NORTH CHICAGO, Ill.,
June 11, 2019 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced new results showing a
significant number of patients treated with SKYRIZI™ (risankizumab)
experienced complete skin clearance at week 94.1 In the
study, at week 28 patients who achieved a static Physician Global
Assessment (sPGA) score of clear or almost clear (sPGA 0/1) were
re-randomized to continue treatment with SKYRIZI or
withdrawal.1 After 94 weeks of continuous treatment with
SKYRIZI, 73 percent and 72 percent of these patients achieved a
sPGA score of clear (sPGA 0) and a 100 percent improvement in the
Psoriasis Area and Severity Index (PASI 100), respectively,
compared to 2 percent of patients re-randomized to withdrawal
(p<0.001).1 These two-year results (up to 104 weeks)
from the Phase 3 IMMhance study, evaluating the efficacy and safety
of SKYRIZI in adult patients with moderate to severe psoriasis,
will be presented today at the 24th World Congress of Dermatology
(WCD) in Milan.
"Results show that SKYRIZI has the potential to provide
long-term relief from the signs and symptoms of psoriasis," said
Marek Honczarenko, M.D., Ph. D.,
vice president, immunology development, AbbVie. "Our studies
demonstrated that SKYRIZI can not only offer complete skin
clearance at two years of treatment for the majority of patients,
but re-treatment with SKYRIZI following a relapse can help patients
regain skin clearance in just 16 weeks. We are pleased to add
positive long-term data to the growing body of evidence supporting
the efficacy and safety profile of SKYRIZI for adult patients with
moderate to severe psoriasis."
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
globally.
There were two phases in the IMMhance study.1 Results
from the first phase were previously reported and showed that
after 16 weeks of treatment, SKYRIZI (n=407) met the co-primary
endpoints of PASI 90 and sPGA 0/1 versus placebo (n=100)
(p<0.001).1 The second phase (week 28 through week
104) evaluated the efficacy and safety of continuous therapy with
SKYRIZI versus randomized withdrawal, as well as
re-treatment.1 Patients who achieved sPGA 0/1 at week 28
with SKYRIZI were re-randomized to continue SKYRIZI (n=111) every
12 weeks or to withdrawal (n=225).1 The primary endpoint
from the second phase of the study, sPGA 0/1, was also met at one
year (52 weeks) (p<0.001).1
For those re-randomized to continue SKYRIZI, the last dose was
given at week 88.1 Between one year (week 52) and week
94, the proportion of these patients who achieved complete skin
clearance continued to increase.1 sPGA 0 and PASI 100
responses increased from 65 percent and 64 percent at week 52 to 73
percent and 72 percent at week 94, respectively
(p<0.001).1 At two years, 81 percent and 78 percent
of patients treated with continuous SKYRIZI maintained clear or
almost clear skin (sPGA 0/1 or PASI 90) compared to 7 percent
and 4 percent re-randomized to withdrawal, respectively
(p<0.001).1
Among patients re-randomized to withdrawal who experienced a
loss of response (defined as a sPGA score of moderate to severe
[≥3]) on or after week 32 (n=153), 84 percent regained clear or
almost clear skin (sPGA 0/1) after 16 weeks of re-treatment with
SKYRIZI.1
"In the IMMhance study, SKYRIZI provided an increasing number of
patients with complete skin clearance up to 94 weeks," said
Melinda Gooderham, M.D.,
dermatologist and medical director at the SKiN Centre for
Dermatology in Peterborough,
Ontario and a study investigator. "SKYRIZI not only offers
relief from the signs and symptoms of psoriasis following a
withdrawal from medication, but the study further demonstrates the
significant rates of complete skin clearance that can be achieved
with continuous treatment at the recommended dose. These data
underscore the lasting impact this new treatment option could
provide for people living with psoriasis."
No new safety findings were observed in patients who continued
with SKYRIZI for two years compared with those who withdrew to
placebo at week 28.1 Rates of treatment-emergent adverse
events were similar to placebo at week 16 and remained stable over
time in patients treated with SKYRIZI.1
About the Phase 3 IMMhance Study1
The IMMhance study is an ongoing Phase 3, multicenter,
randomized, double-blind, placebo-controlled study designed to
evaluate the safety and efficacy of SKYRIZI compared to placebo in
adult patients with moderate to severe plaque psoriasis. In the
first phase, patients were randomized 4:1 to SKYRIZI (n=407)(150
mg), given as a subcutaneous injection at baseline, 4 weeks later
and every 12 weeks thereafter, or placebo (n=100). In the second
phase of this study (week 28 through week 104), patients originally
randomized to SKYRIZI who achieved sPGA 0/1 at week 28 were
re-randomized to SKYRIZI (maintenance, n=111) or placebo
(withdrawal, n=225). Safety was assessed in all patients. Patients
received their last dose of SKYRIZI at week 88 and follow up was
conducted until week 104.
This Phase 3 study was conducted in cooperation between AbbVie
and Boehringer Ingelheim. More information on this trial can be
found at www.clinicaltrials.gov (NCT02672852).
About SKYRIZI (risankizumab) in the European
Union3
SKYRIZI (risankizumab) is indicated for the treatment of
moderate to severe plaque psoriasis in adults who are candidates
for systemic therapy.
Important EU Safety Information3
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:
- 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. 24th World Congress of
Dermatology. 2019.
- Papp K.A., et al. Risankizumab versus Ustekinumab for
Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;
376:1551-1560.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd.
Available at: https://www.ema.europa.eu.
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SOURCE AbbVie