ClinicalTrials.gov identifier: NCT02629159. | Other specific adverse reactions reported in atopic dermatitis patients included eczema herpeticum/Kaposi's varicelliform eruption. &ldquo;This . Accessed on, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. Subscription management. north chicago, ill., oct. 21, 2022 /prnewswire/ -- abbvie (nyse: abbv) today announces that the u.s. food and drug administration (fda) has approved rinvoq ( upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation who have Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. AbbVie. If you are having difficulty paying for your medicine, AbbVie may be able to help. ", "There are limited treatment options for people living with nr-axSpA, a condition that can pose many challenges for patients and significantly impact their quality of life as their symptoms persist despite treatment," said Cassie Shafer, chief executive officer, Spondylitis Association of America (SAA). Uses and Important Safety Information About Rinvoq (upadacitinib) 1. Vermeire S, et al. In the SELECT-AXIS 2 nr-axSpA trial, patients receiving Rinvoq 15 mg experienced greater improvements at week 14 compared to placebo in the individual components of the ASAS composite index, including total back pain, patient global assessment of disease activity, morning stiffness, and physical function. The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021. For more information about Rinvoq, visit Rinvoq.com. van der Heijde D, Baraliakos X, Sieper J, et al. More information can be found on www.clinicaltrials.gov(NCT03006068, NCT03653026, NCT02819635). Company: AbbVie Inc. Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. What is the most important information I should know about Rinvoq? Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Rinvoq (upadacitinib) FDA Approval History. A significantly greater improvement in physical function (-2.61 change from baseline) as assessed by mean change from baseline in BASFI compared to patients on placebo (-1.47). For more information about AbbVie, please visit us atwww.abbvie.com. ClinicalTrials.gov. RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis. Accessed onDecember 10, 2021. About RINVOQ (upadacitinib) " " 1( ( ))" ' 2 3456 7 2 1 0 8 0 9 " ! ) Terms of use Accessed onMarch 10, 2021. RINVOQ may pass into your breast milk. For more information, talk to your HCP. 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. Accessed. 3 "Rinvoq has demonstrated strong efficacy data, a safety profile that is well characterized from large long-term studies and a favorable benefit-risk profile," said Michael Severino, MD, vice chairman and president, AbbVie. Available at:https://clinicaltrials.gov/ct2/show/NCT03725202. Available at:https://clinicaltrials.gov/ct2/show/NCT03569293. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA-approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December. Accessed onMarch 9, 2021. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. The recommended dose of Rinvoq for maintenance treatment is 15 mg once daily. Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as: Warm, red, or painful skin or sores on your body, Burning when urinating or urinating more often than normal. More information about this assistance program can be found on www.AbbVie.com/myAbbVieAssist. 2021. These press releases remain on AbbVie's website for historical purposes only. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Approximately five percent of patients with nr-axSpA will progress to AS after five years, and 19 percent will progress after ten years.7, "This latest FDA approval of Rinvoq in active nr-axSpA provides a new oral, once-daily treatment option for patients who historically have had limited treatment options for this painful, chronic disease," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. 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). No use of any AbbVie trademark, trade name, or trade dress in this site may be made without the prior written authorization of AbbVie Inc., except to identify the product or services of the company. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. | Approximately 52 percent of the patients had prior exposure to systemic atopic dermatitis treatment. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis. In the clinical trial, the primary endpoint was the percentage of subjects achieving an ASAS40 response after 14 weeks of treatment with Rinvoq versus placebo. Topline results of the U-ACHIEVE induction study were announced inDecember 2020, topline results of the second induction study, U-ACCOMPLISH, were announced inFebruary 2021, and topline results of the U-ACHIEVE maintenance study were announced inJune 2021. These include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections, including cold sores, bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, low white blood cell count (neutropenia), muscle pain, and flu-like illness. More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT04169373). The Internet site that you have requested may not be optimized to your screen size. AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. ClinicalTrials.gov. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. It's also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions. If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. 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. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Rinvoq may cause serious side effects, including: Do not take Rinvoq if you are allergic to upadacitinib or any of the ingredients in Rinvoq. Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Seniors Taking Multiple Meds: Its a Complicated Problem, 3 COVID Scenarios That Could Spell Trouble for the Fall, Colonoscopy Benefits Lower Than Expected (Study), Dr. Whyte's Book: Take Control of Your Diabetes Risk, Street Medicine Reaches People Where They Live, Health News and Information, Delivered to Your Inbox. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomized, placebo-controlled phase 3 trial. Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.5,6 The hallmark signs and symptoms ofulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.7,8 The disease course ofulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease.5,8 The severity of symptoms and unpredictability of disease course can lead to substantial burden among those living with the disease.9. Subscribe for email alerts ClinicalTrials.gov. See full prescribing information for RINVOQ. Accessed on. This area is reserved for members of the news media. 2021. Mucosal healing was achieved in U-ACHIEVE and U-ACCOMPLISH and is defined by HEMI, which combines an ES of 1 without friability with a Geboes score of 3.1 (indicating neutrophil infiltration in <5 percent of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue); the relationship between HEMI and disease progression and/or long-term outcomes has not been established. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides RINVOQ at no charge to those who qualify. Upadacitinib Earns FDA Approval for Ankylosing Spondylitis-Medscape-May02,2022. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies1-4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. 2005 - 2022 WebMD LLC. Credit: Tatiana Ayazo. 2016 Mar;22(3 Suppl):s51-60. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). Available at: A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). During the maintenance trial, 42 percent and 52 percent of patients treated with RINVOQ 15 mg or 30 mg, respectively, achieved clinical remission at week 52, the primary endpoint, compared to 12 percent of patients who received placebo. Rinvoq 15 mg once daily can also be initiated in adults and children 12 years of age and older weighing at least 40 kg with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other system drug products, including biologics or when use of those therapies is inadvisable. For more information, visit AbbVie in rheumatology. The FDA's new approval was based on the SELECT-AXIS 2 clinical trial, which assessed the drug's efficacy and safety in 314 adults with nr . If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. Two main clinical studies form the basis for the FDA's approval decision. The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety ofupadacitinib 45 mg once daily as induction therapy, andupadacitinib 15 mg and 30 mg once daily as maintenance therapy in subjects with moderately to severely active ulcerative colitis. Pipeline Our Science | AbbVie. 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. ABBV +0.01% + Free Alerts. Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. How should I take Rinvoq? "This additional approval for RINVOQ provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. If you are unsure if you've been to these types of areas, ask your HCP. How Does Ankylosing Spondylitis Progress. Have other medical conditions including liver problems, low red or white blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Do not split, crush, or chew the tablet. Learn about a popular treatment for psoriasis, Rinvoq (upadacitinib) Receives FDA Approval for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis, AbbVie Submits Regulatory Applications to FDA and EMA for Rinvoq in Crohn's Disease, Rinvoq (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis, Rinvoq (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis, U.S. FDA Approves Rinvoq (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis, Rinvoq (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis, FDA Approves Rinvoq (upadacitinib), an Oral JAK Inhibitor for the Treatment of Moderate to Severe Rheumatoid Arthritis, New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR, AbbVie Announces New Drug Application Accepted for Priority Review by FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis, AbbVie Submits New Drug Application to U.S. FDA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis, AbbVie's Upadacitinib Shows Significant Improvements in Physical Function, Pain and Quality of Life as a Monotherapy in Patients with Rheumatoid Arthritis in Phase 3 Patient-Reported Outcomes Data, Positive Phase 2b Data for AbbVie's Upadacitinib Show Significant Induction of Clinical Remission and Response in Patients with Ulcerative Colitis, AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress, Upadacitinib Monotherapy Meets All Primary and Ranked Secondary Endpoints Versus Methotrexate in a Phase 3 Study in Rheumatoid Arthritis, Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis, AbbVie Announces New Phase 2 Data for Upadacitinib Showing Clinical and Endoscopic Outcomes in Crohn's Disease at 52 Weeks, AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis, AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints, AbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis, AbbVie's Upadacitinib (ABT-494) Meets Primary Endpoint in Phase 2b Study in Atopic Dermatitis, AbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Phase 3 Study in Rheumatoid Arthritis. Copyright 2022 AbbVie Inc. North Chicago, Illinois, U.S.A. Take Rinvoq exactly as your HCP tells you to use it. RINVOQ (upadacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2019 You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose. Sign up Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefitsof AbbVie's acquisition of Allergan plc ("Allergan"), failure to effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 2021. Follow @abbvie onTwitter,Facebook,LinkedInorInstagram. Accessed onDecember 10, 2021. 2021. Subscription management. What are the common side effects of RINVOQ? Have had any type of cancer, hepatitis B or C, shingles (herpes zoster),blood clots in the veins of your legs or lungs,diverticulitis (inflammation in parts of the large intestine),or ulcers in your stomach or intestines. ClinicalTrials.gov. Rinvoq (upadacitinib) Consumer information. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). If you qualify, please, https://www.multivu.com/players/English/8978351-abbvie-fda-ulcerative-colitis/, https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html, https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf, https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326, https://www.abbvie.com/our-science/pipeline.html. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. Other serious side effects include serious allergic reactions, tears in the stomach or intestines and changes in certain laboratory test results.