News

NORTH CHICAGO, Ill., Nov. 4, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from multiple studies of RINVOQ™ (upadacitinib), HUMIRA® (adalimumab) and SKYRIZI™ (risankizumab) at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, November 8-13, in Atlanta. A total of 38 abstracts will be presented across multiple rheumatic conditions, including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA).

"AbbVie looks forward to sharing the latest research across our recently expanded rheumatology portfolio at this year's meeting, including data that further support our recent FDA approval of RINVOQ," said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. "New data being presented on upadacitinib, risankizumab and adalimumab across multiple rheumatic diseases will highlight the potential for all three treatment options to help more patients achieve their treatment goals."

For the first time, safety and efficacy data evaluating upadacitinib versus placebo for the treatment of signs and symptoms in patients with active AS who had an inadequate response to nonsteroidal anti-inflammatory drugs will be presented during a plenary session at the meeting. A number of upadacitinib RA abstracts will also be featured, including:

• Investigators will present clinical remission data in patients treated with upadacitinib compared to placebo and methotrexate
• Long-term data from the SELECT program will be presented evaluating the efficacy and safety of upadacitinib across clinical measures and patient reported outcomes
• Investigators will share data evaluating upadacitinib compared to adalimumab across clinical and functional responses
• Data will also be presented among patients who experience an initial insufficient response to either upadacitinib or adalimumab and switched to the other therapy

Investigators will also present new patient-reported outcomes in patients with moderate to severe PsA who were treated with adalimumab, as well as data evaluating the safety and efficacy of risankizumab in patients with active PsA.

KEY ABSTRACTS OF INTEREST:

UPADACITINIB ABSTRACTS

Ankylosing Spondylitis 

• Exposure-Response Analyses for Upadacitinib Efficacy and Safety in Ankylosing Spondylitis – Analyses of the SELECT-AXIS I Study; Poster Session; Monday, November 11, 2019, 9:00 a.m.-11:00 a.m. EST 
• Efficacy and Safety of Upadacitinib in a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2/3 Clinical Study of Patients with Active Ankylosing Spondylitis; Plenary Session III; Tuesday, November 12, 2019, 11:00 a.m.-12:30 p.m. EST

Rheumatoid Arthritis 

• Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis: Results at 48 weeks; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST
• Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological DMARDs: Results at 60 Weeks; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST
• Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 48 Weeks; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST
• Characterization of Remission in Patients with Rheumatoid Arthritis Treated with Upadacitinib or Comparators; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST 
• Inhibition of Structural Joint Damage with Upadacitinib as Monotherapy or in Combination with Methotrexate in Patients with Rheumatoid Arthritis; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST
• Upadacitinib Treatment and the Routine Assessment of Patient Index Data 3 (RAPID3) Among Patients with Rheumatoid Arthritis; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST 
• Monotherapy with Upadacitinib in MTX-naïve Patients with Rheumatoid Arthritis: Results at 48 Weeks; Oral Presentation; Sunday, November 10, 2019, 4:30 p.m.-6:00 p.m. EST
• Effects of Upadacitinib on Patient-Reported Outcomes After 24 Weeks in Patients with Active Rheumatoid Arthritis and an Inadequate Response to Conventional Synthetic or Biologic Disease-Modifying Anti-Rheumatic Drugs: Results from SELECT-NEXT and SELECT-BEYOND Phase 3 Studies; Poster Session; Monday, November 11, 2019, 9:00 a.m.-11:00 a.m. EST
• Patient-Reported Outcomes of Upadacitinib versus Adalimumab Use in Patients with Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate: 26-Week Analysis of a Phase 3 Study; Poster Session; Monday, November 11, 2019, 9:00 a.m.-11:00 a.m. EST
• Impact of 24- or 26-Week Upadacitinib Monotherapy on Patient-Reported Outcomes in Patients with Moderately to Severely Active Rheumatoid Arthritis and No Prior Use of or an Inadequate Response to Methotrexate: Results from Two Phase 3 Trials; Poster Session; Monday, November 11, 2019, 9:00 a.m.-11:00 a.m. EST
• Clinical and Functional Outcomes Among Rheumatoid Arthritis Patients Switching Between JAK1-Selective Inhibitor Upadacitinib and Adalimumab Following Insufficient Response; Oral Presentation; Wednesday, November 13, 2019, 11:00 a.m.-12:30 p.m. EST

