NORTH CHICAGO, Ill.,
April 30, 2019 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced that the European Commission (EC) has approved
SKYRIZI™ (risankizumab) for the treatment of moderate to severe
plaque psoriasis in adult patients who are candidates for
systemic therapy. SKYRIZI (150 mg) is approved to be administered
by two subcutaneous injections every 12 weeks following two
initiation doses at week 0 and week 4. In clinical studies, SKYRIZI
demonstrated high rates of skin clearance at 16 weeks and this
clearance was durable at one year (52 weeks).1-4 This
approval allows for the marketing of SKYRIZI in all member states
of the European Union, as well as Iceland, Liechtenstein and Norway.
"This approval is an important step forward in providing people
living with moderate to severe psoriasis with a new treatment
option," said Michael Severino,
M.D., vice chairman and president, AbbVie. "The results seen in our
clinical studies, including high levels of complete skin clearance
with 12-week dosing and a favorable safety profile, suggest SKYRIZI
has the potential to provide long-term relief from the signs and
symptoms of psoriasis. We are proud to expand our portfolio of
treatment options for people living with this condition in
Europe."
"In clinical studies, patients saw significantly higher rates of
skin clearance with SKYRIZI compared to current standards of care,"
said Hervé Bachelez, professor at the University Paris Diderot and
the Department of Dermatology of the
Saint-Louis Hospital-Assistance Publique Hôpitaux de
Paris, France and a principal
investigator of the ultIMMa-2 study. "As many as 80 percent of
patients who achieved clear skin at 16 weeks maintained completely
clear skin through one year. We look forward to seeing more of the
two-year data from the IMMhance study at the World Congress of
Dermatology in June."
SKYRIZI received EC approval based on results from four pivotal
Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance
evaluating more than 2,000 patients with moderate to severe plaque
psoriasis.1-4 Across all four studies, the co-primary
endpoints were at least a 90 percent improvement in the Psoriasis
Area and Severity Index (PASI 90) and a static Physician Global
Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at week
16.1-4 SKYRIZI is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
Highlights from the pivotal Phase 3 program
- In the ultIMMa-1 and ultIMMa-2 studies, SKYRIZI met the
co-primary endpoints of sPGA 0/1 and PASI 90 at week 16
(p<0.001).1,4 After 16 weeks of treatment, 88 percent
(ultIMMa-1) and 84 percent (ultIMMa-2) of SKYRIZI patients achieved
sPGA 0/1 and 75 percent of patients receiving SKYRIZI in both
studies achieved PASI 90.1,4
- An integrated analysis of patients who received SKYRIZI in the
ultIMMa-1 and ultIMMa-2 studies showed that, of patients who
achieved PASI 90 with SKYRIZI at week 16, 88 percent of these
patients maintained PASI 90 with SKYRIZI at one year (52 weeks). Of
patients who achieved PASI 100 with SKYRIZI at week 16, 80 percent
maintained PASI 100 with SKYRIZI at one year (52
weeks).4
- SKYRIZI demonstrated superiority versus adalimumab in the
IMMvent study, with 72 percent of patients achieving PASI 90
compared to 47 percent of patients treated with adalimumab at week
16 (p<0.001).2,4 Following re-randomization at week
16, 66 percent of patients who started on adalimumab and switched
to SKYRIZI achieved PASI 90, compared to 21 percent who continued
on adalimumab at week 44 (p<0.001).2,4 The co-primary
endpoints of sPGA 0/1 and PASI 90 at week 16 were met
(p<0.001).2,4
- Results from IMMhance showed that, among people receiving
SKYRIZI who achieved clear or almost clear skin (sPGA 0/1) response
at week 28 and were re-randomized to continue SKYRIZI (n=111), 87
percent maintained this response at week 52 compared to 61 percent
re-randomized to withdraw (n=225).9 The co-primary
endpoints of sPGA 0/1 at week 16 and week 52 were met
(p<0.001).3,4
- SKYRIZI was also reported to improve health-related quality of
life in Phase 3 studies. In ultIMMa-1 and ultIMMa-2, significantly
more patients treated with SKYRIZI self-reported a Dermatology Life
Quality Index (DLQI) score of 0 or 1 (75 percent in ultIMMa-1 and
71 percent in ultIMMa-2) compared with ustekinumab (47 percent in
ultIMMa-1 and 44 percent in ultIMMa-2) at one year
(p<0.001).1,4 DLQI is a measure of a patient's
health-related quality of life, ranging from 0 to 30, with lower
scores indicating the disease has less impact on life
quality.10
More information about this program can be found on
www.clinicaltrials.gov (NCT02672852, NCT02694523, NCT02684370,
NCT02684357).
