NORTH CHICAGO, Ill.,
Jan. 21, 2022 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug
Administration (FDA) has approved SKYRIZI®
(risankizumab-rzaa) for the treatment of adults with active
psoriatic arthritis (PsA), a systemic inflammatory disease that
affects the skin and joints and impacts approximately 30 percent of
patients with psoriasis.1,4-7
The FDA approval is supported by data from two pivotal studies,
KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety
of SKYRIZI in adults with active PsA, including those who had
responded inadequately or were intolerant to biologic therapy
and/or non-biologic disease-modifying antirheumatic drugs
(DMARDs).2,3 Across the two Phase 3 studies, SKYRIZI met
the primary endpoint of ACR20 response at week 24 compared to
placebo and demonstrated significant improvements across several
other manifestations of PsA, including swollen, tender and painful
joints.2,3
"Patients often do not suspect a connection between their
psoriasis skin symptoms and the joint pain, swelling and stiffness
they may be experiencing, potentially leading to a delay in
diagnosis and treatment of psoriatic arthritis," said Thomas Hudson, M.D., senior vice president,
research and development, chief scientific officer, AbbVie. "We're
proud to expand the use of SKYRIZI to patients with psoriatic
arthritis who are living with the debilitating combination of skin
and joint symptoms."
SKYRIZI maintains a dosing regimen for PsA that is consistent
with the existing regimen for moderate to severe plaque psoriasis
patients – a single 150 mg subcutaneous injection four times a year
(after two starter doses at weeks 0 and 4) – and can be
administered alone or in combination with DMARDs.1
"In the pivotal KEEPsAKE trials, SKYRIZI demonstrated
improvements across a number of psoriatic arthritis symptoms,
including joint pain, enthesitis and dactylitis," said Alan J. Kivitz, M.D., CPI, founder and medical
director of the Altoona Center for Clinical Research and Altoona
Arthritis and Osteoporosis Center in Duncansville, Pa. and KEEPsAKE clinical trial
investigator. "This approval provides both dermatologists and
rheumatologists with an option that helps improve skin and joint
symptoms in patients with active psoriatic arthritis, alongside a
quarterly dosing schedule that may fit their patients'
lifestyle."
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
of SKYRIZI globally.
Highlights from the Pivotal Phase 3
Program1,2,3
- In KEEPsAKE-1 and KEEPsAKE-2, 57.3 percent and 51.3 percent of
patients receiving SKYRIZI achieved the primary endpoint of ACR20
response at week 24, respectively, versus 33.5 percent and 26.5
percent receiving placebo. SKYRIZI also demonstrated improvements
in ACR50 and ACR70 responses compared to placebo at week 24.
- SKYRIZI showed improvements in other key manifestations of PsA
compared to placebo at week 24, including improvements in
dactylitis and enthesitis for patients with pre-existing dactylitis
and enthesitis.
- Patients with coexistent plaque psoriasis receiving SKYRIZI saw
improvements in the skin lesions of psoriasis, compared to placebo,
as measured by the Psoriasis Area Severity Index (PASI 90) at week
24.
- SKYRIZI showed a statistically significant improvement in
physical function, compared to placebo, as measured by the Health
Assessment Questionnaire-Disability Index at week 24, with a mean
difference of 0.20 in KEEPsAKE-1 and 0.16 in KEEPsAKE-2.
Safety1
- The overall safety profile observed in patients with psoriatic
arthritis treated with SKYRIZI is generally consistent with the
safety profile in patients with plaque psoriasis.
- SKYRIZI may cause serious side effects, including:
-
- Serious Allergic Reactions: Stop using SKYRIZI and get
medical help right away if you get any symptoms of a serious
allergic reaction.
- Infections: SKYRIZI may increase your risk of
infections. Before starting treatment, your doctor should check you
for infections and tuberculosis. Tell your doctor right away if you
have an infection or symptoms of one.
Do not take SKYRIZI if you are allergic to
risankizumab-rzaa or any of the ingredients in SKYRIZI.
Also, tell your doctor if you plan to or recently received a
vaccine.
Patient Access and Support
AbbVie is committed to helping people access SKYRIZI and other
medicines, including offering a patient support program and co-pay
card that may reduce out-of-pocket costs to as little as
$5 per month for eligible,
commercially-insured patients. For those with health insurance,
AbbVie offers myAbbVie Assist, a patient assistance program that
provides SKYRIZI at no charge to those who qualify. More
information about this assistance program can be found at
www.AbbVie.com/myAbbVieAssist.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a heterogeneous, systemic inflammatory
disease involving the joints and skin.5 In PsA, the
immune system causes inflammation that can lead to skin lesions
associated with psoriasis, pain, fatigue and stiffness in the
joints.5,6 PsA affects about 30 percent of patients with
psoriasis.4-7
About KEEPsAKE-1 and
KEEPsAKE-22,3
KEEPsAKE-1 and KEEPsAKE-2
are both Phase 3, multicenter, randomized, double-blind,
placebo-controlled studies designed to evaluate the safety and
efficacy of SKYRIZI in adult patients with active psoriatic
arthritis. KEEPsAKE-1 evaluated SKYRIZI in patients who had an
inadequate response or intolerance to at least one DMARD.
