NORTH CHICAGO, Ill.,
Feb. 1, 2022 /PRNewswire/ -- AbbVie
(NYSE: ABBV) will present further analyses on HUMIRA®
(adalimumab) and the investigational uses of risankizumab
(SKYRIZI®) and upadacitinib (RINVOQ®) at
the 17th Congress of European Crohn's and Colitis Organisation
(ECCO), to be held February 16-19. AbbVie will present 26
abstracts, including 8 oral presentations, 8 digital oral
presentations and 10 posters from a broad range of studies across
its inflammatory bowel disease (IBD) portfolio.
"We are excited for the opportunity to present further analyses
from our IBD portfolio, including studies of our pipeline
assets and HUMIRA. Our presence at ECCO underscores our
relentless commitment to research that we hope will help transform
patient care and change the lives of those living with inflammatory
bowel disease," said Chiedzo Mpofu, MBChB, PhD, vice president,
global medical affairs, immunology, AbbVie.
The presentations at ECCO 2022 include new post-hoc analyses
from the pivotal Phase 3 risankizumab program (ADVANCE, MOTIVATE
and FORTIFY) in Crohn's disease, evaluating efficacy by baseline
Crohn's disease location, durable improvements in endoscopic
outcomes and treatment outcomes based on baseline disease duration.
Top-line results from the induction and maintenance studies were
previously announced in January
2021 and June 2021,
respectively.
Additionally, AbbVie will present results from a post-hoc
analysis of Phase 3 upadacitinib pivotal trials (U-ACHIEVE
induction and U-ACCOMPLISH) evaluating ulcerative colitis
symptoms as early as day 1 in upadacitinib-treated patients with
ulcerative colitis. Top-line induction results were previously
announced in December
2020 and February
2021. Top-line results from the maintenance study were
announced in June
2021.
"By understanding the needs of IBD patients, we've embraced the
challenge that is finding additional solutions for today and
tomorrow," said Remo Panaccione, MD,
professor of medicine and director of the IBD unit, University of Calgary. "AbbVie's research at ECCO
represents their dedication to seek solutions that will help serve
many of these patients who continue to be in need of relief from
the burden of living with IBD, particularly those who haven't
responded well enough to conventional therapy."
AbbVie abstracts in the ECCO 2022 program include:
Risankizumab Abstracts
Crohn's Disease
(CD)
- Achievement of steroid-free remission in patients with
moderately to severely active Crohn's disease during treatment with
risankizumab; DOP82; digital oral presentation; Feb. 18; 17:25-17:31
CET
- Normalization of biomarkers and improvement in clinical
outcomes in patients with Crohn's disease treated with risankizumab
in the Phase 3 ADVANCE, MOTIVATE, and FORTIFY studies; DOP83;
digital oral presentation; Feb. 18;
17:32-17:38 CET
- Risankizumab maintenance therapy results in sustained
improvements in endoscopic outcomes in patients with moderate to
severe Crohn's disease: Post-hoc analysis from the Phase 3 study
FORTIFY; DOP84; digital oral presentation; Feb. 18; 17:39-17:45
CET
- Efficacy of risankizumab rescue therapy in patients with
moderately to severely active Crohn's disease and inadequate
response to risankizumab maintenance therapy; DOP85; digital oral
presentation; Feb. 18; 17:46-17:52 CET
- Patients with moderate to severe Crohn's disease with and
without prior biologic failure demonstrate improved endoscopic
outcomes with risankizumab: Results from Phase 3 induction and
maintenance trials; OP25; oral presentation; Feb. 18; 16:34-16:44
CET
- Shorter disease duration is associated with better outcomes in
patients with moderately to severely active Crohn's disease treated
with risankizumab: Results from the Phase 3 ADVANCE, MOTIVATE, and
FORTIFY studies; OP39; oral presentation; Feb. 19; 11:40-11:50
CET
- Efficacy of risankizumab induction and maintenance therapy by
baseline Crohn's disease location: Post hoc analysis of the Phase 3
ADVANCE, MOTIVATE, and FORTIFY studies; OP40; oral presentation;
Feb. 19; 11:50-12:00 CET
- Early improvement of endoscopic outcomes with risankizumab is
associated with reduced hospitalization and surgery rates in
patients with Crohn's disease; P380; poster session; Feb. 18; 12:30-13:30
CET
- Patients with moderate to severe Crohn's disease with and
without prior biologic failure demonstrated improved clinical
outcomes with risankizumab: Results from Phase 3 induction and
maintenance trials; P544; poster session; Feb. 18; 12:30-13:30
CET
- Population pharmacokinetic and exposure-response analyses for
efficacy and safety of risankizumab in subjects with active Crohn's
disease; P574; poster session; Feb.
