– First indications of RINVOQ (upadacitinib) for pediatric patients two years of age and older1
– RINVOQ is now approved for eight indications across immune-mediated inflammatory diseases1
NORTH CHICAGO, Ill., June 4, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that RINVOQ® (upadacitinib) is indicated in the U.S. for the treatment of pediatric patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) as well as psoriatic arthritis (PsA), provided they have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Additionally, a new weight-based oral solution, RINVOQ® LQ (upadacitinib), is now available as an option for these pediatric populations.1
Experience the interactive Multimedia News Release here: https://www.multivu.com/players/English/9254951-rinvoq-upadacitinib-available-pediatric-polyarticular-juvenile-idiopathic-and-psoriatic-arthritis/
"RINVOQ has been an important addition to the treatment landscape for various rheumatic diseases, helping adult patients achieve meaningful disease control," said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie. "AbbVie is proud to now offer RINVOQ as a tablet and oral solution to some of our youngest patients."
Nearly 300,000 children and adolescents in the U.S. have a form of juvenile idiopathic arthritis, which includes pJIA and PsA.2-3 The polyarticular form of juvenile idiopathic arthritis is characterized by inflammation in five or more joints that persists for at least six weeks in children and adolescents before 16 years of age.2 The psoriatic arthritis form of juvenile idiopathic arthritis is characterized by both joint inflammation and skin lesions associated with psoriasis.4 These chronic diseases can be painful and debilitating and, if left untreated, may lead to joint damage.5-6 Despite treatment advancements, achieving long-term remission remains elusive for many patients living with a form of juvenile idiopathic arthritis, with approximately half requiring ongoing treatment into adulthood.7-8
"Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options," said Aarat Patel, M.D., adult and pediatric rheumatology, Bon Secours Rheumatology Center of St. Mary's Hospital and the Department of Pediatrics at the University of Virginia Children's Hospital. "Having a treatment option available for patients who do not respond well to a TNFi addresses a need for the healthcare community, patients, and their families."
Data Supporting the Approvals1
The approvals of RINVOQ and RINVOQ LQ oral solution are supported by evidence from well-controlled studies of RINVOQ in adult patients with rheumatoid arthritis (RA) and PsA, pharmacokinetic data from adult patients with RA and PsA, as well as 51 pediatric patients with juvenile idiopathic arthritis with active polyarthritis, in addition to safety data from 83 pediatric patients two to less than 18 years of age with juvenile idiopathic arthritis with active polyarthritis. Upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage are predicted to be comparable to those observed in adults with RA and PsA based on population pharmacokinetic modeling and simulation.
RINVOQ*/RINVOQ LQ Safety Considerations
*Unless otherwise stated, "RINVOQ" in the Safety Considerations refers to RINVOQ and RINVOQ LQ.
For more information about RINVOQ, visit RINVOQ.com.
Patient Access and Support
AbbVie is committed to helping people access RINVOQ and other medicines, including offering a patient support program and a co-pay card that may reduce out-of-pocket costs to $5 per month for eligible, commercially insured patients. 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. For more details, please visit AbbVie.com/myAbbVieAssist.
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.1
Phase 3 trials of RINVOQ in alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus (SLE), Takayasu arteritis, ulcerative colitis and vitiligo are ongoing.9,10,11,12,13,14,15,16,17,18,19,20,21,22
RINVOQ® (upadacitinib) U.S. Uses and Important Safety Information
RINVOQ is a prescription medicine used to treat:
It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease.
It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis.
RINVOQ/RINVOQ LQ is a prescription medicine used to treat:
It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis.
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 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 HCP.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ/RINVOQ LQ?
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. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP.
*Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ.
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.
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.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
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 2023 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.
REFERENCES
1 RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2024.
2 Petty RE, Southwood TR, Manners P, et al. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004;31(2):390-392.
3 Helmick CG, Felson DT, Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;58(1):15-25. doi:10.1002/art.23177.
4 Brunello F, Tirelli F, Pegoraro L, et al. New Insights on Juvenile Psoriatic Arthritis. Front Pediatr. 2022;10:884727. Published 2022 May 26. doi:10.3389/fped.2022.884727.
5 Garner AJ, Saatchi R, Ward O, Hawley DP. Juvenile Idiopathic Arthritis: A Review of Novel Diagnostic and Monitoring Technologies. Healthcare (Basel). 2021;9(12):1683. Published 2021 Dec 4. doi:10.3390/healthcare9121683.
6 Hashkes PJ, Laxer RM. Medical Treatment of Juvenile Idiopathic Arthritis. JAMA. 2005;294(13):1671–1684. doi:10.1001/jama.294.13.1671.
7 Hashkes PJ, Laxer RM. Medical Treatment of Juvenile Idiopathic Arthritis. JAMA. 2005;294(13):1671–1684. doi:10.1001/jama.294.13.1671.
8 Glerup M, Rypdal V, Arnstad ED, et al. Long-Term Outcomes in Juvenile Idiopathic Arthritis: Eighteen Years of Follow-Up in the Population-Based Nordic Juvenile Idiopathic Arthritis Cohort. Arthritis Care Res (Hoboken). 2020;72(4):507-516. doi:10.1002/acr.23853.
9 A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06012240. Accessed February 19, 2024.
10 A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed March 24, 2023.
11 Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT03569293 . Accessed February 22, 2024.
12 A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT03607422. Accessed February 22, 2024.
13 A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (AD Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT03568318. Accessed February 22, 2024.
14 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. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed March 24, 2023.
15 A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed March 30, 2023.
16 A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05889182. Accessed February 19, 2024.
17 A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed March 24, 2023.
18 A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults with Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02629159. Accessed March 24, 2023.
19 Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05843643. Accessed February 19, 2024.
20 A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04161898. Accessed March 30, 2023.
21 A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed March 24, 2023.
22 A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06118411. Accessed February 19, 2024.
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