11-Oct-2023

AbbVie Showcases Breadth and Depth of Research in Crohn's Disease and Ulcerative Colitis at UEG Week 2023

– Late-breaking data from a head-to-head study evaluating SKYRIZI^®(risankizumab) versus STELARA^® (ustekinumab) in moderate to severe Crohn's disease will be presented
–   Analyses on clinical and endoscopic outcomes from AbbVie's maintenance trials for SKYRIZI^® (risankizumab) and RINVOQ^® (upadacitinib) in moderate to severe Crohn's disease and for RINVOQ in moderate to severe ulcerative colitis
–   Primary efficacy and safety results from the Phase 3 INSPIRE induction study for risankizumab in ulcerative colitis will be presented
–   A total of 23 abstracts, including a late-breaker, with 11 oral presentations, reinforce AbbVie's commitment to research into advancing standards of care for people living with inflammatory bowel diseases (IBD)

NORTH CHICAGO, Ill., Oct. 10, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) will share new data from its robust gastroenterology portfolio at the United European Gastroenterology (UEG) Week 2023 Congress taking place in Copenhagen, Denmark from October 14-17. AbbVie will showcase a total of 23 abstracts, including a late-breaker, with 11 oral presentations and 12 poster presentations spanning research on risankizumab (SKYRIZI^®) and upadacitinib (RINVOQ^®) in both Crohn's disease (CD) and ulcerative colitis (UC).

"Our continued commitment to research in IBD demonstrates our relentless quest to elevating standards of care for those living with disruptive gastroenterological conditions," said Sofie Berg, PharmD, Ph.D., head of gastroenterology, global medical affairs, AbbVie. "We look forward to convening with the IBD community at UEG Week once again to share recent findings from our IBD portfolio and also learning more about the recent progress across the field."

Key data presentations will include:

Research highlighting endoscopic outcomes with SKYRIZI and RINVOQ for CD:
- LB01: Risankizumab versus ustekinumab for patients with moderate to severe Crohn's disease: results from the phase 3b SEQUENCE study; Sunday, October 15, 17:00-17:12 CEST
- OP100: Maintenance of clinical, endoscopic, and biomarker improvements with upadacitinib in patients with moderately to severely active Crohn's disease: a post hoc analysis of the phase 3 U-ENDURE study; Monday, October 16, 15:06-15:18 CEST
Insights on long-term use with RINVOQ for UC:
- PP0853: Achievement of long-term treatment goals with upadacitinib in patients with moderately to severely active ulcerative colitis: a post-hoc analysis of induction and maintenance phase 3 trials; Sunday, October 15, 10:00 CEST
- OP149: Efficacy and safety of upadacitinib after 2 years of treatment in patients with moderately to severely active ulcerative colitis: interim results from the phase 3 open-label extension study (U-ACTIVATE); Tuesday, October 17, 08:54-09:06 CEST
Primary efficacy and safety results from the Phase 3 induction study for risankizumab in UC:
- OP021: Risankizumab induction therapy in patients with moderately to severely active ulcerative colitis: efficacy and safety in the randomized phase 3 INSPIRE study; Sunday, October 15, 17:48-18:00 CEST

The full scientific program for the UEG 2023 is available here.

"Recently, there have been many positive strides made in the IBD treatment landscape. However, those suffering with IBD are still experiencing unpredictable flare-ups and ongoing unresolved inflammation," said Remo Panaccione, MD, professor of medicine and director of the IBD unit, University of Calgary. "The research that will be presented by AbbVie at UEG Week 2023 will advance knowledge to better address how new therapies may further benefit patients with these challenging conditions with the aim to maximize clinical and endoscopic outcomes."

The use of risankizumab is investigational in ulcerative colitis.

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

About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.^1,2 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.^1,2 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.¹

About Ulcerative Colitis
Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.^3,4 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.^3,4 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or life-threatening complications.^5,6 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.⁷

About Risankizumab (SKYRIZI^®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.⁸ IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.⁹ SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease. Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.^9-11

U.S. Indications and Important Safety Information about SKYRIZI^®(risankizumab-rzaa)¹²SKYRIZI 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.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SKYRIZI^® (risankizumab-rzaa)?
SKYRIZI is a prescription medicine that may cause serious side effects, including:
Serious allergic reactions:

Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a 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). Medicines 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 on-body injector.

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 Full Prescribing Information and Medication Guide for SKYRIZI.

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

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.¹³ Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 and JAK-2 relative to JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.¹⁴

Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis, Takayasu arteritis, and systemic juvenile idiopathic arthritis are ongoing.^15-23

RINVOQ (upadacitinib) U.S. Uses and Important Safety Information¹⁴

RINVOQ is a prescription medicine used to treat:

Adults with moderate to severe rheumatoid arthritis (RA) 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 (PsA) 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 (AS) 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.
Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have 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, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease.

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 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. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting.
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.
There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110.
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, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis).

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.

Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your healthcare provider.

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.

About AbbVie in Gastroenterology
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X (formerly 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 and uses of future or conditional verbs, 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 expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, 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 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, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

NORTH CHICAGO, Ill., Oct. 10, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) will share new data from its robust gastroenterology portfolio at the United European Gastroenterology (UEG) Week 2023 Congress taking place in Copenhagen, Denmark from October 14-17. AbbVie will showcase a total of 23 abstracts, including a late-breaker, with 11 oral presentations and 12 poster presentations spanning research on risankizumab (SKYRIZI^®) and upadacitinib (RINVOQ^®) in both Crohn's disease (CD) and ulcerative colitis (UC).

