NORTH CHICAGO, Ill.,
May 24, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced The Lancet
published primary analysis results from the pivotal global Phase 3
clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating
RINVOQ® (upadacitinib) in adults and adolescents with
moderate to severe atopic dermatitis who were candidates for
systemic treatment. The results were published in two separate
manuscripts as part of the May 22, 2021 issue of The
Lancet.
The publication of Measure Up 1 and Measure Up 2 shares efficacy
and safety results of patients treated with upadacitinib (15 mg or
30 mg, once daily) monotherapy versus placebo for 16
weeks.1 The publication of AD Up shares efficacy and
safety results of patients treated with either dose of upadacitinib
with topical corticosteroids (TCS) versus placebo with TCS for 16
weeks.2 Across all three studies, RINVOQ met all primary
and secondary endpoints.1,2
About Atopic Dermatitis
Atopic dermatitis is a chronic, relapsing inflammatory condition
characterized by a cycle of intense itching and scratching leading
to cracked, scaly, oozing skin.3,4 It affects up to an
estimated 10 percent of adults and 25 percent of
children.4,5 Between 20 and 46 percent of adults with
atopic dermatitis have moderate to severe disease.6 The
range of symptoms pose significant physical, psychological and
economic burden on individuals impacted by the
disease.4,7
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a
selective and reversible JAK inhibitor that is being studied in
several immune-mediated inflammatory diseases.1,2,8-14
In human cellular assays, RINVOQ preferentially inhibits signaling
by JAK1 or JAK1/3 with functional selectivity over cytokine
receptors that signal via pairs of JAK2.14 In
August 2019, RINVOQ received U.S. FDA
approval for adult patients with moderately to severely active
rheumatoid arthritis who have had an inadequate response or
intolerance to methotrexate. RINVOQ is approved by the European
Commission for the treatment of adult patients with moderate to
severe active rheumatoid arthritis who have responded inadequately
to, or who are intolerant to one or more disease-modifying
anti-rheumatic drugs (DMARDs); for the treatment of active
psoriatic arthritis (PsA) in adult patients who have responded
inadequately to, or who are intolerant to one or more DMARDs; and
for the treatment of active ankylosing spondylitis (AS) in adult
patients who have responded inadequately to conventional therapy.
The approved dose for RINVOQ is 15 mg. Phase 3 trials of RINVOQ in
atopic dermatitis, axial spondyloarthritis, Crohn's disease,
ulcerative colitis, giant cell arteritis and Takayasu arteritis are
ongoing.1,2,8-13 Use of RINVOQ in atopic dermatitis is
not approved and its safety and efficacy are under evaluation by
regulatory authorities.
RINVOQ U.S. Use and Important Safety
Information14
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.
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.
- 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.
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
Ask your HCP or pharmacist if you are not sure if you are taking
any of these medicines.
What should I 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.
- 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.
What are the common side effects of RINVOQ?
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
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 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.
References:
- Guttman-Yassky E., 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, randomized
controlled phase 3 studies. Lancet.
doi:10.1016/s0140-6736(21)00588-2.
- Reich K., et al. Safety and efficacy of upadacitinib in
combination with topical corticosteroids in adolescents and adults
with moderate-to-severe atopic dermatitis(AD Up): results from a
randomized, double-blind, placebo-controlled phase 3 trial. Lancet.
doi:10.1016/s0140-6736(21)00589-4.
- Nutten S. Atopic Dermatitis: Global Epidemiology and Risk
Factors. Ann Nutr Metab 2015;66(suppl 1):8–16. doi:
10.1159/000370220.
- Weidinger, S., et al. Atopic dermatitis. Nat Rev Dis Primers 4,
1(2018). doi: 10.1038/s41572-018-0001-z.
- Eichenfield L.F., et al. Guidelines of care for the management
of atopic dermatitis: section 1. Diagnosis and assessment of atopic
dermatitis. J Am Acad Dermatol. 2014;70(2):338-351.
doi:10.1016/j.jaad.2013.10.010.
- Shrestha S., et al. Burden of Atopic Dermatitis in the
United States: Analysis of
Healthcare Claims Data in the Commercial, Medicare, and Medi-Cal
Databases. Adv Ther. 2017;34(8):1989–2006.
- EFA. Atopic Eczema: Itching for Life Report. 2018. Accessed
on April 20, 2021.
https://www.efanet.org/images/2018/EN_-_Itching_for_life_Quality_of_Life_and_costs_for_people_with_severe_atopic_eczema_in_Europe_.pdf.
- Pipeline – Our Science. Upadacitinib. AbbVie. 2021. Accessed on
April 20, 2021.
https://www.abbvie.com/our-science/pipeline.html.
- A Study to Evaluate Efficacy and Safety of Upadacitinib in
Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2).
ClinicalTrials.gov. 2021. Accessed on April
20, 2021.
https://clinicaltrials.gov/ct2/show/NCT04169373.
- 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.
Accessed on April 20, 2021.
https://clinicaltrials.gov/ct2/show/NCT02365649.
- A Study to Evaluate the Safety and Efficacy of ABT-494 for
Induction and Maintenance Therapy in Subjects With Moderately to
Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2021.
Accessed on April 20, 2021.
https://clinicaltrials.gov/ct2/show/NCT02819635.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in
Participants With Giant Cell Arteritis (SELECT-GCA).
ClinicalTrials.gov. 2021. Accessed on April
20, 2021.
https://clinicaltrials.gov/ct2/show/NCT03725202.
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in
Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov.
2021. Accessed on April 20, 2021.
https://clinicaltrials.gov/ct2/show/record/NCT04161898.
- RINVOQ® (upadacitinib) [Package Insert].
North Chicago, Ill.: AbbVie
Inc.
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