Good news for people age 12 and up that suffer from the endless cycle of itching and scratching that comes with moderate to severe atopic dermatitis. Upadacitinib, a selective and reversible JAK inhibitor was discovered and developed by AbbVie. The milestone marks the second U.S. Food & Drug Administration (FDA) approved indication for Rinvoq (upadacitinib).
Rinvoq was also approved by The European Commission (EC) for the treatment of rheumatoid arthritis in 2019 when conventional therapy is not effective or not tolerated.
This study is one of the largest registrational Phase 3 programs for atopic dermatitis with more than 2,500 patients age 12 and up with moderate to severe atopic dermatitis evaluated across three studies. These studies evaluated the efficacy and safety of Rinvoq monotherapy (Measure Up 1 and 2) and with topical corticosteroids (AD Up), compared to placebo.
As an oral pill with two dose strengths, this serves as a welcome treatment option for patients who have not yet achieved adequate control of their condition.
In all three studies, as early as week one, a significant improvement in itch was observed, compared to placebo. At week 16 across the three atopic dermatitis pivotal studies, Rinvoq (15 mg and 30 mg, once daily) monotherapy and with topical corticosteroids met all primary and secondary endpoints. Results showed a robust response across skin and itch symptoms, with some patients achieving high levels of clear skin.
AbbVie reports that overall, the safety profile observed in patients with atopic dermatitis treated with Rinvoq 15 mg or 30 mg was similar to the safety profile observed in patients with rheumatoid arthritis. Other specific adverse reactions reported in atopic dermatitis patients included eczema herpeticum/Kaposi’s varicelliform eruption.
It is important to note that Rinvoq may cause serious side effects, such as serious infections, blood clots, increase the risk of certain cancers, increase the risk of major cardiovascular events or death in people age 50 and older.
The news headlines for AbbVie’s Rinvoq (upadacitinib) has not been all fanfare. Effectively, the FDA is telling patients who are current (or past) smokers, who have had a heart attacks or other heart problems, or who have suffered a stroke or experienced blood clots in the past that the JAK inhibitors may put you at higher risk for serious problems.
Despite the warnings, Rinvoq (upadacitinib) may provide relief for millions of people. According to the National Eczema Association, atopic dermatitis (AD) is the most common type of eczema, affecting more than 9.6 million children and about 16.5 million adults in the United States. It’s a chronic condition that can come and go for years or throughout life, and can overlap with other types of eczema.
This drug also has positive data in treating patients with ankylosing spondylitis. According to The University of Washington Department of Orthopaedics and Sports Medicine, about 300,000 Americans (less than one percent of the adult population) have ankylosing spondylitis. Akylosing spondylitis is a chronic, inflammatory disease that primarily causes pain and stiffness in the spine that typically progresses from early adulthood. Treatment is limited for sufferers of ankylosing spondylitis. While Rinvoq is not yet FDA approved, it did show significant improvements to the painful symptoms of ankylosing spondylitis that you can read about here.
In addition, upadacitinib is being studied as an oral pill treatment (45 mg, once daily) for moderate to severe ulcerative colitis. Ulcerative colitis is a chronic, systemic disease caused by inflammation of the large intestine that is difficult to treat. Positive top-line results from U-EXCEED, a Phase 3 induction study, achieved both primary endpoints of clinical remission and endoscopic response, including being steroid-free at 12 weeks in patients living with Crohn’s disease. This is a treatment goal for most patients.
Many adults still struggle to find a treatment option that helps them manage their skin condition. With this FDA approval, RINVOQ has the potential to help more people find meaningful relief from the signs and symptoms of rheumatic diseases. This will pave the path for future treatment options for other inflammatory diseases.