Now available: upadacitinib to treat JIA, psoriatic arthritis in patients 2 years and up

Now available: upadacitinib to treat JIA, psoriatic arthritis in patients 2 years and up | Image Credit: © vectorwin - © vectorwin - stock.adobe.com.

Upadacitinib (RINVOQ; AbbVie) is now available for patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who have had an inadequate response or intolerance to 1 or more tumor necrosis factor (TNF) blockers, according to a press release from AbbVie.

Additionally, the company announced that a new, weight-based oral solution RINVOQ LQ, is now available as an option for the pediatric populations.

pJIA is characterized by inflammation in 5 or more joints, persisting for at least 6 weeks in children and adolescents before 16 years of age. The PsA form of JIA can be characterized by joint inflammation and skin lesions associated with psoriasis. Some 300,000 children and adolescents in the United States have a form of JIA, and despite treatment advancements, long-term remission remains elusive for many patients, as approximately half require ongoing treatment in adulthood.

"[Upadacitinib] has been an important addition to the treatment landscape for various rheumatic diseases, helping adult patients achieve meaningful disease control," said Roopal Thakkar, MD in a press release. Thakkar is the senior vice president, chief medical officer of global affairs at AbbVie.

"AbbVie is proud to now offer [upadacitinib] as a tablet and oral solution to some of our youngest patients," Thakkar added.

The approval of upadacitinib and RINVOQ LQ oral solution are based on evidence in studies of upadacitinib in adults with rheumatoid arthritis (RA) and PsA, along with pharmacokinetic data from adults with RA and PsA, as well as 51 pediatric patients with JIA with active polyarthritis. Additional safety data from 83 pediatric patients 2 years to less than 18 years of age with JIA with active polyarthritis also supported the approval.

"Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities," said Aarat Patel, MD, adult and pediatric rheumatology, Bon Secours Rheumatology Center of St. Mary's Hospital, in a statement.

"Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options. 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," added Patel.

Upadacitinib could cause the following side effects, according to the press release from AbbVie:

• Serious infection: upadacitinib can lower ability to fight infection. Serious infections, of which some were fatal, occurred, including tuberculosis, and infections caused by bacteria, fungi, or viruses.
• Increased risk of death in individuals aged 50 years and older with at least 1 heart disease risk factor.
• Cancer and immune system problems.
• Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially in current or past smokers.
• Blood clots, some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50 years and older who have at least 1 heart disease (CV) risk factor.
• Serious allergic reactions. Do not take if allergic to RINVOQ or its ingredients.
• Tears in the stomach or intestines; changes in certain laboratory test results.

Upadacitinib currently has phase 3 trials ongoing for alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus (SLE), Takayasu arteritis, ulcerative colitis and vitiligo.

Reference:

RINVOQ (upadacitinib) Now Available for Pediatric Patients Two Years and Older with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis. AbbVie. Press release. June 4, 2024. Accessed June 4, 2024. https://news.abbvie.com/2024-06-04-RINVOQ-R-upadacitinib-Now-Available-for-Pediatric-Patients-Two-Years-and-Older-with-Polyarticular-Juvenile-Idiopathic-Arthritis-and-Psoriatic-Arthritis