NORTH CHICAGO, Ill.,
June 28, 2021 /PRNewswire/ -- AbbVie
today announced new data on upadacitinib (RINVOQ®) in
ulcerative colitis and risankizumab (SKYRIZI®) in
Crohn's disease will be presented as oral presentations at the
16th Congress of European Crohn's and Colitis
Organisation (ECCO), to be held virtually July 2-3 and July
8-10. AbbVie is presenting a total of nine abstracts, five
of which are oral presentations, across a broad range of studies in
inflammatory bowel diseases (IBD).
"We know many people with IBD are still suffering with the
debilitating effects of their disease," said Remo Panaccione, M.D., professor of medicine and
director of the IBD unit, University of
Calgary. "AbbVie's robust research on display at ECCO
highlights meaningful developments that have the potential to
positively impact the lives and improve the standards of care for
people living with gastrointestinal diseases, including ulcerative
colitis and Crohn's disease."
Two separate oral presentations will feature data from the
pivotal Phase 3 induction studies evaluating the efficacy and
safety of upadacitinib (45 mg, once daily) as induction therapy in
patients with moderate to severe ulcerative colitis. These studies,
U-ACHIEVE and U-ACCOMPLISH, will highlight the impact of
upadacitinib on clinical, endoscopic and histologic outcomes after
8 weeks of treatment. Top-line results from these studies were
previously announced in December 2020
and February 2021, respectively.
Data from the global Phase 3 program evaluating risankizumab in
adults with moderate to severe Crohn's disease will be presented as
three separate oral presentations. Phase 3 induction studies,
ADVANCE and MOTIVATE, for risankizumab (600 mg or 1200 mg)
evaluated clinical remission and response and improvements in
endoscopic outcomes at week 12. The third oral presentation from
ADVANCE AND MOTIVATE will highlight the impact of risankizumab
induction therapy on patient-reported outcomes. Top-line results
from these studies were previously announced in January 2021.
In addition, several presentations will focus on advancing
research surrounding the importance of understanding patient
preferences and the impact of patient-reported outcomes. In
partnership with the European Federation of Crohn's &
Ulcerative Colitis Associations (EFCCA), AbbVie will present
results from the P-POWER IBD study that evaluated clinical outcomes
and challenges in patients with IBD.
"This study investigated how difficult it is for patients to
manage their IBD," said Salvo Leone, chairman of EFCCA. "Patients
are seeking further treatment options to control the
unpredictability of this disease and its debilitating impact on
their daily lives."
Results from the ICONIC study will also be presented, evaluating
the correlation between patient-reported outcomes and
patient-reported disease activity in ulcerative colitis.
AbbVie abstracts in the 16th Congress of ECCO
programme include:
Upadacitinib Abstracts
Ulcerative Colitis
(UC)
- Efficacy and safety of upadacitinib as induction therapy in
patients with Moderately to Severely Active Ulcerative Colitis:
Results from phase 3 U-ACCOMPLISH study; OP23; scientific programme
oral presentation; July 9;
15:35-15:45 CEST
- Efficacy and safety of upadacitinib induction therapy in
patients with Moderately to Severely Active Ulcerative Colitis:
Results from the phase 3 U-ACHIEVE study; OP24; scientific
programme oral presentation; July 9;
15:45-15:55 CEST
Risankizumab Abstracts
Crohn's Disease (CD)
- Risankizumab induces early clinical remission and response in
patients with Moderate-to-Severe Crohn's Disease: Results from the
phase 3 ADVANCE and MOTIVATE studies; OP26; scientific programme
oral presentation; July 9;
16:05-16:15 CEST
- Effect of risankizumab on patient-reported outcomes in patients
with Crohn's Disease who had an inadequate response or intolerance
to conventional and/or biologic treatments: Results from phase 3
MOTIVATE and ADVANCE trials; DOP88; digital oral presentation;
July 9; 16:45-17:45 CEST
- Risankizumab therapy induces improvements in endoscopic
endpoints in patients with Moderate-to-Severe Crohn's Disease:
Results from the phase 3 ADVANCE and MOTIVATE studies; OP36;
scientific programme oral presentation; July
10; 11:40-11:50 CEST
Disease State Abstracts
- Analysis of international spontaneous reporting system
databases for corticosteroids in Inflammatory Bowel Disease: The
Determinants, Incidence and Consequences of Corticosteroid Excess
(DICE)-impact study; P468; e-Poster presentation; July 9; 8:30
CEST
- Correlation between patient-reported outcomes (PROs) and
patient-reported disease activity in Ulcerative Colitis (UC):
Findings from the ICONIC study; P365; e-Poster presentation;
July 9; 8:30
CEST
- IBD patients' treatment preferences are heterogeneous, but
largely affected by the avoidance of abdominal pain and side
effects (P-POWER IBD study); P153; e-Poster presentation; July
9; 8:30 CEST
- Preliminary validation of a multi-stage machine learning
algorithm to assess histological inflammation in inflammatory bowel
disease; P137; e-Poster presentation; July
9; 8:30 CEST
The full scientific programme for the 16th 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 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.1,2 The
hallmark signs and symptoms of ulcerative colitis include rectal
bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of
pressure), urgency and fecal incontinence.1,3 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.2,4 The severity of symptoms and
unpredictability of disease course can lead to substantial burden
and often disability among those living with the
disease.5
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, abdominal pain and rectal
bleeding.2,6-7 It is a progressive disease, meaning it
gets worse over time.2,7 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.5
About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK
inhibitor that is being studied in several immune-mediated
inflammatory diseases.8-15 In human cellular
assays, RINVOQ preferentially inhibits signalling by JAK1 or JAK1/3
with functional selectivity over cytokine receptors that signal via
pairs of JAK2.8 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.9-15 Use of RINVOQ in ulcerative colitis is not
approved and its safety and efficacy are under evaluation by
regulatory authorities.
About Risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit.16,17 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.16 In April
2019, SKYRIZI received U.S. Food and Drug Administration
approval for the treatment of moderate to severe plaque psoriasis
in adults who are candidates for systemic therapy or phototherapy.
The approved dose for SKYRIZI is 150 mg, administered by prefilled
pen or prefilled syringe at week 0 and 4, and every 12 weeks
thereafter. SKYRIZI was also approved in psoriasis by the European
Commission in April 2019. Phase 3
trials of SKYRIZI in psoriatic arthritis, Crohn's disease and
ulcerative colitis are ongoing.18-20 Use of SKYRIZI in
Crohn's disease is not approved and its safety and efficacy have
not been evaluated by regulatory authorities.
Important EU Safety Information about RINVOQ®
(upadacitinib)8
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
recommended.
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 ≥65 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
management.
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
care.
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
treatment.
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.
Overall, the safety profile observed in patients with active
ankylosing spondylitis treated with upadacitinib 15 mg was
consistent with the safety profile observed in patients with
rheumatoid arthritis. No new safety findings were identified.
Please see the full 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 SKYRIZI® (risankizumab) in the European
Union17
SKYRIZI (risankizumab) is indicated for the treatment of moderate
to severe plaque psoriasis in adults who are candidates for
systemic therapy.
Important EU Safety Information
about SKYRIZI® (risankizumab)17
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 past 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, which occurred in 13 percent of patients.
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.
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, Instagram, YouTube and LinkedIn.
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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