- At week 24, upadacitinib 30 mg given alone or as a
combination therapy (ABBV-599 high dose [elsubrutinib 60 mg
and upadacitinib 30 mg]) met the primary endpoint of
systemic lupus erythematosus (SLE) Responder Index (SRI-4) and
steroid dose less than or equal to 10 mg prednisone equivalent once
per day in patients with moderately to severely active SLE
receiving standard lupus therapies1
-
Upadacitinib maintained greater improvements in SLE disease
activity at week 48 as measured by the British Isles Lupus
Assessment Group-Based Composite Lupus
Assessment (BICLA), SRI-4, Lupus Low
Disease Activity State (LLDAS) and lupus flares compared with
placebo2
- No new safety signals were
observed beyond the known safety profile for upadacitinib. Types of
adverse events reported with ABBV-599 high dose were similar to
those reported for patients treated with upadacitinib
alone2
- Study results are being
presented as an oral presentation at the European Congress of
Rheumatology, EULAR 2023
NORTH
CHICAGO, Ill., May 31, 2023
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the results of
the Phase 2 SLEek study evaluating upadacitinib (RINVOQ®
30 mg) alone and in combination [ABBV-599 high dose (elsubrutinib
60 mg and upadacitinib 30 mg)] in adults with moderately to
severely active systemic lupus erythematosus (SLE) who continued to
receive standard lupus therapies. The study results are being
presented as an oral presentation during the European Congress of
Rheumatology, EULAR 2023.
In the Phase 2 SLEek study, a greater proportion of patients
receiving upadacitinib 30 mg or ABBV-599 high dose achieved the
primary endpoint, SLE Responder Index (SRI-4) and steroid dose less
than or equal to 10 mg prednisone equivalent once per day at week
24, compared to placebo (54.8 percent; p=0.028 and 48.5 percent;
p=0.081* versus 37.3 percent, respectively).1 SRI-4 and
steroid dose less than or equal to 10 mg prednisone equivalent per
day assess reductions in disease activity and glucocorticoid use,
respectively.3
"There are limited treatment options for people living with SLE,
leaving physicians challenged on how to effectively slow disease
progression and limit potential organ damage in their patients,"
said Roopal Thakkar, M.D., senior
vice president, development and regulatory affairs and chief
medical officer, AbbVie. "As a leader in immunology, AbbVie is
committed to advancing care in areas of unmet need, such as SLE. We
are encouraged by these positive Phase 2 data and look forward to
continuing to study upadacitinib for systemic lupus erythematosus
in two Phase 3 trials as part of our ongoing clinical program."
Key secondary endpoints were also achieved at week 48 in both
active treatment groups, including lupus flares measured by the
Safety of Estrogens in Lupus Erythematosus National Assessment
(SELENA) Systemic Lupus Erythematosus Disease Activity Index
(SLEDAI) Flare Index (SFI) and time to first flare, which showed
greater treatment effect in the upadacitinib 30 mg and ABBV-599
high dose groups compared to placebo.2 Other measures of
disease activity and treatment response were also met, including
achievement of BICLA response, SRI-4, and Lupus Low Disease
Activity State (LLDAS) in the upadacitinib 30 mg and ABBV-599 high
dose groups compared to placebo.2
Efficacy Results at
Week 482
|
Endpoint
|
PBO
(N=75)
|
UPA 30 mg
(N=62)
|
ABBV-599 HD
(N=68)
|
Flares per SELENA
SLEDAI Flare Index
|
Overall flares;
Events/PY
|
2.8
|
2.0
|
1.5
|
Adj. Diff** (- PBO)
[95% CI], p-value
|
|
-0.78 [-1.37,
-0.20],
p=0.008
|
-1.3 [-1.84,
-0.76],
p<0.001
|
BICLA
|
Week 48; n
(%)
|
19 (25.3)
|
33 (53.2)
|
33 (48.5)
|
Adj. Diff** (- PBO)
[95% CI], p-value
|
|
30.8 [17.6, 44.1],
p<0.001
|
22.9 [9.3, 36.4],
p<0.001
|
SRI-4 and steroid
dose ≤ 10 mg QD
|
Week 48; n
(%)
|
24 (32.0)
|
28 (45.2)
|
35 (51.5)
|
Adj. Diff** (- PBO)
[95% CI], p-value
|
|
13.4 [-1.4, 28.2],
p=0.075
|
18.5 [4.1, 32.9],
p=0.012
|
LLDAS
|
Week 48; n
(%)
|
18 (24.0)
|
31 (50.0)
|
27 (39.7)
|
Adj. Diff** (- PBO)
[95% CI], p-value
|
|
26.6 [12.9, 40.4],
p<0.001
|
14.6 [1.3, 27.9],
p=0.031
|
*For statistical
analyses of efficacy assessments, the prespecified 2-sided alpha
level was 0.1, without multiplicity control
|
**Adj. Diff: stratum-adjusted treatment difference
except for the flares, which were summarized as observed. P-values
for treatment difference were based on the CMH test for categorical
endpoints and MMRM for continuous endpoints, controlling for
stratification factors and based on the normal approximation for
flare rate through week 48.
