Le Lézard
Classified in: Health, Science and technology
Subject: TRI

New Positive Data for RINVOQtm (upadacitinib) on Signs and Symptoms in Patients with Ankylosing Spondylitis Presented at 2019 ACR/ARP Annual Meeting

NORTH CHICAGO, Ill., Nov. 12, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive data from the Phase 2/3 SELECT-AXIS 1 trial in which twice as many adult patients with active ankylosing spondylitis (AS) treated with RINVOQtm (upadacitinib; 15 mg, once-daily) achieved the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 14 versus placebo (52 percent vs. 26 percent; p<0.001).1 SELECT-AXIS 1 is the first trial to evaluate the efficacy and safety of RINVOQ in adult patients with active AS who are naïve to biologic disease-modifying antirheumatic drugs (bDMARDs) and had inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).1

Full results were presented today at the 2019 American College of Rheumatology (ACR)/Association for Rheumatology Professionals (ARP) Annual Meeting in Atlanta and have been published concurrently in The Lancet. RINVOQ, a JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily therapy in AS and multiple immune-mediated inflammatory diseases.1,5-18

"Ankylosing spondylitis is a chronic, progressive, inflammatory disease that causes pain and stiffness, primarily in the spine, starting in early adulthood," said Désirée van der Heijde, Professor, Leiden University Medical Center, the Netherlands. "Apart from biologics, there are limited options available for patients who have an inadequate response or contraindication to NSAIDs. The results of this study highlight the potential of RINVOQ as an additional treatment option for patients living with ankylosing spondylitis."

"Results from the SELECT-AXIS 1 study show that RINVOQ was able to provide significant improvements to signs and symptoms for patients living with ankylosing spondylitis," said Marek Honczarenko, M.D., Ph.D., vice president, immunology development, AbbVie. "These data highlight AbbVie's commitment to discovering and developing additional therapies for patients living with rheumatic diseases."

The safety profile of RINVOQ was consistent with that of previous studies in rheumatoid arthritis, with no new safety risks detected.1,2 Through week 14, the proportions of patients with adverse events leading to discontinuation, serious adverse events and infections were 2 percent/1 percent/20 percent for RINVOQ and 3 percent/1 percent/28 percent for placebo, respectively.1 No serious infections, herpes zoster, malignancy, adjudicated major adverse cardiovascular events, venous thromboembolic events or deaths were reported.1


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 AS who are bDMARD-naïve and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs.

The study includes two periods. Results from Period 1 were presented today. In the 14-week Period 1, the primary endpoint was the percentage of subjects achieving an ASAS40 response after 14 weeks of treatment. Ranked secondary endpoints included proportion of subjects achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 and ASAS partial remission (PR) at week 14, as well as change from baseline in Ankylosing Spondylitis Disease Activity Scores (ASDAS), MRI Spondyloarthritis Research Consortium of Canada (SPARCC) score (spine) and Bath Ankylosing Spondylitis Functional Index (BASFI) at week 14. Period 2 is an open-label extension period to evaluate the long-term safety, tolerability and efficacy of upadacitinib in subjects who completed Period 1. More information on this trial can be found at www.clinicaltrials.gov (NCT03178487).

About RINVOQ (upadacitinib)

Discovered and developed by AbbVie, RINVOQ is a JAK inhibitor studied in several immune-mediated inflammatory diseases.1,5-18 Earlier this year, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis. RINVOQ also received a positive opinion from the European Union's Committee for Medicinal Products for Human Use and is currently awaiting final approval by the European Commission. Phase 3 trials of RINVOQ in psoriatic arthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.1,6,12-18

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.

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:

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:

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.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, FacebookLinkedIn 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, competition from other products, challenges to intellectual property, 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 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. 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.


  1. Van der Heijde D, et al. Efficacy and Safety of Upadacitinib in a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2/3 Clinical Study of Patients With Active Ankylosing Spondylitis. 2019 ACR/ARP Annual Meeting; 2728.
  2. Cohen S, et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR 2019; THU0167.
  3. Sieper J, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002 Nov; 61(Suppl 3): iii8?iii18. doi: 10.1136/ard.61.suppl_3.iii8.
  4. Dean, LE, et al. Global prevalence of ankylosing spondylitis. Rheumatology (Oxford). 2014 Apr;53(4):650-7. doi: 10.1093/rheumatology/ket387. Epub 2013 Dec 9.
  5. Bergman M, et al. Upadacitinib Treatment and the Routine Assessment of Patient Index Data 3 (RAPID3) Among Patients with Rheumatoid Arthritis. 2019 ACR/ARP Annual Meeting; 551.
  6. Pipeline ? Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on November 7, 2019.
  7. Burmester GR, 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 13.
  8. Genovese MC, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 13.
  9. Smolen JS, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019. May 23. pii: S0140-6736(19)30419-2. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019 May 23.
  10. Fleischmann R, et al. Upadacitinib versus Placebo or Adalimumab in Rheumatoid Arthritis: Results of a Phase 3, Double-Blind, Randomized Controlled Trial. Arthritis and Rheumatology. 2019. Jul 9. doi: 10.1002/art.41032.
  11. van Vollenhoven R, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891.
  12. A Phase 3 Study to Compare ABT-494 to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE). Clinicaltrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03086343. Accessed on November 7, 2019.
  13. 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. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on November 7, 2019.
  14. 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. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed on November 7, 2019.
  15. 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. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on November 7, 2019
  16. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on November 7, 2019.
  17. 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. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on November 7, 2019.
  18. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on November 7, 2019.



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