NORTH CHICAGO, Ill.,
Feb. 5, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced positive top-line results from the Phase 3
SELECT-PsA 1 clinical trial. In this study, both doses of
RINVOQTM (upadacitinib; 15 mg and 30 mg, once daily) met
the primary endpoint of ACR20 response at week 12 versus placebo in
adult patients with active psoriatic arthritis who have responded
inadequately or are intolerant to one or more non-biologic disease
modifying anti-rheumatic drugs (DMARDs).1 RINVOQ also
demonstrated significant improvements in signs and symptoms of the
disease across a variety of endpoints compared to
placebo.1 RINVOQ, a selective and reversible JAK
inhibitor discovered and developed by AbbVie, is being studied as a
once-daily therapy in psoriatic arthritis and multiple
immune-mediated inflammatory diseases.1,3-10
"Patients living with psoriatic arthritis often suffer from
joint pain, stiffness and fatigue, impacting their ability to work
and lead a physically active life," said Michael Severino, M.D., vice chairman and
president, AbbVie. "The results of this large Phase 3 study further
support the potential of RINVOQ to help these patients. We look
forward to sharing these data with regulatory bodies around the
world to support our application for label expansion for RINVOQ to
include adult patients with active psoriatic arthritis."
Results show that at week 12, 71 percent and 79 percent of
patients receiving 15 mg and 30 mg of RINVOQ achieved ACR20,
respectively, compared to 36 percent of patients receiving placebo
(p<0.0001).1 In terms of ACR20 response at week 12
versus adalimumab, both RINVOQ doses achieved non-inferiority and
only the 30 mg dose showed superiority.1 ACR50 at
week 12 was achieved by 38 percent and 52 percent of patients
receiving 15 mg and 30 mg of RINVOQ, respectively, compared to 13
percent of patients receiving placebo (nominal
p<0.0001).1 In addition, 16 percent and 25 percent of
patients receiving 15 mg and 30 mg of RINVOQ achieved ACR70,
respectively, at week 12 compared to 2 percent of the placebo group
(nominal p<0.0001).1
Patients receiving RINVOQ also had greater improvements in
physical function at week 12, as measured by the Health Assessment
Questionnaire Disability Index (HAQ-DI).1 Patients in
the 15 mg and 30 mg RINVOQ groups reported a -0.42 and -0.47 change
from baseline in HAQ-DI score, respectively, compared to -0.14 on
placebo (p<0.0001).1 RINVOQ also showed improvement
in skin symptoms at week 16, with 63 percent and 62 percent of
patients receiving 15 mg and 30 mg of RINVOQ achieving a 75 percent
improvement in the Psoriasis Area Severity Index (PASI 75),
respectively, compared to 21 percent on placebo
(p<0.0001).1 Minimal disease activity (MDA) at week
24 was achieved in 37 percent and 45 percent of 15 mg and 30 mg
RINVOQ-treated patients, respectively, versus 12 percent of the
placebo group (p<0.0001).1
"The results of SELECT-PsA 1 showed that both doses of
upadacitinib demonstrated significantly greater efficacy in joint
and skin symptoms, as well as inhibition of radiographic
progression, compared to placebo," said Professor Iain McInnes, F.R.C.P., Ph.D., University of Glasgow Institute of Infection,
Immunity & Inflammation. "These data are encouraging and add to
the growing body of evidence that upadacitinib has the potential to
improve outcomes for people living with psoriatic arthritis."
