Saturday, June 22, 2024

Arthritis Treatment Expanded: FDA Approves Upadacitinib for Pediatric Use

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Arthritis treatment with upadacitinib (Rinvoq) by Abbvie has been approved by the U.S. Food and Drug Administration (FDA) for pediatric patients with juvenile idiopathic arthritis (JIA), specifically those with polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (juvenile PsA). This development offers a new treatment option for children and adolescents, providing an alternative to tumor necrosis factor (TNF) blockers, according to a press release from the drug’s manufacturer, AbbVie.

Juvenile idiopathic arthritis, encompassing pJIA and juvenile PsA, affects nearly 300,000 children and adolescents in the United States. These conditions can severely limit the ability of young patients to perform daily tasks and participate in normal activities. Despite the prevalence of these conditions, treatment options have been limited, particularly for patients who do not respond well to TNF inhibitor (TNFi) therapy.

“Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options,” said Dr. Aarat Patel, a pediatric rheumatologist at Bon Secours Rheumatology Center in Richmond, Virginia, in the press release. “Having a treatment option available for patients who do not respond well to a TNFi addresses a need for the healthcare community, patients, and their families.”

Upadacitinib’s New Pediatric Indication Shows Promising Safety and Efficacy Data

Upadacitinib is a Janus kinase (JAK) inhibitor being studied for multiple immune-mediated inflammatory diseases. This new indication for pediatric use is based on data from various studies, including those conducted on adults with rheumatoid arthritis (RA) and PsA, as well as studies involving 51 pediatric patients with pJIA and active polyarthritis. Additionally, safety data from 83 pediatric patients aged 2 to 18 years with pJIA and active polyarthritis were considered.

The studies showed that the safety profile of upadacitinib in pediatric patients is similar to that observed in adults. Known risks include serious infections such as tuberculosis, cancer, immune system problems, blood clots, and severe allergic reactions to components of the drug. It is important to note that the safety and effectiveness of upadacitinib for pJIA and PsA in patients younger than 2 years are unknown.

“Upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage are predicted to be comparable to those observed in adults with RA and PsA based on population pharmacokinetic modeling and simulation,” according to the press release.

Arthritis

Upadacitinib Approved for Pediatric Use in Arthritis, Expanding Treatment Options

Apart from the new indication for pJIA and juvenile PsA, upadacitinib is also approved for treating moderate to severe atopic dermatitis in children aged 12 years or older. For adults, upadacitinib is indicated for several conditions, including moderate to severe RA, active PsA, active ankylosing spondylitis, active non-radiographic axial spondyloarthritis, moderate to severe ulcerative colitis, and Crohn’s disease. However, the safety and efficacy of upadacitinib for treating these conditions in children and adolescents are still unknown.

Ongoing research includes phase 3 trials investigating upadacitinib for various conditions such as alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, RA, systemic lupus erythematosus, Takayasu arteritis, ulcerative colitis, and vitiligo.

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The FDA’s approval of upadacitinib for treating pediatric patients with pJIA and juvenile PsA marks a significant step forward in addressing the needs of children and adolescents with these debilitating conditions. With limited alternatives to TNFi therapy, upadacitinib provides a much-needed option for patients who do not respond well to existing treatments. As research continues, the potential for upadacitinib to treat a broader range of conditions offers hope for improved management of immune-mediated inflammatory diseases across different age groups.

 

Resource: Abbvie, June 04, 2024

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