NORTH CHICAGO, Ill.,
Nov. 5, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced the presentation of integrated data
from two Phase 3 clinical trials, KEEPsAKE 1 and KEEPsAKE 2,
evaluating the efficacy and safety of risankizumab
(SKYRIZI®) in adult patients with active psoriatic
arthritis (PsA). The data showed that 24-weeks of treatment with
risankizumab resulted in greater improvements in PsA signs and
symptoms compared with placebo with no new safety
signals.1 These results will be featured in an American
College of Rheumatology (ACR) Convergence 2021 plenary session on
Saturday, Nov. 6, from 9:45-10 a.m. CT (Abstract #0453).
"Psoriatic arthritis is a chronic, progressive and debilitating
disease. These results support the potential of risankizumab to
help improve joint and skin symptoms for people living with this
disease and assist more people in their pursuit of reaching their
treatment goals," said Thomas
Hudson, M.D., senior vice president, research and
development, chief scientific officer, AbbVie.
Patients receiving risankizumab achieved higher rates of ACR20
(55.5%) than patients receiving placebo (31.3%) at week
24.1 Additionally, patients receiving risankizumab
showed greater improvements in the key clinical and
patient-reported outcome endpoints compared to patients receiving
placebo.1
Efficacy at Week
241***
|
|
|
Risankizumab 150
mg
(N=707)
|
Placebo
(N=700)
|
|
ACR20, %
|
55.5
|
31.3
|
|
HAQ-DIa, change from
baseline
|
-0.27
|
-0.08
|
|
PASI 90b,
%
|
53.2
|
10.0
|
|
MDA, %
|
25.2
|
10.6
|
|
Resolution of
enthesitisc, %
|
48.4
|
34.8
|
|
Resolution of
dactylitisd, %
|
68.1
|
51.0
|
|
ACR20, ≥ 20
improvement in American College of Rheumatology score; HAQ-DI,
Health Assessment Questionnaire-Disability Index; PASI 90, ≥90%
reduction in Psoriasis Area Severity Index; MDA, minimal disease
activity; PBO, placebo; RZB, risankizumab.
|
*** P-value
<0.001
|
a
Non-missing data at baseline RZB N=706; PBO N=6
|
b For
patients with involved body surface area ≥ 3% at baseline (RZB
N=396; PBO N=391).
|
c For
patients with enthesitis at baseline (RZB N=444; PBO
N=448).
|
d For
patients with dactylitis at baseline (RZB N=188; PBO
N=204).
|
"Many people living with psoriatic arthritis continue to
experience burdensome symptoms, including joint pain, red and scaly
skin and other manifestations of the disease," said Andrew Östör,
M.D., study author, associate professor and consultant
rheumatologist at Cabrini Hospital, Monash University and Emeritus
Research, Melbourne, Australia.
"The data in this analysis show risankizumab could be a valuable
treatment option to help patients find meaningful relief from the
signs and symptoms of psoriatic arthritis."
Across these integrated week 24 data, the safety profile of
risankizumab was generally similar to that observed in patients
with psoriasis, and no new safety signals were
identified.1 Serious treatment-emergent adverse events
(TEAE) occurred in 3.0% of patients treated with risankizumab
compared with 4.4% on placebo.1 Serious infections
occurred in 1% of patients treated with risankizumab and 1.6% of
patients treated with placebo.1 The rates of adverse
events leading to discontinuation of the study drug were 0.8% of
patients treated with risankizumab compared with 1.4% on
placebo.1 In the risankizumab group, there was one death
not related to the study drug per investigator and one major
adverse cardiac event (MACE) was reported.1
Risankizumab is part of a collaboration between Boehringer
Ingelheim and AbbVie, with AbbVie leading development and
commercialization globally.
Use of risankizumab in psoriatic arthritis is not approved in
the U.S. or EU, and its safety and efficacy are currently under
review by the respective regulatory authorities. Recently, the
European Medicines Agency's Committee for Medicinal Products for
Human Use (CHMP) adopted a positive opinion recommending the
approval of risankizumab for the treatment of active psoriatic
arthritis.
The ACR Convergence 2021 abstracts can be found here.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a heterogeneous, systemic
inflammatory disease with hallmark manifestations across multiple
domains including joints and skin.2 In PsA, the immune
system causes inflammation that can lead to skin lesions associated
with psoriasis, pain, fatigue and stiffness in the
joints.2,3 PsA affects about 30% of people with
psoriasis.4,5
About KEEPsAKE 1 and KEEPsAKE 26-9
KEEPsAKE 1 and KEEPsAKE 2 are both Phase 3, multicenter,
randomized, double-blind, placebo-controlled studies designed to
evaluate the safety and efficacy of risankizumab in adult patients
with active psoriatic arthritis. KEEPsAKE 1 evaluated risankizumab
in patients who had an inadequate response or intolerance to at
least one disease modifying anti-rheumatic drug (DMARD). KEEPsAKE 2
evaluated risankizumab in patients who had an inadequate response
or intolerance to biologic therapy and/or DMARDs. Patients were
randomized to risankizumab 150 mg or placebo followed by
risankizumab 150 mg at week 24.
The primary endpoint for both studies was the achievement of
ACR20 response at week 24. Ranked secondary endpoints included, but
were not limited to, change from baseline in Health Assessment
Questionnaire-Disability Index (HAQ-DI), resolution of enthesitis
and dactylitis, as well as the achievement of PASI 90 and 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 risankizumab 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 Risankizumab-rzaa (SKYRIZI®)
in the United States10
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 Information
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). 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 in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care
for people living with rheumatic diseases. Our longstanding
commitment to discovering and delivering transformative therapies
is underscored by our pursuit of cutting-edge science that improves
our understanding of promising new pathways and targets in order to
help more people living with rheumatic diseases reach their
treatment goals. For more information on AbbVie in rheumatology,
visit
https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.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 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:
- Östör A, et al. Efficacy and Safety of Risankizumab for Active
Psoriatic Arthritis: 24-Week Integrated Results from 2 Phase 3,
Randomized, Double-blind Clinical Trials for CsDMARD-IR and Bio-IR
Patients. 2021 American College of Rheumatology Convergence;
0453.
- 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: November 2021.
- Rodrigo Valdes-Rodriguez MD, et
al. (2018). Itch in Psoriasis: From Basic Mechanisms to Practical
Treatments. Psoriasis Forum, Volume: 18a issue: 3,page(s):
110-117.
- Mease PJ, et al. (2013). Prevalence of rheumatologist-diagnosed
psoriatic arthritis in patients with psoriasis in European/North
American dermatology clinics. J Am Acad Dermatol, 69(5),
729-735.
- Kristensen LE, 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. Annals of the
Rheumatic Diseases 2021;80:1315-1316.
- 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. Annals of the
Rheumatic Diseases 2021;80:138-139.
- 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. Available at:
https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed:
November 2021.
- 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. Available at:
https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed:
November 2021.
- SKYRIZI® (risankizumab-rzaa) [Package Insert].
North Chicago, Ill.: AbbVie
Inc.
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