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

–   Late-breaking information from a head-to-head research evaluating SKYRIZI^® (risankizumab) versus STELARA^® (ustekinumab) in reasonable to extreme Crohn’s illness will probably be introduced
–   Analyses on scientific and endoscopic outcomes from AbbVie’s upkeep trials for SKYRIZI^® (risankizumab) and RINVOQ^® (upadacitinib) in reasonable to extreme Crohn’s illness and for RINVOQ in reasonable to extreme ulcerative colitis
–   Major efficacy and security outcomes from the Section 3 INSPIRE induction research for risankizumab in ulcerative colitis will probably be introduced
–   A complete of 23 abstracts, together with a late-breaker, with 11 oral shows, reinforce AbbVie’s dedication to analysis into advancing requirements of take care of individuals dwelling with inflammatory bowel illnesses (IBD) 

NORTH CHICAGO, Sick., Oct. 10, 2023 /PRNewswire/ — AbbVie (NYSE: ABBV) will share new information from its strong gastroenterology portfolio on the United European Gastroenterology (UEG) Week 2023 Congress going down in Copenhagen, Denmark from October 14-17. AbbVie will showcase a complete of 23 abstracts, together with a late-breaker, with 11 oral shows and 12 poster shows spanning analysis on risankizumab (SKYRIZI^®) and upadacitinib (RINVOQ^®) in each Crohn’s illness (CD) and ulcerative colitis (UC).

“Our continued dedication to analysis in IBD demonstrates our relentless quest to elevating requirements of take care of these dwelling with disruptive gastroenterological situations,” mentioned Sofie Berg, PharmD, Ph.D., head of gastroenterology, world medical affairs, AbbVie. “We stay up for convening with the IBD group at UEG Week as soon as once more to share latest findings from our IBD portfolio and in addition studying extra in regards to the latest progress throughout the sphere.”

Key information shows will embrace:

• Analysis highlighting endoscopic outcomes with SKYRIZI and RINVOQ for CD:
  • LB01: Risankizumab versus ustekinumab for sufferers with reasonable to extreme Crohn’s illness: outcomes from the section 3b SEQUENCE research; Sunday, October 15, 17:00-17:12 CEST
  • OP100: Upkeep of scientific, endoscopic, and biomarker enhancements with upadacitinib in sufferers with reasonably to severely energetic Crohn’s illness: a put up hoc evaluation of the section 3 U-ENDURE research; Monday, October 16, 15:06-15:18 CEST
• Insights on long-term use with RINVOQ for UC:
  • PP0853: Achievement of long-term remedy objectives with upadacitinib in sufferers with reasonably to severely energetic ulcerative colitis: a post-hoc evaluation of induction and upkeep section 3 trials; Sunday, October 15, 10:00 CEST
  • OP149: Efficacy and security of upadacitinib after 2 years of remedy in sufferers with reasonably to severely energetic ulcerative colitis: interim outcomes from the section 3 open-label extension research (U-ACTIVATE); Tuesday, October 17, 08:54-09:06 CEST
• Major efficacy and security outcomes from the Section 3 induction research for risankizumab in UC:
  • OP021: Risankizumab induction remedy in sufferers with reasonably to severely energetic ulcerative colitis: efficacy and security within the randomized section 3 INSPIRE research; Sunday, October 15, 17:48-18:00 CEST

The complete scientific program for the UEG 2023 is accessible right here.

“Just lately, there have been many optimistic strides made within the IBD remedy panorama. Nonetheless, these struggling with IBD are nonetheless experiencing unpredictable flare-ups and ongoing unresolved irritation,” mentioned Remo Panaccione, MD, professor of drugs and director of the IBD unit, College of Calgary. “The analysis that will probably be introduced by AbbVie at UEG Week 2023 will advance information to raised deal with how new therapies might additional profit sufferers with these difficult situations with the goal to maximise scientific and endoscopic outcomes.”

The usage of risankizumab is investigational in ulcerative colitis.

