New biologics show promise for pediatric psoriasis but clinical trials needed first

Several biologic medications used to treat adult psoriasis appears to show promise for also treating pediatric psoriasis. However, clinical trials in children are needed to resolve concerns about increased risk of infections and malignancy.

So states a review study published online Feb. 26, 2015, in the journal Pediatric Dermatology authored by Kara Shah, MD, PhD, director of the Division of Dermatology, and Fernanda Bellodi- Schmidt, MD, an assistant professor in the division within the UC College of Medicine.

Currently, there are no FDA-approved medications to treat more severe cases of pediatric psoriasis. Shah and Bellodi-Schmidt reviewed the current literature of the use of systemic medications to treat pediatric psoriasis, including case reports, case series, and a large clinical trial involving the use of etanercept, a biopharmaceutical effective in treating autoimmune diseases by acting as a tumor necrosis factor inhibitor. Clinical trials have demonstrated that etanercept and several other drugs in its class have shown safety and effectiveness in treating other pediatric inflammatory diseases such as Crohn's disease and juvenile arthritis. Only etanercept has been formally studied in pediatric psoriasis, and currently only the European Union has approved its use for the treatment of psoriasis in children.

“Pediatric dermatologists strongly support clinical trials evaluating the comparative efficacy and risks of medications used for the treatment of psoriasis in children, in particular systemic medications,” Shah says.

Scientific concerns about this class of biologic response modifiers, which also includes adalimumab and infliximab, as well other biologic response modifiers such as ustekinumab, center on increased susceptibility to infection and increased risk of certain malignancies, particularly lymphoreticular malignancy.

"These risks appear low,” says Shah, “and must be weighed against the concerns inherent to a chronic disease such as psoriasis, especially when severe enough to warrant systemic therapy.”

Psoriasis, a chronic skin condition, varies in severity but pediatric dermatologists have long been challenged by the lack of biologic medications approved specifically for severe cases in children. Psoriasis changes the life cycle of skin cells, prompting them to build up rapidly on the skin, forming thick scales. The resulting itchy, dry, red patches can be painful. In this study, researchers analyzed previous reports, case series and clinical-trial data that might one day lead to FDA approval of a drug that resolves concerns about infection-risk and malignancy. The top image shows three different patients with, from left to right, a progression of improvement.
Click on image to view caption.

Citation

Bellodi Schmidt F, Shah KN. Biologic response modifiers and pediatric psoriasis. Pediatr Dermatol. 2015;32(3):303-320.

Lead Researcher:

A photo of Kara Shah, MD, PhD.
Kara Shah, MD, PhD

A photo of Fernanda Bellodi Schmidt, MD . 
Fernanda Bellodi Schmidt, MD