SELECT-PsA 1
Efficacy Results1,†
|
|
RINVOQ 15
mg (n=429)
|
RINVOQ 30
mg (n=423)
|
Placebo (n=423)
|
ACR20a at
week 12
|
71%
|
79%
|
36%
|
ACR50a at
week 12
|
38%
|
52%
|
13%
|
ACR70a at
week 12
|
16%
|
25%
|
2%
|
HAQ-DIb at
week 12
|
-0.42
|
-0.47
|
-0.14
|
PASI 75c
at week 16
|
63%
|
62%
|
21%
|
MDAd at
week 24
|
37%
|
45%
|
12%
|
|
† Primary
endpoint was ACR20 at week 12 versus placebo. Ranked secondary
endpoints included change in HAQ-DI from baseline at week 12 versus
placebo, proportion of patients achieving PASI 75 at week 16 versus
placebo and proportion of patients achieving MDA at week 24 versus
placebo. All comparisons as defined above achieved p-values of
<0.0001. Not all ranked secondary endpoints
shown.
|
a
ACR20/50/70 is defined as at least a 20 percent/50 percent/70
percent reduction from baseline in the number of both tender and
swollen joint counts and equivalent improvement in three or more of
the five remaining American College of Rheumatology core set
measures: patient assessments of pain, global disease activity,
physical function, physician global assessment of disease activity
and acute phase reactant.
|
b HAQ-DI
is defined as change in baseline in the Health Assessment
Questionnaire Disability Index, which is a is a patient-reported
questionnaire including categories of dressing and grooming,
arising, eating, walking, hygiene, reach, grip and common daily
activities. It asks patients about the amount of difficulty they
experience in these activities as well as the use of aids and/or
devices.
|
c PASI 75
is defined as a 75 percent improvement in the Psoriasis Area
Severity Index. It was assessed in patients with ≥3 percent body
surface area (BSA) psoriasis at baseline.
|
d MDA
is defined as the fulfillment of 5 of 7 outcome measures: TJC≤1;
SJC≤1; PASI≤1 or BSA-Ps≤3 percent; Patient's Assessment of Pain
NRS≤1.5; PtGA-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and LEI
(Leeds Enthesitis Index) ≤1.
|
Following 24 weeks of treatment, RINVOQ at 15 mg and 30 mg
significantly inhibited radiographic progression, as measured by
the change from baseline in modified PsA Sharp/van der Heijde
Score, compared to placebo (p<0.01).1 The inhibition
of joint damage is important for psoriatic arthritis patients as
this can impact physical function and disability.11
The safety profile of RINVOQ was consistent with that observed
in previously reported studies, with no new safety risks
detected.1 Through week 24, serious infections occurred
in 1.2 percent and 2.6 percent of patients in the 15 mg and 30 mg
RINVOQ groups, respectively, compared to 0.9 percent in the placebo
group and 0.7 percent in the adalimumab
group.1 There was one case of adjudicated venous
thromboembolic events (VTE) in the RINVOQ 30 mg group (0.2
percent), no cases in the RINVOQ 15 mg group, two cases in the
adalimumab group (0.5 percent) and one case in the placebo group
(0.2 percent).1 No major adverse cardiovascular events
(MACE) were reported in either RINVOQ group.1 There was
one MACE reported in the placebo group and two MACE reported in the
adalimumab group.1 There were no deaths in either RINVOQ
group, one death in the placebo group (0.2 percent) and no deaths
in the adalimumab group.1
Psoriatic arthritis is a heterogeneous systemic inflammatory
disease with hallmark manifestations in joints and skin, affecting
more than 50 million people worldwide.12,13 In psoriatic
arthritis, the immune system creates inflammation that can
lead to pain, fatigue and stiffness in the joints.12
Results from the SELECT-PsA 1 study will be presented at a
future medical meeting and published in a peer-reviewed
publication.
About SELECT-PsA 11,14
SELECT-PsA 1 is a Phase 3, multicenter, randomized,
double-blind, parallel-group, active and placebo-controlled study
designed to evaluate the safety and efficacy of RINVOQ compared to
placebo and adalimumab in adult patients with active psoriatic
arthritis who have a history of inadequate response to at least one
non-biologic DMARD. Patients were randomized to RINVOQ 15 mg,
RINVOQ 30 mg, adalimumab (40 mg EOW) or placebo followed by either
RINVOQ 15 mg or RINVOQ 30 mg at week 24.
