- Analyses included 100-week efficacy and safety data from
the four-year, open-label extension period of KEEPsAKE 1 and 2
evaluating SKYRIZI in patients with active psoriatic
arthritis1
- Ongoing treatment with SKYRIZI demonstrated consistent
long-term efficacy in psoriatic arthritis with similar rates of
improvement in skin (PASI 90) and joint (ACR, enthesitis,
dactylitis) symptoms at week 100 as those reported at week
521
- No new safety signals were observed through 100
weeks1-4
NORTH
CHICAGO, Ill., Sept. 10,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV)
announced new, long-term data analyses of KEEPsAKE 1 and 2, Phase 3
trials evaluating SKYRIZI® (risankizumab, 150 mg) in
adult patients with active psoriatic arthritis. Results showed that
at week 100 of the open-label extension period, patients receiving
SKYRIZI reported improvement in skin and joint symptoms, with more
than half of patients in KEEPsAKE 1 and 2 achieving a 90 percent
reduction in the Psoriasis Area and Severity Index (PASI 90) and an
American College of Rheumatology 20 (ACR20) response. Additionally,
the data demonstrated no new observed safety signals through 100
weeks.1-4 These results were featured during the "Late
Breaking News" session at the 31st European Academy of
Dermatology and Venereology (EADV) Hybrid Congress onsite in
Milan and online.
"We're pleased to share these new, nearly two-year analyses,
which showed SKYRIZI maintained improvements across joint and skin
measures of psoriatic arthritis over time," said Doina Cosma-Roman, M.D., vice president and
global head, Clinical Development, Immunology, AbbVie. "It is
critically important for physicians to have treatment options that
demonstrate lasting efficacy, as we know people living with
psoriatic arthritis discontinue therapies due to loss of efficacy
or tolerability."
The new data from the open-label extension period showed that at
100 weeks, 64 and 57 percent of patients initially treated with
SKYRIZI achieved ACR20 response in KEEPsAKE 1 and 2,
respectively.1 Additionally, at week 100, 71 and 67
percent of patients from KEEPsAKE 1 and 2, respectively, initially
treated with SKYRIZI and who had a body surface area involvement
greater than or equal to ≥3 percent at baseline, achieved PASI
90.1
Furthermore, at week 100, pooled results from KEEPsAKE 1 and 2
showed that 76 and 57 percent of patients, respectively, initially
treated with SKYRIZI achieved resolution of dactylitis and
enthesitis.1 For patients in KEEPsAKE 1 with nail
psoriasis at baseline and who were initially treated with SKYRIZI,
mean scores for Physician's Global Assessment of Fingernail
Psoriasis (PGA-F) and modified Nail Psoriasis Severity Index
(mNAPSI) were maintained at week 100 compared with week
52.1
"Psoriatic arthritis often presents with musculoskeletal
symptoms, including pain and swelling in the knees, wrists, ankles
and fingers, as well as pain in the hips and heels, which can
significantly reduce a person's quality of life," said Lars Erik Kristensen, M.D., Ph.D., consultant
and head of science at the Parker Institute in Copenhagen, Denmark and associate professor,
SUS University Hospital in Lund,
Sweden. "These results highlight SKYRIZI's potential to
relieve symptoms in both biologic-naïve and -experienced patients
with active psoriatic arthritis in the long-term."
SKYRIZI was generally well-tolerated, and no new safety signals
were noted in both KEEPsAKE 1 and 2 at 100 weeks of
treatment.1-4 Serious treatment-emergent adverse events
(TEAEs) occurred at 7.6 events/100 patient-years (E/100PY) and 9.9
E/100PY in KEEPsAKE 1 and 2, respectively.1 Rates of
serious infections in KEEPsAKE 1 and 2 were 2.3 and 1.6 E/100PY,
respectively.1 Major adverse cardiac events (MACE)
occurred at 0.1 E/100PY in KEEPsAKE 1 and 0.5 E/100PY in KEEPsAKE
2.1 The rates of TEAEs leading to discontinuation of the
study drug in KEEPsAKE 1 was 2.1 E/100PY and 1.2 E/100PY in
KEEPsAKE 2.1 There were six deaths in KEEPsAKE 1, which
were not related to the study drug, per investigator.1*
In KEEPsAKE 2, there was one death not related to the study drug,
per investigator.1
SKYRIZI 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 and
inflammatory disease with hallmark manifestations across multiple
domains including joints and skin.5,6 In psoriatic
arthritis, the immune system creates inflammation that can lead to
pain, fatigue, stiffness in the joints and cause a red, scaly
rash.5,6
About KEEPsAKE 1 and 21-4,7,8
KEEPsAKE 1 and 2 are both Phase 3, multicenter, randomized,
double-blind and placebo-controlled studies designed to evaluate
the safety and efficacy of SKYRIZI in adult patients with active
psoriatic arthritis. KEEPsAKE 1 included patients with an
inadequate response or intolerance to one or more conventional
synthetic disease modifying antirheumatic drugs (csDMARD-IR), while
KEEPsAKE 2 included patients with an inadequate response to
csDMARD-IR and/or with an inadequate response or intolerance to one
or two biologic therapies. In the first phase of the studies
(Period 1), patients were randomized to SKYRIZI or placebo through
week 24. At week 24, the open-label extension (Period 2) began, and
all patients were treated with SKYRIZI.
