- Five-year results from SELECT-COMPARE evaluating the
efficacy and safety of RINVOQ® (upadacitinib) and
HUMIRA® (adalimumab), both in combination with
methotrexate (MTX), are reported for adult patients with moderate
to severely active rheumatoid arthritis (RA) who had an inadequate
response to MTX1
- Three-year results from SELECT-PsA 1 evaluating the
efficacy and safety of RINVOQ are reported in psoriatic arthritis
(PsA) patients with prior inadequate response (IR) or intolerance
to one or more non-biologic disease-modifying antirheumatic drugs
(DMARDs)2
- One-year efficacy and safety data of RINVOQ are
reported in SELECT-AXIS 2 for patients with active ankylosing
spondylitis (AS) who had an inadequate response to biologic DMARD
therapy3
NORTH
CHICAGO, Ill., May 24, 2023
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that
researchers will present new, long-term data supporting the
efficacy and safety profile of RINVOQ® (upadacitinib)
from the SELECT-COMPARE, SELECT-PsA 1 and SELECT-AXIS 2 studies at
the European Congress of Rheumatology, EULAR 2023, taking place
from 31 May – 3 June in Milan.
"These new results from the SELECT trial programs continue to
strengthen the breadth of evidence available for RINVOQ's efficacy
and safety profile in several rheumatic diseases," said Mudra
Kapoor, vice president, global medical affairs, immunology, AbbVie.
"Our investment in long-term data is an essential part of AbbVie's
ongoing commitment to ensure we are supporting patients living with
immune-mediated diseases."
Long-term data supporting the efficacy and safety profile of
RINVOQ that will be presented at the EULAR 2023 Congress include
more than 20 clinical endpoints and safety data from approximately
2,450 patients representing more than 6,700 patient-years across
rheumatoid arthritis (RA), psoriatic arthritis (PsA), and
ankylosing spondylitis (AS).1,2,3
"The impact of rheumatic diseases, such as rheumatoid arthritis,
psoriatic arthritis, and ankylosing spondylitis, can be life-long
and deeply affect a patient's quality of life," said Roy Fleischmann, M.D., SELECT-COMPARE study
investigator and clinical professor of medicine, University of Texas Southwestern Medical Center,
co-medical director, Metroplex Clinical Research Center. "These
efficacy and safety data provide additional information to help
healthcare providers make important treatment choices with their
patients and highlight the ability to maintain disease control with
long-term treatment."
Highlights from these trials include:
Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in
Patients with Rheumatoid Arthritis: Five-Year Data From the
SELECT-COMPARE Study
POS0849. Thurs, 1 June; 14:45-15:45
CEST
The abstract reported the safety and efficacy of
RINVOQ and HUMIRA across five years in adult patients with moderate
to severely active RA who had an inadequate response to
methotrexate (MTX), as part of the ongoing long-term extension
(LTE) of SELECT-COMPARE. Patients receiving background MTX were
randomized to receive RINVOQ 15 mg once daily, HUMIRA 40 mg every
other week or placebo and those who completed the 48-week
double-blind period could continue to receive open label RINVOQ or
HUMIRA in the LTE up to 10 years. Efficacy endpoints included
Clinical Disease Activity Index (CDAI) low disease activity (LDA),
CDAI remission, and disease activity scores based on 28 joints and
C-reactive protein (DAS28[CRP]) ≤ 3.2 (LDA) and <2.6 (clinical
remission) at five years and radiographic data at 192 weeks. Rates
of treatment-emergent adverse events (TEAEs) and AEs of special
interest were calculated per 100 patient-years through five years
for all patients receiving RINVOQ or HUMIRA. Through five years,
1,417 patients were exposed to RINVOQ (4,497 patient-years) and 579
patients to HUMIRA (1,472 patient-years). The study results
support the long-term efficacy and safety profile of RINVOQ in the
studied patient population.1
Long-Term Efficacy and Safety of Upadacitinib in Patients with
Psoriatic Arthritis: Three-Year Results from the Phase 3 SELECT-PsA
1 Study
POS1541. Sat, 3 June; 10:30-11:30
CEST
The abstract reported the efficacy and safety of
RINVOQ as part of the SELECT-PsA 1 study – an ongoing long-term
open-label extension study in PsA patients with prior IR or
intolerance to one or more non-biologic DMARD. Patients were
randomized to receive RINVOQ 15 mg or 30 mg once daily, HUMIRA 40
mg every other week, or placebo. Efficacy endpoints including the
American College of Rheumatology criteria (ACR20/50/70), minimal
disease activity, Psoriasis Area and Severity Index
(PASI75/90/100), resolution of enthesitis, resolution of
