NORTH CHICAGO, Ill.,
Nov. 17, 2021 /PRNewswire/ --
AbbVie (NYSE: ABBV) today announced that the European
Commission (EC) has approved SKYRIZI® (risankizumab, 150
mg, subcutaneous injection at week 0, week 4 and every 12 weeks
thereafter) alone or in combination with methotrexate (MTX), for
the treatment of active psoriatic arthritis in adults who have had
an inadequate response or who have been intolerant to one or more
disease-modifying anti-rheumatic drugs (DMARDs). Marking the second
indication for SKYRIZI, the Marketing Authorization will be valid
in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern
Ireland.
"People living with psoriatic arthritis struggle with psoriatic
lesions and joint inflammation that causes swelling and pain.
Reducing these symptoms may give people the ability to resume their
daily activities and improve their quality of life," said
Michael Severino, M.D., vice
chairman and president, AbbVie. "We are excited by the EC approval
of SKYRIZI for the treatment of adults with active psoriatic
arthritis."
SKYRIZI received EC approval based on data from two Phase 3
clinical studies, KEEPsAKE-1 and KEEPsAKE-2.1-3,6 In
these studies, SKYRIZI met the primary endpoint of ACR20 response
at week 24 versus placebo, and ranked secondary endpoints
including, but not limited to, improvements in several clinical
manifestations of psoriatic arthritis such as physical function (as
measured by the Health Assessment Questionnaire Disability Index
[HAQ-DI]) and minimal disease activity (MDA) at week
24.1-3,6
Highlights from the pivotal Phase 3
program1-3,6
- In KEEPsAKE-1 and KEEPsAKE-2, 57.3 and 51.3 percent of patients
receiving SKYRIZI achieved the primary endpoint of ACR20 response
at week 24, respectively, versus 33.5 and 26.5 percent receiving
placebo (p<0.001).
- SKYRIZI-treated patients showed significantly greater
improvement from baseline in physical function as measured by
HAQ-DI -0.31 and -0.22, compared to placebo -0.11 and -0.05 at week
24 (p<0.001) in KEEPSAKE-1 and KEEPSAKE-2, respectively.
- At week 24, 25.0 percent and 25.6 percent of SKYRIZI-treated
patients achieved MDA, in KEEPSAKE-1 and KEEPSAKE-2 respectively,
compared to 10.2 percent and 11.4 percent of those on placebo
(p<0.001).
"Millions of people living with psoriatic arthritis are impacted
by psoriatic lesions, joint pain, stiffness and fatigue," said
Lars Erik Kristensen, M.D., Ph.D.,
consultant and head of science at the Parker Institute in
Copenhagen Denmark, associate
professor, Lund Sweden, SUS
University Hospital. "As seen in this Phase 3 clinical trial
program in psoriatic arthritis, SKYRIZI has the potential to be a
valuable new treatment option, helping to improve the signs and
symptoms of the disease."
The safety profile of SKYRIZI in psoriatic arthritis was
consistent with the safety profile of SKYRIZI in plaque psoriasis,
with no new safety risks observed.6 Through week 24,
serious adverse events occurred in 2.5 percent and 4.0 percent of
patients treated with SKYRIZI in KEEPsAKE-1 and KEEPsAKE-2,
respectively, compared with 3.7 percent and 5.5 percent on
placebo.1-3,6 Rates of serious infections were 1.0 and
0.9 percent in SKYRIZI-treated patients in KEEPsAKE-1 and
KEEPsAKE-2, respectively, and 1.2 and 2.3 percent in patients who
received placebo.1-3,6 The rates of adverse events
leading to discontinuation of the study drug were 0.8 percent and
0.9 percent of patients treated with SKYRIZI in KEEPsAKE-1 and
KEEPsAKE-2, respectively, compared with 0.8 percent and 2.3 percent
on placebo.1-3,6 In KEEPsAKE-1, there was one death
in the SKYRIZI group not related to the study drug per
investigator.1,2,6 There were no deaths reported in
KEEPsAKE-2.1,3,6
SKYRIZI (risankizumab) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
About Psoriatic Arthritis
Psoriatic arthritis is a heterogeneous, systemic inflammatory
disease with hallmark manifestations across multiple domains
including joints and skin.9,10 In psoriatic arthritis,
the immune system creates inflammation that can lead to pain,
fatigue, stiffness in the joints and the presence of psoriatic
lesions.9,10
About KEEPsAKE-1 and KEEPsAKE-21-6
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, but
were not limited to, the achievement of MDA as well as the change
from baseline in HAQ-DI at week 24. The studies are ongoing, and
the long-term extension remains blinded to the original
randomization and evaluates 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.6,11 IL-23, a
cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic immune-mediated diseases, including
psoriasis.11 The approved dose for SKYRIZI is 150
mg (either as two 75 mg pre-filled syringe injections or one 150 mg
pre-filled pen or pre-filled syringe injection), administered by
subcutaneous injection at week 0 and 4, and every 12 weeks
thereafter. The SKYRIZI 150 mg formulation was approved by the
European Union in May 2021. Phase 3
trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative
colitis and psoriatic arthritis are
ongoing.6,12-14
Important EU Indication and Safety Information
about SKYRIZI® (risankizumab)6
SKYRIZI is indicated for the treatment of moderate to severe
plaque psoriasis in adults who are candidates for systemic therapy.
