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

- In SELECT-AXIS 1, RINVOQ™ (upadacitinib; 15 mg, once-daily) achieved the primary endpoint of ASAS40 response in adult patients with active ankylosing spondylitis (AS) at 14 weeks versus placebo[1]

- Full results were presented today at the 2019 ACR/ARP Annual Meeting in Atlanta

- The safety profile was consistent with that of previous studies across indications, with no new safety risks detected[1,2]

- Affecting more than five million people worldwide, AS is a chronic inflammatory disease that causes pain and stiffness in the joints, mainly in the spine[3,4]

News provided by

AbbVie

Nov 12, 2019, 11:15 ET

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 RINVOQ™ (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

About SELECT-AXIS 1¹

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.

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
Pain or tenderness in the leg
Sudden unexplained chest pain
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.

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, 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, 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.

References:

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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.
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.
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