- Treatment with SKYRIZI (risankizumab) demonstrated short-
and long-term efficacy of psoriasis signs and symptoms (sPGA 0/1)
at week 16 and week 52 in a difficult-to-treat population, with no
new safety signals observed in an open-label, single-arm phase
3b study
- Patients with moderate to severe psoriasis previously
received at least six months of treatment with secukinumab or
ixekizumab with a suboptimal response, defined as a static
Physician's Global Assessment (sPGA) score of 2 or 3 and body
surface area of 3% to <10%, before switching to
risankizumab
NORTH
CHICAGO, Ill., March 18,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced new 52-week data from an open-label, single-arm study
demonstrating improved plaque psoriasis signs and symptoms among a
difficult-to-treat patient population who received
SKYRIZI® (risankizumab), an IL-23 inhibitor. These
moderate to severe plaque psoriasis patients previously had a
suboptimal response to treatment with secukinumab or ixekizumab,
both IL-17A inhibitor therapies, for at least six months before
switching to risankizumab. The data were presented at a
Late-Breaking Research session during the 2023 American Academy of
Dermatology (AAD) Annual Meeting in New
Orleans, Louisiana.
"The evidence presented at the AAD meeting underscores the
important role of SKYRIZI in helping patients in a
difficult-to-treat population achieve skin clearance and a
resolution of their burdensome psoriasis symptoms," said
Nicole Selenko-Gebauer, M.D., MBA,
vice president, global medical affairs, AbbVie. "Science is at the
core of our work, and our continuing research represents our steady
commitment to improving the standards of care, now and in the
future, for patients with serious immune-mediated conditions like
plaque psoriasis."
Findings from this phase 3b,
open-label single-arm study showed that 56.3% of patients who
received risankizumab, without a washout period following a
suboptimal response to secukinumab or ixekizumab achieved the week
16 primary endpoint of reduced signs and symptoms of psoriasis
(sPGA 0/1). A suboptimal response was defined as a static
Physician's Global Assessment (sPGA) score of 2 or 3 and body
surface area of 3% to <10% after at least six months of
treatment with secukinumab or ixekizumab. The mean duration of
treatment was 2.6 years for patients receiving secukinumab, and 2.1
years for patients receiving ixekizumab.
Highlights from this new aIMM 52-week analysis include:
- The majority of patients (63.0%) achieved clear or almost clear
skin (sPGA 0/1) at the week 52 primary endpoint
- Patients achieved completely clear skin (sPGA score of 0) at
week 16 (19.8%) and week 52 (26.2%), a secondary endpoint
- Patients reported no symptoms such as pain, itching, redness
and burning, as shown by a Psoriasis Symptom Scale (PSS) score of 0
at week 16 (20.2%) and week 52 (27.4%), a secondary endpoint
No new safety signals were observed in this analysis.
"Advanced therapies represent an important option in the
treatment of plaque psoriasis, but as a physician, it's critically
important to continually assess if patients are having an optimal
response to treatment, as residual psoriasis can still have a
significant impact on a patient's life," said Professor
Richard Warren from the University of Manchester and Norten
Care Alliance, UK. This study showed that risankizumab
was able to improve clinical signs and symptoms of patients who had
a suboptimal response with the anti-IL-17 therapies secukinumab and
ixekizumab, contributing to the whole of evidence supporting
risankizumab use in moderate to severe plaque psoriasis."
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
globally.
About Psoriasis
Psoriasis is a chronic, immune-mediated, inflammatory skin
condition that produces thickened, scaling skin due to rapid growth
of skin cells.1 It affects an estimated 7.5 million
people in the U.S.,2 with approximately 80-90% having
plaque psoriasis.1 People with psoriasis also experience
a significant emotional, psychological and social burden that can
negatively impact their quality of life.4
About the Phase 3b, Open-Label
Study
The findings presented today are part of a Phase 3b, multicenter, interventional, open-label,
single-arm study of adults ages 18 years or older with moderate to
severe plaque psoriasis. The trial included 252 participants
who had been treated with secukinumab or ixekizumab for
at least six months and experienced a suboptimal response,
defined as sPGA score of 2 or 3 and body surface area of 3% to
<10%.
Participants received SKYRIZI 150mg at weeks 0, 4, and once
every 12 weeks for 52 weeks without a washout period. The primary
endpoint was the percentage of participants achieving an sPGA score
of 0/1 at week 16. The secondary endpoints were sPGA 0/1 at week
52, and sPGA 0, DLQI 0/1 and PSS 0 at weeks 16 and 52. The mean
duration of treatment was 2.6 years for patients receiving
secukinumab and 2.1 years for ixekizumab-treated patients. This
finding was previously reported at the European Academy of
Dermatology and Venereology (EADV) 2022 Congress.
Efficacy results were assessed by non-responder imputation.
Limitations of this analysis include lack of placebo control or
active comparator; definition of suboptimal response has been based
on expert feedback and to reflect clinical practice. Safety was
monitored throughout the study.
More information on these trials can be found
at www.clinicaltrials.gov (NCT04102007).
About SKYRIZI® (risankizumab-rzaa)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit.5 IL-23, a
cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic immune-mediated diseases, including
psoriasis.5 Phase 3 trials of SKYRIZI in psoriasis,
Crohn's disease, ulcerative colitis and psoriatic arthritis
are ongoing.6-11
SKYRIZI U.S. Uses and Important Safety
Information12
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
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.
AbbVie 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:
- AAD. Psoriasis: Overview.
https://www.aad.org/public/diseases/psoriasis/what/overview.
Accessed February 16, 2023.
- National Psoriasis Foundation. About Psoriasis.
https://www.psoriasis.org/about-psoriasis/. Accessed February 16, 2023.
- National Psoriasis Foundation. Statistics.
https://www.psoriasis.org/content/statistics. Accessed February 16, 2023.
- Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a
key cytokine in inflammatory diseases. Ann Med. 2011. Nov
43(7):503-11.
- A Study on the long-term efficacy and safety of risankizumab
for the treatment of moderate-to-severe plaque psoriasis.
ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on
February 17, 2023.
- A Study of the Efficacy and Safety of Risankizumab in
Participants With Moderately to Severely Active Crohn's Disease.
ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on
March 8, 2022.
- A Study to Assess the Efficacy and Safety of Risankizumab in
Participants With Ulcerative Colitis. ClinicalTrials.gov. 2021.
Available at: https://clinicaltrials.gov/ct2/show/NCT03398135.
Accessed on March 8, 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. Available at:
https://clinicaltrials.gov/ct2/show/NCT03398148. Accessed on
March 8, 2022.
- BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients
With Active Psoriatic Arthritis. Available at:
https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed on
March 8, 2022.
- BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients
With Active Psoriatic Arthritis. Available at:
https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on
March 8, 2022.
- SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
US-SKZD-230113
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