NORTH CHICAGO, Ill.,
Jan. 14, 2020 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced that
SKYRIZI™ met both primary and all ranked secondary
endpoints, including superiority at week 52, versus
Cosentyx® in a head-to-head Phase 3
study.1 SKYRIZI showed significantly higher rates of
skin clearance compared to Cosentyx, meeting the primary endpoint
of superiority with at least a 90 percent improvement from baseline
in the Psoriasis Area and Severity Index (PASI 90) at week
52.1 Of patients treated with SKYRIZI, 87 percent
achieved PASI 90 compared to 57 percent of Cosentyx-treated
patients at 52 weeks (p<0.001).1 At week 16, SKYRIZI
also met the other primary endpoint of non-inferiority to Cosentyx
with 74 percent of SKYRIZI patients achieving PASI 90 compared to
66 percent of Cosentyx patients.1
"In this study, SKYRIZI showed superior efficacy compared to
Cosentyx in helping patients achieve and maintain high levels of
skin clearance at week 52," said Michael
Severino, M.D., vice chairman and president, AbbVie.
"Head-to-head data like these are crucial to help patients and
their doctors make informed treatment decisions. We are pleased to
add these results to the growing body of evidence supporting
SKYRIZI as a differentiated treatment option for adults living with
psoriasis."
SKYRIZI also showed superiority compared to Cosentyx for all
ranked secondary endpoints, including PASI 100, and PASI 75,
as well as a static Physician Global Assessment score of clear or
almost clear (sPGA 0/1) at week 52 (p<0.001).1
Current safety data available demonstrated that the safety
profile of SKYRIZI was consistent with that observed in previously
reported studies, with no new safety signals observed through week
52.1-4 The rates of adverse events (AEs) were comparable
between SKYRIZI and Cosentyx.1 The most common AEs were
nasopharyngitis, upper respiratory tract infection, headache,
arthralgia and diarrhea.1 The rate of serious AEs were
5.5 percent in the SKYRIZI group and 3.7 percent in the Cosentyx
group.1 Adverse events leading to discontinuation of the
study drug were 1.2 percent in the SKYRIZI group and 4.9 percent in
the Cosentyx group.1 There were no deaths in either
treatment group.1
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
globally.
About the Head-to-Head Phase 3 Study1,5
This Phase 3, multicenter, randomized, open-label, efficacy
assessor-blinded, active-comparator study was designed to evaluate
the safety and efficacy of SKYRIZI compared to Cosentyx in adult
patients with moderate to severe plaque psoriasis. Patients were
randomized 1:1 to SKYRIZI (n=164) (150 mg), given as two 75 mg
subcutaneous injections at baseline, 4 weeks later and every 12
weeks thereafter, or Cosentyx (n=163) (300 mg) given as two 150 mg
subcutaneous injections, at baseline, weeks 1, 2, 3 and 4, and then
every 4 weeks thereafter. The study has two primary endpoints
(non-inferiority at week 16 as well as superiority at week 52, both
at PASI 90) and three ranked secondary endpoints (PASI 100 at week
52, sPGA 0/1 at week 52 and PASI 75 at week 52). Safety was
assessed in all patients.
More information on this trial can be found at
www.clinicaltrials.gov (NCT03478787).
About SKYRIZI (risankizumab) in the European
Union6
SKYRIZI (risankizumab) is indicated for the treatment of
moderate to severe plaque psoriasis in adults who are candidates
for systemic therapy.
Important EU Safety Information6
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 past 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, which occurred in 13 percent of patients.
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 is a global, research and development-based
biopharmaceutical company committed to developing innovative
advanced therapies for some of the world's most complex and
critical conditions. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to markedly
improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, LinkedIn or Instagram.
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, competition from
other products, challenges to intellectual property, difficulties
inherent in the research and development process, adverse
litigation or government action, and changes to laws and
regulations applicable to our industry. 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 2018 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. 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. ABVRRTI69849.
- 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.
- Risankizumab Versus Secukinumab for Subjects With Moderate to
Severe Plaque Psoriasis. ClinicalTrials.gov. 2019. Available at:
https://clinicaltrials.gov/ct2/show/NCT03478787.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd.
Available at: https://www.ema.europa.eu.
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