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

About Crohn’s Illness
Crohn’s illness is a power, systemic illness that manifests as irritation throughout the gastrointestinal tract, inflicting persistent diarrhea and belly ache.^1,2 It’s a progressive illness, that means it will get worse over time in a considerable proportion of sufferers or might develop problems that require pressing medical care, together with surgical procedure.^1,2 As a result of the indicators and signs of Crohn’s illness are unpredictable, it causes a major burden on individuals dwelling with the illness—not solely bodily, but additionally emotionally and economically.¹

About Ulcerative Colitis
Ulcerative colitis is a power, idiopathic, immune-mediated inflammatory bowel illness (IBD) of the massive gut that causes steady mucosal irritation extending, to a variable extent, from the rectum to the extra proximal colon.^3,4 The hallmark indicators and signs of ulcerative colitis embrace rectal bleeding, belly ache, bloody diarrhea, tenesmus (a way of stress), urgency and fecal incontinence.^3,4 The illness course of ulcerative colitis varies between sufferers and might vary from quiescent illness to power refractory illness, which in some instances can result in surgical procedure or life-threatening problems.^5,6 The severity of signs and unpredictability of illness course can result in substantial burden and infrequently incapacity amongst these dwelling with the illness.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 concerned in inflammatory processes, is regarded as linked to numerous power immune-mediated illnesses.⁹ SKYRIZI is permitted by the U.S. Meals and Drug Administration (FDA) and the European Medicines Company for the remedy of plaque psoriasis, psoriatic arthritis and Crohn’s illness. Section 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn’s illness and ulcerative colitis are ongoing.^{Sep 11}

U.S. Indications and Essential Security Details about SKYRIZI^® (risankizumab-rzaa)¹²
SKYRIZI is a prescription medication used to deal with adults with:

• reasonable to extreme plaque psoriasis who might profit from taking injections or tablets (systemic remedy) or remedy utilizing ultraviolet or UV gentle (phototherapy).
• energetic psoriatic arthritis (PsA).
• reasonable to extreme Crohn’s illness.

IMPORTANT SAFETY INFORMATION

What’s a very powerful data I ought to learn about SKYRIZI^® (risankizumab-rzaa)?
SKYRIZI is a prescription medication which will trigger critical unintended effects, together with:
Severe allergic reactions:

• Cease utilizing SKYRIZI and get emergency medical assist straight away when you get any of the next signs of a critical allergic response:

–  fainting, dizziness, feeling lightheaded (low blood stress)
– swelling of your face, eyelids, lips, mouth, tongue, or throat
– hassle respiratory or throat tightness
– chest tightness
– pores and skin rash, hives
– itching

Infections:
SKYRIZI might decrease the flexibility of your immune system to combat infections and should enhance your threat of infections. Your healthcare supplier ought to examine you for infections and tuberculosis (TB) earlier than beginning remedy with SKYRIZI and should deal with you for TB earlier than you start remedy with SKYRIZI you probably have a historical past of TB or have energetic TB. Your healthcare supplier ought to watch you carefully for indicators and signs of TB throughout and after remedy with SKYRIZI.

• Inform your healthcare supplier straight away you probably have an an infection or have signs of an an infection, together with:

– fever, sweats, or chills
– cough
– shortness of breath
– blood in your mucus (phlegm)
– muscle aches
– heat, crimson, or painful pores and skin or sores in your physique totally different out of your psoriasis
– weight reduction
– diarrhea or abdomen ache
– burning if you urinate or urinating extra usually than regular

Don’t use SKYRIZI if you’re allergic to risankizumab-rzaa or any of the substances in SKYRIZI. See the Medicine Information or Shopper Temporary Abstract for a whole checklist of substances.

