Full Press Release Details
NORTH CHICAGO, Ill. , March 23, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV ) today announced topline results from a Phase 2 study of upadacitinib (RINVOQ ® , 30 mg) given alone or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), once daily in patients with moderately to severely active systemic lupus erythematosus (SLE). 1 The SLEek study met the primary endpoint of SLE Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 in the upadacitinib 30 mg group. 1,2 Based on the results, AbbVie is advancing its clinical program of upadacitinib in SLE to Phase 3.
"Systemic lupus erythematosus is a very unpredictable life-long condition and the way it affects a patient can change over time. Therefore, there is a critical need for additional treatment options," said Roopal Thakkar , M.D., senior vice president, development and regulatory affairs and chief medical officer, AbbVie. "With a quarter-century of experience and commitment to the treatment of rheumatic diseases, our focus remains on areas of high unmet need like systemic lupus erythematosus, and we look forward to further evaluation of the potential benefits that upadacitinib could bring to patients."
A total of 341 participants enrolled in the Phase 2 study and were subsequently divided into five experimental groups according to treatment regimen (upadacitinib in combination with placebo; upadacitinib, at two different doses, combined with elsubrutinib; elsubrutinib in combination with placebo; placebo only). 1 The primary outcome measure was achievement of the SRI-4 with a steroid dose less than or equal to 10 mg prednisone equivalent once daily at week 24. 1 SRI-4 is defined as a greater or equal to 4-point reduction in SLE Disease Activity Index 2000 score without worsening of the overall condition or the development of significant disease activity in new organ systems. 1
The safety results for the upadacitinib 30 mg arm of the study were generally consistent with the known safety profile of upadacitinib, with no new safety signals identified. 2-7 Types of adverse events reported with upadacitinib combined with elsubrutinib were similar to those reported for patients treated with upadacitinib alone. 2 Full results from the study will be presented at a future medical congress. Use of upadacitinib and elsubrutinib in SLE are not approved and their safety and efficacy have not been evaluated by regulatory authorities.
Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT03978520.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a complex, multi-organ, autoimmune disorder characterized by the production of pathogenic autoantibodies and tissue deposition of immune complexes. 8,9 In SLE, the body's immune system attacks healthy tissue of the musculoskeletal system, skin, kidneys, and other critical organs, leading to symptoms such as fatigue, joint pain and impaired function. 8,9 The prevalence of SLE is higher in women compared to men, and SLE occurs more frequently in people of color. 10,11
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. 3-7,12,13,14,15,16,17,18,19 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3 and TYK-2. 3 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. 3
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. 3-7,12-19 The use of upadacitinib in systemic lupus erythematosus is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
US Indications and Important Safety Information about RINVOQ ® (upadacitinib) 3
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, ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
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.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about RINVOQ?
RINVOQ may cause serious side effects, including:
Do not take RINVOQ if:
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), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels.
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.
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.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology .
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 our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram .
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, 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 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. 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.