The most frequently reported adverse reactions were upper
respiratory infections, which occurred in 13 percent of
patients.4 Common adverse reactions (frequency defined
as greater than or equal to 1/100 events to less than 1/10)
included tinea infections, headache, pruritus, fatigue and
injection site reactions.4
AbbVie received approval of SKYRIZI from the Japanese Ministry
of Health, Labour and Welfare for the treatment of plaque
psoriasis, generalized pustular psoriasis, erythrodermic psoriasis
and psoriatic arthritis in March
2019, as well as approval for the treatment of adults with
moderate to severe plaque psoriasis from Health Canada and the U.S.
Food and Drug Administration in April
2019.
About SKYRIZI (risankizumab) in the European Union
SKYRIZI (risankizumab) is indicated for the treatment of
moderate to severe plaque psoriasis in adults who are candidates
for systemic therapy.
Important EU Safety Information4
Risankizumab is contraindicated in patients with
hypersensitivity to the active substance or to any of the
excipients. Risankizumab may increase the risk of infection. In
patients with a chronic infection, a history of recurrent
infection, or known risk factors for infection, risankizumab should
be used with caution. Treatment with risankizumab 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 risankizumab, patients should
be evaluated for tuberculosis (TB) infection. Patients receiving
risankizumab should be monitored for signs and symptoms of active
TB. Anti-TB therapy should be considered prior to initiating
risankizumab 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 risankizumab, 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 risankizumab. Patients treated
with risankizumab 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 HUMIRA® (adalimumab) in the European
Union
HUMIRA is indicated for the treatment of moderate to severe
chronic plaque psoriasis in adult patients who are candidates for
systemic therapy.
Important EU Safety Information11
HUMIRA is contraindicated in patients with active tuberculosis
or other severe infections such as sepsis, and opportunistic
infections and in patients with moderate to severe heart failure
(NYHA class III/IV). It is also contraindicated in patients
hypersensitive to the active substance or to any of the excipients;
serious allergic reactions including anaphylaxis have been
reported. The use of HUMIRA increases the risk of developing
serious infections, including hepatitis B reactivation, which may,
in rare cases, be life-threatening. Rare cases of lymphoma and
leukemia have been reported in patients treated with HUMIRA. On
rare occasions, a severe type of cancer called hepatosplenic T-cell
lymphoma has been observed and often results in death. A risk for
the development of malignancies in patients treated with
TNF-antagonists cannot be excluded. Rare cases of pancytopenia,
aplastic anaemia, demyelinating disease, lupus, lupus-related
conditions and Stevens-Johnson syndrome have been reported in
patients treated with HUMIRA. The most frequently reported adverse
events across all indications included respiratory infections,
injection site reactions, headache and musculoskeletal pain.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
Full summary of product characteristics is available at:
www.ema.europa.eu
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:
- 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. Efficacy and Safety of Risankizumab Compared
with Adalimumab in Patients with Moderate-to-Severe Plaque
Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813.
European Academy of Dermatology and Venereology Congress.
2018.
- Blauvelt, A. et al. Risankizumab Efficacy/Safety in
Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance
[abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd.
Available at: https://www.ema.europa.eu.
- Papp K.A., et al. Risankizumab versus Ustekinumab for
Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;
376:1551-1560.
- International Federation of Psoriasis Associations. Available
at:
https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf.
Accessed March 22, 2019.
- Mroweitz, U., et al. Definition of treatment goals for moderate
to severe psoriasis: a European consensus. Arch Dermatol Res. 2011
Jan; 303(1): 1–10.
- Levin, et al. Biologic fatigue in psoriasis. J Dermatolog
Treat. 2014 Feb;25(1):78-82. doi:
10.3109/09546634.2013.826341.
- Langley, et al. Efficacy and Safety of Continuous Q12W
Risankizumab versus Treatment Withdrawal: Results from the Phase 3
IMMhance Trial. Poster #10093. 2019 American Academy of Dermatology
Annual Meeting. 2019.
- Hongbo Y, et al. Translating the science of quality of life
into practice: What do dermatology life quality index scores mean?
J Invest Dermatol. 2005 Oct;125(4):659-64.
- HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.;
Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf.
Last updated October 5, 2017.
Accessed March 22, 2019.
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