Earlier than utilizing SKYRIZI, inform your healthcare supplier about your entire medical situations,
together with when you:

• have any of the situations or signs listed within the part “What’s a very powerful data I ought to learn about SKYRIZI?”
• have an an infection that doesn’t go away or that retains coming again.
• have TB or have been in shut contact with somebody with TB.
• have not too long ago obtained or are scheduled to obtain an immunization (vaccine). Medicines that work together with the immune system might enhance your threat of getting an an infection after receiving reside vaccines. You need to keep away from receiving reside vaccines proper earlier than, throughout, or proper after remedy with SKYRIZI. Inform your healthcare supplier that you’re taking SKYRIZI earlier than receiving a vaccine.
• are pregnant or plan to turn into pregnant. It isn’t recognized if SKYRIZI can hurt your unborn child.
• are breastfeeding or plan to breastfeed. It isn’t recognized if SKYRIZI passes into your breast milk.
• turn into pregnant whereas taking SKYRIZI. You might be inspired to enroll within the Being pregnant Registry, which is used to gather details about the well being of you and your child. Speak to your healthcare supplier or name 1-877-302-2161 to enroll on this registry.

Inform your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements.

What are the doable unintended effects of SKYRIZI?
SKYRIZI might trigger critical unintended effects. See “What’s a very powerful data I ought to learn about SKYRIZI?”

Liver issues in Crohn’s illness: An individual with Crohn’s illness who obtained SKYRIZI via a vein within the arm developed adjustments in liver blood checks with a rash that led to hospitalization. Your healthcare supplier will do blood checks to examine your liver earlier than, throughout, and as much as 12 weeks of remedy and should cease remedy with SKYRIZI when you develop liver issues. Inform your healthcare supplier straight away when you discover any of the next signs: unexplained rash, nausea, vomiting, abdomen (belly) ache, tiredness (fatigue), lack of urge for food, yellowing of the pores and skin and eyes (jaundice), and darkish urine.

The most typical unintended effects of SKYRIZI in individuals handled for Crohn’s illness embrace: higher respiratory infections, headache, joint ache, abdomen (belly) ache, injection website reactions, low crimson blood cells (anemia), fever, again ache, and urinary tract an infection.

The most typical unintended effects of SKYRIZI in individuals handled for plaque psoriasis and psoriatic arthritis embrace: higher respiratory infections, headache, feeling drained, injection website reactions, and fungal pores and skin infections.

These usually are not all of the doable unintended effects of SKYRIZI. Name your physician for medical recommendation about
unintended effects.

Use SKYRIZI precisely as your healthcare supplier tells you to make use of it.

SKYRIZI is accessible 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 might be inspired to report unfavourable unintended effects of pharmaceuticals to the FDA. Go to http://www.fda.gov/medwatch or name 1-800-FDA-1088.

If you’re having problem paying to your medication, AbbVie might be able to assist. Go to AbbVie.com/myAbbVieAssist to study extra.

Please click on right here for Full Prescribing Data and Medicine Information for SKYRIZI.

Globally, prescribing data varies; check with the person nation product label for full data.

About RINVOQ^® (upadacitinib)
Found and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that’s being studied in a number of immune-mediated inflammatory illnesses.¹³ Based mostly on enzymatic and mobile assays, RINVOQ demonstrated larger inhibitory efficiency for JAK-1 and JAK-2 relative to JAK-3, and TYK-2. The relevance of inhibition of particular JAK enzymes to therapeutic effectiveness and security will not be presently recognized.¹⁴

Section 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s illness, ulcerative colitis, large cell arteritis, Takayasu arteritis, and systemic juvenile idiopathic arthritis are ongoing.^15-23 

RINVOQ (upadacitinib) U.S. Makes use of and Essential Security Data¹⁴

RINVOQ is a prescription medication used to deal with:

• Adults with reasonable to extreme rheumatoid arthritis (RA) when 1 or extra medicines referred to as tumor necrosis issue (TNF) blockers have been used, and didn’t work properly or couldn’t be tolerated.
• Adults with energetic psoriatic arthritis (PsA) when 1 or extra medicines referred to as TNF blockers have been used, and didn’t work properly or couldn’t be tolerated.
• Adults with energetic ankylosing spondylitis (AS) when 1 or extra medicines referred to as TNF blockers have been used, and didn’t work properly or couldn’t be tolerated.
• Adults with energetic non-radiographic axial spondyloarthritis (nr-axSpA) with goal indicators of irritation when a TNF blocker medication has been used, and didn’t work properly or couldn’t be tolerated.
• Adults with reasonable to extreme ulcerative colitis (UC) when 1 or extra medicines referred to as TNF blockers have been used, and didn’t work properly or couldn’t be tolerated.
• Adults with reasonable to extreme Crohn’s illness (CD) when 1 or extra medicines referred to as TNF blockers have been used, and didn’t work properly or couldn’t be tolerated.

