NORTH CHICAGO, Ill.,
June 12, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced new late-breaking Phase 3b head-to-head data showing superior rates of
skin clearance for SKYRIZI® (risankizumab-rzaa) to
COSENTYX® (secukinumab) at week 52.1
Particularly, 66 percent of psoriasis patients receiving
SKYRIZI achieved completely clear skin—100 percent clearance
in the Psoriasis Area and Severity Index (PASI 100)—versus 40
percent of patients receiving COSENTYX at week 52
(p<0.001).1
These new head-to-head results from the IMMerge Phase
3b open-label study were shared today
during an online late-breaking presentation by the American Academy
of Dermatology (AAD). AbbVie previously announced top-line
results from this study in January.
"I've seen first-hand how achieving and maintaining completely
clear skin can have an incredibly positive impact on the lives of
my psoriasis patients," said chief investigator Richard B. Warren, M.D., Ph.D., professor and
honorary consultant dermatologist at the Dermatology Centre Salford
Royal NHS Foundation Trust, University of Manchester. "These new data are critical as
they underscore that complete skin clearance is a realistic
treatment goal for people living with psoriasis."
SKYRIZI met both PASI 90 primary endpoints of non-inferiority to
COSENTYX at week 16 and superiority to COSENTYX at week
52.1 At week 16, 74 percent of SKYRIZI-treated patients
achieved PASI 90 compared to 66 percent of COSENTYX-treated
patients.1 Of patients treated with SKYRIZI, 87 percent
achieved PASI 90 at week 52 compared to 57 percent of patients
treated with COSENTYX
(p<0.001).1
Additional results demonstrated a significantly higher
proportion of patients treated with SKYRIZI achieved a static
Physician Global Assessment (sPGA) score of clear or almost clear
(sPGA 0/1) compared to those treated with COSENTYX at week 52 (88
percent versus 58 percent, respectively,
p<0.001).1
Current safety data available demonstrated that the safety
profile of SKYRIZI was consistent with that seen 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 rates 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 IMMerge Phase 3b
Study1,5
IMMerge is a Phase 3b,
multicenter, randomized, open-label (both arms), efficacy
assessor-blinded, active-comparator study 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, four weeks later and every 12
weeks thereafter, or to COSENTYX (n=163) (300 mg), given as two 150
mg subcutaneous injections at baseline, weeks 1, 2, 3 and 4, and
then every four 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-rzaa) in the United States6
SKYRIZI is indicated for the treatment of moderate-to-severe
plaque psoriasis in adults who are candidates for systemic therapy
or phototherapy.
Important Safety Information
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. See
SKYRIZI.com for full prescribing information. 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, 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 2019 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:
- Warren, R.B., et al. Risankizumab Versus Secukinumab in
Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 3 Trial.
2020 AAD Meeting (Virtual). American Academy of Dermatology Annual
Meeting. 2020.
- 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. 2020. Available at:
https://clinicaltrials.gov/ct2/show/NCT03478787.
- SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
COSENTYX® is a registered trademark of Novartis
AG
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