18; 12:30-13:30 CET
Upadacitinib Abstracts
Ulcerative Colitis
(UC)
- Upadacitinib therapy reduces ulcerative colitis symptoms as
early as day 1; DOP38; digital oral presentation; Feb. 17; 17:37-17:43
CET
- Effect of baseline disease characteristics on clinical outcomes
in moderate-to-severe ulcerative colitis treated with upadacitinib:
Results from a Phase 3 trials program; DOP39; digital oral
presentation; Feb. 17; 17:44-17:50 CET
- Impact of corticosteroid usage on efficacy and safety outcomes
in patients receiving upadacitinib for ulcerative colitis; DOP40;
digital oral presentation; Feb. 17;
17:51-17:57 CET
- Efficacy and safety of extended induction treatment with
upadacitinib 45 mg once daily followed by maintenance upadacitinib
15 or 30 mg once daily in patients with moderately to severely
active ulcerative colitis; DOP41; digital oral presentation;
Feb. 17; 17:58-18:04 CET
- The effects of maintenance therapy with upadacitinib on
abdominal pain, bowel urgency, and fatigue in patients with
moderately to severely active ulcerative colitis: Phase 3 U-ACHIEVE
maintenance results; OP08; oral presentation; Feb. 17; 16:50-17:00
CET
- Upadacitinib modulates inflammatory pathways in gut tissue in
patients with ulcerative colitis: Transcriptomic profiling from the
Phase 2b study, U-ACHIEVE; OP30; oral
presentation; Feb. 18; 16:00-16:10 CET
- Effect of upadacitinib (UPA) treatment on extraintestinal
manifestations (EIMs) in patients with moderate-to-severe
ulcerative colitis (UC): Results from the UPA Phase 3 program;
OP33; oral presentation; Feb. 18;
08:50-09:00 CET
- Efficacy and safety of advanced induction and maintenance
therapies in patients with moderately to severely active ulcerative
colitis: An indirect treatment comparison using Bayesian network
meta-analysis; OP34; oral presentation; Feb.
18; 09:20-09:30 CET
- Pharmacokinetics and exposure-response analyses of upadacitinib
in patients with moderate to severe ulcerative colitis – Analyses
of induction and maintenance clinical trials; P341; poster session;
Feb. 18; 12:30-13:30 CET
- Maintenance of health-related quality of life improvements with
upadacitinib treatment among patients with moderately to severely
active ulcerative colitis: results from 52-week Phase 3 study U
ACHIEVE maintenance; P370; poster session; Feb. 18; 12:30-13:30
CET
- Correlation of histological assessment of mucosal healing with
long-term clinical and patient-reported outcomes in patients with
moderately to severely active ulcerative colitis treated with
upadacitinib: results from the Phase 3 U-ACHIEVE maintenance trial;
P521; poster session; Feb. 18;
12:30-13:30 CET
- Upadacitinib promotes histologic and endoscopic mucosal
healing: Results from the upadacitinib ulcerative colitis Phase 3
Program; P522; poster session; Feb.
18; 12:30-13:30 CET
- The effect of multiple doses of upadacitinib 45 mg on the
pharmacokinetics of cytochrome P450 substrates in healthy adult
subjects; P556; poster session; Feb.
18; 12:30-13:30 CET
- The safety profile of upadacitinib maintenance therapy in
ulcerative colitis in the Phase 3 U-ACHIEVE study is consistent
with that in approved indications; P573; poster session;
Feb. 18; 12:30-13:30 CET
Adalimumab Abstracts
Inflammatory Bowel Disease
(IBD)
- Baseline whole-blood gene expression of TREM1 does not predict
clinical or endoscopic outcomes following adalimumab treatment in
patients with ulcerative colitis or Crohn's disease in the SERENE
studies; DOP81; digital oral presentation; Feb. 18; 18:21-18:27
CET
Disease State Abstracts
- Trends in corticosteroid (CS) use over time and following
diagnosis in patients with inflammatory bowel disease (IBD), using
IBM® MarketScan®; P488; poster session;
Feb. 18; 8:00-18:00 CET
The full scientific program for 17th Congress of ECCO
is available here.
