RINVOQ® (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

• In clinical trials, RINVOQ (upadacitinib) achieved the primary endpoints of clinical remission (per modified Mayo Score [mMS]) at weeks 8 and 52^1-4 
• A greater proportion of RINVOQ-treated patients achieved clinical response (per partial mMS [pmMS]) as early as week 2 and steroid-free clinical remission at one year, as well as key endoscopic and histologic improvement endpoints, at weeks 8 and 52⁴ 
• First approved in 2019, RINVOQ is a JAK inhibitor approved for four indications across gastroenterology, dermatology and rheumatology⁴

NORTH CHICAGO, Ill., March 16, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ^® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. This FDA approval is the first indication for RINVOQ in gastroenterology and is supported by efficacy and safety data from three Phase 3 randomized, double-blind, placebo-controlled clinical studies.

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"There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome," said Thomas Hudson, MD, senior vice president of research and development, chief scientific officer, AbbVie. "With the approval of RINVOQ as a new treatment option, AbbVie continues our leadership in advancing research that can help impact the lives of people living with ulcerative colitis." 

The two induction studies (U-ACHIEVE and U-ACCOMPLISH) utilized RINVOQ 45 mg once daily for 8 weeks, and then 15 mg or 30 mg once daily for the maintenance study (U-ACHIEVE maintenance) through 52 weeks.^1-4 Across all clinical trials, significantly more patients treated with RINVOQ achieved clinical remission at weeks 8 and 52, the primary endpoint based on the mMS: stool frequency subscore (SFS) ≤ 1 and not greater than Baseline, rectal bleeding subscore (RBS) = 0, endoscopy subscore (ES) of ≤ 1 without friability, compared to placebo. In addition, the studies met all ranked secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), as well as corticosteroid-free clinical remission in the maintenance study. All primary and ranked secondary endpoints achieved p-values of <0.001 versus placebo.^1-3

"Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult," said Maria T. Abreu, M.D., Professor of Medicine, Professor of Microbiology and Immunology, University of Miami Miller School of Medicine and Director, Crohn's & Colitis Center, University of Miami Health System.* "In clinical trials, RINVOQ showed its ability to rapidly control symptoms in just eight weeks for many patients and sustained responses at one year. I believe these types of improvements can make a positive difference for my patients."

Clinical Response and Durable Remission^1-4

• During the U-ACHIEVE and U-ACCOMPLISH induction trials at week 8, 26 percent and 33 percent of patients treated with RINVOQ 45 mg achieved clinical remission, the primary endpoint based on mMS, compared to 5 percent and 4 percent of patients who received placebo.
• Onset of response occurred as early as Week 2, with a greater proportion of patients receiving RINVOQ 45 mg once daily achieving clinical response, defined as a decrease of ≥1 point and ≥30 percent from Baseline and a decrease in RBS of ≥1 or an absolute RBS ≤1 per the pmMS, compared to placebo.
• During the maintenance trial, 42 percent and 52 percent of patients treated with RINVOQ 15 mg or 30 mg, respectively, achieved clinical remission at week 52, the primary endpoint, compared to 12 percent of patients who received placebo.
• Additionally, 57 percent and 68 percent of patients receiving RINVOQ 15 mg or 30 mg, respectively, achieved corticosteroid free remission, defined as clinical remission (per mMS) and corticosteroid free for ≥90 days immediately preceding Week 52 among patients who achieved clinical remission at the end of the induction treatment, compared to 22 percent of patients on placebo.

Endoscopic Improvement and Mucosal Healing^1-4

• Endoscopic improvement is defined as a ES of ≤1 without friability and was achieved in U-ACHIEVE and U-ACCOMPLISH.
  • In the induction studies at week 8, endoscopic improvement was observed in 36 percent and 44 percent of patients treated with RINVOQ 45 mg in U-ACHIEVE and U-ACCOMPLISH, respectively, compared to 7 percent and 8 percent, respectively, of patients on placebo.
  • In the maintenance study at week 52, endoscopic improvement was seen in 49 percent and 62 percent of patients with RINVOQ 15 mg and 30 mg, respectively, compared to 14 percent of patients on placebo.
• Mucosal healing was achieved in U-ACHIEVE and U-ACCOMPLISH and is defined by HEMI, which combines an ES of ≤1 without friability with a Geboes score of ≤ 3.1 (indicating neutrophil infiltration in <5 percent of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue); the relationship between HEMI and disease progression and/or long-term outcomes has not been established.
  • Mucosal healing was observed in 30 percent and 37 percent of patients treated with RINVOQ 45 mg in U-ACHIEVE and U-ACCOMPLISH, respectively, at week 8, compared to 7 percent and 6 percent of patients, respectively, who received placebo.
  • At Week 52, mucosal healing was seen in 35 percent and 50 percent of patients treated with RINVOQ 15 mg and 30 mg, respectively, compared to 12 percent patients who received placebo.

