Third Pivotal Phase 3 Study Shows RINVOQ™ (upadacitinib) Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients
NORTH CHICAGO, Ill., July 28, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced upadacitinib (15 mg and 30 mg, once daily) plus topical corticosteroids (TCS) met the co-primary endpoints and all secondary endpoints in AD Up, the third pivotal Phase 3 study of RINVOQ in atopic dermatitis.1 AD Up evaluated the efficacy and safety of both doses of upadacitinib therapy versus placebo in adults and adolescents with moderate to severe atopic dermatitis; all treatment groups, including placebo, received concomitant TCS.1 The co-primary endpoints were at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.1
Significantly more patients receiving either dose of upadacitinib plus TCS showed improvement in skin clearance compared to placebo plus TCS at week 16.1 In the study, 65/77 percent of patients receiving upadacitinib 15/30 mg plus TCS achieved EASI 75, respectively, versus 26 percent receiving placebo plus TCS (p<0.001).1 Of patients treated with upadacitinib 15/30 mg plus TCS, 40/59 percent achieved vIGA-AD 0/1, respectively, versus 11 percent of patients receiving placebo plus TCS (p<0.001).1
"These data build on the positive results from our previous studies in atopic dermatitis, now with additional perspective on the efficacy of RINVOQ used with a mainstay treatment for people living with the disease – topical steroids," said Tom Hudson, M.D., senior vice president of R&D and chief scientific officer, AbbVie. "With our deep heritage in serious skin diseases, we look forward to advancing research with RINVOQ as part of our ultimate goal to address unmet needs and improve care for people living with the relentless itch and skin symptoms of atopic dermatitis."
Additionally, more patients treated with upadacitinib plus TCS experienced a clinically meaningful reduction in itch, defined as improvement in Worst Pruritus Numerical Rating Scale (NRS)≥4, compared to patients treated with placebo plus TCS.1 At week 16, 52/64 percent of patients receiving upadacitinib 15/30 mg plus TCS achieved this endpoint compared to 15 percent of patients receiving placebo plus TCS (p<0.001).1
In a pre-specified additional analysis, treatment with either dose of upadacitinib also led to a higher mean number of topical corticosteroid-free days (TCS-free days) up to week 16 versus placebo.1 A TCS-free day is defined by a response of EASI 75 or greater without the use of TCS.1 Patients treated with upadacitinib 15/30 mg had a mean of 34/47 TCS-free days while maintaining EASI 75, respectively, compared with a mean of 8 days for those treated with placebo plus TCS (nominal p<0.001).1
"These results are encouraging, including the analysis showing some patients in the upadacitinib treatment groups were able to control their skin symptoms without topical corticosteroids," said Kristian Reich, M.D., professor of translational research in inflammatory skin diseases at the University Medical Center Hamburg Eppendorf, and Skinflammation Center, Hamburg, Germany and principal investigator. "Many of the current treatment options rely on patients to self-manage their condition, often with multiple applications of topicals. Patients could benefit from more therapeutic options that can help control symptoms without the constant need for concomitant topicals, as they strive for relief from this life-long, chronic disease."
Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching leading to cracked, scaly, oozing skin.12,13 It affects up to an estimated 25 percent of adolescents and 10 percent of adults at some point in their lifetime.13 Between 20 and 46 percent of adults with atopic dermatitis have moderate to severe disease.14 The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.13,15
Safety results were consistent with the two previously reported Phase 3 studies in atopic dermatitis, with no new safety risks observed during the 16-week placebo-controlled period.1-3 Serious adverse events (SAEs) occurred in 2.3 percent of patients in the upadacitinib 15 mg plus TCS group and 1.3 percent of patients in the upadacitinib 30 mg plus TCS group compared to 3.0 percent of patients in the placebo plus TCS group.1 The most common AEs for the upadacitinib groups were nasopharyngitis, acne and upper respiratory tract infection.1 Acne was observed at higher rates in the 15 mg and 30 mg upadacitinib plus TCS groups (10.0 percent and 13.8 percent, respectively) versus placebo plus TCS group (2.0 percent); all events were mild or moderate in severity and none led to treatment discontinuation.1 Eczema herpeticum was observed in 1.0 percent of patients on upadacitinib 15 mg plus TCS and 1.3 percent of patients on upadacitinib 30 mg plus TCS; none were reported in patients on placebo plus TCS.1 Serious infections were reported infrequently (1.0 percent in the upadacitinib 15 mg plus TCS group, 1.0 percent in the placebo plus TCS group; none were reported in the upadacitinib 30 mg plus TCS group).1 One event of arterial thrombosis occurred in a patient on placebo plus TCS.1 No deaths, major adverse cardiac events or venous thromboembolic events were reported in any of the treatment groups.1
Full results from the AD Up study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Use of RINVOQ in atopic dermatitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
About AD Up1,11
AD Up, together with Measure Up 1 and Measure Up 2 (top-line results announced in June and July 2020), make up AbbVie's Phase 3 pivotal trial program evaluating RINVOQ for the treatment of individuals with moderate to severe atopic dermatitis (ages 12 and older) who are candidates for systemic treatment.
AD Up is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study. Patients were randomized to upadacitinib 15 mg, upadacitinib 30 mg or placebo, all in combination with TCS. Patients receiving placebo plus TCS were switched to either upadacitinib 15 mg or upadacitinib 30 mg plus TCS at week 16.
The co-primary endpoints were the percentage of patients achieving EASI 75 and a vIGA-AD of 0/1 after 16 weeks of treatment. Secondary endpoints included improvement in Worst Pruritus NRS≥4, EASI 90, percent change in Worst Pruritus NRS, percent change in EASI at week 16. The trial is ongoing, and the long-term extension period remains blinded to investigators and patients, to evaluate the long-term safety, tolerability and efficacy of the two once daily doses (15 mg and 30 mg) of upadacitinib plus TCS in patients who have completed the placebo-controlled period. More information on this trial can be found at www.clinicaltrials.gov (NCT03568318).
About RINVOQ (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is an oral, once-daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.1,4-11 It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2.16 In August 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ also received approval 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. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis and giant cell arteritis are ongoing.5-11 Use of RINVOQ in atopic dermatitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
Important Safety Information about RINVOQ™ (upadacitinib)
RINVOQ U.S. Use and Important Safety Information
What is the most important information I should know about RINVOQ?
What should I tell my HCP BEFORE starting RINVOQ?
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?
What are the common 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.
About AbbVie in Dermatology
For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease. For more information on AbbVie in dermatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.html.
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.
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. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and 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. 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 2019 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. 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.
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