbrel; Amgen) for the treatment of chronic moderate-to-severe plaque psoriasis in children. This will make etanercept the first systemic therapy (biologic) to be approved for the pediatric population.
The FDA approval marks a significant turning point in the clinical management of moderate-to-severe plaque psoriasis in children, noted the agency, a condition that has lacked safety and efficacy data for the use of systemic therapies to treat serious cases of the condition found in younger patients.
"As many parents of children with moderate-to-severe plaque psoriasis can tell you, there is a need for FDA approved systemic therapies in the pediatric setting,” said Randy Beranek, president and CEO of the National Psoriasis Foundation, in a press release published by the drug’s manufacturer, Amgen.
“Until now, no biologics — which are effective in treating adults with moderate-to-severe plaque psoriasis — had been approved in the US for the treatment of moderate-to-severe plaque psoriasis in children,” Beranek said.
The FDA’s approval comes as a major policy change, as pediatric patients being considered for systemic therapy or phototherapy will now be eligible for the use of etanercept to treat their chronic moderate-to-severe plaque psoriasis.
The approval was based on the results of a Phase 3 1-year study, in addition to a 5-year open-label extension study. According to Amgen, the trials showed etanercept had significant efficacy in treating pediatric patients suffering from chronic moderate-to-severe plaque psoriasis. The drug also showed adverse events similar to those seen in previous trials with adult patients with moderate-to-severe plaque psoriasis.
"This new approval is an important development for this patient community, as well as their parents and families, and marks a significant milestone in advancing the treatment of children living with this devastating disease," Beranek said.
Management of Chronic Plaque Psoriasis in Children
Topical agents largely are considered the first line of defense for treating plaque psoriasis seen in patients, regardless of age. Topical corticosteroids are most commonly used, many of which do include provisions for use in pediatric patients.1
Some topical therapies, such as emollients, are used to help decrease the scaling and itching of the skin typical for plaque psoriasis sufferers. Other topical therapies are used to decrease the growth of skin cells and/or thin the skin in and around plaque lesions. Some of these topical therapies include:
- salicylic acid
Psoriasis is considered a common chronic inflammatory skin condition. Affecting as many as 3.5% of the general population, it’s been estimated that a third of all cases actually begin during childhood.2-5 Clinicial management of childhood psoriasis is a priority, especially considering incidence rates of the condition reported in children have doubled since 1970,6 which suggests the condition is becoming a more prevalent pediatric issue.
Untreated psoriasis symptoms could have negative long-term consequences, as well. Children and adolescents with the condition commonly report a negative quality of life, as the condition can have significant impact on a young patient’s self-esteem, social life, and relationships with family.7-10
Use of Etanercept and Other Systemic Therapies
While the use of topical therapies is common for the pediatric population, many topical agents, such as tazarotene and calcipotriene, have not had their safety and efficacy determined for use in pediatric populations.
The use of systemic therapies is less common, in part because there has never been a systemic agent approved for use in this patient group. For instance, there has been no established safety or efficacy for the use of cyclosporine (Neoral; Novartis) in children under the age of 18, according to the FDA.1 Even for methotrexate, safety and efficacy only has been established for pediatric patients with cancer chemotherapy or polyarticular-course juvenile rheumatoid arthritis.
Typically, only severe cases of plaque psoriasis in children have warranted such systemic therapies. This can include the pustular and erythrodermic psoriasis, severe variants of the disease that are known to be resistant to topical therapies.1
Etanercept, which was first approved back in 1998, has become a popular therapy with multiple immune-mediated indications, including chronic moderate-to-severe plaque psoriasis in patients 18 years or older who are candidates for systemic therapy or phototherapy.
While etanercept has been approved in Europe and Canada for children 8 years and older, only until now has the FDA approved the use of the drug in the pediatric population.
Etanercept does show positive data in its efficacy and safety for younger patients, with the most common side effects including pharyngitis, bronchitis, and gastroenteritis.11-12 However, these infections are typically short term, and there does not appear to be any signs of cancers or opportunistic infections.
However, long-term investigation into etanercept treatment for children is still an ongoing topic of study.10,13 For now, etanercept is considered a third-line therapy for pediatric patients.14-15 With the recent FDA go-ahead, other biologic agents soon may be considered for serious cases of psoriasis seen in the pediatric patient population, which could include ustekinumab, infliximab, and adalimumab.