RINVOQ Safety Profile⁴

• Overall, the safety profile observed in patients with UC treated with RINVOQ was generally similar to the safety profile in patients with RA and AD.
• RINVOQ may cause serious side effects, including:
  • Serious infections. RINVOQ can lower your ability to fight infections. Serious infections, some fatal, occurred while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses.
  • Increased risk of death in people 50 years and older with at least 1 heart disease risk factor.
  • Cancer and immune system problems. RINVOQ may increase your risk of certain cancers, including lymphoma and skin cancer. Current or past smokers are at higher risk for lymphoma and lung cancer.
  • Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years and older with at least 1 heart disease risk factor, especially in current or past smokers.
  • Blood clots, some fatal, in the veins of the legs or lungs and arteries. This occurred more often in people 50 years and older with at least 1 heart disease risk factor.
  • Serious allergic reactions. Do not take if allergic to RINVOQ or any of its ingredients.
  • Tears in the stomach or intestines and changes in certain laboratory test results.

Patient Access and Support
AbbVie is committed to helping people access RINVOQ and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $5 per month for eligible, commercially-insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides RINVOQ at no charge to those who qualify. More information about this assistance program can be found at www.AbbVie.com/myAbbVieAssist.

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.^5,6 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.^7,8 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease.^5,8 The severity of symptoms and unpredictability of disease course can lead to substantial burden among those living with the disease.⁹

About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies^1-4
The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of upadacitinib 45 mg once daily as induction therapy, and upadacitinib 15 mg and 30 mg once daily as maintenance therapy in subjects with moderately to severely active ulcerative colitis. The primary endpoints were clinical remission per mMS at week 8 for the induction clinical trials and at week 52 for the maintenance trial. Topline results of the U-ACHIEVE induction study were announced in December 2020, topline results of the second induction study, U-ACCOMPLISH, were announced in February 2021, and topline results of the U-ACHIEVE maintenance study were announced in June 2021. More information can be found on www.clinicaltrials.gov (NCT03006068, NCT03653026, NCT02819635).

*Dr. Abreu is a consultant and advisor for AbbVie.

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.^4,10 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.⁴ The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

In the U.S., RINVOQ 45 mg is approved for use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers as an induction therapy once daily for 8 weeks. The recommended dose of RINVOQ for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dosage needed to maintain response. RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other system drug products, including biologics or when use of those therapies is inadvisable. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily. RINVOQ 15 mg is also approved in the U.S. for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers as well as adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.⁴ In the EU, RINVOQ 15 mg is approved for the treatment of adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is also approved in the EU for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis.⁴

Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, giant cell arteritis and Takayasu arteritis are ongoing.^11-17

RINVOQ (upadacitinib) U.S. Use and Important Safety Information⁴

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.
• To treat 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.
• To treat adults with moderately to severely active ulcerative colitis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

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

• To treat 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 when the use of other pills or injections is not recommended.

RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

What is the most important information I should know about RINVOQ?

RINVOQ may cause serious side effects, including:

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

Do not take RINVOQ if:

• You are allergic to upadacitinib or any of the ingredients in RINVOQ.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

• Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:
  • Fever, sweating, or chills
  • Shortness of breath
  • Warm, red, or painful skin or sores on your body
  • Muscle aches
  • Feeling tired
  • Blood in phlegm
  • Diarrhea or stomach pain
  • Cough
  • Weight loss
  • Burning when urinating or urinating more often than normal
• Have TB or have been in close contact with someone with TB.
• Are a current or past smoker.
• Have had a heart attack, other heart problems, or stroke.
• Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
• Have other medical conditions including liver problems, low red or white blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
• Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
• Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
• Are pregnant or plan to become pregnant. Based on findings in animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.
• Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

• Medicines for fungal or bacterial infections
• Rifampicin or phenytoin
• Medicines that affect your immune system

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

What should I 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 the common side effects of RINVOQ?
These 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.

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 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 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 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 its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 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.

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