dactylitis, Health Assessment Questionnaire-Disability Index
(HAQ-DI), pain, Bath Ankylosing Spondylitis Disease Activity Index
(BASDAI), and modified total Sharp/van der Heijde score (mTSS) were
assessed through week 152, and safety data through 13 June, 2022 (1,694.7 patient-years of
exposure).2 The study results support the efficacy and
safety profile of RINVOQ in the studied patient population over
three years.2
Efficacy and Safety of Upadacitinib in Patients with Active
Ankylosing Spondylitis and an Inadequate Response to Biologic DMARD
Therapy: One-Year Results from a Phase 3 Study
POS1122. Fri, 2 June; 9:30-10:30
CEST
This analysis evaluated efficacy over 52 weeks
in patients who received RINVOQ for the whole study duration, and
those who switched from placebo to RINVOQ at week 14, from the
Phase 3 SELECT-AXIS 2 program. Efficacy endpoints included
Assessment of SpondyloArthritis international Society 40 response
(ASAS40), ASAS partial remission (PR), AS Disease Activity Score
(ASDAS) with C-reactive protein [CRP], low disease activity (LDA;
<2.1), ASDAS inactive disease (ID; <1.3), and changes from
baseline in ASDAS and high-sensitivity CRP (hsCRP). Safety was
assessed through the cut-off date of 19 May,
2022, representing 534.4 patient-years of exposure to
RINVOQ.3 The study results support the efficacy and
safety profile of RINVOQ in patients with active AS who had an IR
or intolerance to biologic DMARDs through one year. AbbVie reported
initial results at week 14 from the SELECT-AXIS 2 AS bDMARD-IR
study during the EULAR 2022 Congress.
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.4-16 In human cellular assays, RINVOQ
preferentially inhibits signaling by JAK1 or JAK1/3 with functional
selectivity over cytokine receptors that signal via pairs of
JAK2.4
Upadacitinib (RINVOQ) is in Phase 3 for giant cell arteritis,
Takayasu arteritis and systemic lupus
erythematosus.11,15,18
EU Indications and Important Safety Information about
RINVOQ® (upadacitinib)4
Indications
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe
active rheumatoid arthritis (RA) in adult
patients who have responded
inadequately to, or who are intolerant to one or more disease-modifying
anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or
in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated 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.
RINVOQ may be used as monotherapy or in
combination with methotrexate.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic
axial spondyloarthritis in adult patients with objective
signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or
magnetic resonance imaging (MRI), who have responded inadequately
to nonsteroidal anti- inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated
for the treatment of active
ankylosing spondylitis in adult patients
who have responded inadequately to conventional therapy.
Atopic dermatitis
RINVOQ is indicated
for the treatment of moderate
to severe atopic
dermatitis (AD) in adults and adolescents 12
years and older who are candidates for systemic therapy.
Ulcerative colitis
RINVOQ is indicated for the treatment
of adult patients
with moderately to severely active ulcerative
colitis (UC) who have had an inadequate response, lost response or
were intolerant to either conventional therapy or a biologic
agent.
Crohn's disease
RINVOQ is indicated for the treatment of adult patients with
moderately to severely active Crohn's disease who have had an
inadequate response, lost response or were intolerant to either
conventional therapy or a biologic agent.
Important Safety Information
Contraindications
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.
Special warnings and precautions for
use
RINVOQ should only be used if no suitable treatment
alternatives are available in patients:
- 65 years of age and older;
-
patients with history of atherosclerotic
cardiovascular (CV) disease or other CV
risk factors (such as current or past long-time
smokers);
-
patients with malignancy risk factors (e.g. current malignancy or history of malignancy)
Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious
infections, and all-cause mortality in
patients ≥65 years of age, as
observed in a large randomised study of tofacitinib (another JAK
inhibitor), RINVOQ should only be used in these patients if no
suitable treatment alternatives are available. In
patients ≥65 years of age, there
is an increased risk of adverse reactions with RINVOQ
30 mg once daily. Consequently, the recommended dose
for long-term use in this patient population is 15 mg once
daily.
Immunosuppressive medicinal products
Use in combination with other potent
immunosuppressants is not recommended.
