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- First registered, randomized Phase 3 trial in hidradenitis suppurativa (HS) evaluating the efficacy and safety of upadacitinib (RINVOQ ® ) in adults and adolescents with moderate to severe HS 1
- HS is a difficult-to-treat chronic, inflammatory disease with few therapeutic options available 2,3
- AbbVie applies proven expertise in immunology and HS in continued efforts to bring new treatment options to patients living with this underserved condition 4
NORTH CHICAGO, Ill. , July 24, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV ) today announced that the first patient has been dosed in the Phase 3 Step-Up HS study evaluating upadacitinib (RINVOQ ® ) in adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have failed anti-tumor necrosis factor (TNF) therapy and/or one approved non-anti-TNF inhibitor therapy for HS. 1
"Hidradenitis suppurativa is a chronic, inflammatory disease that often leads to irreversible skin damage and extreme pain for patients," said Roopal Thakkar , M.D., senior vice president, development and regulatory affairs and chief medical officer, AbbVie. "Leveraging our proven expertise in immunology and experience in HS, we continue to drive innovation and pursue advancement of care in patient populations with difficult-to-treat immune-mediated diseases that have limited therapeutic options."
HS can appear on the skin as painful bumps, nodules or abscesses that leak fluid, lead to scarring and even connect under the skin as tunnels. 5 Nodules generally develop in areas of the body where hair grows or skin rubs against skin, such as the underarms, groin or back of the neck. 5
While HS is estimated to affect up to one percent of the global population, patients can experience increasing disease severity and symptoms for as long as seven to 10 years before receiving an accurate diagnosis. 6,7 There is no cure for HS, and there are limited treatment options, making further study of this disease critical to better understand its impact and help meet patients' unmet needs. 3,8
About Step-Up HS 1 Step-Up HS is the first Phase 3, randomized, placebo-controlled, double-blind, multicenter study to evaluate the efficacy and safety of upadacitinib compared to placebo in adults and adolescents (12 to less than 18 years old) with moderate to severe HS who have failed anti-TNF therapy and/or one approved non-anti-TNF inhibitor therapy for HS. Aiming to enroll approximately 1,300 participants across 275 sites worldwide, the study consists of three periods. In Period 1 (0 to 16 weeks), the safety and efficacy of upadacitinib 30 mg will be evaluated versus placebo, which is the primary analysis of the study. In Period 2 (16 to 20 weeks), based on clinical response, patients will be re-randomized to upadacitinib 30 mg, upadacitinib 15 mg or placebo, followed by a long-term extension Period 3 (20 to 68 weeks).
The study's primary endpoint will measure the percentage of participants achieving HS clinical response (HiSCR) 50, defined as at least a 50 percent reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline at week 16.
The Phase 2 study was completed and study results were presented at the American Academy of Dermatology (AAD) Annual Meeting in March 2023 and are planned for publication in a scientific journal. Additional results from the Phase 2 study will be presented at a future medical congress.
Additional information about the study can be found at https://clinicaltrials.gov/ under the identifier NCT05889182.
About RINVOQ ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. 4 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. 9 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.
Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis, Takayasu arteritis, and systemic juvenile idiopathic arthritis are ongoing. 10-18 Use of upadacitinib in HS is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
RINVOQ (upadacitinib) U.S. Uses and Important Safety Information 9
RINVOQ is a prescription medicine used to treat:
It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease.
RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.
It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
What is the most important information I should know about RINVOQ? RINVOQ may cause serious side effects, including:
Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.
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:
If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.
What should I avoid while taking RINVOQ? Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.
What should I do or tell my HCP AFTER starting RINVOQ?
What are other possible side effects of RINVOQ? Common side effects 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, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis).
A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.
Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your healthcare provider.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ? RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets.
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 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.
Please click here for the Full Prescribing Information and Medication Guide .
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie 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 and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Forward-Looking Statements 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 and uses of future or conditional verbs, 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 expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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 2022 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, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.