AbbVie announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.1 RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily. The FDA approval is supported by efficacy and safety data from one of the larger registrational Phase 3 programs for atopic dermatitis with more than 2,500 patients evaluated across three studies.

Approximately 52% of the patients had prior exposure to systemic atopic dermatitis treatment. These studies evaluated the efficacy and safety of RINVOQ monotherapy (Measure Up 1 and 2) and with topical corticosteroids (AD Up), compared to placebo, in adults and children 12 years of age and older with moderate to severe atopic dermatitis. 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 at week 16, with some patients achieving higher levels of skin clearance (EASI 90 and 100).

In all three studies, a significant improvement in itch (Worst Pruritus NRS =4) was observed as early as week one, compared to placebo. 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.

Serious infections. RINVOQ can lower ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Some people have died from these infections. Increased risk of death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase risk of certain cancers, including lymphoma, skin, and lung cancer, as these can happen.

Current or past smokers are at higher risk. Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor, especially in current or past smokers. Blood clots.

Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. This has happened more often in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.

Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching that leads to cracked, scaly and oozing skin.4-6 It affects an estimated 7 percent of adults and 12 percent of adolescents in the U.S., with approximately 40 percent of adults experiencing moderate to severe disease.7-8 It manifests differently across individuals, with symptoms posing significant physical, psychological and economic burdens. Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.10 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.1 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. In the U.S., RINVOQ 15 mg and 30 mg is approved for use in adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.1 RINVOQ 15 mg is also approved in the U.S. for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers as well as adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

In the EU, RINVOQ 15 mg is approved for the treatment of adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is also approved in the EU for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.