AbbVie to Present New Long-term Analysis Evaluating the Sustainability of Response to RINVOQ® (Upadacitinib) Among Patients with Rheumatoid Arthritis

NORTH CHICAGO, Ill., Nov. 9, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new results from a post-hoc analysis of the Phase 3 SELECT-BEYOND clinical trial evaluating RINVOQ^® (upadacitinib; 15 mg, once daily) in patients with moderate to severe rheumatoid arthritis (RA) on stable background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) with prior inadequate response or intolerance to at least one biologic DMARD.

Results showed that 34% of patients receiving RINVOQ and background csDMARDs achieved Clinical Disease Activity Index (CDAI) remission (CDAI ≤2.8) at first occurrence of response before week 60, while 79% achieved CDAI low disease activity (LDA) (CDAI ≤10).¹ Maintenance of response, defined as not losing response at two consecutive study visits, was seen for CDAI remission and CDAI LDA in 39% and 61% of patients, respectively, at 60 weeks.¹ The study results (Abstract #1694) are among the 38 abstracts across multiple rheumatic diseases being presented by AbbVie at the American College of Rheumatology (ACR) Convergence 2021, taking place virtually Nov. 3-9.

"Many people living with rheumatoid arthritis continue to experience debilitating joint pain and decreased physical functioning despite being on therapy," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "These data underscore the potential of RINVOQ to be an important treatment option to help people who face the daily challenges of rheumatoid arthritis."

Of patients treated with RINVOQ who lost CDAI remission, 58% remained in CDAI LDA, and 22% recaptured remission by the analysis cut-off date.¹ Similar patterns of sustained response were observed for remission and LDA based on Simplified Disease Activity Index (SDAI) criteria and for DAS28(CRP) ˂2.6/≤3.2.¹

"Achieving remission or low disease activity are the primary treatment goals for people with rheumatoid arthritis. I'm encouraged by these data, which add to the growing body of evidence that upadacitinib may help more people living with rheumatoid arthritis take control of this chronic, progressive disease and reach these important treatment goals," said Professor Ronald van Vollenhoven, M.D., Ph.D., chair of rheumatology and director, Amsterdam Rheumatology Center (ARC).

For additional information on the safety profile of RINVOQ in rheumatoid arthritis, as well as psoriatic arthritis and ankylosing spondylitis, refer to the long-term safety data being presented at ACR Convergence 2021 (Abstract #1691, Long-Term Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis).

The ACR Convergence 2021 abstracts can be found here.

About Rheumatoid Arthritis
Affecting 1.3 million Americans, rheumatoid arthritis is a complex, systemic autoimmune disease that occurs when the immune system mistakenly attacks joints, creating inflammation that causes the tissue inside of joints to thicken, damaging the bones and associated connective tissue.^2,3 Pain, fatigue and stiffness are among the signs and symptoms of RA that can have an impact on daily living.⁴ If not properly treated, RA can lead to permanent, debilitating bone and cartilage damage.⁵

About SELECT-BEYOND¹SELECT-BEYOND is a Phase 3, randomized, placebo-controlled trial that enrolled a population of patients with moderately to severely active rheumatoid arthritis who failed or were intolerant to as least one prior biologic therapy. Patients on stable background conventional synthetic (cs) DMARD(s) were randomized to receive upadacitinib 15 mg or 30 mg once-daily orally or placebo for 12 weeks, followed by a 12-week double-blind phase where placebo patients were switched to upadacitinib (15 mg or 30 mg); patients who completed the week 24 visit were able to enter a long-term extension of up to five years thereafter. Initiation, change, or discontinuation of background RA medications, including ≤2 csDMARDs, was allowed starting at week 24.

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-2.⁶ The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. RINVOQ 15 mg is approved by the U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis. RINVOQ 15 mg is also approved by the European Commission for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is approved by the European Commission for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. 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.^7-14

Important Safety Information about RINVOQ^® (upadacitinib)⁶

RINVOQ U.S. Use and Important Safety Information
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

What is the most important information I should know about RINVOQ?
RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).
Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.
Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.
Tears in the stomach or intestines and changes in certain laboratory tests can happen. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:
- Fever, sweating or chills
- Shortness of breath
- Warm, red, or painful skin or sores on your body
- Muscle aches
- Feeling tired
- Blood in phlegm
- Diarrhea or stomach pain
- Cough
- Weight loss
- Burning when urinating or urinating more often than normal
Have TB or have been in close contact with someone with TB.
Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
Live, have lived, or have traveled to parts of the country that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you've been to these areas, ask your HCP.
Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.
Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.

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:

Medicines for fungal or bacterial infections
Rifampicin or phenytoin
Medicines that affect your immune system

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?
Tell your HCP right away if you:

Have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
Have any signs or symptoms of blood clots during treatment with RINVOQ, including:
- Swelling
- Sudden unexplained chest pain
- Pain or tenderness in the leg
- Shortness of breath
Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are the common side effects of RINVOQ?
These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible 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.

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 in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

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, 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.

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 2020 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.

References:

1. Vollenhoven, R. V., et al. Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs. ACR Convergence 2021; Poster 1694.
2. Arthritis Foundation. What is Rheumatoid Arthritis. Available at: https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed on July 9, 2019
3. Hunter T, et al. Rheumatology International. Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004–2014. April 2017.
4. American College of Rheumatology. Rheumatoid Arthritis. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis. Accessed on June 7, 2019.
5. Ostrowska, M., Maśliński, W., Prochorec-Sobieszek, M., Nieciecki, M., & Sudoł-Szopińska, I. 2018. Cartilage and bone damage in rheumatoid arthritis. Reumatologia, 56(2), 111–120. https://doi.org/10.5114/reum.2018.75523. Accessed on November 1, 2021.
6. RINVOQ^® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed: June 2021.
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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed: June 2021.
10. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed: June 2021.
11. A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (SELECT-PsA 2). Clinicaltrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed: June 2021.
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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed: June 2021.
13. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed: June 2021.
14. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. 2020. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed: June 2021.

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