NORTH CHICAGO, Ill.,
June 2, 2021 /PRNewswire/ --
AbbVie (NYSE: ABBV) today announced results of an analysis
from the Phase 3 SELECT-PsA 2 clinical trial, showing that
continuous treatment with RINVOQ® (upadacitinib, 15 mg,
once daily) resulted in sustained improvements in disease activity
for more than one year (56 weeks) among patients with active
psoriatic arthritis who have responded inadequately to one or more
biologic disease modifying anti-rheumatic drugs
(bDMARDs).1 At week 56, 29 percent of patients
treated with continuous RINVOQ 15 mg achieved minimal disease
activitya (MDA).1 Results at week 56 were not
multiplicity controlled.1 The full, long-term results
from the Phase 3 SELECT-PsA 2 clinical trial will be presented at
the EULAR 2021 Virtual Congress. These results were also recently
published online in Rheumatology and Therapy in
"We are pleased to share results showing that RINVOQ maintained
improvements in these diverse musculoskeletal and skin symptoms of
psoriatic arthritis over time," said Mudra Kapoor, M.D.,
rheumatology head, global medical affairs, AbbVie. "Building
upon the recent approval of RINVOQ for psoriatic arthritis in the
EU, these results further reinforce the critical role RINVOQ can
play in providing adequate disease control that is maintained over
time in multiple signs and symptoms of psoriatic arthritis."
In SELECT-PsA 2, 60 percent of patients treated with continuous
RINVOQ 15 mg achieved ACR20 response at week 56.1
Additionally, 41 percent/24 percent of patients treated with
continuous RINVOQ achieved ACR50/ACR70 response,
respectively.1 The proportion of patients achieving
resolution of enthesitis, dactylitis and improvements from baseline
in skin clearance (as measured by PASI 75/90/100) was maintained in
patients treated with continuous RINVOQ 15 mg.1
Efficacy Results Observed at Week 56*,1
* Efficacy data
reported based on randomized treatment. For patients who were
discontinued from study medication, non-responder imputation (NRI)
was used for binary endpoints. All reported endpoints were not
controlled for multiplicity.
a 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.
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.
"Managing psoriatic arthritis can be complex due to persistent
musculoskeletal and skin symptoms, often causing pain and loss of
physical function," said Philip
Mease, M.D., director of the Rheumatology Research Division
at Swedish Medical Center/Providence St. Joseph Health. "These data
show that RINVOQ was able to maintain symptom improvement of
psoriatic arthritis over one year with no new significant safety
signals. RINVOQ can be an important treatment option to help
rheumatologists provide their patients with long-term maintenance
of improvements in disease activity."
Safety results of RINVOQ 15 mg at week 24 have been previously
reported and were consistent with those observed in the rheumatoid
arthritis clinical trial program, with no new significant safety
risks identified.1,3 At week 56, the rate of serious
infections was 2.6 events/100PY on RINVOQ 15 mg.1 The
rate of major adverse cardiovascular events was 0.2/100PY and the
rate of venous thromboembolic events was 0.2/100PY.1
There were no deaths reported in the RINVOQ 15 mg group through
AbbVie has previously announced top-line data from SELECT-PsA 2
showing that RINVOQ met the primary endpoint of ACR20 response and
all key ranked secondary endpoints versus placebo.5
About Psoriatic Arthritis
Psoriatic arthritis is a heterogeneous, systemic inflammatory
disease with hallmark manifestations across multiple domains
including joints and skin.6,7 In psoriatic arthritis,
the immune system creates inflammation that can lead to pain,
fatigue, stiffness in the joints and cause a red, scaly
About SELECT-PsA 21,8
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 biologic (bDMARD). Patients were initially
randomized to RINVOQ 15 mg, upadacitinib 30 mg or placebo followed
by either RINVOQ 15 mg or upadacitinib 30 mg at week 24.
The primary endpoint was the percentage of subjects achieving an
ACR20 response after 12 weeks of treatment. Key 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. These are not all of the secondary
endpoints. The trial is ongoing, and the long-term extension will
provide data on the long-term safety, tolerability and efficacy of
RINVOQ in patients who have completed the placebo-controlled
More information on this trial can be found at
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.2,9-15 In human cellular assays, RINVOQ
preferentially inhibits signaling by JAK1 or JAK1/3 with functional
selectivity over cytokine receptors that signal via pairs of
JAK2.2 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.10-15
Important EU Safety Information about RINVOQ®
RINVOQ is contraindicated in patients hypersensitive to the
active substance or to any of the excipients, in patients with
active tuberculosis (TB) or active serious infections, in patients
with severe hepatic impairment, and during pregnancy.
Use in combination with other potent immunosuppressants is not
Serious and sometimes fatal infections have been reported in
patients receiving upadacitinib. The most frequent serious
infections reported included pneumonia and cellulitis. Cases of
bacterial meningitis have been reported. Among opportunistic
infections, TB, multidermatomal herpes zoster, oral/oesophageal
candidiasis, and cryptococcosis have been reported with
upadacitinib. Prior to initiating upadacitinib, consider the risks
and benefits of treatment in patients with chronic or recurrent
infection or with a history of a serious or opportunistic
infection, in patients who have been exposed to TB or have resided
or travelled in areas of endemic TB or endemic mycoses, and in
patients with underlying conditions that may predispose them to
infection. Upadacitinib therapy should be interrupted if a patient
develops a serious or opportunistic infection. As there is a higher
incidence of infections in patients ≥75 years of age, caution
should be used when treating this population.
