NORTH CHICAGO, Ill.,
Feb. 17, 2018 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a global research and development-based
biopharmaceutical company, today presented new positive results
from the pivotal Phase 3 ultIMMa-1 and ultIMMa-2 replicate clinical
trials that evaluated the safety and efficacy of risankizumab (150
mg) compared to placebo or ustekinumab (45 or 90 mg, based on
patient weight). These results were featured during the
"Late-breaking Research: Clinical Trials" session at the 2018
American Academy of Dermatology Annual Meeting in San Diego.
Risankizumab is an investigational interleukin-23 (IL-23)
inhibitor being evaluated for the treatment of patients with
moderate to severe plaque psoriasis.1 Risankizumab is
not approved by regulatory authorities and its safety and efficacy
have not been established.
In October of 2017, AbbVie announced positive top-line results
from these two pivotal trials, an evaluation of the primary and
ranked secondary endpoints, including the Psoriasis Area and
Severity Index (PASI 90 and PASI 100) at 16 weeks and one year and
clear or almost clear skin (sPGA 0/1) at 16 weeks. The press
release is available here. Risankizumab is part of a collaboration
with Boehringer Ingelheim, with AbbVie leading future development
and commercialization of risankizumab globally.
In today's presentation, additional ranked secondary endpoints
showed significantly higher rates of skin clearance at week 16 and
at one year of treatment, compared with ustekinumab, as measured by
static Physician Global Assessment (sPGA 0).1 The skin
clearance rates (sPGA 0) presented today are consistent with the
previously reported PASI 100 rates at one
year.1
In addition, through one year of treatment, significantly more
patients receiving risankizumab self-reported a Dermatology Life
Quality Index (DLQI) score of 0 or 1 compared with
ustekinumab.1 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.3
"Not only do these data show significant rates of clear skin,
but because we know the burden of psoriasis extends beyond the
skin, we are encouraged by the patient-reported improvement in
quality of life after one year of treatment," said Kenneth B. Gordon, M.D., professor and chair of
the Department of Dermatology at the Medical
College of Wisconsin, dermatologist at the Froedtert &
the Medical College of Wisconsin
Froedtert Hospital and principal investigator of the ultIMMa-1
study. "Given the significant impact of psoriasis, it is important
to continue to investigate additional treatment options."
Evaluation of Clear Skin (sPGA 0) at 16 Weeks and One
Year
- Results at week 16 and one year (52 weeks) demonstrated
significantly higher rates of clear skin (sPGA 0), both ranked
secondary endpoints, in patients treated with risankizumab,
compared to ustekinumab patients in ultIMMa-1 and
ultIMMa-2.1
ultIMMa-1 and
ultIMMa-2 sPGA 0 Results at Week 16 and One Year*
|
|
ultIMMa-1
|
ultIMMa-2
|
Risankizumab 150
mg (n=304)
|
Ustekinumab 45/90 mg
(n=100)
|
Risankizumab 150
mg (n=294)
|
Ustekinumab 45/90
mg (n=99)
|
sPGA 0 at Week
16*
|
37%
|
14%
|
51%
|
25%
|
sPGA 0
at Week 52*
|
58%
|
21%
|
60%
|
30%
|
*P<0.001. Not all
secondary endpoints for the trials are shown.
|
Evaluation of Clear or Almost Clear Skin (sPGA 0/1) at One
Year
- In an exploratory analysis at one year (52 weeks), more
risankizumab patients also demonstrated clear or almost clear skin
(sPGA 0/1), compared to ustekinumab patients in ultIMMa-1 and
ultIMMa-2.1
ultIMMa-1 and
ultIMMa-2 sPGA 0/1 Results at One Year*
|
|
ultIMMa-1
|
ultIMMa-2
|
Risankizumab 150
mg (n=304)
|
Ustekinumab 45/90 mg (n=100)
|
Risankizumab 150
mg (n=294)
|
Ustekinumab 45/90
mg (n=99)
|
sPGA 0/1 at Week
52*
|
86%
|
54%
|
83%
|
55%
|
*P <0.001. Not all
secondary endpoints for the trials are shown.
|
Evaluation of Quality of Life (DLQI) at 16 Weeks and One
Year
- More patients treated with risankizumab reported a DLQI score
of 0 or 1 versus ustekinumab at 16 weeks, a ranked secondary
endpoint, and one year (52 weeks), an exploratory
analysis.1
ultIMMa-1 and
ultIMMa-2 DLQI 0/1 Results at Week 16 and One Year*
|
|
ultIMMa-1
|
ultIMMa-2
|
Risankizumab 150
mg (n=304)
|
Ustekinumab 45/90 mg (n=100)
|
Risankizumab 150
mg (n=294)
|
Ustekinumab 45/90
mg (n=99)
|
DLQI 0/1 at Week
16*
|
66%
|
43%
|
67%
|
47%
|
DLQI 0/1 at Week
52*
|
75%
|
47%
|
71%
|
44%
|
*P <0.001. Not all
secondary endpoints for the trials are shown.
|
In both the ultIMMa-1 and ultIMMa-2 trials, the most frequently
reported treatment-emergent adverse events in the risankizumab arms
were upper respiratory tract infection.4 In ultIMMa-1,
one patient receiving risankizumab presented with latent
tuberculosis and was treated with rifampicin.1 Safety
findings were previously reported here.