KEEPsAKE-2 evaluated SKYRIZI in patients who had an inadequate
response or intolerance to biologic therapy and/or DMARDs. Patients
were randomized to SKYRIZI 150 mg or placebo followed by SKYRIZI
150 mg at week 24 in the open-label extension. Patients randomized
to SKYRIZI received four maintenance doses a year, following two
initiation doses.
The primary endpoint for both studies was the achievement of
ACR20 response at week 24. Some of the ranked secondary endpoints
included change from baseline in Health Assessment
Questionnaire-Disability Index and the achievement of PASI 90 at
week 24. The studies are ongoing, and patients in the long-term
extension remain blinded to the original randomized allocation for
the duration of the study, which will evaluate the long-term
safety, tolerability and efficacy of SKYRIZI in patients who have
completed the placebo-controlled period.
More information on these trials can be found on
www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2:
NCT03671148).
About SKYRIZI® (risankizumab-rzaa)
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, including
psoriasis.8 SKYRIZI is approved in the U.S. to treat
moderate to severe plaque psoriasis in adults who are candidates
for systemic therapy or phototherapy, as well as to treat active
psoriatic arthritis in adults. The approved dose for SKYRIZI is 150
mg (one 150 mg pre-filled pen or pre-filled syringe) administered
by subcutaneous injection at weeks 0 and 4, and every 12 weeks
thereafter. Phase 3 trials of SKYRIZI in psoriasis, Crohn's
disease, ulcerative colitis and psoriatic arthritis are
ongoing.9-17
SKYRIZI U.S. Uses and Important Safety
Information1
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).
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 help right away if you get any of the following
symptoms of 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.
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). Medications 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.
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?"
The most common side effects of SKYRIZI include upper
respiratory infections, feeling tired, fungal skin infections,
headache, and injection site reactions.
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.
This is not a complete summary of all safety
information.
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.
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 2020 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:
- SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- Kristensen L.E., et al. Efficacy and safety of risankizumab for
active psoriatic arthritis: 24-week results from the randomised,
double-blind, phase2 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2021;
0:1–7. doi: 10.1136/annrheumdis-2021-221019.
- Östör A., et al. Efficacy and safety of risankizumab for active
psoriatic arthritis: 24-week results from the randomised,
double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2021; 0:1–8.
doi: 10.1136/annrheumdis-2021-221048.
- Galezowski, A., et al. Rhumatisme psoriasique en France, du nourrisson à la personne âgée:
données de deux études transversales multicentriques [Psoriatic
arthritis in France, from infants
to the elderly: Findings from two cross-sectional, multicenter
studies]. Ann Dermatol Venereol. 2018;145(1):13-20.
doi:10.1016/j.annder.2017.10.008.
- Duarte GV, et al. Psoriatic arthritis. Best Pract Res Clin
Rheumatol. 2012 Feb;26(1):147-56. doi:
10.1016/j.berh.2012.01.003.
- Diseases & Conditions: Psoriatic Arthritis. 2019. American
College of Rheumatology. Available at:
https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis.
Accessed on December 15, 2021.
- Psoriatic Arthritis. 2019. Mayo Clinic. Available at:
https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076.
Accessed on December 15, 2021.
- Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a
key cytokine in inflammatory diseases. Ann Med. 2011. Nov
43(7):503-11.
- BI 655066 (Risankizumab) Compared to Placebo and Active
Comparator (Ustekinumab) in Patients With Moderate to Severe
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https://clinicaltrials.gov/ct2/show/NCT02684370. Accessed on
December 14, 2021.
- BI 655066 Versus Placebo & Active Comparator (Ustekinumab)
in Patients With Moderate to Severe Chronic Plaque Psoriasis.
ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT02684357. Accessed on
December 14, 2021.
- BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe
Plaque Psoriasis With Randomized Withdrawal and Re-treatment.
ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT02672852. Accessed on
December 14, 2021.
- BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator
(Adalimumab) in Patients With Moderate to Severe Chronic Plaque
Psoriasis. ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT02694523. Accessed on
December 14, 2021.
- 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
December 14, 2021.
- 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 December 14, 2021.
- 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
December 14, 2021.
- BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients
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https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed on
December 14, 2021.
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on December 14, 2021.
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