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Rinvoq (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis

NORTH CHICAGO, Ill., April 29, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib; 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.1

"Ankylosing spondylitis is a debilitating disease that often affects younger adults and, over time, can result in lasting structural damage that can take an emotional toll on a patient's life," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "This latest approval demonstrates another important step forward in our mission to advance the standards of care in rheumatic diseases."

The FDA approval in AS is supported by efficacy and safety data from the Phase 3 SELECT-AXIS 2 clinical trial (Study 1) evaluating Rinvoq in patients who had an inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs (bDMARDs) and the Phase 2/3 SELECT-AXIS 1 clinical trial evaluating Rinvoq in patients who were naïve to bDMARDs and had an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs (NSAIDs).1-3

"Many patients with ankylosing spondylitis do not achieve disease control with current biologic therapies and additional treatments are needed to help relieve the signs and symptoms of this disease," said Atul Deodhar, M.D., professor of medicine and medical director of the Rheumatology Clinics for the Division of Arthritis and Rheumatic Diseases at Oregon Health & Science University, and investigator of the SELECT-AXIS 1 trial. "With today's FDA approval, patients who do not respond to a TNF inhibitor have an additional oral treatment option, in partnership with their rheumatologist, to help take control of this disease."

In both SELECT-AXIS 1 and SELECT-AXIS 2 clinical trials, a significantly greater proportion of patients receiving Rinvoq 15 mg achieved an ASAS40* response, the primary endpoint, (51% and 44.5%, respectively) compared to those receiving placebo (26% and 18.2%, respectively) at week 14. Clinical responses were observed as early as week four in SELECT-AXIS 2 for ASAS40.1,3

"Currently, there are limited treatment options for people living with ankylosing spondylitis, particularly when painful symptoms persist despite being on a TNF blocker treatment," said Cassie Shafer, chief executive officer, Spondylitis Association of America (SAA). "The approval of a new medicine is welcome news to our community of patients, offering the potential to help more people find meaningful relief from the symptoms of AS and to help reach their treatment goals."

AS is a chronic inflammatory musculoskeletal disease primarily affecting the spine and characterized by debilitating symptoms of inflammatory back pain, stiffness and restricted mobility. An estimated one out of every 200 adults in the U.S., or approximately 1.1 million people, is affected by AS.5

Additional study results include the following:

Improvement in AS Signs & Symptoms at Week 141-3

Treatment with Rinvoq 15 mg resulted in improvements in the signs and symptoms of AS, including total back pain, as well as improvements in physical function (Bath Ankylosing Spondylitis Functional Index (BASFI)) and disease activity (Patient Global Assessment of Disease Activity) versus placebo at week 14.

In SELECT-AXIS 2, patients receiving Rinvoq 15 mg at week 14 experienced:

*ASAS40 is a composite index that measures disease activity.2 To achieve an ASAS40 response, a patient's disease activity must have improved by at least 40%, as well as improved by two units in at least three of four disease areas assessed, and the remaining area must not have gotten worse, including back pain, patient global assessment of disease activity, physical functional and morning stiffness.2

Safety1

For more information about Rinvoq in AS, visit Rinvoq.com.

Patient Access & 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 SELECT-AXIS 1 and SELECT-AXIS 2 trial programs2,3
SELECT-AXIS 1 is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of Rinvoq in adult patients with active ankylosing spondylitis (AS) who are bDMARD-naïve and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs. Period 2 is an open-label extension period to evaluate the long-term safety, tolerability and efficacy of Rinvoq in subjects who completed Period 1. More information on this trial can be found at www.clinicaltrials.gov (NCT03178487).

SELECT-AXIS 2 was conducted as a master study protocol that contains two standalone studies with randomization, data collection, analysis and reporting conducted independently. The Phase 3, randomized, placebo-controlled, double-blind studies are evaluating the efficacy and safety of Rinvoq compared with placebo on reduction of signs and symptoms in adult participants with active axial spondyloarthritis (axSpA), including bDMARD-IR AS (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT04169373).

In both clinical trials, the primary endpoint was the percentage of subjects achieving an ASAS40 response after 14 weeks of treatment with Rinvoq versus placebo.

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. Based on enzymatic and cellular assays, Rinvoq demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.1 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

In the U.S., Rinvoq 15 mg is approved for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers; adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers; and adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.1 Rinvoq 45 mg is approved for use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers as an induction therapy once daily for 8 weeks. The recommended dose of Rinvoq for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue Rinvoq if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dosage needed to maintain response. 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. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.

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.7-13

Rinvoq® (upadacitinib) U.S. Use and Important Safety Information1

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, or ankylosing spondylitis.

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:

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 do or tell my HCP AFTER starting Rinvoq?

What are the 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 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 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 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 women's health, 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.

*Dr. Atul Deodhar, M.D., is a researcher/consultant for AbbVie.

References:

  1. Rinvoq® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
  2. Van der Heijde, D., et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019 Dec 7;394(10214):2108-2117. doi: 10.1016/S0140-6736(19)32534-6. Epub 2019 Nov 12.
  3. 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 on April 29, 2022.
  4. Cohen S., et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2020 Oct 28;80(3):304-11.
  5. Reveille J. D. (2011). Epidemiology of spondyloarthritis in North America. The American journal of the medical sciences. 341(4), 284–286. https://doi.org/10.1097/MAJ.0b013e31820f8c99.
  6. Data on File. ABVRRTI73541.
  7. Burmester G.R., et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
  8. 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 on April 29, 2022.
  9. 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 on April 29, 2022.
  10. 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: April 29, 2022.
  11. 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 on April 29, 2022.
  12. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed: April 29, 2022.
  13. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed: April 29, 2022.

SOURCE AbbVie

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Posted: April 2022

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