- An open-label, efficacy assessor-blinded study
comparing SKYRIZI® (risankizumab) to
Otezla® (apremilast) for the treatment of adult patients
with moderate plaque psoriasis who were candidates for systemic
therapy was published in the British Journal of
Dermatology1
- Significantly more patients in the study achieved co-primary
endpoints of PASI 90 and sPGA 0/1 at Week 16 with risankizumab
versus apremilast1
- In apremilast patients not achieving PASI 75 at Week
16, significantly more achieved the primary endpoint of PASI 90 at
Week 52 who were re-randomized to risankizumab versus continued
with apremilast1
- Based on TSQM-9, higher treatment satisfaction domain scores
were reported at Week 16 for patients taking risankizumab
(nominal p-values versus apremilast)1
- Risankizumab was well-tolerated with no new safety signals
identified1
NORTH
CHICAGO, Ill., July 26,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced the British Journal of Dermatology published
results from the head-to-head Phase 4 IMMpulse study that evaluated
the efficacy and safety of SKYRIZI® (risankizumab)
compared to Otezla® (apremilast) among adult patients
with moderate plaque psoriasis eligible for systemic
therapy.1 This study achieved all primary and ranked
secondary endpoints with no new safety signals
identified.1
"This study highlights the efficacy of SKYRIZI compared to
Otezla in helping systemic-eligible patients achieve high levels of
skin clearance and reinforces the safety profile observed in
previous studies," said Mudra Kapoor, M.D., vice president, global
medical affairs, immunology, AbbVie. "These head-to-head data are
crucial to help patients and their doctors make informed treatment
decisions for uncontrolled disease and add to the body of evidence
supporting SKYRIZI as a treatment option for adults living with
moderate psoriasis."
Highlights from this open-label, efficacy assessor-blinded study
include:
- At Week 16, a significantly higher proportion of patients who
received risankizumab achieved the Period A co-primary
endpoints of Psoriasis Area and Severity Index (PASI) 90 and Static
Physician's Global Assessment (sPGA) 0/1 [55.9% (66/118) of
patients achieved PASI 90 and 75.4% (89/118) achieved sPGA 0/1 with
risankizumab versus 5.1% (12/234) and 18.4% (43/234) with
apremilast; both with P<0.001].1
-
- The proportion of patients achieving the ranked secondary
endpoint of PASI 75 at Week 16 was also significantly higher
in risankizumab- versus apremilast-treated patients [84.7%
(100/118) versus 18.8% (44/234) respectively;
P<0.001].1
- At Week 52, among patients who failed to achieve PASI 75
after 16 weeks of treatment with apremilast, a significantly higher
proportion of patients re-randomized to treatment with risankizumab
achieved the Period B primary endpoint of PASI 90 as compared to
those re-assigned to continue treatment with apremilast [72.3%
(60/83) versus 2.6% (2/78); P<0.001].1
-
- After 52 weeks of continuous treatment, 73.7%
of risankizumab patients achieved the pre-specified endpoints
of PASI 90 and 63.6% PASI 100, with 4.5% and 2.7% of apremilast
patients achieving PASI 90 and PASI 100 at Week 52, respectively
(nominal p-value <0.001 for both comparisons).
The safety profile for risankizumab in this study was consistent
with previously reported studies; it was well-tolerated with no new
safety signals identified.1 The most frequent adverse
events (reported in ≥5%) in risankizumab-treated patients were
COVID-19, nasopharyngitis and upper respiratory tract
infection.1 Diarrhea, nausea and headache were most
frequent among apremilast-treated patients.1 Serious
adverse events were reported in 0.8% and 2.9% of
risankizumab-treated patients and 1.7% and 2.1% of
apremilast-treated patients in Periods A and B,
respectively.1 During Period A and Period B among the
re-randomization arms, 6.8% and 5.2% of apremilast-treated patients
discontinued treatment due to an adverse event, respectively, while
no patient discontinued on risankizumab; on the continuous
risankizumab arm, one patient discontinued due to an adverse
event.1
"As a physician, it's crucial to validate different options that
can achieve high treatment targets, and this study provides
practice-relevant data," said lead study investigator,
Linda Stein Gold, M.D., director of
clinical research, department of dermatology, Henry Ford Health
System. "These data reinforce the efficacy of SKYRIZI for use
in systemic-eligible moderate psoriasis patients with an observed
safety profile similar to prior studies."
Based on analyses of the Treatment Satisfaction Questionnaire
for Medication version 9 (TSQM-9), which were pre-specified
unranked endpoints, risankizumab-treated patients reported greater
treatment satisfaction at Week 16, with higher scores (out of 100)
in all three domains of satisfaction with effectiveness (80.6),
satisfaction with convenience (84.9) and global satisfaction (86.2)
compared to apremilast-treated patients (46.9, 69.0 and 47.7,
respectively; nominal p-value <0.001 for all
comparisons).1
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
globally.
