FDA Expands Stelara (ustekinumab) Indication to Treat Pediatric Patients with Active Psoriatic Arthritis

The Janssen Pharmaceutical Companies of Johnson & Johnson this week announced the US Food and Drug Administration (FDA) approval of Stelara (ustekinumab) to treat active psoriatic arthritis in pediatric patients six years and older.

Stelara was previously approved for adults with active psoriatic arthritis , moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis. This new indication will be the second for Stelara in pediatric patients, as it also can be used to treat patients 6 years and older with moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.

Treatment Options for Pediatric Active Psoriatic Arthritis

Psoriatic arthritis is a type of arthritis that can affect people with psoriasis, a chronic, inflammatory condition that damages the joints. Common signs of psoriatic arthritis include pain, tenderness and swelling around the joints. Patients may also experience fatigue, nail changes, eye redness, back pain and swollen fingers and toes. These symptoms are also accompanied by the characteristic redness and itchiness of the skin associated with psoriasis. While most people present with psoriatic arthritis in their 30s or 40s, children are also affected by the condition; the prevalence in pediatric patients is approximately three percent in those who have psoriasis.

Several types of treatments are available for psoriatic arthritis, including nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen for joint pain and glucocorticoids like prednisone to reduce inflammation. Disease-modifying anti-rheumatic drugs, or DMARDs, can treat both skin and joint symptoms by addressing systemic inflammation. These are grouped into three categories — conventional, targeted and biologic — and work in different ways to slow or stop symptoms.

Psoriatic arthritis is considered active when symptoms are inadequately managed and cause significant life disruptions despite treatment. Active psoriatic arthritis indicates that the disease has progressed and can potentially cause joint damage.

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Stelara Clinical Trial Results

Stelara is a human IgG1қ monoclonal antibody that inhibits interleukin (IL) IL-12 and IL-23 cytokines, which are involved in inflammatory and immune responses. Its previous indications were approved based on safety and efficacy demonstrated in several clinical trials for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Stelara is administered by subcutaneous injection and dosage is weight based.

Two randomized, double-blind, placebo-controlled trials evaluated the safety and efficacy of Stelara in adult patients 18 years of age and older with active psoriatic arthritis. These trials demonstrated improvement in composite measures of joint (number of tender and swollen joints, as well as global health assessment, disability, pain scale response and inflammatory markers) and skin symptoms (regions of the body affected by psoriasis), as well as physical function. Side effects in this patient population included arthralgia (joint pain), nausea and dental infections.

A New Option for Pediatric Patients with Active Psoriatic Arthritis

Approval of the pediatric indication for active psoriatic arthritis was based on pharmacokinetics data from multiple Phase III trials. Due to the small number of pediatric patients in these trials, data were extrapolated from previous observations from pediatric patients with moderate to severe plaque psoriasis with active psoriatic arthritis, as well as adults with moderate to severe plaque psoriasis or active psoriatic arthritis. These data showed that drug exposure and efficacy were consistent with previous results from adult trials.

“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,” said Terence Rooney, MD, PhD, vice president, Rheumatology and Maternal Fetal Disease Area at Janssen Research & Development, LLC., in a press release.

Psoriatic Arthritis Clinical Trial Pipeline

Several other types of treatments are currently under development for psoriatic arthritis. As of 2021, over 35 companies are pursuing research on new therapies. These include biologics, oral and topical treatments with different mechanisms of action, such as monoclonal antibodies, tyrosine kinase (TYK) 2 inhibitors, Janus kinase (JAK) 1 inhibitors and a combined TYK2/JAK1 inhibitor.