Stelara Receives Expanded Pediatric Plaque Psoriasis Indication

July 30, 2020 – The U.S. FDA has approved an expanded indication for Stelara® (ustekinumab), manufactured by Janssen Pharmaceuticals. The drug is now indicated to treat moderate to severe plaque psoriasis in patients who are at least six years of age and candidates for phototherapy or systemic therapy. Previously, the indication applied only to patients 12 years and older.

Plaque psoriasis is the most common form of a psoriasis, a chronic inflammatory disease that affects the skin. It causes raised, rough patches of skin (plaques) that can itch and be painful. The skin of the plaques is discolored and prone to cracking and bleeding. Although there are several approaches to treatment (topical treatments, phototherapy, and systemic treatment), psoriasis can be difficult to manage.

In a clinical trial, 77% of patients who received Stelara achieved clear or almost clear skin at week 12 after two doses. Recommended dosing is based on weight. Pediatric patients should receive the first two doses four weeks apart, and then move to a maintenance schedule of one subcutaneous injection every 12 weeks.

First FDA approved in 2009, Stelara is also indicated to treat adults who have moderately to severely active Chrohn’s disease, active psoriatic arthritis, or moderately to severely active ulcerative colitis.