Risankizumab (SKYRIZI) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as
inflammation within the gastrointestinal (or digestive) tract,
causing persistent diarrhea and abdominal
pain.1-3 It is a progressive disease, meaning it
gets worse over time in a substantial proportion of
patients.2,3 Because the signs and symptoms of
Crohn's disease are unpredictable, it causes a significant burden
on people living with the disease—not only physically, but also
emotionally and economically.4
About Ulcerative Colitis
Ulcerative colitis is a chronic, idiopathic, immune-mediated
inflammatory bowel disease (IBD) of the large intestine that causes
continuous mucosal inflammation extending, to a variable extent,
from the rectum to the more proximal colon.2,6 The
hallmark signs and symptoms of ulcerative colitis include rectal
bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of
pressure), urgency and fecal incontinence.5,7 The
disease course of ulcerative colitis varies between patients and
can range from quiescent disease to chronic refractory disease,
which in some cases can lead to surgery or complications, including
cancer or death.2,7 The severity of symptoms and
unpredictability of disease course can lead to substantial burden
and often disability among those living with the
disease.8
About Risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19
subunit.9,10 IL-23, a cytokine involved in
inflammatory processes, is thought to be linked to a number of
chronic immune-mediated diseases, including Crohn's
disease.9 The approved dose for SKYRIZI for
moderate to severe plaque psoriasis and active psoriatic arthritis
in the European Union is 150 mg (either as two 75 mg pre-filled
syringe injections or one 150 mg prefilled pen or pre-filled
injections) administered by subcutaneous injections at week 0 and 4
and every 12 weeks thereafter. The use of risankizumab in
Crohn's disease is not approved and its safety and efficacy have
not been established by regulatory authorities. Phase 3 trials of
SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and
ulcerative colitis are ongoing.9,11-14
About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ is a
selective and reversible JAK inhibitor that is being
studied in several immune-mediated inflammatory
diseases.14-23 In human cellular assays, upadacitinib
preferentially inhibits signalling by JAK1 or JAK1/3 with
functional selectivity over cytokine receptors that signal via
pairs of JAK-2. RINVOQ 15 mg is approved by the European Commission
for adults with moderate to severe active rheumatoid arthritis,
adults with active psoriatic arthritis and adults with active
ankylosing spondylitis. RINVOQ is also approved by
the European Commission for adults (15 mg and 30 mg) and
adolescents (15 mg) with moderate to severe atopic dermatitis.
RINVOQ 15 mg is approved by the U.S. Food and Drug
Administration (FDA) for adults with moderately to severely active
rheumatoid arthritis who have had an inadequate response or
intolerance to one or more TNF blockers as well as adults with
active psoriatic arthritis who have had an inadequate response or
intolerance to one or more TNF blockers. RINVOQ 15 mg and 30
mg is approved for use in the U.S. in adults and pediatric patients
12 years of age and older with refractory, moderate to severe
atopic dermatitis whose disease is not adequately controlled with
other systemic drug products, including biologics, or when use of
those therapies are inadvisable. Phase 3 trials of RINVOQ in
rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial
spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell
arteritis and Takayasu arteritis are
ongoing.14,16-22 The use of upadacitinib
in ulcerative colitis is not approved and its safety
and efficacy have not been evaluated by regulatory
authorities.
About HUMIRA® (adalimumab) in the European
Union24
HUMIRA is approved for the treatment of moderate to severe
Crohn's disease and moderate to severe ulcerative colitis.
EU Indications and Important Safety Information
about SKYRIZI® (risankizumab)9
SKYRIZI is indicated for the treatment of moderate to severe
plaque psoriasis in adults who are candidates for systemic therapy.
SKYRIZI, alone or in combination with methotrexate (MTX), is
indicated for the treatment of active psoriatic arthritis in adults
who have had an inadequate response or who have been intolerant to
one or more disease-modifying antirheumatic drugs (DMARDs).
SKYRIZI is contraindicated in patients with hypersensitivity to
the active substance or to any of the excipients. SKYRIZI may
increase the risk of infection. In patients with a chronic
infection, a history of recurrent infection, or known risk factors
for infection, SKYRIZI should be used with caution. Treatment with
SKYRIZI should not be initiated in patients with any clinically
important active infection until the infection resolves or is
adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be
evaluated for tuberculosis (TB) infection. Patients receiving
SKYRIZI should be monitored for signs and symptoms of active TB.
Anti-TB therapy should be considered prior to initiating SKYRIZI in
patients with a history of latent or active TB in whom an adequate
course of treatment cannot be confirmed.
