- A significantly higher proportion of patients with
moderately to severely active ulcerative colitis treated with
risankizumab achieved the primary endpoint of clinical
remissiona (per Adapted Mayo Score) compared to placebo
at week 12 in the Phase 3 INSPIRE induction study
- All secondary endpoints, including clinical, endoscopic and
histologic outcomes, were met
- Safety results in this study were consistent with the known
safety profile of risankizumab, with no new safety risks
observed1
- Building on AbbVie's growing gastroenterology portfolio,
risankizumab is an IL-23 inhibitor being evaluated as a treatment
for adults with moderate to severe ulcerative colitis and approved
for Crohn's disease, psoriatic arthritis, and
psoriasis1
NORTH
CHICAGO, Ill., March 23,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced positive top-line results from INSPIRE, a Phase 3
induction study, showing risankizumab (SKYRIZI®,1200 mg
intravenous [IV], at weeks 0, 4 and 8) met the primary endpoint of
clinical remission (per Adapted Mayo Score) at week 12, as well as
all secondary endpoints in adult patients with moderately to
severely active ulcerative colitis.1 In the study, 20.3%
of patients receiving risankizumab achieved clinical remission
compared to 6.2% of patients receiving placebo
(p<0.00001).1 The INSPIRE study enrolled patients
that demonstrated intolerance or inadequate response to
conventional therapies and/or advanced therapies (biologics, JAK
inhibitors and S1P receptor modulators).1
"Our commitment to people living with gastroenterological
conditions continues to grow," said Roopal
Thakkar, M.D., senior vice president, development,
regulatory affairs and chief medical officer, AbbVie. "These
encouraging results help support the potential
risankizumab has to improve clinical, endoscopic and histologic
outcomes in patients with ulcerative colitis."
A significantly greater proportion of patients treated with
risankizumab achieved endoscopic improvement at week 12 compared to
placebo (36.5% vs 12.1%; p<0.00001).1 Furthermore,
24.5% of patients treated with risankizumab achieved
histologic-endoscopic mucosal improvement at week 12 vs 7.7% of
those receiving placebo (p<0.00001).1
"It is impressive to see the meaningful responses that were
achieved in the INSPIRE study, which demonstrates the
potential of risankizumab to serve as an option across inflammatory
bowel diseases," said Edouard Louis,
M.D., Ph.D., professor and head of the department of
gastroenterology, University Hospital CHU of Liège Belgium, INSPIRE study investigator. "These
results suggest that risankizumab may help patients coping with the
challenging symptoms of ulcerative colitis, which include abdominal
pain, bowel urgency and fecal incontinence."
Efficacy Results at
Week 12*,1
|
|
Risankizumab 1200 mg
IV
(n=650)
|
Placebo
(n=325)
|
Clinical Remission
(Adapted Mayo Score)a
|
20.3 %
|
6.2 %
|
Clinical Response
(Adapted Mayo Score)b
|
64.3 %
|
35.7 %
|
Endoscopic
Improvementc
|
36.5 %
|
12.1 %
|
Histologic-Endoscopic
Mucosal Improvementd
|
24.5 %
|
7.7 %
|
|
*
Primary endpoint was clinical remission
(per Adapted Mayo Score). Clinical response (per Adapted Mayo
Score), endoscopic improvement and histologic-endoscopic mucosal
improvement were secondary endpoints. Not all secondary endpoints
are shown. All primary and secondary endpoints in this study
achieved statistical significance under the overall type I error
rate at 0.05 (2-sided).
a Clinical remission per Adapted Mayo Score is
defined as stool frequency subscore (SFS)
≤1 and not greater than baseline, rectal bleeding subscore (RBS) of
0 and endoscopic subscore ≤1 without friability.
|
b
Clinical response per Adapted Mayo Score
is defined as a decrease from baseline in the Adapted Mayo score ≥2
points and ≥30% from baseline, plus a decrease in RBS ≥1 or an
absolute RBS ≤1.
|
c Endoscopic improvement is defined as endoscopic
subscore ≤1 without friability.
d
Histologic-endoscopic mucosal improvement
is defined as Geboes score ≤3.1 and endoscopic subscore ≤1 without
friability.
|
During the 12-week, double-blind, placebo-controlled period, the
safety profile of risankizumab 1200 mg IV was consistent with the
safety profile observed in previous studies across other
indications, with no new safety risks
observed.1 The most common adverse events observed
in the risankizumab group were COVID-19, anemia and arthralgia.
