Stelara Shows Greater Efficacy than Etanercept for Treatment Of Moderate-To-Severe Plaque Psoriasis
Study Also Evaluated Etanercept Non-responders Switched to STELARA®
Toronto, ON, (January 14, 2010) —Findings from an
international, Phase 3 clinical study comparing the efficacy and
safety of <!-- ppurl -->STELARA<!-- /ppurl -->® (ustekinumab)
with <!-- ppurl -->Enbrel<!-- /ppurl -->* (etanercept) in the
treatment of moderate to severe plaque psoriasis showed a
significantly higher clinical response with both doses of
STELARA® than etanercept over a 12-week period. The
first-of-its-kind head-to-head study comparing two biologic agents
for plaque psoriasis also shows the efficacy of STELARA® among
patients in the study who failed to respond to etanercept.
The international study included 18 Canadian sites. Findings
from this study have been published in the January issue of The
New England Journal of Medicine.
Psoriasis is an inflammatory disorder characterized by raised,
inflamed, red lesions, or plaques, which can cause physical
pain. It is estimated that approximately one million Canadian
adults1 and nearly three per cent of the world’s
population are living with psoriasis, which can present in various
forms, ranging from mild to severe and disabling. Nearly
one-quarter of people with psoriasis have cases that are considered
moderate to severe.2 Plaque psoriasis is the most
common form of psoriasis, affecting approximately 80 per cent of
those suffering from this condition.3
“Over the course of the 12 week comparison study, patients
with moderate to severe plaque psoriasis were to receive two
injections of STELARA® or 24 injections of etanercept. A
substantial proportion of patients achieved high levels of skin
clearance with STELARA® at the study’s primary endpoint
at week 12 and following crossover from etanercept. Those
crossing over from etanercept, patients who showed a lack of
response to etanercept during 12 weeks of treatment, generally
responded very well to STELARA,” said Dr. Kim Papp,
dermatologist and study investigator. “Treatment
convenience is an important factor in the management of psoriasis
as it can lead to greater compliance. The high level of
efficacy observed in this study with an infrequent dosing schedule
of STELARA® is encouraging as we have a new, effective, and
convenient treatment of moderate to severe plaque
psoriasis.”
In the comparator study, 68 and 74 per cent of patients receiving
subcutaneous injections of STELARA® (45 mg or 90 mg) at weeks
zero and four achieved at least a 75 per cent reduction in
psoriasis as measured by the Psoriasis Area and Severity Index
(PASI 75) at week 12, the primary endpoint, compared with 57 per
cent of patients receiving subcutaneous injections of 50 mg
etanercept twice per week for 12 weeks (P = 0.01 for
STELARA® 45 mg; P < 0.001 for STELARA® 90 mg,
each compared with etanercept). Onset of clinical response
appeared more rapidly among STELARA®-treated patients, with
higher numbers of patients achieving PASI 75 by week eight compared
with patients receiving etanercept.
Investigators also reported that a greater proportion of patients
receiving STELARA® achieved a marked improvement in psoriasis
as assessed by PASI 90 response, or nearly complete clearance of
psoriasis. At week 12, 36 per cent of patients receiving
STELARA® 45 mg and 45 per cent of patients receiving
STELARA® 90 mg achieved PASI 90 compared with 23 per cent of
patients receiving etanercept (P < 0.001 for each
comparison versus etanercept). Moreover, a greater proportion
of patients in the STELARA® 45 mg and 90 mg treatment groups
achieved a Physician Global Assessment (PGA) score of
“cleared” or “minimal” (65 per cent and 71
per cent, respectively) compared with patients in the etanercept
treatment group (49 per cent) [P < 0.001 for each
comparison versus etanercept].
Patients who had an inadequate response to etanercept, as measured
by PGA score (classified as moderate, marked or severe psoriasis at
week 12) received two injections of STELARA® 90 mg at weeks 16
and 20. At week 28, investigators reported that 49 and 23 per
cent of patients who failed to respond to etanercept and who
crossed over to STELARA® achieved PASI 75 and PASI 90,
respectively.
In addition, patients classified as responders (having a PGA score
of cleared, minimal or mild) at week 12, discontinued therapy until
recurrence of psoriasis (PGA of moderate or greater). In these
patients, the median length of time to disease recurrence was
longer for STELARA® patients (14.4 and 18.1 weeks for 45 and 90
mg, respectively) than etanercept patients (7.3 weeks).
Response was regained in 84 per cent of patients following
retreatment with two STELARA® (45mg or 90 mg) injections.
Through week 12 of the study, the percentages of study participants
experiencing at least one adverse event (AE) were comparable
between the STELARA® 45 mg group (66 percent), the STELARA®
90 mg group (69 percent) and the etanercept 50 mg group (70
percent). Those patients experiencing at least one serious AE
through week 12 were reported as follows: 1.9 percent and 1.2
percent of patients receiving STELARA® 45 mg or 90 mg,
respectively, compared with 1.2 percent of patients receiving
etanercept. Rates of specific AEs were generally
comparable between treatment groups with the exception of injection
site reactions, which were reported in 25 percent of patients
treated with etanercept versus 4.3 percent and 3.7 percent with
STELARA® 45 mg and 90 mg, respectively, though this disparity
may have been influenced by the greater number of etanercept
injections administered (at least 24 in the 12-week portion of the
study) compared with two STELARA® injections.