Patients should be screened for TB before starting upadacitinib
therapy. Anti-TB therapy should be considered prior to initiation
of upadacitinib in patients with previously untreated latent TB or
in patients with risk factors for TB infection.
Viral reactivation, including cases of herpes zoster, were
reported in clinical studies. The risk of herpes zoster appears to
be higher in Japanese patients treated with upadacitinib. Consider
interruption of therapy if a patient develops herpes zoster until
the episode resolves. Screening for viral hepatitis and monitoring
for reactivation should be performed before starting and during
therapy with upadacitinib.
The use of live, attenuated vaccines during, or immediately
prior to therapy is not recommended. It is recommended that
patients be brought up to date with all immunizations, including
prophylactic zoster vaccinations, prior to initiating upadacitinib,
in agreement with current immunization guidelines.
The risk of malignancies, including lymphoma is increased in
patients with rheumatoid arthritis (RA). Immunomodulatory medicinal
products may increase the risk of malignancies, including lymphoma.
The clinical data are currently limited and long-term studies are
ongoing. Malignancies, including non-melanoma skin cancer (NMSC),
have been reported in patients treated with upadacitinib. Consider
the risks and benefits of upadacitinib treatment prior to
initiating therapy in patients with a known malignancy other than a
successfully treated NMSC or when considering continuing
upadacitinib therapy in patients who develop a
malignancy. Periodic skin examination is recommended for
patients who are at increased risk for skin cancer.
Absolute neutrophil count <1000 cells/mm3,
absolute lymphocyte count <500 cells/mm3, or
haemoglobin levels <8 g/dL were reported in <1% of
patients in clinical trials. Treatment should not be initiated, or
should be temporarily interrupted, in patients with these
haematological abnormalities observed during routine patient
RA patients have an increased risk for cardiovascular disorders.
Patients treated with upadacitinib should have risk factors (e.g.,
hypertension, hyperlipidaemia) managed as part of usual standard of
Upadacitinib treatment was associated with increases in lipid
parameters, including total cholesterol, low-density lipoprotein
cholesterol, and high-density lipoprotein cholesterol. The effect
of these lipid parameter elevations on cardiovascular morbidity and
mortality has not been determined.
Treatment with upadacitinib was associated with an increased
incidence of liver enzyme elevation compared to placebo. If
increases in ALT or AST are observed during routine patient
management and drug-induced liver injury is suspected, upadacitinib
therapy should be interrupted until this diagnosis is excluded.
Events of deep vein thrombosis (DVT) and pulmonary embolism (PE)
have been reported in patients receiving JAK inhibitors, including
upadacitinib. Upadacitinib should be used with caution in patients
at high risk for DVT/PE. Risk factors that should be considered in
determining the patient's risk for DVT/PE include older age,
obesity, a medical history of DVT/PE, patients undergoing major
surgery, and prolonged immobilisation. If clinical features of
DVT/PE occur, upadacitinib treatment should be discontinued and
patients should be evaluated promptly, followed by appropriate
The most commonly reported adverse drug reactions were upper
respiratory tract infections, bronchitis, nausea, blood creatine
phosphokinase (CPK) increased and cough. The most common serious
adverse reactions were serious infections.
Overall, the safety profile observed in patients with active
psoriatic arthritis treated with upadacitinib 15 mg was consistent
with rheumatoid arthritis. A higher incidence of acne and
bronchitis was observed in patients treated with upadacitinib
compared to placebo. A higher rate of serious infections and
hepatic transaminase elevations was observed in patients treated
with upadacitinib in combination with MTX compared to monotherapy.
There was a higher rate of serious infections in patients ≥65 years
of age, although data are limited.
Please see the full SmPC for complete prescribing information
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving
care for people living with rheumatic diseases. Our longstanding
commitment to discovering and delivering transformative therapies
is underscored by our pursuit of cutting-edge science that improves
our understanding of promising new pathways and targets in order to
help more people living with rheumatic diseases reach their
treatment goals. For more information on AbbVie in rheumatology,
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.
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.
- Mease, P.J., et al. Upadacitinib in patients with psoriatic
arthritis refractory to biologic disease-modifying antirheumatic
drugs: 56-week data from the phase 3 SELECT-PsA 2 study. 2021 EULAR
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- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland
GmbH & Co. KG; May 2021.
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arthritis: integrated analysis from the SELECT phase III clinical
programme. Ann Rheum Dis. 2020 Oct 28;80(3):304-11.
- Mease, P.J., et al. Upadacitinib in Patients with Psoriatic
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the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol
Ther. 2021 Apr 28. doi: 10.1007/s40744-021-00305-z. Online ahead of
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refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2020
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- A Multicenter, Randomized, Double-Blind, Placebo-Controlled
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Subjects With Takayasu Arteritis (TAK) (SELECT-TAK).
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