- Submissions are supported by two Phase 3 clinical trials
demonstrating risankizumab achieved the primary endpoint of
clinical remission (per Adapted Mayo Score) and key secondary
endpoints as an induction and maintenance
treatment1,2
- Safety results were generally consistent with the known
safety profile of risankizumab, with no new safety risks
observed1,2
- Risankizumab is an IL-23 inhibitor being evaluated as a
treatment for adults with moderately to severely active ulcerative
colitis and is currently approved by FDA and EMA in Crohn's
disease, psoriatic arthritis and psoriasis1
NORTH
CHICAGO, Ill., Aug. 28,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that it has submitted applications for a new indication
to the U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA) for risankizumab (SKYRIZI®, 1200
mg intravenous [IV] [induction dose] and 180 mg and 360 mg
subcutaneous [SC] [maintenance dose]) for the treatment of adult
patients with moderately to severely active ulcerative colitis.
"While there has been advancement in therapies to treat
ulcerative colitis, there is still an ongoing need for additional
treatments to help those seeking relief from its disruptive
effects," said Roopal Thakkar, M.D.,
senior vice president, development, regulatory affairs and chief
medical officer, AbbVie. "These submissions demonstrate our
continued commitment to helping people living with IBD, and we look
forward to providing a potential new treatment option for the
management of ulcerative colitis."
Applications to the FDA and EMA are supported by data from two
Phase 3 clinical trials: an induction study, INSPIRE, and a
maintenance study, COMMAND.1,2 Significantly more
patients treated with risankizumab 1200 mg IV at week 12 in the
induction study and 180 mg or 360 mg SC at week 52 in the
maintenance study achieved the primary endpoint of clinical
remission (per Adapted Mayo Score), compared to patients receiving
placebo.1,2 Additionally, more risankizumab-treated
patients in both the induction and maintenance studies achieved the
key secondary endpoints of endoscopic improvement (endoscopic
subscore ≤1 without evidence of friability) and histologic
endoscopic mucosal improvement (HEMI, defined as endoscopic
subscore ≤1 without evidence of friability and Geboes score ≤3.1)
compared to placebo.1,2
The safety results in INSPIRE and COMMAND were generally
consistent with the safety profile of risankizumab observed in
previous studies across other indications, with no new safety risks
observed.1,2
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.3,4 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 life-threatening
complications.5,6 The severity of symptoms and
unpredictability of disease course can lead to substantial burden
and often disability among those living with the
disease.7
About INSPIRE Induction Study1
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. Key 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 HEMI (endoscopic subscore of 0 or 1
without friability and Geboes score ≤3.1) at week 12.
Topline results of the study were shared in March 2023. More information can be found on
www.clinicaltrials.gov (NCT03398148).
About COMMAND Maintenance Study2
The COMMAND study is a Phase 3, multicenter, randomized,
double-blind, controlled, 52-week maintenance study designed to
evaluate the efficacy and safety of risankizumab 180 mg or 360 mg
SC in adults with moderately to severely active ulcerative colitis.
This study had a re-randomized withdrawal design in which all
patients received risankizumab IV induction and those who responded
to risankizumab were re-randomized to receive risankizumab 180 mg
or 360 mg SC or withdrawal from risankizumab treatment
(induction-only control group). For those randomized to the
withdrawal from risankizumab treatment (induction-only control
group), the rest of the study duration was a risankizumab washout.
The objective of the Phase 3 study is to evaluate the efficacy and
safety of risankizumab 180 mg or 360 mg as maintenance therapy
versus withdrawal from risankizumab treatment (control) in patients
with moderately to severely active ulcerative colitis who responded
to risankizumab IV induction in the INSPIRE study.
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 evidence of friability) at week
52. Key secondary endpoints include endoscopic improvement
(endoscopic subscore ≤1 without evidence of friability), HEMI
(endoscopic subscore of ≤1 without evidence of friability and
Geboes score ≤3.1), and steroid-free clinical remission (defined as
clinical remission per Adapted Mayo Score at week 52 and
corticosteroid free for ≥90 days prior to week 52) at week 52.
Topline results from this study were shared in June 2023. More information can be found on
www.clinicaltrials.gov (NCT03398135).
About Risankizumab (SKYRIZI®)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit.8 IL-23, a
cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic immune-mediated diseases.9
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. The use of
risankizumab in ulcerative colitis is not approved and its safety
and efficacy have not been established by regulatory authorities.
Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis,
Crohn's disease and ulcerative colitis are
ongoing.9-11
U.S. Indications and Important Safety Information about
SKYRIZI® (risankizumab-rzaa)12
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
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: ABVRRTI75696.
- AbbVie. Data on file: ABVRRTI76012.
- Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive
review and update on ulcerative colitis. Dis Mon.
2019;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
- Surgery for Crohn's Disease and Ulcerative Colitis.
Crohn's & Colitis Foundation of America. Accessed August 21, 2023.
https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/surgery_brochure_final.pdf
- Mehta F. Report: economic implications of inflammatory bowel
disease and its management. Am J Manag Care. 2016;22(3
Suppl):s51-60.
- 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 August 21, 2023.
- Pipeline. AbbVie. 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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SOURCE AbbVie