Serious adverse events occurred in 2.3% of patients in the
risankizumab 1200 mg IV group compared to 10.2% of patients in the
placebo group.1 Rates of serious infections were 0.6% in
those treated with risankizumab 1200 mg IV and 1.2% in patients who
received placebo.1 There was one death in the
risankizumab 1200 mg group due to COVID-19 pneumonia on study day
33. There were no adjudicated major adverse cardiac events
(MACE), no adjudicated anaphylactic reaction events and no
malignancy events reported in the risankizumab
group.1
Use of risankizumab in ulcerative colitis is not approved and
its safety and efficacy have not been evaluated by regulatory
authorities. The maintenance study for ulcerative colitis is
ongoing.
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.2,3 The
hallmark signs and symptoms of ulcerative colitis include rectal
bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of
pressure), urgency and fecal incontinence.3,4 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.4,5 The severity of symptoms and
unpredictability of disease course can lead to substantial burden
and often disability among those living with the
disease.6
About INSPIRE1
INSPIRE is a multicenter, randomized, double-blind,
placebo-controlled Phase 3 study evaluating the efficacy and safety
of risankizumab 1200 mg IV administered every four weeks as
induction therapy in subjects with moderately to severely active
ulcerative colitis.
The primary endpoint is clinical remission (per adapted
Mayo Score, defined as SFS ≤1 and
not greater than baseline, RBS of 0 and endoscopic subscore ≤1
without friability) at week 12. Secondary endpoints include
clinical response (decrease from baseline in the Adapted Mayo score
≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an
absolute RBS ≤1), endoscopic improvement (endoscopic subscore
≤1 without friability), and histologic endoscopic mucosal
improvement (HEMI, endoscopic subscore of 0 or 1 without
friability and Geboes score ≤3.1) at week 12. More information can
be found on www.clinicaltrials.gov (NCT03398148).
About Risankizumab (SKYRIZI®)
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.8
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 SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and
ulcerative colitis are ongoing.8,9,10
U.S. Indications and Important Safety Information about
SKYRIZI® (risankizumab-rzaa)11
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 medication 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
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from
your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your mucus (phlegm)
- 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 people with Crohn's disease: A person
with Crohn's disease who received SKYRIZI by intravenous infusion
developed changes in liver blood tests with a rash that led to
hospitalization. Your doctor 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
doctor 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
600mg/10mL intravenous infusion, and a 360mg/2.4mL single-dose
prefilled cartridge with on-body injector.
This is the most important information to know about SKYRIZI.
For more information, talk to your HCP.
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
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 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.
References:
- AbbVie. Data on file: ABVRRTI75696.
- Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive
review and update on ulcerative colitis. Dis Mon. 2019
Dec;65(12):100851. doi: 10.1016/j.disamonth.2019.02.004
- The facts about inflammatory bowel diseases. Crohn's &
Colitis Foundation of America. Accessed March 8, 2023.
https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
- Ulcerative colitis. Mayo Clinic. Accessed March 3, 2023.
https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326
- Monstad, I, Hovde O, Solberg IC, A Moum B. Clinical course and
prognosis in ulcerative colitis: results from population-based and
observational studies. Ann Gastroenterol. 2014; 27(2):
95–104.
- Mehta F. Report: economic implications of inflammatory bowel
disease and its management. Am J Manag Care. 2016;22(3
Suppl):s51-60.
- Duvallet E, Sererano L, Assier E, Falgarone G, Boissier MC.
Interleukin-23: a key cytokine in inflammatory diseases. Ann
Med. 2011;43(7):503-11. doi:10.3109/07853890.2011.577093
- Pipeline. AbbVie. 2021. Accessed March
3, 2023.
https://www.abbvie.com/our-science/pipeline.html
- 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. 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. 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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