NORTH CHICAGO, Ill.,
April 7, 2021 /PRNewswire/ --
AbbVie (NYSE: ABBV) today announced that it has submitted
applications seeking approval for SKYRIZI®
(risankizumab-rzaa, 150 mg) to the U.S. Food and Drug
Administration (FDA) and for SKYRIZI® (risankizumab, 150
mg) to the European Medicines Agency (EMA) for the treatment
of adults with active psoriatic arthritis.1 The
submissions were supported by two pivotal Phase 3 studies,
KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with
active psoriatic arthritis including those who had responded
inadequately or were intolerant to biologic therapy and/or
non-biologic disease-modifying anti-rheumatic drugs
(DMARDs).1
"Most patients living with psoriatic arthritis experience both
skin and joint disease which can be especially burdensome. Despite
advancements, many patients cannot find relief from the signs and
symptoms of this disease," said Michael
Severino, M.D., vice chairman and president, AbbVie. "We are
dedicated to providing options that can help more patients living
with psoriatic arthritis reach their treatment goals."
In the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, SKYRIZI
demonstrated significant improvements in disease activity (as
measured by ACR20 response and minimal disease activity), skin
clearance (as measured by at least a 90 percent improvement in
Psoriasis Area Severity Index [PASI 90]) and physical function
(as measured by the Health Assessment Questionnaire Disability
Index [HAQ-DI]) at week 24 versus
placebo.1* In both studies, significantly more
patients treated with SKYRIZI achieved the primary endpoint of
ACR20 response at week 24 versus placebo.1 The
safety profile of SKYRIZI in these studies was generally consistent
with the safety profile of SKYRIZI in plaque psoriasis, with no new
safety risks observed.1,6-8
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
globally.
*Minimal disease activity is defined as the fulfillment of
five of seven outcome measures: Tender joint count ≤1; swollen
joint count ≤1; PASI ≤1 or body surface area-psoriasis ≤3 percent;
Patient's Assessment of Pain Numerical Rating Scale (NRS) ≤1.5;
Patient Global Assessment-Disease Activity NRS ≤2.0; HAQ-DI score
≤0.5; and Leeds Enthesitis Index ≤1. Skin symptoms were measured by
a 90 percent improvement in the Psoriasis Area Severity Index (PASI
90). Physical function was measured by the HAQ-DI.
About Psoriatic Arthritis
Psoriatic arthritis is a heterogeneous, systemic inflammatory
disease with hallmark manifestations across multiple domains
including joints and skin.3,4 In psoriatic arthritis,
the immune system creates inflammation that can lead to pain,
fatigue, stiffness in the joints and cause a red, scaly
rash.3,4
About KEEPsAKE-1 and KEEPsAKE-21,9,10
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. 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. Ranked secondary endpoints included
change from baseline in HAQ-DI, as well as the achievement of PASI
90 and minimal disease activity (MDA) at week 24. The studies are
ongoing, and the long-term extension remains blinded to 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 at
www.clinicaltrials.gov (KEEPsAKE-1:
NCT03675308; KEEPsAKE-2: NCT03671148).
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine
involved in inflammatory processes, is thought to be linked to a
number of chronic immune-mediated diseases, including
psoriasis.11,12 In April
2019, SKYRIZI received U.S. Food and Drug Administration
approval for the treatment of moderate to severe plaque psoriasis
in adults who are candidates for systemic therapy or phototherapy.
The approved dose for SKYRIZI is 150 mg (two 75 mg injections),
administered by subcutaneous injection at week 0 and 4, and every
12 weeks thereafter. SKYRIZI was also approved by the European
Commission in April 2019. Phase 3
trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative
colitis and psoriatic arthritis are
ongoing.9,10,13-15 Use of SKYRIZI in psoriatic arthritis
is not approved and its safety and efficacy have not been
established by regulatory authorities.
About SKYRIZI® (risankizumab-rzaa) in the
United States12
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).
Important Safety Information12
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI may cause serious side effects, including
infections. SKYRIZI is a prescription medicine that 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
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). You should avoid receiving live vaccines
during treatment with SKYRIZI.
- 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, fungal skin infections,
headache, feeling tired, 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.
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, 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, 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:
- AbbVie. Data on File: ABVRRTI71470.
- 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 G.V., 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 April 1, 2021.
- Psoriatic Arthritis. 2019. Mayo Clinic. Available at:
https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076.
Accessed on April 1, 2021.
- Gordon K., et al. Efficacy and safety
of risankizumab in moderate-to-severe plaque psoriasis
(UltIMMa-1 and UltIMMa-2): results from two
double-blind, randomised, placebo-controlled
and ustekinumab-controlled phase 3 trials. The Lancet. 2018
Aug 25;392(10148):650-661.
- Reich, K., et al. Risankizumab compared with adalimumab in
patients with moderate-to-severe plaque psoriasis (IMMvent):
a randomised, double-blind, active-comparator-controlled phase
3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi:
10.1016/S0140-6736(19)30952-3.
- Blauvelt, A., et al. Efficacy and Safety of Continuous Q12W
Risankizumab Versus Treatment Withdrawal: 2-Year Double-Blinded
Results from the Phase 3 IMMhance Trial. Poster #478.
24th World Congress of Dermatology. 2019.
- A Study Comparing Risankizumab to Placebo in Participants With
Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate
Response to or Intolerance to at Least One Disease Modifying
Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1).
ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/record/NCT03675308. Accessed on
April 1, 2021.
- 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. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on
April 1, 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.
- SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- A Study to Assess the Safety and Efficacy of Risankizumab for
Maintenance in Moderate to Severe Plaque Type Psoriasis
(LIMMITLESS). ClinicalTrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on
April 1, 2021.
- A Study of the Efficacy and Safety of Risankizumab in
Participants With Crohn's Disease. ClinicalTrials.gov.
2021. Available at:
https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed on
April 1, 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. ClinicalTrials.gov. 2020. Available at:
https://clinicaltrials.gov/ct2/show/NCT03398148. April 1, 2021.
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