- SEQUENCE, a Phase 3 head-to-head study (study drug
open-label and efficacy assessment blinded)
compared risankizumab to ustekinumab for the treatment of
adult patients with moderately to severely active Crohn's disease
who have failed one or more anti-TNFs1
- Risankizumab met both primary endpoints of non-inferiority
for clinical remission (Crohn's Disease Activity Index [CDAI]) at
week 24 and superiority of endoscopic remission at week 48 versus
ustekinumab
- All secondary endpoints achieved statistical significance
for superiority versus ustekinumab
- Safety results were consistent with the overall safety
profile of risankizumab, with no new safety risks
identified
NORTH
CHICAGO, Ill., Sept. 12,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced top-line results from the Phase 3 SEQUENCE clinical trial
evaluating risankizumab (SKYRIZI®, 600 mg intravenous
[IV] induction at week 0, 4 and 8 and 360 mg subcutaneous injection
[SC] starting at week 12 and every 8 weeks thereafter) versus
ustekinumab (STELARA®, IV dose at week 0 and 90 mg SC
every 8 weeks thereafter) through week 48 in patients with
moderately to severely active Crohn's disease who have failed one
or more anti-TNFs.
The results of the first primary endpoint, clinical remission
(per Crohn's Disease Activity Index [CDAI], defined as CDAI
<150) at week 24, met non-inferiority of risankizumab
versus ustekinumab (non-inferiority margin of 10%); remission
rates were 59% in risankizumab group and 40% in ustekinumab
group.1
The results of the second primary endpoint, endoscopic remission
(SES-CD ≤4 and at least a 2-point reduction versus baseline and no
sub-score greater than 1 in any individual component) at week 48
met superiority of risankizumab versus ustekinumab;
remission rates were 32% in risankizumab group and 16% in
ustekinumab group (p <0.0001).1
"We are encouraged by these results, which demonstrate the
impact SKYRIZI can have in helping patients achieve both clinical
and endoscopic remission," said Roopal
Thakkar, senior vice president, development and regulatory
affairs and chief medical officer, AbbVie. "These head-to-head data
reinforce SKYRIZI is an effective treatment option for patients
living with Crohn's disease."
The safety profile of risankizumab in the SEQUENCE study was
consistent with the known safety profile of risankizumab, with no
new safety risks observed.1 The most common adverse
events were COVID-19, headache and Crohn's disease for the
risankizumab group and COVID-19, Crohn's disease, and arthralgia
for the ustekinumab group.1
"Head-to-head studies like the SEQUENCE study are important in
helping physicians understand differences in therapies and define
treatment algorithms in clinical practice," said Laurent
Peyrin-Biroulet, M.D., Ph.D., director of the Infinity
Institute, professor of gastroenterology and head of the
Inflammatory Bowel Disease group at the Gastroenterology
Department, University Hospital of Nancy, France. "These results add to our growing body
of evidence for SKYRIZI in Crohn's Disease. This study highlights
the efficacy of SKYRIZI compared to ustekinumab in helping eligible
patients achieve clinical and endoscopic treatment goals and also
reinforces the safety profile observed in previous studies."
Full results from the SEQUENCE study will be presented at a
future medical meeting and submitted for publication in a
peer-reviewed journal.
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 tract, causing persistent diarrhea and abdominal
pain.2,3 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.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.2
About the SEQUENCE Study1
The SEQUENCE
study is a Phase 3, multicenter, randomized, head-to-head study
(study drug open-label and efficacy assessment blinded) to
evaluate risankizumab with ustekinumab for the treatment of adults
with moderate to severe Crohn's disease with a history of one or
more failed anti-tumor necrosis factor (TNF) therapies. All
participants had confirmed diagnosis of Crohn's disease for at
least 3 months, Crohn's Disease Activity Index (CDAI) score of 220
to 450 at baseline, confirmed diagnosis of moderate to severe
Crohn's disease assessed by stool frequency, abdominal pain score,
Simple Endoscopy Score for Crohn's Disease (SES-CD), and
demonstrated intolerance or inadequate response to one or more
anti-TNF therapies.
More information on this trial can be found at
https://www.clinicaltrials.gov/ (NCT04524611).
About Risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit.4 IL-23, a
cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic immune-mediated diseases.5
SKYRIZI is approved by the U.S. Food and Drug Administration (FDA)
and the European Medicines Agency for the treatment of plaque
psoriasis, psoriatic arthritis and Crohn's disease. Phase 3 trials
of risankizumab in psoriasis, psoriatic arthritis, Crohn's disease
and ulcerative colitis are ongoing.5-7
U.S. Indications and Important Safety Information about
SKYRIZI® (risankizumab-rzaa)8
SKYRIZI
is a prescription medicine used to treat adults with:
- moderate to severe plaque psoriasis who may benefit from taking
injections or pills (systemic therapy) or treatment using
ultraviolet or UV light (phototherapy).
