- Third approved
SKYRIZI® (risankizumab) and the
first specific IL-23 inhibitor for the treatment of Crohn's
disease in the European Union (EU)
- A significantly
higher proportion of patients on SKYRIZI achieved clinical
remission, endoscopic response, mucosal healing and endoscopic
remission at week 12 in induction studies compared to
A significantly higher proportion of patients
achieved clinical remission and endoscopic response at week
52 with SKYRIZI
- Crohn's disease is a
chronic, systemic inflammatory disease that manifests as
inflammation within the gastrointestinal tract, causing persistent
diarrhea, abdominal pain and can require urgent medical
CHICAGO, Ill., Nov. 23,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced
the European Commission (EC) approved SKYRIZI®
(risankizumab, 600 mg intravenous [IV] induction and 360 mg
subcutaneous [SC] maintenance therapy) as the first specific
interleukin-23 (IL-23) inhibitor for the treatment of adults with
moderately to severely active Crohn's disease who have had
inadequate response, lost response or were intolerant to
conventional or biologic therapy.1,2,3
"There are still many patients suffering from debilitating
symptoms associated with Crohn's disease, such as abdominal pain
and stool frequency, which is why we've embraced the challenge of
serving these patients in need," said Thomas Hudson, M.D., senior vice president,
research and development, chief scientific officer, AbbVie. "The
approval of SKYRIZI in the European Union is a significant
milestone in our pursuit to expand our IBD portfolio."
The EC approval for SKYRIZI in Crohn's disease is supported by
results from the global Phase 3 program, which included three
studies: ADVANCE induction, MOTIVATE induction and FORTIFY
maintenance.1 The three Phase 3 studies are
multicenter, randomized, double-blind, placebo-controlled studies
and include assessments of efficacy, safety and tolerability of
Clinical Remission & Endoscopic
- In the ADVANCE and MOTIVATE induction trials, a
significantly greater proportion of patients treated with SKYRIZI
600 mg IV achieved the co-primary endpoints of clinical remission
(per SF/AP) and endoscopic response.1,2,3
- In ADVANCE and MOTIVATE, 43% and 35% of patients treated with
SKYRIZI 600 mg IV achieved clinical remission at week 12,
respectively, compared to 22% and 19% of patients receiving
- Additionally, 40% and 29% of SKYRIZI treated patients achieved
endoscopic response at week 12 compared to 12% and 11% of patients
- In the FORTIFY maintenance trial, a significantly greater
proportion of patients treated with SKYRIZI 360 mg SC achieved the
co-primary endpoints of clinical remission (per SF/AP) and
- In FORTIFY, 52% of patients treated with SKYRIZI 360 mg SC
achieved clinical remission at week 52 compared to 40% of patients
- Additionally, 47% of patients treated with SKYRIZI achieved
endoscopic response at week 52 compared to 22% of patients
Mucosal Healing & Endoscopic
- During the ADVANCE and MOTIVATE induction studies, a
significantly greater proportion of patients treated with SKYRIZI
600 mg IV achieved mucosal healing and endoscopic
- In ADVANCE and MOTIVATE, 21% and 14% of patients treated with
SKYRIZI 600 mg IV achieved mucosal healing at week 12,
respectively, compared to 8% and 4% of patients receiving
- Additionally, during the induction studies, 24% and 19% of
patients treated with SKYRIZI 600 mg IV achieved endoscopic
remission at week 12, respectively, compared to 9% and 4% of
patients receiving placebo.1
- Mucosal healing and endoscopic remission were observed during
the FORTIFY maintenance trial in patients treated with SKYRIZI 360
- In FORTIFY, mucosal healing was observed at week 52 in 31% of
patients treated with SKYRIZI 360 mg SC compared to 10% of patients
receiving placebo (nominal p-value<0.001).1
- Additionally, endoscopic remission was observed at week 52 in
39% of patients treated with SKYRIZI 360 mg SC compared to 13% of
patients receiving placebo (nominal
"Beyond managing daily symptoms, clinical remission and
endoscopic goals are key treatment targets in Crohn's disease,"
said Marc Ferrante, M.D., Ph.D.,
Department of Gastroenterology and Hepatology, University Hospitals
Leuven, Belgium. "Research
advancements have made it possible for patients to aim for higher
treatment goals, including mucosal healing. The approval of SKYRIZI
as the first IL-23 inhibitor for moderate to severe Crohn's disease
is a critical step forward towards a treatment option that can
support a patient's health goals."
Additionally, across all three studies, safety results of
SKYRIZI in Crohn's disease were consistent with the known safety
profile of SKYRIZI, with no new safety risks
observed.1,2,3 In ADVANCE, the most common adverse
events (AEs) observed in the SKYRIZI treatment groups were
headache, nasopharyngitis and fatigue.2 In
MOTIVATE, the most common AEs observed were headache, arthralgia
and nasopharyngitis.2 In FORTIFY, the most common
AEs were exacerbation of Crohn's disease, nasopharyngitis and
SKYRIZI is also approved in the EU for the treatment of adults
with psoriasis and psoriatic arthritis.