Prior to initiating therapy with SKYRIZI, completion of all
appropriate immunizations should be considered according to current
immunization guidelines. If a patient has received live vaccination
(viral or bacterial), it is recommended to wait at least 4 weeks
prior to starting treatment with SKYRIZI. Patients treated with
SKYRIZI should not receive live vaccines during treatment and for
at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper
respiratory infections. Commonly (greater than or equal to 1/100 to
less than 1/10) reported adverse reactions included tinea
infections, headache, pruritus, fatigue and injection site
reactions.
This is not a complete summary of all safety
information.
See SKYRIZI 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.
EU Indications and Important Safety Information about
RINVOQ® (upadacitinib)15
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active
rheumatoid arthritis 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
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.
Ankylosing spondylitis
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 in adults and adolescents 12 years and older who are
candidates for systemic therapy.
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
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 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/esophageal candidiasis, and cryptococcosis have been reported
with upadacitinib. As there is a higher incidence of infections in
patients ≥65 years of age, caution should be used when treating
this population.
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 upadacitinib.
Vaccinations
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.
Malignancy
The risk of malignancies, including
lymphoma is increased in patients with rheumatoid arthritis (RA).
Malignancies, including nonmelanoma 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.
Hematological abnormalities
Treatment should not be
initiated, or should be temporarily interrupted, in patients with
hematological abnormalities observed during routine patient
management.
Diverticulitis
Upadacitinib should be used with
caution in patients with diverticular disease and especially in
patients chronically treated with concomitant medications
associated with an increased risk of diverticulitis.
Cardiovascular risk
RA patients have an increased risk
for cardiovascular disorders. Patients treated with upadacitinib
should have risk factors (e.g., hypertension, hyperlipidemia)
managed as part of usual standard of care.
Lipids
Upadacitinib 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
upadacitinib was associated with an increased incidence of liver
enzyme elevation compared to placebo
Venous thromboembolisms
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.
Adverse reactions
The most commonly reported adverse
reactions in rheumatoid arthritis, psoriatic arthritis, and
ankylosing spondylitis clinical trials (≥2% of patients in at least
one of the indications) with upadacitinib 15 mg were upper
respiratory tract infections, blood creatine phosphokinase (CPK)
increased, alanine transaminase (ALT) increased, bronchitis,
nausea, cough, aspartate transaminase (AST) increased, and
hypercholesterolemia.
The most commonly reported adverse reactions in atopic
dermatitis trials (≥2% of patients) with upadacitinib 15 mg or 30
mg were upper respiratory tract infection, acne, herpes simplex,
headache, CPK increased, cough, folliculitis, abdominal pain,
nausea, neutropenia, pyrexia, and influenza.
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.
Overall, the safety profile observed in patients with psoriatic
arthritis or active ankylosing spondylitis treated with
upadacitinib 15 mg was consistent with the safety profile observed
in patients with RA.
In atopic dermatitis, dose-dependent increased risks of
infection and herpes zoster were observed with upadacitinib. Based
on limited data, there was a higher rate of overall adverse
reactions with the upadacitinib 30 mg dose compared to the 15 mg
dose in patients aged 65 years and older. The safety profile for
upadacitinib 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. Dose-dependent changes in ALT increased and/or
AST increased (≥ 3 x ULN), lipid parameters, CPK values (> 5 x
ULN), and neutropenia (ANC < 1 x 109 cells/L)
associated with upadacitinib treatment were similar to what was
observed in the rheumatologic disease clinical studies.
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.
EU Indications and Important Safety Information about
HUMIRA® (adalimumab)24
Crohn's disease
HUMIRA is indicated for treatment of moderately to severely active
Crohn's disease, in adult patients who have not responded despite a
full and adequate course of therapy with a corticosteroid and/or an
immunosuppressant; or who are intolerant to or have medical
contraindications for such therapies
Ulcerative colitis
HUMIRA is indicated for treatment of moderately to severely active
ulcerative colitis in adult patients who have had an inadequate
response to conventional therapy including corticosteroids and
6-mercaptopurine (6-MP) or azathioprine (AZA), or who are
intolerant to or have medical contraindications for such
therapies.
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 anaemia, 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 Gastroenterology
With a robust clinical trial program, AbbVie is committed to
cutting-edge research to drive exciting developments in
inflammatory bowel diseases (IBD), like ulcerative colitis and
Crohn's disease. By innovating, learning and adapting, AbbVie
aspires to eliminate the burden of IBD and make a positive
long-term impact on the lives of people with IBD. For more
information on AbbVie in gastroenterology,
visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.
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 its
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, 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.
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