Through week 64, AEs were generally comparable between patients in
the 45 mg (87 percent) and 90 mg (89 percent) STELARA® groups.
In patients who crossed over from etanercept to ustekinumab,
generally similar proportions experienced AEs (79 percent versus 65
percent) and serious AEs (3.5 percent versus 3.4 percent) before
versus after transitioning to STELARA®.
About the ACCEPT Trial
The Phase 3, Multicenter, Randomized Study Evaluating the Efficacy
and Safety of Ustekinumab Compared to Etanercept in the Treatment
of Subjects with Moderate to Severe Plaque Psoriasis (ACCEPT)
included 903 patients with chronic plaque psoriasis
(etanercept=347, STELARA® 45 mg=209, STELARA® 90
mg=347). Patients were randomized to receive subcutaneously
administered STELARA or etanercept. Patients randomized to
receive STELARA® received 45 mg or 90 mg doses at weeks zero
and four. Patients in the etanercept group received
twice-weekly doses of 50 mg for 12 weeks. The primary
endpoint of the study was the proportion of patients who achieved
PASI 75 at week 12. At week 12, patients in the etanercept group
who were classified as non-responders (i.e., had moderate, marked
or severe psoriasis) received 90 mg of STELARA® at weeks 16 and
20. STELARA® non-responders received one additional dose
of STELARA® at week 16. Treatment was interrupted for all
patients who had cleared, minimal or mild psoriasis at the end of
week 12, and all patients were retreated with 45 or 90 mg
STELARA® when their disease worsened to moderate or
worse.
About Psoriasis
Psoriasis is an immune mediated skin disease in adults and one of
the oldest skin conditions known to man4 The symptoms of
psoriasis usually appear between the ages of 15 and 35 with 75 per
cent of people developing it before the age of
40.5
The severity of psoriasis can have a profound impact on a
patient’s quality of life. Even mild psoriasis can undermine
self esteem and disturb personal relationships. For some
individuals, reduction in physical and mental functioning may be
similar to the distress caused by other chronic diseases such as
cancer, heart disease, diabetes and hypertension.6
Plaque psoriasis is the most common form and affects approximately
80 per cent of those suffering from the
condition.7 It usually results in painful, itchy,
sore patches of thick, red or inflamed skin covered with silvery
scales known as plaques. Plaques can occur anywhere on the
body – most commonly on the elbows, knees, lower back and the
area around the bellybutton. Severity ranges from minor localized
patches to complete body coverage.
About STELARA® (ustekinumab)
STELARA® is a first-in-class, human, monoclonal antibody
approved first in the world by Health Canada in December 2008 for
the treatment of psoriasis. A selective immunomodulating agent,
STELARA® is indicated for the treatment of adult patients with
chronic moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy.8
STELARA® works by targeting and regulating the activity of
cytokines interleukin-12 (IL-12) and interleukin-23
(IL-23).9 These cytokines are naturally occurring
proteins that are important in regulating immune responses, and are
thought to be associated with immune-mediated inflammatory
disorders, including plaque psoriasis.10
<!-- cpurl -->Centocor<!-- /cpurl --> Ortho Biotech Inc. discovered
STELARA® and has exclusive marketing rights to the product in
the United States. <!-- cpurl --> Janssen-Ortho
<!-- /cpurl --> Inc. has exclusive marketing rights in Canada for
the treatment of moderate-to-severe plaque psoriasis.
About Janssen-Ortho Inc.
Janssen-Ortho Inc. is a healthcare company committed to providing
Canadians with innovative treatment options that enhance and
improve life. Headquartered in Toronto, the company offers a broad
range of medications used in psychiatry, dementia, attention
deficit hyperactivity disorder, psoriasis, pain management,
women’s health, infectious disease, anemia, oncology, and
virology.
# # #
For more information, please contact:
Jennifer Runza
MS&L
416-847-1329
jennifer.runza@mslworldwide.com
Maggie Wang
Janssen-Ortho Inc.
416-449-9444
mwang12@its.jnj.com
References
*All trademark rights used under license
*etanercept is a product of Amgen Canada, Inc., and Wyeth
Canada.
1Canadian Skin Patient Alliance web site:
http://www.skinpatientalliance.ca/en/skin-conditions-diseases/psoriasis
2National Psoriasis Foundation, About Psoriasis
Available at http://www.psoriasis.org/about/stats/.
3American Academy of Dermatology web site
http://www.aad.org/media/background/factsheets/fact_psoriasis.html.
4Psoriasis Society of Canada. Available at
http://www.psoriasissociety.org/education.htm
5Skin Care Physicians. What is Psoriasis? Available at:
www.skincarephysicians.com/psoriasisnet/whatis.html
6Canadian Skin Patient Alliance web site. Available at:
http://www.skinpatientalliance.ca/en/skin-conditions-diseases/psoriasis/impacts-quality-life
7National Psoriasis Foundation. About Psoriasis.
Available at
http://www.psoriasis.org/about/psoriasis/plaque.php
8STELARA product monograph – December
12th, 2008.
9STELARA product monograph – December 12th,
2008.
10Kikly K, Liu L, Na S, Sedgwick J. The IL-23TH (17)
axis: therapeutic targets for autoimmune inflammation. Curr
Opin Immunol. 2006;18:670-675
Posted: January 2010