ADALIMUMAB ABSTRACTS

Psoriatic Arthritis

• The Impact of Adalimumab vs Placebo on Patient-Reported Outcomes and Utility Measures Among Patients with Moderately to Severely Active Psoriatic Arthritis; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST
• The Impact of Psoriasis Severity on Outcomes Among Psoriatic Arthritis Patients Receiving Adalimumab; Poster Session; Tuesday, November 12, 2019, 9:00 a.m.-11:00 a.m. EST

RISANKIZUMAB ABSTRACT

Psoriatic Arthritis

• Safety and Efficacy Results from the Open Label Extension of a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor in Patients with Active Psoriatic Arthritis; Oral Presentation; Wednesday, November 13, 2019, 9:00 a.m.-10:30 a.m. EST

The 2019 ACR/ARP Annual Meeting abstracts are available at www.acrabstracts.org.

Rheumatic diseases affect patients' joints, tendons, ligaments, bones and muscles.¹ Early diagnosis and intervention with an effective treatment is critical to controlling rheumatic diseases and preventing permanent damage.²

About RINVOQ³
Discovered and developed by AbbVie, RINVOQ is an oral JAK inhibitor approved by the U.S. Food and Drug Administration (FDA) and under review with health authorities globally for the treatment of moderately to severely active rheumatoid arthritis and being studied in other immune-mediated inflammatory diseases.^4-13 Earlier this year, RINVOQ received U.S. Food and Drug Administration approval for patients with moderately to severely active rheumatoid arthritis. RINVOQ also received a positive opinion from the Committee for Medicinal Products for Human Use and is currently in European Union regulatory review for patients with moderately to severely active rheumatoid arthritis. Phase 3 trials of RINVOQ in psoriatic arthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing and it is also being investigated to treat ankylosing spondylitis. ^4,8-12

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.

Important Safety Information about RINVOQ™ (upadacitinib)

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:

• 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:

• 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 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 SKYRIZI¹⁴
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.¹⁵

SKYRIZI is approved in the U.S., European Union and Canada for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies.

Phase 3 trials of SKYRIZI in Crohn's disease and psoriatic arthritis are ongoing, and it is also being investigated to treat ulcerative colitis.^13,16-19

SKYRIZI (risankizumab-rzaa) U.S. Use and Important Safety Information
SKYRIZI™ is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

What is the most important information I should know about SKYRIZI?
SKYRIZI may cause serious side effects, including infections. SKYRIZI is a prescription medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

• Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
  • fever, sweats, or chills
  • muscle aches
  • weight loss
  • cough
  • warm, red, or painful skin or sores on your body different from your psoriasis
  • diarrhea or stomach pain
  • shortness of breath
  • blood in your mucus (phlegm)
  • burning when you urinate or urinating more often than normal

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?"
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with SKYRIZI.
• are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"

The most common side effects of SKYRIZI include upper respiratory infections, fungal skin infections, headache, feeling tired and injection site reactions.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it.

Please click here for the Full Prescribing Information and Medication Guide.

About HUMIRA in the U.S.
Uses²⁰

HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
  • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
  • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
  • Ankylosing spondylitis (AS) in adults.
  • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
  • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
  • Moderate to severe hidradenitis suppurativa in people 12 years and older.
• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

Important Safety Information
HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy, even if their TB test was negative. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated.

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA.

Common side effects of HUMIRA include injection site reactions (redness, rash, swelling,

itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

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.

SOURCE AbbVie