It isn’t recognized if RINVOQ is protected and efficient in kids with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn’s illness.

• Adults and kids 12 years of age and older with reasonable to extreme eczema (atopic dermatitis [AD]) that didn’t reply to earlier remedy and their eczema will not be properly managed with different tablets or injections, together with biologic medicines, or the usage of different tablets or injections will not be beneficial.

RINVOQ is protected and efficient in kids 12 years of age and older weighing no less than 88 kilos (40 kg) with atopic dermatitis.

It isn’t recognized if RINVOQ is protected and efficient in kids below 12 years of age with atopic dermatitis.

What’s a very powerful data I ought to learn about RINVOQ?
RINVOQ might trigger critical unintended effects, together with:

• Severe infections. RINVOQ can decrease your capacity to combat infections. Severe infections have occurred whereas taking RINVOQ, together with tuberculosis (TB) and infections attributable to micro organism, fungi, or viruses that may unfold all through the physique. Some individuals have died from these infections. Your healthcare supplier (HCP) ought to check you for TB earlier than beginning RINVOQ and examine you carefully for indicators and signs of TB throughout remedy with RINVOQ. You shouldn’t begin taking RINVOQ you probably have any type of an infection until your HCP tells you it’s okay. When you get a critical an infection, your HCP might cease your remedy till your an infection is managed. It’s possible you’ll be at greater threat of creating shingles (herpes zoster).
• Elevated threat of demise in individuals 50 years and older who’ve no less than 1 coronary heart illness (cardiovascular) threat issue.
• Most cancers and immune system issues. RINVOQ might enhance your threat of sure cancers. Lymphoma and different cancers, together with pores and skin cancers, can occur. Present or previous people who smoke are at greater threat of sure cancers, together with lymphoma and lung most cancers. Comply with your HCP’s recommendation about having your pores and skin checked for pores and skin most cancers throughout remedy with RINVOQ. Restrict the period of time you spend in daylight. Put on protecting clothes if you find yourself within the solar and use sunscreen.
• Elevated threat of main cardiovascular (CV) occasions, similar to coronary heart assault, stroke, or demise, in individuals 50 years and older who’ve no less than 1 coronary heart illness (CV) threat issue, particularly if you’re a present or previous smoker.
• Blood clots: Blood clots within the veins of the legs or lungs and arteries can occur with RINVOQ. This can be life-threatening and trigger demise. Blood clots within the veins of the legs and lungs have occurred extra usually in people who find themselves 50 years and older and with no less than 1 coronary heart illness (CV) threat issue.
• Allergic reactions. Signs similar to rash (hives), hassle respiratory, feeling faint or dizzy, or swelling of your lips, tongue, or throat, which will imply you might be having an allergic response have been seen in individuals taking RINVOQ. A few of these reactions have been critical. If any of those signs happen throughout remedy with RINVOQ, cease taking RINVOQ and get emergency medical assist straight away.
• Tears within the abdomen or intestines. This occurs most frequently in individuals who take nonsteroidal anti-inflammatory medication (NSAIDs) or corticosteroids. Get medical assist straight away when you get stomach-area ache, fever, chills, nausea, or vomiting.
• Adjustments in sure laboratory checks. Your HCP ought to do blood checks earlier than you begin taking RINVOQ and whilst you take it. Your HCP might cease your RINVOQ remedy for a time period if wanted due to adjustments in these blood check outcomes.

Don’t take RINVOQ if you’re allergic to upadacitinib or any of the substances in RINVOQ. See the Medicine Information or Shopper Temporary Abstract for a whole checklist of substances.

