The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis
NORTH CHICAGO, Ill., May 24, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment. The results were published in two separate manuscripts as part of the May 22, 2021 issue of The Lancet.
The publication of Measure Up 1 and Measure Up 2 shares efficacy and safety results of patients treated with upadacitinib (15 mg or 30 mg, once daily) monotherapy versus placebo for 16 weeks.1 The publication of AD Up shares efficacy and safety results of patients treated with either dose of upadacitinib with topical corticosteroids (TCS) versus placebo with TCS for 16 weeks.2 Across all three studies, RINVOQ met all primary and secondary endpoints.1,2
About Atopic Dermatitis
Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching leading to cracked, scaly, oozing skin.3,4 It affects up to an estimated 10 percent of adults and 25 percent of children.4,5 Between 20 and 46 percent of adults with atopic dermatitis have moderate to severe disease.6 The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.4,7
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1,2,8-14 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.14 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ is 15 mg. Phase 3 trials of RINVOQ in atopic dermatitis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.1,2,8-13 Use of RINVOQ in atopic dermatitis is not approved and its safety and efficacy are under evaluation by regulatory authorities.
RINVOQ U.S. Use and Important Safety Information14
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.
What is the most important information I should know about RINVOQ?
RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.
What should I tell my HCP AFTER starting RINVOQ?
Tell your HCP right away if you:
What are the common side effects of RINVOQ?
These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.
RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet.
Take RINVOQ exactly as your HCP tells you to use it.
This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Globally, prescribing information varies; refer to the individual country product label for complete information.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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