NORTH CHICAGO, Ill.,
Jan. 5, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced positive top-line
results from two Phase 3 studies in adults with active psoriatic
arthritis, KEEPsAKE-1 and KEEPsAKE-2, showing that significantly
more patients treated with risankizumab (150 mg) achieved the
primary endpoint of ACR20 response at week 24 versus
placebo.1 In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51
percent of patients receiving risankizumab achieved ACR20 response
at week 24, respectively, versus 34 and 27 percent receiving
placebo (p<0.001).1
Results of ranked secondary endpoints showed significant
improvements in skin clearance (as measured by at least a 90
percent improvement in Psoriasis Area Severity Index [PASI 90]),
physical function (as measured by the Health Assessment
Questionnaire Disability Index [HAQ-DI]) and minimal disease
activity (MDA) at week 24.1 These two Phase 3 studies
evaluated risankizumab in adult patients with active psoriatic
arthritis, and included patients who had responded inadequately or
were intolerant to biologic therapy and/or non-biologic
disease-modifying anti-rheumatic drugs (DMARDs).1
"We are encouraged by these positive results showing the
potential of risankizumab in psoriatic arthritis,"
said Michael Severino, M.D., vice chairman and president,
AbbVie. "These results underscore our commitment to research that
can provide health care practitioners with important treatment
options for patients with psoriatic disease."
KEEPsAKE-1 and
KEEPsAKE-2 Results at Week 24*,1
|
|
KEEPsAKE-1
|
KEEPsAKE-2
|
|
Risankizumab
150 mg (n=483)
|
Placebo (n=481)
|
Risankizumab
150 mg (n=224)
|
Placebo (n=219)
|
ACR20a
|
57%
|
34%
|
51%
|
27%
|
ACR50a,f
|
33%
|
11%
|
26%
|
9%
|
ACR70a,f
|
15%
|
5%
|
12%
|
6%
|
PASI
90b
|
52%
|
10%
|
55%
|
10%
|
HAQ-DIc
|
-0.31
|
-0.11
|
-0.22
|
-0.05
|
MDAd
|
25%
|
10%
|
26%
|
11%
|
PsA-mTSSe,†
|
0.23
|
0.32
|
N/A
|
N/A
|
|
* In both
studies, ACR20 at week 24 was the primary endpoint, and PASI 90,
HAQ-DI and MDA at week 24 were ranked secondary endpoints. ACR20,
PASI 90, HAQ-DI and MDA achieved p-values of <0.001. Not all
ranked secondary endpoints are shown.
|
a
ACR20/50/70 is defined as at least a 20 percent/50 percent/70
percent reduction from baseline in the number of both tender and
swollen joint counts and equivalent improvement in three or more of
the five American College of Rheumatology core set measures:
patient assessments of pain, patient global assessment of disease
activity, physical function, physician global assessment of disease
activity and acute phase reactant.
|
b PASI 90
is defined as achievement of at least a 90 percent reduction in
Psoriasis Area Severity Index. It was assessed in patients with a
body surface area (BSA) ≥3 percent at baseline.
|
c HAQ-DI
is defined as change in baseline in the Health Assessment
Questionnaire Disability Index, which is a patient-reported
questionnaire including categories of dressing and grooming,
arising, eating, walking, hygiene, reach, grip and common daily
activities. It asks patients about the amount of difficulty they
experience in these activities as well as the use of aids and/or
devices.
|
d MDA is
defined as the fulfillment of 5 of 7 outcome measures: TJC ≤1; SJC
≤1; PASI ≤1 or BSA-Ps ≤3 percent; Patient's Assessment of Pain
Numerical Rating Scale (NRS) ≤1.5; PtGA-Disease Activity NRS ≤2.0;
HAQ-DI score ≤0.5; and LEI (Leeds Enthesitis Index) ≤1.
|
e PsA-mTSS
is defined as a change in modified total Sharp score (mTSS) from
baseline.
|
f ACR50 and ACR70 at week 24 were
secondary endpoints and achieved nominal p-values of <0.05.