Serious infections
Serious and sometimes fatal infections have been reported in
patients receiving RINVOQ. The most frequent serious
infections reported included
pneumonia and cellulitis. Cases of bacterial meningitis and
sepsis have been reported with RINVOQ. Among opportunistic
infections, TB, multidermatomal herpes zoster, oral/esophageal
candidiasis, and cryptococcosis have been reported. RINVOQ should
not be initiated in patients with an active, serious infection,
including localized infections. RINVOQ should be interrupted if a
patient develops a serious or opportunistic infection until the
infection is controlled. A higher rate of serious infections was
observed with RINVOQ 30 mg compared to 15 mg. As there is a higher
incidence of infections in the elderly and patients with diabetes
in general, caution should be used when treating these populations.
In patients ≥65 years of age, RINVOQ should only be used if no
suitable treatment alternatives are available.
Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ
should not be given to patients
with active TB. Anti-TB
therapy may be appropriate for select patients
in consultation with a physician with expertise
in the treatment of TB. Patients
should be monitored for the development of signs and
symptoms of TB.
Viral reactivation
Viral reactivation, including cases of herpes
zoster, was reported in clinical studies.
The risk of herpes zoster appears to be higher in
Japanese patients treated with RINVOQ. Consider interruption of
RINVOQ if the patient develops
herpes zoster until the episode resolves.
Screening for viral hepatitis and monitoring
for reactivation should occur before and during therapy. If
hepatitis B virus DNA is detected, a liver specialist should be
consulted.
Vaccination
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 RINVOQ, in agreement with current
immunization guidelines.
Malignancy
Lymphoma and other malignancies have been reported
in patients receiving JAK inhibitors, including
RINVOQ. In a large randomised active–controlled study of
tofacitinib (another JAK inhibitor) in RA patients ≥50
years of age with ≥1 additional CV risk factor,
a higher rate of malignancies, particularly lung
cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed
with tofacitinib compared to tumour necrosis
factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was
observed with RINVOQ 30 mg compared to 15 mg. Periodic skin
examination is recommended for all patients, particularly those
with risk factors for skin cancer. In patients ≥65 years of age,
patients who are current or past long-time smokers, or patients
with other malignancy risk factors (e.g., current malignancy or
history of malignancy), RINVOQ should only be used if no suitable
treatment alternatives are available.
Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological
abnormalities observed during routine patient management.
Gastrointestinal Perforations
Events of diverticulitis and gastrointestinal perforations have
been reported in clinical trials and from post–marketing sources.
RINVOQ should be used with caution in patients who may be at risk
for gastrointestinal perforation (e.g., patients with diverticular
disease, a history of diverticulitis, or who are taking
nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids, or
opioids. Patients with active Crohn's disease are at increased risk
for developing intestinal perforation. Patients presenting with new
onset abdominal signs and symptoms should be evaluated promptly for
early identification of diverticulitis or gastrointestinal
perforation.
Major adverse cardiovascular events
MACE were observed in clinical studies
of RINVOQ. In a large
randomised active-controlled study of
tofacitinib (another JAK inhibitor) in RA patients
≥50 years of age with ≥1 additional CV risk factor,
a higher rate of MACE, defined as
CV death, non-fatal myocardial infarction and non-fatal stroke,
was
observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients
who are current or past long-time smokers, and patients with
history of atherosclerotic CV disease or other CV risk factors,
RINVOQ should only be used if no suitable treatment alternatives
are available.
Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total
cholesterol, low-density lipoprotein cholesterol, and high-density
lipoprotein cholesterol.
Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of
liver enzyme elevation. If
alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced
liver injury is suspected, RINVOQ should be interrupted until this
diagnosis is excluded.
Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE)
were observed in clinical trials for RINVOQ. In a large randomised
active-controlled study of tofacitinib (another JAK inhibitor) in
RA patients ≥50 years of age with ≥1 additional CV risk factor, a
dose–dependent higher rate of VTE including DVT and PE was observed
with tofacitinib compared to TNF inhibitors. In patients with CV or
malignancy risk factors, RINVOQ should only be used if no suitable
treatment alternatives are available. In patients with known VTE
risk factors other than CV or malignancy risk factors (e.g.
previous VTE, patients undergoing major surgery, immobilisation,
use of combined hormonal contraceptives or hormone replacement
therapy, and inherited coagulation disorder), RINVOQ should be used
with caution. Patients
should be re-evaluated periodically to assess
for changes in VTE risk. Promptly evaluate
patients with signs and symptoms of VTE and discontinue RINVOQ in
patients with suspected VTE.
Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported
in patients receiving RINVOQ. If a clinically significant
hypersensitivity reaction occurs, discontinue RINVOQ and institute
appropriate therapy.
Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA
clinical trials (≥2% of patients in at least one of the
indications) with RINVOQ 15 mg were upper respiratory tract
infections, blood creatine phosphokinase (CPK) increased, ALT
increased, bronchitis, nausea, neutropenia, cough, AST increased,
and hypercholesterolemia. Overall, the safety profile observed in
patients with psoriatic arthritis or active axial spondyloarthritis
treated with RINVOQ 15 mg was consistent with the safety profile
observed in patients with RA.
The most commonly reported adverse reactions in AD trials (≥2%
of patients) with RINVOQ 15 mg or 30 mg were upper respiratory
tract infection, acne, herpes simplex, headache, blood CPK
increased, cough, folliculitis, abdominal pain, nausea,
neutropenia, pyrexia, and influenza. Dose dependent increased risks
of infection and herpes zoster were observed with RINVOQ. The
safety profile for RINVOQ 15 mg in adolescents was similar to that
in adults. The safety and efficacy of the 30 mg dose in adolescents
are still being investigated.
The most commonly reported adverse reactions in the UC and CD
trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were
upper respiratory tract infection, pyrexia, blood CPK increased,
anemia, headache, acne, herpes zoster, neutropaenia, rash,
pneumonia, hypercholesterolemia, bronchitis, aspartate transaminase
increased, fatigue, folliculitis, alanine transaminase increased,
herpes simplex, and influenza.
The overall safety profile observed in patients with UC was
generally consistent with that observed in patients with RA.
Overall, the safety profile observed in patients with CD treated
with RINVOQ was consistent with the known safety profile for
RINVOQ.
The most common serious adverse reactions were serious
infections.
The safety profile of upadacitinib with long–term treatment was
generally similar to the safety profile during the
placebo–controlled period across indications.
This is not a complete
summary of all safety information.
See RINVOQ
full Summary of Product Characteristics (SmPC) at www.ema.europa.eu
Globally, prescribing information varies; refer to the individual country product label for complete
information.
About HUMIRA® (adalimumab) in the European
Union17
Rheumatoid arthritis
HUMIRA in combination with methotrexate, is indicated for:
- the treatment of moderate to severe, active rheumatoid
arthritis in adult patients when the response to disease-modifying
anti-rheumatic drugs including methotrexate has been
inadequate.
- the treatment of severe, active and progressive rheumatoid
arthritis in adults not previously treated with methotrexate.
HUMIRA can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment with methotrexate is
inappropriate.
HUMIRA has been shown to reduce the rate of progression of joint
damage as measured by X-ray and to improve physical function, when
given in combination with methotrexate.
Psoriatic arthritis
HUMIRA is indicated for the treatment of active and progressive
psoriatic arthritis in adults when the response to previous
disease-modifying anti-rheumatic drug therapy has been inadequate.
Humira has been shown to reduce the rate of progression of
peripheral joint damage as measured by X-ray in patients with
polyarticular symmetrical subtypes of the disease and to improve
physical function.
Important EU Safety Information about
HUMIRA® (adalimumab)17
HUMIRA is contraindicated in patients with active tuberculosis or other severe
infections such as sepsis, and opportunistic
infections and in patients with moderate to severe heart failure
(NYHA class III/IV). It is also contraindicated in patients
hypersensitive to the active substance or to any of the excipients;
serious allergic reactions including anaphylaxis have been
reported.
The use of HUMIRA
increases the risk of developing serious infections, including hepatitis B reactivation,
which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported
in patients treated with HUMIRA.
On rare occasions, a severe type of cancer
called hepatosplenic T-cell lymphoma has been observed
and often results in death. A risk for the development of
malignancies in patients treated with TNF- antagonists cannot be
excluded. Rare cases of pancytopenia, aplastic anemia,
demyelinating disease, lupus, lupus-related conditions and
Stevens-Johnson syndrome have been reported in patients treated
with HUMIRA.
The most frequently reported adverse events
across all indications included respiratory infections,
injection site reactions, headache and musculoskeletal pain.
This is not a complete summary of all safety
information.
See HUMIRA full summary of product characteristics (SmPC) for
complete prescribing information at www.ema.europa.eu.
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. Anchored by a longstanding commitment to
discovering and delivering transformative therapies, we pursue
cutting-edge science that improves our understanding of promising
new pathways and targets, ultimately helping more people living
with rheumatic diseases reach their treatment goals. For more
information, visit AbbVie in rheumatology.
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 our
Allergan Aesthetics portfolio. 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 and uses of future
or conditional verbs, 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 expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, 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 2022 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, and specifically declines, 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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