Treatment Approved by FDA for Childhood Arthritis

On August 1, Janssen Pharmaceutical, a pharmaceutical company wholly owned by Johnson & Johnson, announced that the U.S. Food and Drug Administration (FDA) had approved STELARA® (ustekinumab) as a treatment for pediatric patients 6 years of age and older with active psoriatic arthritis (PsA). The FDA decided to apply this treatment to childhood arthritis based on data backing up this established treatment.

Related Article: New Mitochondrial Response Pathway May Advance Treatments for Inflammatory Diseases

PsA and Other Diseases STELARA Treats

PsA in children is a rare disease that resembles PsA in adults. The condition affects about 5%-8% of children under 18 years of age who have chronic inflammatory arthritis. Symptoms include joint inflammation and skin lesions, all of which flare up and subside at differing times. In addition, the severity and presentation of these symptoms vary from patient to patient.

First approved by the FDA in 2009, STELARA is an antibody designed to treat the symptoms of PsA. It selectively inhibits the cytokines interleukin (IL)-12 and IL-23. These immune system factors play a role in moderating the overactive inflammatory response in autoimmune diseases like PsA.

Before this most recent approval, STELARA treats adults and children 6 years and older with moderate to severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease, and adults with moderately to severely active ulcerative colitis.

Terence Rooney, M.D., Ph.D., Vice President, Rheumatology and Maternal Fetal Disease Area at Janssen Research & Development, said in a statement, “With this pediatric approval of STELARA, we’re pleased to help address the unmet needs of these young patients and provide physicians with a much-needed treatment option that has an established track record of safety and efficacy.”

The Clinical Trials Proving STELARA’s effectiveness

Scientists conducted Multiple Phase III studies to establish the efficacy of STELARA’s use for this kind of childhood arthritis. 

CADMUS is a randomized, double-blind, placebo-controlled, parallel, multicenter trial. It evaluated the efficacy and safety of STELARA in adolescent patients 12 to 17 years of age with moderate to severe plaque psoriasis. In addition, CADMUS JR assessed the same measures in patients aged 6 to 11. 

PSTELLAR is a randomized, double-blind, active-controlled, multicenter study. This study evaluated the effect STELARA had on patients dosed beyond 12 weeks for maintenance. 

PSUMMIT consists of two Phase III multicenter, randomized, double-blind, placebo-controlled trials. Both trials assessed the safety and efficacy of STELARA when administered at varying dose levels across a period of 12 weeks.

Based on the evidence gathered from all trials, the FDA approved the additional use of STELARA to treat pediatric patients affected by PsA. From now on, those affected by childhood arthritis will have a new treatment option available to them. 

Related Article: Applications for Medicine Treating Crohn’s Disease Submitted to EMA and FDA

Author

Max Heirich