NORTH CHICAGO, Ill.,
Nov. 12, 2019 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced positive data from the Phase 2/3 SELECT-AXIS 1
trial in which twice as many adult patients with active ankylosing
spondylitis (AS) treated with RINVOQ™ (upadacitinib;
15 mg, once-daily) achieved the primary endpoint of Assessment of
SpondyloArthritis International Society (ASAS) 40 response at week
14 versus placebo (52 percent vs. 26 percent;
p<0.001).1 SELECT-AXIS 1 is the first trial to
evaluate the efficacy and safety of RINVOQ in adult patients with
active AS who are naïve to biologic disease-modifying antirheumatic
drugs (bDMARDs) and had inadequate response or intolerance to
nonsteroidal anti-inflammatory drugs (NSAIDs).1
Full results were presented today at the 2019 American College
of Rheumatology (ACR)/Association for Rheumatology Professionals
(ARP) Annual Meeting in Atlanta
and have been published concurrently in The Lancet. RINVOQ,
a JAK inhibitor discovered and developed by AbbVie, is being
studied as a once-daily therapy in AS and multiple immune-mediated
inflammatory diseases.1,5-18
"Ankylosing spondylitis is a chronic, progressive, inflammatory
disease that causes pain and stiffness, primarily in the spine,
starting in early adulthood," said Désirée van der Heijde,
Professor, Leiden University Medical Center, the Netherlands. "Apart from biologics, there
are limited options available for patients who have an inadequate
response or contraindication to NSAIDs. The results of this study
highlight the potential of RINVOQ as an additional treatment option
for patients living with ankylosing spondylitis."
"Results from the SELECT-AXIS 1 study show that RINVOQ was able
to provide significant improvements to signs and symptoms for
patients living with ankylosing spondylitis," said Marek
Honczarenko, M.D., Ph.D., vice president, immunology development,
AbbVie. "These data highlight AbbVie's commitment to discovering
and developing additional therapies for patients living with
rheumatic diseases."
The safety profile of RINVOQ was consistent with that of
previous studies in rheumatoid arthritis, with no new safety risks
detected.1,2 Through week 14, the proportions of
patients with adverse events leading to discontinuation, serious
adverse events and infections were 2 percent/1 percent/20 percent
for RINVOQ and 3 percent/1 percent/28 percent for placebo,
respectively.1 No serious infections, herpes zoster,
malignancy, adjudicated major adverse cardiovascular events, venous
thromboembolic events or deaths were reported.1
About SELECT-AXIS 11
SELECT-AXIS 1 is a Phase 2/3, multicenter, randomized,
double-blind, parallel-group, placebo-controlled study designed to
evaluate the safety and efficacy of RINVOQ in adult patients with
active AS who are bDMARD-naïve and had inadequate response to at
least two NSAIDs or intolerance to/contraindication for NSAIDs.
The study includes two periods. Results from Period 1 were
presented today. In the 14-week Period 1, the primary endpoint was
the percentage of subjects achieving an ASAS40 response after 14
weeks of treatment. Ranked secondary endpoints included proportion
of subjects achieving Bath Ankylosing Spondylitis Disease Activity
Index (BASDAI) 50 and ASAS partial remission (PR) at week 14, as
well as change from baseline in Ankylosing Spondylitis Disease
Activity Scores (ASDAS), MRI Spondyloarthritis Research Consortium
of Canada (SPARCC) score (spine)
and Bath Ankylosing Spondylitis Functional Index (BASFI) at week
14. Period 2 is an open-label extension period to evaluate the
long-term safety, tolerability and efficacy of upadacitinib in
subjects who completed Period 1. More information on this trial can
be found at www.clinicaltrials.gov (NCT03178487).
About RINVOQ (upadacitinib)
Discovered and developed by AbbVie, RINVOQ is a JAK
inhibitor studied in several immune-mediated inflammatory
diseases.1,5-18 Earlier this year, RINVOQ received U.S.
Food and Drug Administration approval for adult patients with
moderately to severely active rheumatoid arthritis. RINVOQ also
received a positive opinion from the European Union's Committee for
Medicinal Products for Human Use and is currently awaiting final
approval by the European Commission. Phase 3 trials of RINVOQ in
psoriatic arthritis, Crohn's disease, atopic dermatitis, ulcerative
colitis and giant cell arteritis are
ongoing.1,6,12-18
RINVOQ U.S. Use and Important Safety
Information
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
- Pain or tenderness in the leg
- Sudden unexplained chest pain
- 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.
About AbbVie
AbbVie is a global, research and development-based
biopharmaceutical company committed to developing innovative
advanced therapies for some of the world's most complex and
critical conditions. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to markedly
improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. 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, competition from
other products, challenges to intellectual property, difficulties
inherent in the research and development process, adverse
litigation or government action, and changes to laws and
regulations applicable to our industry. 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 2018 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. 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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