AbbVie Releases New Data Demonstrating Breadth of Its Gastroenterology Portfolio at 2023 Digestive Disease Week®

- Oral presentations highlight efficacy and safety outcomes from the upadacitinib (RINVOQ ^® ) clinical trial program in adults with moderately to severely active Crohn's disease, and investigational use of linaclotide (LINZESS ^® ) in treating functional constipation in pediatric patients aged 6 to 17 years

- Twenty-nine abstracts showcase AbbVie's   vast portfolio and continued commitment to changing the way patients living with gastrointestinal disorders manage their condition

AbbVie (NYSE: ABBV) today announced it will present 29 abstracts during the 2023 Digestive Disease Week (DDW) Annual Meeting, May 6-9, 2023 being held in Chicago and virtually.

"Our abstracts showcase our comprehensive, well-researched gastroenterology portfolio," said Celine Goldberger , M.D., vice president, and head of U.S. medical affairs, AbbVie. "This collective evidence underscores data across a range of digestive and inflammatory bowel diseases and reinforces our commitment to improving patient care."

The oral and poster presentations from AbbVie feature research across the company's gastroenterology portfolio, including data on Crohn's disease, ulcerative colitis, and functional constipation. Notable data presentations will include:

• Two oral presentations and several posters evaluating investigational upadacitinib in adults with moderately to severely active Crohn's disease, including data on fistulas and fissures and among patients who previously failed biologic or conventional treatment.
• Several posters of risankizumab in adults with moderately to severely active Crohn's disease, including results from three Phase 3 studies (ADVANCE, MOTIVATE, and FORTIFY) assessing risankizumab as induction therapy for patients who did not previously achieve a clinical response to therapy, as well as long-term efficacy and safety data.
• An oral presentation and posters assessing investigational linaclotide in pediatric patients (ages 6 to 17 years) with functional constipation, including efficacy and safety data from a Phase 3 trial and an interim analysis of long-term safety from an open-label trial.

Select AbbVie abstracts at 2023 DDW are outlined below. The full list of 2023 DDW Annual Meeting e-Posters is available here .

SKYRIZI ^® (risankizumab-rzaa) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally.

LINZESS ^® (linaclotide) is part of a collaboration between AbbVie and Ironwood Pharmaceuticals to share development and commercialization of LINZESS in the United States .

The use of upadacitinib in Crohn's disease is not approved   by the U.S. Food and Drug Administration (FDA). Its safety and efficacy are under evaluation as part of ongoing registrational studies.

RINVOQ ^® (upadacitinib) U.S. Uses and Important Safety Information   ¹

RINVOQ is a prescription medicine used to treat:

• Adults with moderate to severe rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used and did not work well or could not be tolerated.
• Adults with active psoriatic arthritis when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
• Adults with moderately to severely active ulcerative colitis when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
• Adults with active ankylosing spondylitis when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
• Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used and did not work well or could not be tolerated.

It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

• Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or when the use of other pills or injections is not recommended.

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:

• Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while 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 healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
• Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
• Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
• Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
• Blood clots: Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
• Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
• Tears in the stomach or intestines and changes in certain laboratory tests. 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.

Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

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.
• Are a current or past smoker.
• Have had a heart attack, other heart problems, or stroke.
• Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), 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 red or white blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
• Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of 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 findings in 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 during treatment with RINVOQ and for 4 weeks after your last dose.
• Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 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

If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.

What should I avoid while taking RINVOQ?

Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.

What should I do or 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.
• Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
• Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
• Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• Pain or discomfort in your arms, back, neck, jaw, or stomach
• Shortness of breath with or without chest discomfort
• Breaking out in a cold sweat
• Nausea or vomiting
• Feeling lightheaded
• Weakness in one part or on one side of your body
• Slurred speech
• Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:
• Swelling
• Pain or tenderness in one or both legs
• Sudden unexplained chest or upper back pain
• Shortness of breath or difficulty breathing
• Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are   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 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.

LINZESS ^® (linaclotide) Uses and Important Safety Information ²

USES

LINZESS ^® (linaclotide) is a prescription medication used in adults to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). "Idiopathic" means the cause of the constipation is unknown. It is not known if LINZESS is safe and effective in children less than 18 years of age.

IMPORTANT RISK INFORMATION

• Do not give LINZESS to children who are less than 2 years of age. It may harm them. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
• Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction).

Before you take LINZESS, tell your doctor about your medical conditions, including if you are:

• Pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby.
• Breastfeeding or plan to breastfeed. You and your doctor should decide if you will take LINZESS and breastfeed.

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

Side Effects

LINZESS can cause serious side effects, including diarrhea, which is the most common side effect and can sometimes be severe. Diarrhea often begins within the first 2 weeks of LINZESS treatment. Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS.

Other common side effects of LINZESS include gas, stomach-area (abdominal) pain, swelling, or a feeling of fullness or pressure in your abdomen (distension). Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdominal) pain, especially if you also have bright red, bloody stools or black stools that look like tar.

These are not all the possible side effects of LINZESS. For more information, ask your doctor or pharmacist.

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 and Ironwood may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please see full Prescribing Information including Boxed Warning.

SKYRIZI (risankizumab-rzaa) U.S. Uses and Important Safety Information   ³

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).
• active psoriatic arthritis (PsA).
• moderate to severe Crohn's disease.

What is the most important information I should know about SKYRIZI ^® (risankizumab-rzaa)?

SKYRIZI is a prescription medication that may cause serious side effects, including:

Serious allergic reactions:

• Stop using SKYRIZI and get emergency help right away if you get any of the following symptoms of serious allergic reaction:
• Fainting, dizziness, feeling lightheaded (low blood pressure)
• Swelling of your face, eyelids, lips, mouth, tongue, or throat
• Trouble breathing or throat tightness
• Chest tightness
• Skin rash, hives
• Itching

Infections:  
SKYRIZI 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
• Cough
• Shortness of breath
• Blood in your mucus (phlegm)
• Muscle aches
• Warm, red, or painful skin or sores on your body different from your psoriasis
• Weight loss
• Diarrhea or stomach pain
• Burning when you urinate or urinating more often than normal

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

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). Medications that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
• 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.
• Become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

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?"

Liver problems in Crohn's disease: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.

The most common side effects of SKYRIZI in people treated for Crohn's disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection.

The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.

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.

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with an on-body injector.

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 Full Prescribing Information and Medication Guide for SKYRIZI.

Globally, prescribing information varies; refer to the individual country product label for complete information .

About Digestive Disease Week®
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 6-9, 2023 . The meeting showcases more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org .

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 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 2022 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.

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References:

1. RINVOQ (upadacitinib) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
2. LINZESS (linaclotide) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
3. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill. : AbbVie Inc.

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SOURCE AbbVie