The two studies are ongoing to evaluate the long-term safety,
tolerability and efficacy of SKYRIZI in patients with psoriatic
arthritis.
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.9,10 IL-23, a
cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic, immune-mediated diseases, including
psoriasis.9 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.11 In the EU, 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).10 The
approved dose for SKYRIZI is 150 mg (one 150 mg pre-filled pen or
pre-filled syringe) administered by subcutaneous injections at week
0 and 4 and every 12 weeks thereafter.10 Phase 3 trials
of SKYRIZI in psoriatic arthritis, psoriasis, Crohn's disease and
ulcerative colitis are ongoing.12-14
EU Indications and Important Safety Information
about SKYRIZI® (risankizumab)10
Indications
Skyrizi (risankizumab) 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).
Important Safety Information
Risankizumab is contraindicated in patients with
hypersensitivity to the active substance or to any of the
excipients. Risankizumab may increase the risk of infection. In
patients with a chronic infection, a history of recurrent
infection, or known risk factors for infection, risankizumab should
be used with caution. Treatment with risankizumab 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 risankizumab, patients should
be evaluated for tuberculosis (TB) infection. Patients receiving
risankizumab should be monitored for signs and symptoms of active
TB. Anti-TB therapy should be considered prior to initiating
risankizumab 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 risankizumab, completion of all
appropriate immunisations should be considered according to current
immunisation 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 risankizumab. Patients treated
with risankizumab 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 (≥ 1/100 to < 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 in Dermatology
For more than a decade, AbbVie has worked to uncover new
solutions and improve care for people with serious skin diseases,
including psoriasis, psoriatic arthritis, hidradenitis suppurativa
and atopic dermatitis. With a broad clinical trial program, we
continue to actively research and adapt to the evolving needs of
the dermatology community and advance our pipeline to help people
achieve their treatment goals and live beyond their skin disease.
For more information on AbbVie in dermatology,
visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.html.
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 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:
- Kristensen, L.E., et al. Efficacy and Safety of Risankizumab
for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE
1 and KEEPsAKE 2 Trials. 2022 European Academy of Dermatology and
Venereology (EADV) Hybrid Congress.
- Kristensen, L.E., et al. Efficacy and Safety of Risankizumab
for Active Psoriatic Arthritis: 52-Week Results From the KEEPsAKE 1
and KEEPsAKE 2 Trials. 2021 European Academy of Dermatology and
Venereology Virtual Congress.
- 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. 2021 World Psoriatic and
Arthritis Conference.
- 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.
- 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 August 17, 2022.
- 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. Available at:
https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed
August 17, 2022.
- 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. Available at:
https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed
August 17, 2022.
- 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 [Summary of Product Characteristics]. AbbVie Ltd.
Available at:
https://www.ema.europa.eu/en/documents/product-
information/skyrizi-epar-product-information_en.pdf. Accessed
August 17, 2022.
- SKYRIZI [package insert]. North
Chicago, IL: AbbVie Inc.; 2022.
- 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 August 17, 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. clinicaltrials.gov. 2021. Available at:
https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed
August 17, 2022.
- Pipeline – Our Science | AbbVie. AbbVie. 2021. Available
at:
https://www.abbvie.com/our-science/pipeline.html.
Accessed August 17,
2022.
* In KEEPsAKE 1, there were six subjects with fatal events, but
seven different events were reported.
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