Key data presentations will include:

Research highlighting endoscopic outcomes with SKYRIZI and RINVOQ for CD:
- LB01: Risankizumab versus ustekinumab for patients with moderate to severe Crohn's disease: results from the phase 3b SEQUENCE study; Sunday, October 15, 17:00-17:12 CEST
- OP100: Maintenance of clinical, endoscopic, and biomarker improvements with upadacitinib in patients with moderately to severely active Crohn's disease: a post hoc analysis of the phase 3 U-ENDURE study; Monday, October 16, 15:06-15:18 CEST
Insights on long-term use with RINVOQ for UC:
- PP0853: Achievement of long-term treatment goals with upadacitinib in patients with moderately to severely active ulcerative colitis: a post-hoc analysis of induction and maintenance phase 3 trials; Sunday, October 15, 10:00 CEST
- OP149: Efficacy and safety of upadacitinib after 2 years of treatment in patients with moderately to severely active ulcerative colitis: interim results from the phase 3 open-label extension study (U-ACTIVATE); Tuesday, October 17, 08:54-09:06 CEST
Primary efficacy and safety results from the Phase 3 induction study for risankizumab in UC:
- OP021: Risankizumab induction therapy in patients with moderately to severely active ulcerative colitis: efficacy and safety in the randomized phase 3 INSPIRE study; Sunday, October 15, 17:48-18:00 CEST

The full scientific program for the UEG 2023 is available here.

The use of risankizumab is investigational in ulcerative colitis.

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

U.S. Indications and Important Safety Information about SKYRIZI^®(risankizumab-rzaa)¹²SKYRIZI 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.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SKYRIZI^® (risankizumab-rzaa)?
SKYRIZI is a prescription medicine that may cause serious side effects, including:
Serious allergic reactions:

Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:

Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

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). Medicines 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?"

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.

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 Full Prescribing Information and Medication Guide for SKYRIZI.

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

RINVOQ (upadacitinib) U.S. Uses and Important Safety Information¹⁴

RINVOQ is a prescription medicine used to treat:

Adults with moderate to severe rheumatoid arthritis (RA) 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 (PsA) 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 (AS) 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.
Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

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 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. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting.
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.
There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110.
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.

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.

Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your healthcare provider.

These are not all the possible side effects of RINVOQ.

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.

References:

Crohn's disease. Symptoms and Causes. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304.
The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.
Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019;65(12):100851. doi:10.1016/j.disamonth.2019.02.004
The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation of America. Accessed September 26, 2023. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
Ulcerative colitis. Mayo Clinic. Accessed September 26, 2023. https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326
Surgery for Crohn's Disease and Ulcerative Colitis. Crohn's & Colitis Foundation of America. Accessed September 26, 2023. https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/surgery_brochure_final.pdf
Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016;22(3 Suppl):s51-60.
Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on September 26, 2023.
A study comparing risankizumab to placebo in participants with active psoriatic arthritis including those who have a history of inadequate response or intolerance to biologic therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. Updated February 28, 2023. Accessed September 26, 2023. https://clinicaltrials.gov/ct2/show/NCT03671148
A multicenter, randomized, double-blind, placebo controlled induction study to evaluate the efficacy and safety of risankizumab in participants with moderately to severely active ulcerative colitis. ClinicalTrials.gov. Updated March 10, 2023. Accessed September 26, 2023. https://clinicaltrials.gov/ct2/show/record/NCT03398148
SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.
Pipeline – Our Science | AbbVie. 2023. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on September 26, 2023.
RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2023.
A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on September 26, 2023.
Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on September 26, 2023.
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. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on September 26, 2023.
A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on September 26, 2023.
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed on September 26, 2023.
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on September 26, 2023.
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell rteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on September 26, 2023.
A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed on September 26, 2023.
A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib With a Tocilizumab Reference Arm in Subjects From 1 Year to Less Than 18 Years Old With Active Systemic Juvenile Idiopathic Arthritis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05609630?cond=Systemic%20Juvenile%20Idiopathic%20Arthritis&intr=Upadacitinib&rank=1. Accessed on September 26, 2023.

Crohn's disease. Symptoms and Causes. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304.
The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.
Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019;65(12):100851. doi:10.1016/j.disamonth.2019.02.004
The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation of America. Accessed September 26, 2023. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
Ulcerative colitis. Mayo Clinic. Accessed September 26, 2023. https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326
Surgery for Crohn's Disease and Ulcerative Colitis. Crohn's & Colitis Foundation of America. Accessed September 26, 2023. https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/surgery_brochure_final.pdf
Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016;22(3 Suppl):s51-60.
Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on September 26, 2023.
A study comparing risankizumab to placebo in participants with active psoriatic arthritis including those who have a history of inadequate response or intolerance to biologic therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. Updated February 28, 2023. Accessed September 26, 2023. https://clinicaltrials.gov/ct2/show/NCT03671148
A multicenter, randomized, double-blind, placebo controlled induction study to evaluate the efficacy and safety of risankizumab in participants with moderately to severely active ulcerative colitis. ClinicalTrials.gov. Updated March 10, 2023. Accessed September 26, 2023. https://clinicaltrials.gov/ct2/show/record/NCT03398148
SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.
Pipeline – Our Science | AbbVie. 2023. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on September 26, 2023.
RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2023.
A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on September 26, 2023.
Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on September 26, 2023.
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. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on September 26, 2023.
A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on September 26, 2023.
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed on September 26, 2023.
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on September 26, 2023.
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell rteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on September 26, 2023.
A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed on September 26, 2023.
A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib With a Tocilizumab Reference Arm in Subjects From 1 Year to Less Than 18 Years Old With Active Systemic Juvenile Idiopathic Arthritis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05609630?cond=Systemic%20Juvenile%20Idiopathic%20Arthritis&intr=Upadacitinib&rank=1. Accessed on September 26, 2023.

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Last Updated: 11-Oct-2023