The primary endpoint was the percentage of subjects receiving
RINVOQ 15 mg or 30 mg who achieved an ACR20 response after 12 weeks
of treatment versus placebo. Ranked secondary endpoints included
change from baseline in HAQ-DI at week 12, proportion of patients
achieving PASI 75 at week 16 and proportion of patients achieving
MDA at week 24. The trial is ongoing, and the long-term extension
remains blinded to evaluate the long-term safety, tolerability and
efficacy of the two once-daily doses (15 mg and 30 mg) of RINVOQ in
patients who have completed the placebo-controlled period. More
information on this trial can be found at www.clinicaltrials.gov
(NCT03104400).
About RINVOQ (upadacitinib)
Discovered and developed by AbbVie, RINVOQ is a selective
and reversible JAK inhibitor studied in several immune-mediated
inflammatory diseases.1-10 In August 2019, RINVOQ received U.S. Food and Drug
Administration approval for adult patients with moderately to
severely active rheumatoid arthritis who have had an inadequate
response or intolerance to methotrexate. In December 2019, RINVOQ also received approval 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. Phase 3 trials of RINVOQ in
rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis,
Crohn's disease, atopic dermatitis, ulcerative colitis and giant
cell arteritis are ongoing.1,6-10
Important Safety Information about RINVOQ™
(upadacitinib)
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.
Please click here for the Full Prescribing Information and
Medication Guide.
This is the most important information to know about RINVOQ.
For more information, talk to your HCP.
Important Safety Information about HUMIRA™
(adalimumab)
HUMIRA U.S. Use and Important Safety Information
HUMIRA is a prescription medicine used alone or with certain other
medicines to reduce the signs and symptoms of psoriatic arthritis
in adults, may prevent further damage to your bones and joints, and
may help your ability to perform daily activities.
HUMIRA is a TNF blocker medicine that affects the immune system
and can lower the body's ability to fight infections. Serious
infections have happened in people taking HUMIRA. These serious
infections include tuberculosis (TB) and infections caused by
viruses, fungi, or bacteria that have spread throughout the body.
Some people have died from these infections. People should be
tested for TB before HUMIRA use and monitored for signs and
symptoms of TB during therapy, even if their TB test was negative.
People at risk of TB may be treated with medicine for TB. Treatment
with HUMIRA should not be started in a person with an active
infection, unless approved by a doctor. HUMIRA should be stopped if
a person develops a serious infection. People should tell their
doctor if they live in or have been to a region where certain
fungal infections are common, as these infections may happen or
become more severe if people use HUMIRA. People should tell their
doctor if they have had TB or hepatitis B, are prone to infections,
or have symptoms such as fever, fatigue, cough, or sores.
For people taking TNF blockers, including HUMIRA, the chance of
getting lymphoma or other cancers may increase. Some people have
developed a rare type of cancer called hepatosplenic T-cell
lymphoma. This type of cancer often results in death. If using TNF
blockers, including HUMIRA, the chance of getting two types of skin
cancer (basal cell and squamous cell) may increase. These types are
generally not life-threatening if treated.
Other possible serious side effects with HUMIRA include
hepatitis B infection in carriers of the virus; allergic reactions;
nervous system problems; blood problems; certain immune reactions,
including a lupus-like syndrome; liver problems; and new or
worsening heart failure or psoriasis. The use of HUMIRA with
anakinra or abatacept is not recommended. People using HUMIRA
should not receive live vaccines. Children should be brought up to
date on all vaccines before starting HUMIRA.
Common side effects of HUMIRA include injection site reactions
(redness, rash, swelling, itching, or bruising), upper respiratory
infections (including sinus infections), headaches, rash, and
nausea.
HUMIRA is given by injection under the skin.
The benefits and risks of HUMIRA should be carefully considered
before starting therapy.
Please click here for the Full Prescribing
Information and Medication
Guide.
This is the most important information to know about HUMIRA.
For more information, talk to your HCP.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
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.
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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