News

• Analyses highlight long-term efficacy and safety results, including real-world data, from studies of SKYRIZI^® (risankizumab) in moderate to severe psoriasis and active psoriatic arthritis
• Presentations include data from the largest-of-its-kind study that demonstrates the real-world burden of atopic dermatitis
• Breadth of data underscores AbbVie's commitment to advancing research in dermatology for people living with immune-mediated skin diseases such as psoriasis, psoriatic arthritis, atopic dermatitis and vitiligo

NORTH CHICAGO, Ill., Aug. 29, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present 23 abstracts at the 31^st European Academy of Dermatology and Venereology (EADV) Congress, including a late-breaking oral presentation on long-term efficacy and safety data of SKYRIZI^® (risankizumab) in psoriatic arthritis and real-world data from MEASURE-AD to assess the multidimensional burden of atopic dermatitis. This research demonstrates AbbVie's commitment to deepening the understanding of immune-mediated skin diseases by investing in studies of difficult-to-treat patient populations, certain disease areas with few existing treatment options as well as real-world patient experience. The hybrid congress will take place from September 7-10, in Milan, as well as virtually.

"Our leadership in dermatology runs deep – from developing innovative technologies to studying lesser-understood diseases where few to no treatment options currently exist," said Chiedzo Mpofu, MBChB, Ph.D., vice president, Global Medical Affairs, Immunology, AbbVie. "At this year's EADV Congress, we're presenting a range of data, including real-world, patient-centered research that will help elevate the community's understanding of the long-term impact of our treatments and the potential to support patients with difficult-to-treat diseases."

Key data to be presented include:

• Late-breaking oral presentation of new data from the ongoing Phase 3 active psoriatic arthritis clinical trials, KEEPsAKE 1 and KEEPsAKE 2, evaluating long-term efficacy and safety, up to 100 weeks, in patients treated with SKYRIZI (risankizumab)
• Analyses from MEASURE-AD, a cross-sectional, 28-country, burden of disease study aimed to characterize global treatment patterns, healthcare resource utilization and costs, and the clinical and economic burden of moderate to severe atopic dermatitis
• Results from VALUE, a 13-month interim analysis from a long-term, prospective observational study that has enrolled 2,700 patients from 21 countries, evaluating real-world efficacy, durability of response and time to first treatment change for moderate to severe psoriasis patients treated with SKYRIZI (risankizumab) compared to other commonly used treatments
• Results from aIMM, a Phase 3b, multicenter, interventional, open-label, single-arm study analyzing clinical efficacy, safety and quality-of-life outcomes after 16 weeks of treatment with SKYRIZI (risankizumab) in psoriasis patients who previously achieved suboptimal responses to one of two IL-17 inhibitors, either secukinumab or ixekizumab
• Interim analysis of the nearly 5-year (256 weeks) LIMMitless open-label extension study evaluating long-term efficacy and safety data with continuous SKYRIZI (risankizumab) treatment in patients with moderate to severe plaque psoriasis
• Two real-world insurance claims database analyses examining economic and comorbidity impacts on patients with vitiligo

AbbVie abstracts at the EADV Congress include:

The full EADV scientific program is available here.

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and commercialization of SKYRIZI globally.

About SKYRIZI^® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.^1,2 Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.^3-5

US Indications and Important Safety Information about SKYRIZI^® (risankizumab-rzaa)²

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.

IMPORTANT SAFETY INFORMATION

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 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
• muscle aches
• weight loss
• cough
• warm, red, or painful skin or sores on your body different from your psoriasis
• diarrhea or stomach pain
• shortness of breath
• blood in your mucus (phlegm)
• burning when you urinate or urinating more often than normal

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.

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.

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 people with Crohn's disease: A person with Crohn's disease who received SKYRIZI by intravenous infusion developed changes in liver blood tests with a rash that led to hospitalization. Your doctor 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 doctor 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, injection site reactions, fever, headache, stomach (abdominal) pain, back pain, joint pain, and low red blood cells (anemia).

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

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

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

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL intravenous infusion, and a 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 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.⁶ Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3 and TYK-2.⁶ The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Phase 3 trials of RINVOQ in atopic dermatitis, axial spondylarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, Takayasu arteritis and ulcerative colitis are ongoing.^5,7-15

US Indications and Important Safety Information about RINVOQ^® (upadacitinib)⁶

USES
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 moderate to severe 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.

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

• Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) 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.

IMPORTANT SAFETY INFORMATION

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.

What should I tell my HCP BEFORE starting RINVOQ?

Tell your HCP if you:

• Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as:

• Have TB or have been in close contact with someone with TB.
• Are a current or past smoker.
• Have had a heart attack, other heart problems, or stroke.
• Have or 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 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 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 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:

• 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.

About AbbVie in Dermatology 
For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease. For more information on AbbVie in dermatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.html. 

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, 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, 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 2021 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.

References:

1. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
2.  SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.
3. A Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed August 5, 2022.
4. 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. 2021. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on August 5, 2022.
5. Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on August 5, 2022.
6. Abbvie, Ltd. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.; 2022.
7. Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. The Lancet. 2022;399(10341):2113-2128. doi:10.1016/S0140-6736(22)00581-5
8. Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Annals of the Rheumatic Diseases. 2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870
9. Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. The Lancet. 2021;397(10290):2151-2168. doi:10.1016/S0140-6736(21)00588-2
10. van der Heijde D, Song IH, Pangan AL, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019;394(10214):2108-2117. doi:10.1016/S0140-6736(19)32534-6.
11. A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants with Ulcerative Colitis (UC). clinicaltrials.gov; 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03006068. Accessed on August 5, 2022.
12. 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 August 5, 2022.
13. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants with Axial Spondyloarthritis. clinicaltrials.gov; 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on August 5, 2022.
14. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis. clinicaltrials.gov; 2022. August 5, 2022. https://clinicaltrials.gov/ct2/show/NCT03725202.
15. A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants with Crohn's Disease Who Completed the Studies M14-431 or M14-433. clinicaltrials.gov; 2022. August 5, 2022. https://clinicaltrials.gov/ct2/show/NCT03345823.

SOURCE AbbVie