These endpoints were not controlled for multiplicity.
|
† PsA-mTSS at week 24 was a ranked
secondary endpoint that did not reach statistical significance
(p=0.496). It was not evaluated in KEEPsAKE-2.
|
In KEEPsAKE-1, the ranked secondary endpoint of PsA Sharp/van
der Heijde Score (PsA-mTSS) was 0.23 and 0.32 at week 24 in the
risankizumab and placebo groups, respectively (p=0.496 [note: a
lower score denotes lower radiographic
progression]).1
In these studies, the safety profile of risankizumab through
week 24 was generally consistent with safety findings in previous
studies in psoriasis.1-4 Serious adverse events occurred
in 2.5 percent and 4.0 percent of patients treated with
risankizumab in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared
with 3.7 percent and 5.5 percent on placebo.1 Rates of
serious infections were similar between treatment groups (1.0 and
0.9 percent in risankizumab-treated patients in KEEPsAKE-1 and
KEEPsAKE-2, respectively, and 1.2 and 2.3 percent in patients who
received placebo).1 The rates of adverse events leading
to discontinuation of the study drug were 0.8 percent and 0.9
percent of patients treated with risankizumab in KEEPsAKE-1 and
KEEPsAKE-2, respectively, compared with 0.8 percent and 2.3 percent
on placebo.1 In KEEPsAKE-1, there was one death in the
risankizumab group not related to the study drug per
investigator.1 There were no deaths reported in
KEEPsAKE-2.1
Full results from the KEEPsAKE studies will be presented at
upcoming medical conferences and published in a peer-reviewed
medical journal. Use of risankizumab in psoriatic arthritis is not
approved and its safety and efficacy have not been evaluated by
regulatory authorities.
Risankizumab (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 inflammatory
disease with hallmark manifestations across multiple domains
including joints and skin.8,9 In psoriatic arthritis,
the immune system creates inflammation that can lead to pain,
fatigue, stiffness in the joints and cause a red, scaly
rash.8,9
About KEEPsAKE-1 and KEEPsAKE-21,10,11
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 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 from the treatment with the study
medication. Ranked secondary endpoints included change from
baseline in HAQ-DI, as well as the achievement of PASI 90 and MDA
at week 24. Other secondary endpoints included ACR50 and ACR70 (not
controlled for multiplicity) 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 (SKYRIZI®)
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.12,13 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 and psoriatic
arthritis are ongoing.5-7,10,11 Use of SKYRIZI in
psoriatic arthritis is not approved and its safety and efficacy
have not been evaluated by regulatory authorities.
About SKYRIZI (risankizumab-rzaa) in the United States13
SKYRIZI is indicated for the treatment of moderate to severe
plaque psoriasis in adults who are candidates for systemic therapy
or phototherapy.
Important Safety Information13
Infection
SKYRIZI may increase the risk of infection. Do not initiate
treatment with SKYRIZI in patients with a clinically important
active infection until it resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent
infection, consider the risks and benefits prior to prescribing
SKYRIZI. Instruct patients to seek medical advice if signs or
symptoms of clinically important infection occur. If a patient
develops such an infection or is not responding to standard
therapy, closely monitor and discontinue SKYRIZI until the
infection resolves.
Pre-Treatment Evaluation for Tuberculosis (TB)
Prior to initiating treatment with SKYRIZI, evaluate for TB
infection and consider treatment in patients with latent or active
TB for whom an adequate course of treatment cannot be confirmed.
Monitor patients for signs and symptoms of active TB during and
after SKYRIZI treatment. Do not administer SKYRIZI to patients with
active TB.
Immunizations
Prior to initiating SKYRIZI, consider completion of all age
appropriate immunizations according to current immunization
guidelines. Avoid use of live vaccines in patients treated with
SKYRIZI.
Adverse Reactions
Most common (≥1%) adverse reactions associated with SKYRIZI
include upper respiratory infections, headache, fatigue, injection
site reactions, and tinea infections.
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 2019 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.
- 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 to Assess the Safety and Efficacy of Risankizumab for
Maintenance in Moderate to Severe Plaque Type Psoriasis
(LIMMITLESS). ClinicalTrials.gov. 2020. Available at:
https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on
December 3, 2020.
- A Study of the Efficacy and Safety of Risankizumab in
Participants With Crohn's Disease. ClinicalTrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT03105102.
Accessed on December 3, 2020.
- 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. Accessed on
December 3, 2020.
- 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 December 3, 2020.
- 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. 2020. Available at:
https://clinicaltrials.gov/ct2/show/record/NCT03675308. Accessed on
December 3, 2020.
- 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. 2020. Available at:
https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on
December 3, 2020.
- 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.
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