"AbbVie's enduring commitment to dermatology is grounded in more
than 20 years of expertise in immunology," said Marek Honczarenko, M.D., Ph.D., vice president,
immunology development, AbbVie. "Risankizumab treatment resulted in
significant rates of complete skin clearance which further supports
its potential to be an important treatment option. We look forward
to submitting our regulatory application for risankizumab in
moderate to severe chronic plaque psoriasis the first half of this
year."
About the Phase 3 ultIMMa-1 and ultIMMa-2
studies1
ultIMMa-1 and ultIMMa-2 are replicate
Phase 3, randomized, double-blind, double-dummy, placebo- and
active-controlled studies designed to evaluate the safety and
efficacy of risankizumab compared to placebo or ustekinumab in
adult patients with moderate to severe chronic plaque psoriasis.
Risankizumab (150 mg) was given as a subcutaneous injection at week
0, 4, 16, 28, 40. Ustekinumab 45 mg or 90 mg, based on screening
weight, was delivered as a subcutaneous injection at week 0, 4, 16,
28, 40. The active comparator used for these studies was sourced
from the European Union. The co-primary endpoints were achievement
of at least a 90 percent improvement in the PASI score (PASI 90) at
week 16 and achievement of a sPGA score of clear or almost clear
(0/1) at week 16 compared to placebo. Key secondary endpoints at
week 16 included PASI 90, sPGA score of clear (sPGA 0), sPGA score
of clear or almost clear (0/1) and DLQI score of 0/1, compared to
ustekinumab. Key secondary endpoints at week 52 included PASI 90,
PASI 100 and sPGA 0 compared to ustekinumab. These Phase 3 studies
have been conducted in cooperation between AbbVie and Boehringer
Ingelheim. More information on these trials can be found at
www.clinicaltrials.gov (ultIMMa-1: NCT02684370; ultIMMa-2:
NCT02684357).
About Risankizumab
Risankizumab is an investigational
compound that is designed to selectively block IL-23 by binding to
its p19 subunit.2 IL-23, a key cytokine involved in
inflammatory processes, is thought to be linked to a number of
chronic immune-mediated diseases.5 Phase 3 trials of
risankizumab in psoriasis and Crohn's disease are ongoing, and it
is also being investigated to treat psoriatic
arthritis.6,7 Future trials are planned to investigate
risankizumab in ulcerative colitis.8,9
Risankizumab is not approved by regulatory authorities. Safety
and efficacy have not been established.
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 or 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, challenges to
intellectual property, competition from other products,
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 2017 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.
1 Gordon K, et al. Efficacy and Safety of
Risankizumab: Results from Two Double-Blind, Placebo- and
Ustekinumab-Controlled, Phase 3 Trials in Moderate-to-Severe Plaque
Psoriasis. American Academy of Dermatology. February 2018.
2 Papp K.A., et al. Risankizumab versus Ustekinumab for
Moderate-to-Severe Plaque Psoriasis. NEJM. 2017.
3 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.
4 Gordon K, et al. Efficacy and Safety of Risankizumab:
Results from Two Double-blind, Placebo- and Ustekinumab-controlled,
Phase 3 Trials in Moderate-to-severe Plaque Psoriasis. [Abstract
F061]. AAD 2018. Available at: https://www.aad.org/File Library/Top
navigation/Media/AM18-F061-Clinical-Trials-Book.pdf. Accessed
February 16, 2018.
5 Duvallet E, Sererano L, Assier E, et. al.
Interleukin-23: a key cytokine in inflammatory diseases. Ann Med.
2011 Nov;43(7):503-11.
6 A Study of the Efficacy and Safety of Risankizumab in
Subjects With Moderately to Severely Active Crohn's Disease.
ClinicalTrials.gov. 2018. Available at:
https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on
February 2, 2018.
7 BI 655066/ABBV-066/Risankizumab Compared to Placebo in
Patients With Active Psoriatic Arthritis. ClinicalTrials.gov. 2018.
Available at: https://clinicaltrials.gov/ct2/show/NCT02719171.
Accessed on February 2, 2018.
8 A Study to Assess the Efficacy and Safety of
Risankizumab in Subjects With Ulcerative Colitis Who Responded to
Induction Treatment in M16-067 or M16-065. ClinicalTrials.gov.
2018. https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed
on February 2, 2018.
9 A Study to Evaluate the Efficacy and Safety of
Risankizumab in Subjects With Moderately to Severely Active
Ulcerative Colitis Who Have Failed Prior Biologic Therapy.
ClinicalTrials.gov. 2018.
https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed on
February 2, 2018.
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