NORTH CHICAGO, Ill.,
May 27, 2022 /PRNewswire/ --
AbbVie (NYSE: ABBV) today announced The
Lancet published results from three pivotal Phase 3
clinical trials – ADVANCE, MOTIVATE (induction studies) and FORTIFY
(maintenance study) – evaluating risankizumab (SKYRIZI®)
in patients with moderately to severely active Crohn's disease who
have had inadequate response, lost response or were intolerant to
conventional or biologic therapy.
Data from the three studies formed the basis of the company's
application for approval by the global health authorities. The
publication of ADVANCE and MOTIVATE reports the efficacy and
safety results of the two induction studies evaluating clinical
remission and endoscopic response with intravenous (IV)
risankizumab versus placebo over 12
weeks.1 The publication of
FORTIFY shares the results of the maintenance study evaluating
the safety and efficacy of subcutaneous (SC) risankizumab versus
placebo (the withdrawal from IV risankizumab) over 52 weeks in
patients who achieved clinical response during the ADVANCE and
MOTIVATE studies.2
The use of risankizumab for Crohn's disease is not approved and
its safety and efficacy remain under regulatory review.
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.3,4,5
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.6
About the ADVANCE and MOTIVATE
Studies7,8,9,10
The
ADVANCE and MOTIVATE studies are Phase 3, multicenter, randomized,
double-blind, placebo-controlled induction studies designed to
evaluate the efficacy and safety of two doses of risankizumab, 600
mg and 1200 mg, in adults with moderate to severe Crohn's disease,
compared to placebo. Both studies included different sets of
primary and secondary endpoints for outside U.S. (OUS) protocol and
U.S. protocol. The primary endpoints were achievement of clinical
remission (per PRO-2 for the OUS protocol, which was measured by
daily stool frequency and abdominal pain score, and per CDAI for
the U.S. protocol, which was measured by a CDAI score less than
150) and endoscopic response (for both protocols) at week 12.
Endoscopic response is defined as a decrease in SES-CD of greater
than 50 percent from baseline (or at least a greater than or equal
to 50 percent decrease from baseline in patients with isolated
ileal disease and a baseline SES-CD of 4), as scored by a central
reviewer.
The ADVANCE study included a mixed population of patients who
had responded inadequately or were intolerant to conventional
and/or biologic therapy. The MOTIVATE study evaluated patients who
had responded inadequately or were intolerant to biologic therapy.
Topline results of the studies were shared in January 2021. More information can be found
on www.clinicaltrials.gov (ADVANCE: NCT03105128;
MOTIVATE: NCT03104413).
About the FORTIFY
Study11,12
The FORTIFY study is a
Phase 3, multicenter, randomized, double-blind, control group,
52-week maintenance study designed to evaluate the efficacy and
safety of risankizumab 180 mg and 360 mg as maintenance therapy
versus withdrawal in patients who responded to risankizumab
induction treatment in the ADVANCE and MOTIVATE studies. This study
included different sets of primary and secondary endpoints for the
OUS analysis plan and U.S. analysis plan due to regulatory
requirements in the different regions. The co-primary endpoints
were achievement of endoscopic response and clinical remission at
week 52. Endoscopic response is defined as a decrease in SES-CD of
greater than 50 percent from baseline (or at least a greater than
or equal to 50 percent decrease from baseline in patients with
isolated ileal disease and a baseline SES-CD of 4), as scored by a
central reviewer. Clinical remission is defined by SF/AP, which was
measured by daily stool frequency and abdominal pain score, in the
OUS analysis plan and defined by CDAI, which was measured by a CDAI
score less than 150, in the U.S. analysis plan.
Topline results were announced in June 2021. An open label extension of FORTIFY
will continue to assess the long-term safety of risankizumab in
subjects who completed participation in FORTIFY. More information
can be found on www.clinicaltrials.gov (NCT03105102).
About SKYRIZI® (Risankizumab)
SKYRIZI is
an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23
by binding to its p19 subunit.13,14 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.7 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
injection) 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.7,9,15,16,17
EU Indications and Important Safety Information about
SKYRIZI® (Risankizumab)7
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.
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, 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 2021 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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1 D'Haens
G., et al. Risankizumab as Induction Therapy for Crohn's Disease.
Lancet.
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2 Ferrante
M., et al. Risankizumab as Maintenance Therapy for Crohn's Disease.
Lancet.
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3 Kaplan, G.
The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol
Hepatol. 2015 Dec; 12(12):720-7. Doi:
10.1038/nrgastro.2015.150.
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4 The Facts
about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation
of America. 2014. Available
at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.
Accessed on January 11, 2022.
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5 Crohn's
disease. Symptoms and Causes. Mayo Clinic. 2022. Available
at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304.
Accessed on January 11, 2022.
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6 The
Economic Costs of Crohn's Disease and Ulcerative Colitis. Access
Economics Pty Limited. 2007. Available
at: https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf.
Accessed on January 11, 2022.
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7 AbbVie.
Data on File: ABVRRTI71474.
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8 AbbVie.
Data on File: ABBVRRI71526.
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9 A Study of
the Efficacy and Safety of Risankizumab in Participants With
Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov.
2020. Available
at: https://clinicaltrials.gov/ct2/show/record/NCT03105128.
Accessed on December 18, 2020.
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10 A Study
to Assess the Efficacy and Safety of Risankizumab in Participants
With Moderately to Severely Active Crohn's Disease Who Failed Prior
Biologic Treatment. ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/record/NCT03104413.
Accessed on December 18, 2020.
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11 AbbVie.
Data on File: ABVRRTI72293.
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12 A Study
of the Efficacy and Safety of Risankizumab in Participants With
Crohn's Disease. ClinicalTrials.gov. 2021. Available
at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed May
21, 2021.
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13 SKYRIZI
[Summary of Product Characteristics]. AbbVie Ltd. Available at:
https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf.
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14 Duvallet,
E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine
in inflammatory diseases. Ann Med. 2011
Nov;43(7):503-11.
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15 A Study
Comparing Risankizumab to Placebo in Participants With Active
Psoriatic Arthritis Including Those Who Have a History of
Inadequate Response or Intolerance to Biologic Therapy(ies)
(KEEPsAKE2). ClinicalTrials.gov. 2022. Available
at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed
on January 13, 2022.
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16 A
Multicenter, Randomized, Double-Blind, Placebo Controlled Induction
Study to Evaluate the Efficacy and Safety of Risankizumab in
Participants With Moderately to Severely Active Ulcerative Colitis.
ClinicalTrials.gov. 2022. Available
at: https://clinicaltrials.gov/ct2/show/record/NCT03398148.
Accessed on January 13, 2022.
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17 Pipeline
– Our Science | AbbVie. AbbVie. 2022. Available
at: https://www.abbvie.com/our-science/pipeline.html. Accessed
on January 13, 2022.
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SOURCE AbbVie