NORTH CHICAGO, Ill.,
Oct. 31, 2019 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced positive top-line data
from the SELECT-PsA 2 Phase 3 study. In this study, both doses of
RINVOQ™ (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 to one or more biologic disease modifying
anti-rheumatic drugs (bDMARDs).1 In addition,
patients on both doses of RINVOQ achieved significantly greater
responses compared to placebo for all ranked secondary
endpoints.1 SELECT-PsA 2 is the first study
evaluating the efficacy and safety of RINVOQ in adult patients with
active psoriatic arthritis.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 diseases1,3-10
"Too many people living with psoriatic arthritis still fail to
achieve their treatment goals, underscoring a clear medical need
for additional therapeutic options," said Michael Severino, M.D., vice chairman and
president, AbbVie. "We are pleased with these data, which show the
potential of RINVOQ to improve outcomes for people with psoriatic
arthritis across a variety of symptoms. Data from this Phase 3
study will support regulatory submissions for RINVOQ in psoriatic
arthritis."
Results show that at week 12, 57/64 percent of patients
receiving 15/30 mg of RINVOQ achieved ACR20, respectively, compared
to 24 percent in the placebo group
(p<0.0001).1 Additionally, ACR50 was achieved by
32/38 percent of patients receiving 15/30 mg of RINVOQ,
respectively, compared to 5 percent on placebo at week 12
(p<0.0001).1 9/17 percent of patients achieved
ACR70 in the 15/30 mg RINVOQ groups, respectively, compared
to 0.5 percent in the placebo group at week 12
(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). RINVOQ showed improvement in skin symptoms at week
16, with 52/57 percent of patients receiving 15/30 mg of RINVOQ
achieving a 75 percent improvement in the Psoriasis Area Severity
Index (PASI 75), respectively, compared to 16 percent on placebo
(p<0.0001).1 25/29 percent of 15/30
mg RINVOQ-treated patients achieved minimal disease activity (MDA)
at week 24 (p<0.0001), respectively, compared to 3 percent in
the placebo group.1
SELECT-PsA 2
Efficacy Results1,†
|
|
RINVOQ 15
mg
(n=211)
|
RINVOQ 30
mg
(n=218)
|
Placebo
(n=212)
|
ACR20a at
week 12
|
57%
|
64%
|
24%
|
ACR50a at
week 12
|
32%
|
38%
|
5%
|
ACR70a at
week 12
|
9%
|
17%
|
0.5%
|
HAQ-DIb at
week 12
|
-0.30
|
-0.41
|
-0.10
|
PASI 75c
at week 16
|
52%
|
57%
|
16%
|
MDAd at
week 24
|
25%
|
29%
|
3%
|
†Primary
endpoint was ACR20 at week 12. All reported endpoints achieved
p-values of <0.0001 versus placebo for both doses. Not all
ranked secondary endpoints shown.
|
aACR20/50/70 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.
|
In this study, the safety profile of RINVOQ was consistent with
that observed in previously reported studies in patients with
rheumatoid arthritis, with no new safety risks
detected.1,2 Through week 24, serious infections
occurred in 0.5/2.8 percent of patients in the 15/30 mg RINVOQ
groups, respectively, compared to 0.5 percent in the placebo
group.1 There was one pulmonary embolism reported
in the 15 mg RINVOQ group and none in the 30 mg and placebo groups.
There was one non-fatal adjudicated major adverse cardiovascular
event (MACE) in the 15 mg RINVOQ group (acute myocardial
infarction) and no MACE in the 30 mg and placebo groups. One death
was reported in a patient receiving placebo (motor vehicle
accident).
Psoriatic arthritis is a heterogeneous systemic inflammatory
disease with hallmark manifestations in joints and skin, affecting
more than 50 million people worldwide.11,12 In psoriatic
arthritis, the immune system creates inflammation that can
lead to pain, fatigue and stiffness in the
joints.11
Full results from the SELECT-PsA 2 study will be presented at a
future medical meeting and published in a peer-reviewed
publication.
About SELECT-PsA 21,13
SELECT-PsA 2 is a Phase 3, multicenter, randomized,
double-blind, parallel-group, placebo-controlled study designed to
evaluate the safety and efficacy of RINVOQ in adult patients with
active psoriatic arthritis who have a history of inadequate
response to at least one bDMARD. Patients were randomized to RINVOQ
15 mg, RINVOQ 30 mg or placebo followed by either RINVOQ 15 mg or
RINVOQ 30 mg at week 24.
The primary endpoint was the percentage of subjects achieving an
ACR20 response after 12 weeks of treatment. Secondary endpoints
included change from baseline in HAQ-DI, proportion of patients
achieving ACR50 and ACR70 at week 12, proportion of patients
achieving PASI 75 at week 16, as well as 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 (NCT03104374).
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 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
and it is also being investigated to treat ankylosing
spondylitis.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
- 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 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.
References:
- AbbVie Data on File. ABVRRTI69484.
- Cohen S., et al. Safety profile of upadacitinib in Rheumatoid
Arthritis: Integrated analysis from the SELECT Phase 3 Clinical
Program. EULAR 2019; THU0167.
- Bergman M., et al. Upadacitinib Treatment and the Routine
Assessment of Patient Index Data 3 (RAPID3) Among Patients with
Rheumatoid Arthritis. 2019 ACR/ARHP Annual Meeting; 551.
- Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed on
September 24, 2019.
- 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
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10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
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Study of ABT-494 for the Induction of Symptomatic and Endoscopic
Remission in Subjects With Moderately to Severely Active Crohn's
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- A Study Evaluating the Safety and Efficacy of Upadacitinib in
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ClinicalTrials.gov. 2019. Available at:
https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on
October 23, 2019.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in
Participants With Giant Cell Arteritis (SELECT-GCA).
ClinicalTrials.gov. 2019. Available at:
https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on
October 23, 2019.
- Duarte, G.V., et al. Psoriatic arthritis. Best Pract Res Clin
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10.1016/j.berh.2012.01.003.
- International Federation of Psoriasis Associations. Psoriasis
is a Serious Disease Deserving Global Attention. Available at:
https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf.
Accessed October 23, 2019.
- A Study Comparing Upadacitinib (ABT-494) to Placebo in
Participants With Active Psoriatic Arthritis Who Have a History of
Inadequate Response to at Least One Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT-PsA 2). ClinicalTrials.gov. 2019.
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Accessed October 23, 2019.
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