- active psoriatic arthritis (PsA).
- moderate to severe Crohn's disease.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription medicine that may cause serious
side effects, including:
Serious allergic reactions:
- Stop using SKYRIZI and get emergency medical help right
away if you get any of the following symptoms of a serious allergic
reaction:
- fainting, dizziness, feeling
lightheaded (low blood pressure)
- swelling of your face, eyelids, lips, mouth, tongue,
or throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
- itching
Infections:
SKYRIZI may lower the ability of your
immune system to fight infections and may increase your risk of
infections. Your healthcare provider should check you for
infections and tuberculosis (TB) before starting treatment with
SKYRIZI and may treat you for TB before you begin treatment with
SKYRIZI if you have a history of TB or have active TB. Your
healthcare provider should watch you closely for signs and symptoms
of TB during and after treatment with SKYRIZI.
- Tell your healthcare provider right away if you have an
infection or have symptoms of an infection, including:
– fever, sweats, or chills
– cough
– shortness of breath
– blood in your mucus (phlegm)
– muscle aches
– warm, red, or painful skin or sores on your body different
from your psoriasis
– weight loss
– diarrhea or stomach pain
– burning when you urinate or urinating more often than
normal
Do not use SKYRIZI if you are allergic to
risankizumab-rzaa or any of the ingredients in SKYRIZI. See the
Medication Guide or Consumer Brief Summary for a complete list of
ingredients.
Before using SKYRIZI, tell your healthcare provider about all
of your medical conditions,
including if you:
- have any of the conditions or symptoms listed in the
section "What is the most important information I should
know about SKYRIZI?"
- have an infection that does not go away or that keeps coming
back.
- have TB or have been in close contact with someone with
TB.
- have recently received or are scheduled to receive an
immunization (vaccine). Medicines that interact with the immune
system may increase your risk of getting an infection after
receiving live vaccines. You should avoid receiving live vaccines
right before, during, or right after treatment with SKYRIZI.
Tell your healthcare provider that you are taking SKYRIZI before
receiving a vaccine.
- are pregnant or plan to become pregnant. It is not known
if SKYRIZI can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
if SKYRIZI passes into your breast milk.
- become pregnant while taking SKYRIZI. You are encouraged
to enroll in the Pregnancy Registry, which is used to collect
information about the health of you and your baby. Talk to your
healthcare provider or call 1-877-302-2161 to enroll in this
registry.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most
important information I should know about SKYRIZI?"
Liver problems in Crohn's disease: A person with Crohn's
disease who received SKYRIZI through a vein in the arm developed
changes in liver blood tests with a rash that led to
hospitalization. Your healthcare provider will do blood tests to
check your liver before, during, and up to 12 weeks of treatment
and may stop treatment with SKYRIZI if you develop liver problems.
Tell your healthcare provider right away if you notice any of the
following symptoms: unexplained rash, nausea, vomiting, stomach
(abdominal) pain, tiredness (fatigue), loss of appetite, yellowing
of the skin and eyes (jaundice), and dark urine.
The most common side effects of SKYRIZI in people treated for
Crohn's disease include: upper respiratory infections,
headache, joint pain, stomach (abdominal) pain, injection site
reactions, low red blood cells (anemia), fever, back pain, and
urinary tract infection.
The most common side effects of SKYRIZI in people treated for
plaque psoriasis and psoriatic arthritis include: upper
respiratory infections, headache, feeling tired, injection site
reactions, and fungal skin infections.
These are not all the possible side effects of SKYRIZI. Call
your doctor for medical advice about
side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use
it.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a
600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or
360 mg/2.4 mL single-dose prefilled cartridge with on-body
injector.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn
more.
Please click here for Full Prescribing
Information and Medication
Guide for SKYRIZI.
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
and solutions 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, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie
on X (formerly 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 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.
References:
- AbbVie. Data on File: ABVRRTI76627
- Crohn's disease. symptoms and causes. Mayo Clinic. Accessed
September 1, 2023.
https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304.
- The facts about inflammatory bowel diseases. Crohn's &
Colitis Foundation of America. Published November 2014. Accessed September 1, 2023.
https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd.
Available at:
https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf.
Accessed on September 11, 2023.
- 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 identifier: NCT03671148. Updated
February 28, 2023. Accessed
March 3, 2023.
https://clinicaltrials.gov/ct2/show/NCT03671148
- 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 identifier: NCT03398148. Updated
March 10, 2023. Accessed March 12, 2023.
https://clinicaltrials.gov/ct2/show/record/NCT03398148
- SKYRIZI [package insert]. North
Chicago, IL: AbbVie Inc.; 2022.
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