SKYRIZI, alone or in combination with methotrexate (MTX), is
indicated for the treatment of active psoriatic arthritis in adults
who have had an inadequate response or who have been intolerant to
one or more disease-modifying antirheumatic drugs (DMARDs).
SKYRIZI is contraindicated in patients with hypersensitivity to
the active substance or to any of the excipients. SKYRIZI may
increase the risk of infection. In patients with a chronic
infection, a history of recurrent infection, or known risk factors
for infection, SKYRIZI should be used with caution. Treatment with
SKYRIZI should not be initiated in patients with any clinically
important active infection until the infection resolves or is
adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be
evaluated for tuberculosis (TB) infection. Patients receiving
SKYRIZI should be monitored for signs and symptoms of active TB.
Anti-TB therapy should be considered prior to initiating SKYRIZI in
patients with a history of latent or active TB in whom an adequate
course of treatment cannot be confirmed.
Prior to initiating therapy with SKYRIZI, completion of all
appropriate immunizations should be considered according to current
immunization guidelines. If a patient has received live vaccination
(viral or bacterial), it is recommended to wait at least 4 weeks
prior to starting treatment with SKYRIZI. Patients treated with
SKYRIZI should not receive live vaccines during treatment and for
at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper
respiratory infections. Commonly (greater than or equal to 1/100 to
less than 1/10) reported adverse reactions included tinea
infections, headache, pruritus, fatigue and injection site
reactions.
This is not a complete summary of all safety information. See
SKYRIZI full summary of product characteristics (SmPC)
at www.ema.europa.eu.
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
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for Active Psoriatic Arthritis: 52-Week Results From the KEEPsAKE 1
and KEEPsAKE 2 Trials. 2021 EADV Virtual Congress. D1T01.4A.
- Kristensen, L.E., et al. Efficacy and Safety of Risankizumab in
Patients With Active Psoriatic Arthritis After Inadequate Response
or Intolerance to DMARDs: 24-Week Results From the Phase 3,
Randomized, Double-Blind KEEPsAKE 1 Trial.
- Östör, A., et al. Efficacy and Safety of Risankizumab for
Active Psoriatic Arthritis, Including Patients With Inadequate
Response or Intolerance to Biologic Therapies: 24-Week Results From
the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial.
- Clinicaltrials.gov. A Phase 3, Randomized, Double-Blind,
Study Comparing Risankizumab to Placebo in Subjects 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.
October 25, 2021.
https://clinicaltrials.gov/ct2/show/NCT03675308.
- Clinicaltrials.gov. A Phase 3, Randomized, Double-Blind
Study Comparing Risankizumab to Placebo in Subjects With Active
Psoriatic Arthritis Including Those Who Have a History of
Inadequate Response or Intolerance to Biologic Therapy(Ies)
(KEEPsAKE 2). clinicaltrials.gov; 2021. Accessed October 25, 2021.
https://clinicaltrials.gov/ct2/show/NCT03671148.
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Accessed on October 25, 2021.
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https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076.
Accessed on October 25, 2021.
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données de deux études transversales multicentriques [Psoriatic
arthritis in France, from infants
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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
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- 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 October 25, 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.
- 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 October 25, 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. 2021. Available at:
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October 25, 2021.
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