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
About Crohn's Disease
Crohn's disease is a chronic,
systemic disease that manifests as inflammation within the
gastrointestinal tract, causing persistent diarrhea and abdominal
pain.4,5 It is a progressive disease, meaning it
gets worse over time in a substantial proportion of patients or may
develop complications that require urgent medical care, including
surgery.4,5 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 the ADVANCE Induction, MOTIVATE Induction & FORTIFY
The three Phase 3 studies are multicenter, randomized,
double-blind, placebo-controlled studies to evaluate the efficacy
and safety of SKYRIZI 600 mg and 1200 mg as induction therapy, and
SKYRIZI 180 mg and 360 mg as maintenance therapy in subjects with
moderately to severely active Crohn's disease. More information can
be found on www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE:
NCT03104413, FORTIFY: NCT03105102).
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit.7 IL-23,
a cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic immune-mediated diseases.7
Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis,
Crohn's disease and ulcerative colitis are
EU Indications and Important Safety Information about
Skyrizi (risankizumab) 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 indicated for the treatment of adult patients with
moderately to severely active Crohn's disease who have had an
inadequate response to, lost response to, or were intolerant to
conventional therapy or a biologic therapy.
Important Safety Information
contraindicated in patients hypersensitive to the active substance
or to any of the excipients, and in patients with clinically
important active infections (e.g. active tuberculosis).
Risankizumab may increase the risk of infection. In patients with a
chronic infection, a history of recurrent infection, or known risk
factors for infection, risankizumab should be used with caution.
Treatment with risankizumab should not be initiated in patients
with any clinically important active infection until the infection
resolves or is adequately treated.
Patients treated with risankizumab should be instructed to seek
medical advice if signs or symptoms of clinically important chronic
or acute infection occur. If a patient develops such an infection
or is not responding to standard therapy for the infection, the
patient should be closely monitored and risankizumab should not be
administered until the infection resolves.
Prior to initiating treatment with risankizumab, patients should
be evaluated for tuberculosis (TB) infection. Patients receiving
risankizumab should be monitored for signs and symptoms of active
TB. Anti-TB therapy should be considered prior to initiating
risankizumab 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 risankizumab, completion of all
appropriate immunisations should be considered according to current
immunisation 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 risankizumab. Patients treated
with risankizumab should not receive live vaccines during treatment
and for at least 21 weeks after treatment.
If a serious hypersensivity reaction occurs, administration of
risankizumab should be discontinued immediately and appropriate
The most frequently reported adverse reactions were upper
respiratory infections (15.6% in Crohn's Disease). Commonly
(≥ 1/100 to < 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.
Please see the SmPC for complete prescribing 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
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.
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.
* Clinical remission (per stool frequency and abdominal pain
[SF/AP]) is based on average daily stool frequency and average
daily abdominal pain score.
† Endoscopic response is defined as a decrease in simple endoscopic
score for Crohn's disease (SES-CD) of >50 percent from
baseline (or ≥50 percent from baseline for subjects with
isolated ileal disease and a baseline SES-CD of 4), as scored by
‡ Mucosal healing: SES-CD ulcerated surface subscore of 0 in
subjects with a subscore of ≥1 at Baseline.
§ Endoscopic remission is defined as SES-CD ≤4 and at least a
2-point reduction versus baseline and no subscore greater than 1 in
any individual component, as scored by a central reviewer.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd.
Accessed on November 17, 2022.
- D'Haens G, Panaccione R, Baert F, et al. Risankizumab as
induction therapy for Crohn's disease: results from the phase 3
ADVANCE and MOTIVATE induction trials. The Lancet.
- Ferrante M, Panaccione R, Baert F, et al. Risankizumab as
maintenance therapy for moderately to severely active Crohn's
disease: results from the multicentre, randomised, double-blind,
placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial.
The Lancet. 2022;399(10340):2031-2046.
- Crohn's disease. Symptoms and Causes. Mayo Clinic. Available
- The Facts about Inflammatory Bowel Diseases. Crohn's &
Colitis Foundation of America. 2014. Available at:
- Alatab S, Sepanlou SG, Ikuta K, et al. The global, regional,
and national burden of inflammatory bowel disease in 195 countries
and territories, 1990–2017: a systematic analysis for the Global
Burden of Disease Study 2017. Lancet Gastroenterol Hepatol.
- Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a
key cytokine in inflammatory diseases. Ann Med. 2011. Nov
- Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed on
August 22, 2022.
- 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. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on
August 22, 2022.
- 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. 2021. Available at:
https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on
August 22, 2022.
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