About Psoriasis
Psoriasis is a chronic,
immune-mediated, inflammatory skin condition that produces
thickened, scaling skin due to rapid growth of skin
cells.2 It affects around 2-3% of people
worldwide.3 People with psoriasis also experience a
significant emotional, psychological and social burden that can
negatively impact their quality of life.4
About IMMpulse Study1,5
IMMpulse is a Phase 4, global, multicenter, randomized, open-label,
efficacy assessor-blinded, active comparator study examining the
effect of risankizumab (150 mg X 1 s.c at wk0, wk4, wk16, wk28,
wk40) compared to apremilast (30 mg BID oral following titration)
in adults with moderate plaque psoriasis who are candidates for
systemic therapy. Patients must have stable moderate psoriasis at
both screening and baseline, defined as: 1) BSA ≥10% and ≤15%; 2)
PASI ≥12; 3) sPGA =3 (moderate) to enter the study. The study
design comprised a screening period of up to 35 days, a 52-week
treatment period and a follow-up phone call for safety. The 52-week
treatment duration included two periods: Period A from Weeks 0 to
16, which evaluated the superiority of risankizumab over
apremilast, and Period B from Weeks 16 to 52, which evaluated the
outcomes following re-randomization to risankizumab versus
continuing apremilast in patients who were PASI 75 non-responders
with apremilast at Week 16.
About SKYRIZI® (risankizumab)
SKYRIZI is an
interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by
binding to its p19 subunit.6 IL-23, a cytokine involved
in inflammatory processes, is thought to be linked to a number of
chronic immune-mediated diseases, including
psoriasis.6
EU Indications and Important Safety Information about
SKYRIZI® (risankizumab)7
Indications
Skyrizi (risankizumab) is indicated for
the treatment of moderate to severe plaque psoriasis in adults who
are candidates for systemic therapy.
Skyrizi, alone or in combination with methotrexate (MTX), is
indicated for the treatment of active psoriatic arthritis in adults
who have had an inadequate response or who have been intolerant to
one or more disease-modifying antirheumatic drugs (DMARDs).
Skyrizi is indicated for the treatment of adult patients with
moderately to severely active Crohn's disease who have had an
inadequate response to, lost response to, or were intolerant to
conventional therapy or a biologic therapy.
Important Safety Information
Risankizumab is
contraindicated in patients hypersensitive to the active substance
or to any of the excipients, and in patients with clinically
important active infections (e.g. active tuberculosis).
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.
Patients treated with risankizumab should be instructed to seek
medical advice if signs or symptoms of clinically important chronic
or acute infection occur. If a patient develops such an infection
or is not responding to standard therapy for the infection, the
patient should be closely monitored and risankizumab should not be
administered until the infection resolves.
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 immunisations should be considered according to current
immunisation 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.
If a serious hypersensitivity reaction occurs, administration of
risankizumab should be discontinued immediately and appropriate
therapy initiated.
The most frequently reported adverse reactions were upper
respiratory infections (from 13% in psoriasis to 15.6% in Crohn's
disease). Commonly (greater than or equal to 1/100 to less than
1/10) reported adverse reactions included tinea infections,
headache, pruritus, rash, fatigue and injection site reactions.
This is not a complete summary of all safety
information.
Please see the SmPC for complete prescribing
information.
Globally, prescribing information varies;
refer to the individual country product label for complete
information.
About the British Journal of Dermatology
(BJD)
The British Journal of
Dermatology (BJD) is a top-ranked international
dermatology journal, publishing the highest-quality research to
advance the understanding and management of skin disease to improve
patient outcomes. The BJD is one of the journals of the British
Association of Dermatologists, the professional membership body for
dermatologists in the UK.
Oxford University Press
(OUP) is BAD's publishing partner. OUP publishes over 500
academic and research journals covering a broad range of subject
areas, two-thirds of which are published in collaboration with
learned societies and other international organizations. OUP has
been publishing journals for more than a century and, as the
world's largest university press, has more than 500 years of
publishing expertise. For more information,
visit academic.oup.com.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines and solutions 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,
and eye care – and products and services in our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram,
YouTube and LinkedIn.
AbbVie 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, failure to realize
the expected benefits from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. 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 2021 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. 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:
- Stein Gold, L.F., et al (2023), Comparison of risankizumab
and apremilast for the treatment of adult patients with moderate
plaque psoriasis eligible for systemic therapy: results from a
randomised, open-label, assessor-blinded phase IV (IMMpulse) study.
British Journal of Dermatology. doi: 10.1093/bjd/ljad252
- National Psoriasis Foundation. About Psoriasis. Available
at: https://www.psoriasis.org/about-psoriasis/. Accessed on
July 19, 2023.
- National Psoriasis Foundation. Psoriasis Statistics.
Available at:
https://www.psoriasis.org/psoriasis-statistics/#:~:text=Prevalence&text=125%20million%20people%20worldwide%20%E2%80%94%202,the%20World%20Psoriasis%20Day%20consortium.
Accessed on July 19, 2023.
- Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a
key cytokine in inflammatory diseases. Ann Med. 2011.
Nov 43(7):503-11.
- Study of subcutaneous risankizumab injection compared to oral
apremilast tablets to assess change in disease activity and adverse
events in adult participants with moderate plaque psoriasis who are
candidates for systemic therapy. ClinicalTrials.gov. 2023.
Available at:
https://classic.clinicaltrials.gov/ct2/show/NCT04908475. Accessed
on July 19, 2023.
- A study on the long-term efficacy and safety of risankizumab
for the treatment of moderate-to-severe plaque psoriasis.
ClinicalTrials.gov. 2021. Available
at: https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed
on July 19, 2023.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd.
Available
at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf.
Accessed on July 19, 2023.
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