NORTH CHICAGO, Ill.,
May 27, 2022 /PRNewswire/ --
AbbVie (NYSE: ABBV) today announced The
Lancet published results from three pivotal Phase 3
clinical trials – U-ACHIEVE (induction), U-ACCOMPLISH and U-ACHIEVE
(maintenance) – evaluating upadacitinib (RINVOQ®) in
patients with moderately to severely active ulcerative colitis who
have had inadequate response, lost response or were intolerant to
conventional or biologic therapy.
Data from the three studies formed the basis of the company's
application for approval by regulatory agencies. The publication
reports the efficacy and safety results of the two induction
studies and a maintenance study evaluating clinical remission and
endoscopic improvement with oral upadacitinib versus placebo over 8
weeks and 52 weeks, respectively.1
The use of upadacitinib for ulcerative colitis is not approved
in the European Union and its safety and efficacy remain under
review by the global health authorities.
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.2,3 The
hallmark signs and symptoms of ulcerative colitis include rectal
bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of
pressure), urgency and fecal incontinence.2,4
The severity of symptoms and unpredictability of disease course can
lead to substantial burden and often disability among those living
with the disease.5 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 complications, including cancer or
death.3,6
About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE
Maintenance Studies6,7-10
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 moderate to severe ulcerative
colitis. 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
http://www.clinicaltrials.gov (NCT03006068, NCT03653026,
NCT02819635).
About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ is a
selective and reversible JAK inhibitor that is being studied in
several immune-mediated inflammatory
diseases.11-17 Based on enzymatic and
cellular assays, RINVOQ demonstrated greater inhibitory potency for
JAK-1 vs JAK-2, JAK-3, and TYK-2.12 The relevance
of inhibition of specific JAK enzymes to therapeutic effectiveness
is not currently known.
RINVOQ is approved in the EU for rheumatoid arthritis, atopic
dermatitis, axial spondyloarthritis and psoriatic arthritis. Phase
3 trials of RINVOQ in axial spondyloarthritis, Crohn's disease,
giant cell arteritis and Takayasu arteritis are
ongoing.12-18
RINVOQ (upadacitinib) U.S. Use and Important Safety
Information18
RINVOQ is a prescription medicine used:
- 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.
- 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.
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 our
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 2020 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.
______________________________
1 S. Danese, et al. Upadacitinib as Induction and
Maintenance Therapy for for Moderately to Severely Active
Ulcerative Colitis: Results from the Phase 3, Multicentre,
Double-Blind, Randomised Trials. Lancet.
2 Gajendran M., et al. A comprehensive review and
update on ulcerative colitis. Dis Mon. 2019 Dec;65(12):100851. doi:
10.1016/j.disamonth.2019.02.004. Epub 2019 Mar 2.
3 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.
Accessed on March 29, 2022.
4 Ulcerative colitis. Symptoms and Causes. Mayo
Clinic. 2020. Available at:
https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326.
Accessed on March 29, 2022.
5 Mehta F. Report: economic implications of
inflammatory bowel disease and its management. Am J Manag Care.
2016 Mar;22(3 Suppl):s51-60.
6 Monstad, I., et al. Clinical course and prognosis
in ulcerative colitis: results from population-based and
observational studies. Ann Gastroenterol. 2014; 27(2): 95–104.
7 Vermeire, S., et al. OP23 Efficacy and safety of
upadacitinib as induction therapy in patients with Moderately to
Severely Active Ulcerative Colitis: Results from phase 3
U-ACCOMPLISH study, Journal of Crohn's and Colitis, Volume 15,
Issue Supplement 1 .May 2021.
8 Danese, S., et al. OP24 Efficacy and safety of
upadacitinib induction therapy in patients with Moderately to
Severely Active Ulcerative Colitis: Results from the phase 3
U-ACHIEVE study, Journal of Crohn's and Colitis, Volume 15, Issue
Supplement 1. May 2021.
9 Danese, S., et al. OP08 The effects of maintenance
therapy with upadacitinib on abdominal pain, bowel urgency, and
fatigue in patients with moderately to severely active Ulcerative
Colitis: Phase 3 U-ACHIEVE maintenance results, Journal of
Crohn's and Colitis, Volume 16, Issue Supplement 1.
January 2022.
10 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://www.clinicaltrials.gov/ct2/show/NCT02819635. Accessed on
March 29, 2022.
11 RINVOQ [Summary of Product Characteristics].
AbbVie Deutschland GmbH & Co. KG; September 2021. Available at:
https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
12 Pipeline – Our Science | AbbVie. AbbVie. 2021.
Available at: https://www.abbvie.com/our-science/pipeline.html.
Accessed on March 29, 2022.
13 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 March 29, 2022.
14 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
March 29, 2022.
15 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 March 29, 2022.
16 A Study to Evaluate the Safety and Efficacy of
Upadacitinib in Participants With Giant Cell Arteritis
(SELECT-GCA). ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on
March 29, 2022.
17 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
March 29, 2022.
18 RINVOQ [package insert]. North
Chicago, IL: AbbVie Inc.;
2022.
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