Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ?) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients
U-ACCOMPLISH Efficacy Results at Week 8*,1 |
||
Upadacitinib 45 mg, once daily (n=341) |
Placebo (n=174) |
|
Clinical remission (per Adapted Mayo Score)a,? |
33% |
4% |
Clinical response (per Adapted Mayo Score)b,? |
74% |
25% |
Endoscopic improvementc,? |
44% |
8% |
Histologic-endoscopic mucosal improvementd,? |
37% |
6% |
*Primary endpoint was clinical remission (per Adapted Mayo Score). Clinical response (per Adapted Mayo Score), endoscopic improvement and histologic-endoscopic mucosal improvement were ranked secondary endpoints. Not all ranked secondary endpoints are shown. All primary and ranked secondary endpoints achieved p-values of <0.001?versus placebo. |
aClinical remission (per Adapted Mayo Score) is defined as stool frequency subscore (SFS) =1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and endoscopic subscore =1. |
b?Clinical response (per Adapted Mayo Score) is defined as a decrease from baseline in the Adapted Mayo score =2 points and =30 percent from baseline, plus a decrease in RBS =1 or an absolute RBS =1. |
cEndoscopic improvement is defined as endoscopic subscore =1. |
dHistologic-endoscopic mucosal improvement is defined as endoscopic subscore of 0 or 1 and Geboes score =3.1. |
?Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopy activity will confer an endoscopic subscore of 2. |
RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age. What is the most important information I should know about RINVOQ?
RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.
- Serious infections have happened in some people 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 HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).
- Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.
- Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.
- Tears in the stomach or intestines and changes in certain laboratory tests can happen. 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.
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
- o Weight loss
- Burning when urinating or urinating more often than normal
- Have TB or have been in close contact with someone with TB.
- Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or 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 that increase your risk of getting certain kinds of fungal infections, such as the?Ohio?and Mississippi River valleys and the Southwest. If you are unsure if you've been to these 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 while taking RINVOQ and for at least 4 weeks after your last dose.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that affect your immune system
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.
- Have any signs or symptoms of blood clots during treatment with RINVOQ, including:
- Swelling
- Sudden unexplained chest pain
- Pain or tenderness in the leg
- Shortness of breath
- Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.
These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ. RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. 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,?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 2019 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:
- AbbVie. Data on File: ABVRRTI71710.
- AbbVie. Data on File: ABVRRTI71469.
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- Burmester G.R., et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512.
- A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-ACCOMPLISH). ClinicalTrials.gov. 2021. Available at:?https://clinicaltrials.gov/ct2/show/NCT03653026. Accessed on?February 12, 2021.
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2021. Available at:?https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on Accessed on?February 12, 2021.
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- 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?February 12, 2021.
- A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2021. Available at:?https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on?February 12, 2021.
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- The Facts about Inflammatory Bowel
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