On August 1, Johnson & Johnson/Janssen announced that the FDA approved an expanded indication of ustekinumab (Stelara) for the treatment of pediatric patients 6 years and older with active psoriatic arthritis (PsA). Stelara is the first and only biologic targeting IL-12/IL-23 for pediatric patients with PsA, administered by subcutaneous injection four times a year after two initial doses.
The FDA’s approval is mainly based on the following three points:
1. Pharmacokinetic (PK) data;
2. Clinical studies of Stelara in adults and children with moderate to severe plaque psoriasis (PsO) (PSTELLAR, CADMUS and CADMUS);
3. Clinical studies of Stelara in adult patients with active PsA (PSUMMIT I and II).
The researchers based their analysis on previous PK data combined with efficacy and safety data in pediatric and adult patients with both active PsA and moderate-to-severe plaque PsO.
Psoriatic arthritis is a type of arthritis associated with psoriasis, and signs and symptoms include joint stiffness, pain, redness, warmth, and swelling of surrounding tissue. Active psoriatic arthritis is a rare disease similar to adult PsA, affecting 5 to 8 percent of children and adolescents with chronic inflammatory arthritis. Stelara is a fully human monoclonal antibody that selectively inhibits IL-12 and IL-23 signaling pathways. It has been reported that the IL-12/IL-23 signaling pathway plays a key role in a variety of immune-mediated chronic inflammatory diseases, including plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
In the 2022H1 results disclosed by Johnson & Johnson on July 19, Stelara’s market performance is still bright, and it is the highest-selling product among all Johnson & Johnson products, with sales reaching US$4.887 billion, a year-on-year increase of 10.5%.
Currently, Stelara is approved in the United States to treat:
1. Adult and pediatric patients six years of age and older with moderate to severe plaque psoriasis;
2. Adults and children six years of age and older with active psoriatic arthritis;
3. Adult patients with moderately to severely active Crohn’s disease;
4. Adult patients with moderately to severely active ulcerative colitis.