- SKYRIZI™(risankizumab) is a novel,
humanized immunoglobulin monoclonal antibody designed to
selectively inhibit IL-23 by binding to its p19 subunit to treat
moderate to severe plaque psoriasis1 . IL-23 is a
naturally occurring cytokine that is involved in inflammatory and
immune responses.
- Approval of SKYRIZI™ (risankizumab) is based on
results from clinical studies showing significant improvement in
levels of skin clearance after just 16 weeks and at 52 weeks with
every 3 month dosing in more than 2000 adult
patients 2-5
MONTREAL, April 18, 2019 /CNW/ - AbbVie (NYSE: ABBV),
a global research and development-based biopharmaceutical company,
announced today that Health Canada has approved SKYRIZI™
(risankizumab) for the treatment of moderate to severe plaque
psoriasis in adult patients who are candidates for systemic
therapy or phototherapy.
Canadians living with moderate to severe plaque psoriasis were
well represented in all four of the pivotal clinical trials leading
to Health Canada's approval, showing the Canadian leadership in
this clinical development program.
In clinical studies, SKYRIZI™ significantly improved levels of
skin clearance after just 16 weeks and maintained clearance at one
year (52 weeks).2-5
"When treating patients with a chronic disease like psoriasis,
it is important to have several options available. With SKYRIZI™,
we can simplify their treatment by offering a greater chance of
clear skin with a safe and easy three-month dosing regimen. As a
dermatologist, this allows me to spend the time I have with my
patients on other issues pertaining to their overall health and
well-being," said Dr. Melinda
Gooderham, Dermatologist from the SKiN Centre for
Dermatology in Peterborough,
Ontario.
Kathryn Clay, President, Canadian
Association of Psoriasis Patients added "Psoriasis is a
chronic condition affecting more than one million Canadians and
many patients still do not reach their treatment goals or lose
response to medication over time so we need options for them.
Despite tremendous progress, there is still much to be done as
highlighted in our report Treat Psoriasis Seriously."
Stéphane Lassignardie, General Manager, AbbVie Canada added: "We
are committed to continuing to find new and better medications that
will improve the lives of those living with psoriasis. There are
still areas of unmet medical need and we are thrilled that people
will be able to access SKYRIZI™."
SKYRIZI™ received Health Canada 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.2-5 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™ I 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 90.2,4,5
- Among patients with sPGA of 0/1 at Week 28 in the IMMhance
study, 87.4% (97/111) maintained response with continued treatment
with SKYRIZI™ compared to 61.3% (138/225) with withdrawal (placebo)
at Week 525.
- 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, 5
- 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 0/1 (no impact on health-related quality of life) at Week 16
(66 percent in ultIMMa-1 and 67 percent in ultIMMa-2)
compared with ustekinumab (43 percent in ultIMMa-1 and 47 percent
in ultIMMa-2)2,5
- The most frequently reported adverse drug reactions through the
16-week placebo-controlled period in the SKYRIZI™ group were upper
respiratory tract infections (13%) compared with 10% in the placebo
group. Common adverse reactions occurring in ≥ 1% of patients
treated with SKYRIZI™ included tinea infections, headache,
pruritus, fatigue and injection site reactions.4, 5
About AbbVie Care
The AbbVie Care program is designed
to provide a wide range of customized services including
reimbursement and financial support, pharmacy services, lab work
reminders and coordination, personalized education and ongoing
disease management support throughout the treatment journey.
For more information, consult www.abbviecare.ca.
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.ca and www.abbvie.com.
Follow @abbvieCanada and @abbvie on Twitter or view
careers on our Facebook or LinkedIn page.
References:
- Papp K.A., et al. Risankizumab versus Ustekinumab for
Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20;
376:1551-1560.
- 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™ (risankizumab) [Canadian Product Monograph].
AbbVie Corporation, 2019.
SOURCE AbbVie