What ought to I inform my HCP BEFORE beginning RINVOQ?
Inform your HCP when you:

• Are being handled for an an infection, have an an infection that will not go away or retains coming again, or have signs of an an infection similar to:
• Fever, sweating, or chills
• Shortness of breath
• Heat, crimson, or painful pores and skin or sores in your physique
• Muscle aches
• Feeling drained
• Blood in phlegm
• Diarrhea or abdomen ache
• Cough
• Weight reduction
• Burning when urinating or urinating extra usually than regular
• Have TB or have been in shut contact with somebody with TB.
• Are a present or previous smoker.
• Have had a coronary heart assault, different coronary heart issues, or stroke.
• Have had any kind of most cancers, hepatitis B or C, shingles (herpes zoster), blood clots within the veins of your legs or lungs, diverticulitis (irritation in elements of the massive gut), or ulcers in your abdomen or intestines.
• Produce other medical situations together with liver issues, low crimson or white blood cell counts, diabetes, power lung illness, HIV, or a weak immune system.
• Reside, have lived, or have traveled to elements of the nation, such because the Ohio and Mississippi River valleys and the Southwest, that enhance your threat of getting sure sorts of fungal infections. If you’re uncertain when you’ve been to a lot of these areas, ask your HCP.
• Have not too long ago obtained or are scheduled to obtain a vaccine. Individuals who take RINVOQ shouldn’t obtain reside vaccines.
• Are pregnant or plan to turn into pregnant. Based mostly on findings in animal research, RINVOQ might hurt your unborn child. Your HCP will examine whether or not or not you might be pregnant earlier than you begin RINVOQ. You need to use efficient contraception (contraception) to keep away from turning into pregnant throughout remedy with RINVOQ and for 4 weeks after your final dose.
• There’s a being pregnant surveillance program for RINVOQ. The aim of this system is to gather details about the well being of you and your child. When you turn into pregnant whereas taking RINVOQ, you might be inspired to report the being pregnant by calling 1-800-633-9110.
• Are breastfeeding or plan to breastfeed. RINVOQ might cross into your breast milk. Don’t breastfeed throughout remedy with RINVOQ and for six days after your final dose.

Inform your HCP about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. RINVOQ and different medicines might have an effect on one another, inflicting unintended effects.

Particularly inform your HCP when you take:

• Medicines for fungal or bacterial infections
• Rifampicin or phenytoin
• Medicines that have an effect on your immune system

If you’re undecided if you’re taking any of those medicines, ask your HCP or pharmacist.

What ought to I keep away from whereas taking RINVOQ?
Keep away from meals or drink containing grapefruit throughout remedy with RINVOQ as it could enhance the chance of unintended effects.

What ought to I do or inform my HCP AFTER beginning RINVOQ?

• Inform your HCP straight away you probably have any signs of an an infection. RINVOQ could make you extra more likely to get infections or make any infections you might have worse.
• Get emergency assist straight away you probably have any signs of a coronary heart assault or stroke whereas taking RINVOQ, together with:
• Discomfort within the heart of your chest that lasts for quite a lot of minutes or that goes away and comes again
• Extreme tightness, ache, stress, or heaviness in your chest, throat, neck, or jaw
• Ache or discomfort in your arms, again, neck, jaw, or abdomen
• Shortness of breath with or with out chest discomfort
• Breaking out in a chilly sweat
• Nausea or vomiting
• Feeling lightheaded
• Weak point in a single half or on one facet of your physique
• Slurred speech
• Inform your HCP straight away you probably have any indicators or signs of blood clots throughout remedy with RINVOQ, together with:
• Swelling
• Ache or tenderness in a single or each legs
• Sudden unexplained chest or higher again ache
• Shortness of breath or problem respiratory
• Inform your HCP straight away you probably have a fever or stomach-area ache that doesn’t go away, and a change in your bowel habits.