|
SLE—the most common type of lupus—is an autoimmune disease where
the immune system attacks its own tissues, causing widespread
inflammation and tissue damage in the affected organs.4
It can impact the joints, skin, brain, lungs, kidneys and blood
vessels, causing a variety of symptoms, including fatigue, skin
rashes, fevers, and pain and swelling in the joints.4
Disease activity in lupus—often called flares—is
unpredictable.5 Flares can appear without warning, come
and go and vary in severity—serious flares can cause organ damage
and require medical attention.6
"Lupus is an imbalance in the immune system caused by a
diverse set of inherited and environmental factors. It impacts over
three million people around the world and causes an overlapping
spectrum of symptoms," said Joan
Merrill, M.D., Oklahoma Medical Research Foundation,
Arthritis & Clinical Immunology Research Program. "To achieve
sustainable progress with SLE, we need more treatment
options for patients with this disease."
No new safety signals were observed beyond the known safety
profile for upadacitinib.2 Types of adverse events
reported with ABBV-599 high dose were similar to those reported for
patients treated with upadacitinib alone.2 The rate
of treatment emergent adverse events (TEAEs) in this study were
similar across groups (ABBV-599 at 86.8 percent, upadacitinib at
82.3 percent and placebo at 78.7 percent).2 Serious AEs
were reported in 10.3 percent of patients in the ABBV-599 high
dose, 21.0 percent in upadacitinib 30 mg, and 17.3 percent in
placebo groups.2 Adjudicated cardiovascular events were
reported in one patient in each of the three treatment
groups.2 There were no reports of malignancies or venous
thromboembolic events.2 The use of upadacitinib and
elsubrutinib in SLE are not approved and their safety and efficacy
have not been evaluated by regulatory authorities.
About the SLEek Phase 2 Study
In the SLEek Phase 2
study, 341 patients undergoing standard lupus therapy were
randomized to receive once daily ABBV-599 high dose, ABBV-599 low
dose (elsubrutinib 60 mg plus upadacitinib 15 mg), elsubrutinib 60
mg, upadacitinib 30 mg or placebo.2 After a planned
interim analysis when 50 percent of patients reached week 24 or
withdrew from the study, the ABBV-599 low dose and elsubrutinib 60
mg arms were discontinued for lack of efficacy. 205 patients
continued in the study to week 48 (ABBV-599 HD n = 68, upadacitinib
30 mg n = 62, placebo n = 75).2
As previously disclosed, AbbVie is advancing its clinical
program of upadacitinib in SLE to Phase 3 based on these results.
ABBV-599 will not move forward to Phase 3 due to no additional
contribution of efficacy by elsubrutinib relative to
upadacitinib alone. Additional results from the SLEek study
are being presented at EULAR in posters 1133 and 1137.
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.7-20 In human cellular assays, RINVOQ
preferentially inhibits signaling by JAK1 or JAK1/3 with functional
selectivity over cytokine receptors that signal via pairs of
JAK2.7 The relevance of inhibition of specific JAK
enzymes to therapeutic effectiveness and safety is not currently
known.7
Upadacitinib (RINVOQ) is in Phase 3 development for giant cell
arteritis, Takayasu arteritis and systemic lupus
erythematosus.14,18,20
EU Indications and Important Safety Information about
RINVOQ® (upadacitinib)7
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 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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in Participants with Giant Cell Arteritis. clinicaltrials.gov;
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