What are different doable unintended effects of RINVOQ?
Frequent unintended effects embrace higher respiratory tract infections (frequent chilly, sinus infections), shingles (herpes zoster), herpes simplex virus infections (together with chilly sores), bronchitis, nausea, cough, fever, zits, headache, elevated blood ranges of creatine phosphokinase, allergic reactions, irritation of hair follicles, stomach-area (belly) ache, elevated weight, flu, tiredness, decrease variety of sure varieties of white blood cells (neutropenia, lymphopenia, leukopenia), muscle ache, flu-like sickness, rash, elevated blood levels of cholesterol,  elevated liver enzyme ranges, pneumonia, low variety of crimson blood cells (anemia), and an infection of the abdomen and gut (gastroenteritis).

A separation or tear to the liner of the again a part of the attention (retinal detachment) has occurred in individuals with atopic dermatitis handled with RINVOQ. Name your HCP straight away you probably have any sudden adjustments in your imaginative and prescient throughout remedy with RINVOQ.

Some individuals taking RINVOQ might even see medication residue (an entire pill or pill items) of their stool. If this occurs, name your healthcare supplier.

These usually are not all of the doable unintended effects of RINVOQ.

How ought to I take RINVOQ?
RINVOQ is taken as soon as a day with or with out meals. Don’t break up, crush, or chew the pill. Take RINVOQ precisely as your HCP tells you to make use of it. RINVOQ is accessible in 15 mg, 30 mg, and 45 mg extended-release tablets.

That is a very powerful data to learn about RINVOQ. For extra data, speak to your HCP. 

You might be inspired to report unfavourable unintended effects of pharmaceuticals to the FDA. Go to www.fda.gov/medwatch or name 1-800-FDA-1088.

If you’re having problem paying to your medication, AbbVie might be able to assist. Go to AbbVie.com/myAbbVieAssist to study extra. 

Please click on right here for the Full Prescribing Data and Medicine Information.

Globally, prescribing data varies; check with the person nation product label for full data.

About AbbVie in Gastroenterology
With a sturdy scientific trial program, AbbVie is dedicated to cutting-edge analysis to drive thrilling developments in inflammatory bowel illnesses (IBD), like ulcerative colitis and Crohn’s illness. By innovating, studying and adapting, AbbVie aspires to eradicate the burden of IBD and make a optimistic long-term influence on the lives of individuals with IBD. For extra data on AbbVie in gastroenterology, go to https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.

About AbbVie
AbbVie’s mission is to find and ship progressive medicines and options that resolve critical well being points as we speak and deal with the medical challenges of tomorrow. We try to have a exceptional influence on individuals’s lives throughout a number of key therapeutic areas – immunology, oncology, neuroscience, and eye care – and services and products in our Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com. Comply with @abbvie on X (formerly Twitter) Fb, Instagram, YouTube and LinkedIn. 

Ahead-Trying Statements
Some statements on this information launch are, or could also be thought-about, forward-looking statements for functions of the Personal Securities Litigation Reform Act of 1995. The phrases “imagine,” “anticipate,” “anticipate,” “mission” and related expressions and makes use of of future or conditional verbs, typically establish forward-looking statements. AbbVie cautions that these forward-looking statements are topic to dangers and uncertainties which will trigger precise outcomes to vary materially from these expressed or implied within the forward-looking statements. Such dangers and uncertainties embrace, however usually are not restricted to, challenges to mental property, competitors from different merchandise, difficulties inherent within the analysis and improvement course of, hostile litigation or authorities motion, and adjustments to legal guidelines and rules relevant to our business. Further details about the financial, aggressive, governmental, technological and different elements which will have an effect on AbbVie’s operations is about forth in Merchandise 1A, “Danger Elements,” of AbbVie’s 2022 Annual Report on Kind 10-Ok, which has been filed with the Securities and Trade Fee, as up to date by its subsequent Quarterly Stories on Kind 10-Q. AbbVie undertakes no obligation, and particularly declines, to launch publicly any revisions to forward-looking statements because of subsequent occasions or developments, besides as required by regulation. 

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SOURCE AbbVie