New Data Reinforce Safety Profile Of ENBREL ... - Dfwpsoriasis.org

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New Data Reinforce Safety Profile Of ENBREL (Etanercept)

07 Oct 2006



There was good news for psoriasis patients this week, as the latest study confirming the established
safety profile of ENBREL® (etanercept) for up to 2.5 years,was presented at the 15
th European Academy
of Dermatology and Venereology (EADV) Congress. ENBREL is a biologic, meaning a biotechnologically
produced medicine, which acts on one of the root causes of psoriasis by targeting one of the key
mediators of the inflammatory process. I
t is the number one biologic prescribed worldwide and is now
approved in 25 mg and 50 mg prefilled syringes offering flexibility to tailor treatment according to patient
needs.


According to Bruce Strober MD PhD, codirector of the Psoriasis and Psoriatic
Arthritis Center at New
York University, "These results are important because they confirm the safety profile of ENBREL, which is
key information in the context of wider discussion about the long
-
term use of biologics."


The 48
-
week open label (OL) extens
ion study (n=921) enrolled patients from two blinded, randomized,
placebo
-
controlled "parent" studies (PS). The OL study confirmed that the overall safety profile of
ENBREL did not change with extended dosing for up to 2.5 years.(1,2) No cases of demyelina
ting
diseases, tuberculosis, opportunistic infections or lymphoma were reported in the study.(1,2) These
findings reinforce the conclusions of an earlier 96
-
week study of ENBREL 50 mg twice weekly in which
the rate of adverse events was similar to that of
placebo, and no new safety signals were identified.


In one of the parent studies, at 24 weeks patients were discontinued from treatment and treatment was
re
-
initiated when at least half of the improvement achieved through week 24 was lost. With re
-
treatm
ent,
PASI 75 rates were similar to those attained during the initial treatment course, resulting in repeated
success after re
-
treatment., There was no treatment interruption in the other parent study.


In Europe, the recommended dose of ENBREL for plaque
psoriasis is 25 mg administered twice weekly.
Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose
of 25 mg twice weekly. Treatment with ENBREL should continue until remission is achieved, for up to 24
we
eks. Treatment should be discontinued in patients who show no response after 12 weeks. If re
-
treatment with ENBREL is indicated, the dose should be 25 mg twice weekly for up to 24 weeks.


"These data reveal an important, practical characteristic of ENBREL

in showing that patients on
interrupted treatment, after reinitiating therapy, regained similar positive efficacy results as the patients
with uninterrupted treatment", said Dr Wolfram Sterry, professor and chairman, department of
dermatology, University
Hospital Charite, Humboldt University, Germany. "In real life, treatment of
psoriasis patients is often suspended for a variety of reasons and then restarted."


The new ENBREL prefilled syringes offer patients an easy to use treatment option because it do
es not
require reconstitution as all doses are premixed and prefilled.(5) ENBREL is the only biologic with two
ready to use dosing options.(5) The prefilled formulation is bioequivalent to ENBREL powder
-
for
-
mixing.


In the European Union, ENBREL is approv
ed for the treatment of adults with moderate to severe plaque
psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic
therapy including cyclosporine, methotrexate or PUVA (Psoralen [a light
-
sensitizing med
ication] combined
with exposure to ultraviolet light A [UVA]).(3) ENBREL is also approved for the treatment of active and
progressive psoriatic arthritis in adults when the response to previous disease
-
modifying antirheumatic
drug therapy has been inadequa
te.(3)


Also in the European Union, ENBREL in combination with methotrexate is indicated for the treatment of
moderate to severe active rheumatoid arthritis in adults when the response to disease
-
modifying
antirheumatic drugs, including methotrextate (unl
ess contraindicated), has been inadequate. ENBREL
can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with
methotrexate is inappropriate. ENBREL is also indicated in the treatment of severe, active and
progressive

rheumatoid arthritis in adults not previously treated with methotrexate. ENBREL, alone or in
combination with methotrexate, has been shown to reduce the rate of progression of joint damage as
measured by X
-
ray and to improve physical function.(3) ENBREL i
s also approved for the treatment of
active polyarticular juvenile idiopathic arthritis in children and adolescents aged 4 to 17 years who have
had an inadequate response to, or who have proved intolerant of, methotrexate.(3) ENBREL has not
been studied in

children aged less than 4 years. ENBREL is also approved for the treatment of adults with
severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.(3)


European physicians have become familiar with the benefits and

long
-
term tolerability profile of ENBREL
since it was approved six years ago. Worldwide, 441,000 patients have been treated with ENBREL. It
acts by binding tumor necrosis factor (TNF),(3) one of the dominant inflammatory cytokines or regulatory
proteins t
hat plays an important role in both normal immune function and the cascade of reactions that
causes the inflammatory processes of psoriasis, psoriatic arthritis and RA.(3) The binding of ENBREL to
TNF inhibits the activity of the bound TNF.(3)


Since the
product was first introduced, serious infections, some involving death, have been reported in
patients using ENBREL.(3) Patients should tell their doctors if they currently have an infection or are
prone to getting infections. Patients should not start ENB
REL if they have an infection(3) of any type or an
allergy to ENBREL or its components. ENBREL should be used with caution in patients prone to
infection.(3)


There have been reports of serious nervous
-
system disorders such as multiple sclerosis and/or
in
flammation of the nerves of the eyes.(3) Patients should inform their doctor if they have ever had any of
these disorders or if they develop them after starting ENBREL. Patients should also tell their doctor if they
have ever been treated for heart failure
.(3) There also have been rare reports of serious blood disorders,
some involving death.(3)


Patients should contact their doctor immediately if they develop symptoms such as persistent fever,
bruising, bleeding, or paleness.(3) If a patient's doctor conf
irms serious blood problems, patients may
need to stop using ENBREL.(3)


The most common adverse events observed during the double blind, placebo
-
controlled portions of three
clinical trials in patients with psoriasis were infections and injection
-
site re
actions.(3) Among patients with
plaque psoriasis treated in placebo
-
controlled trials, the frequency of serious adverse events was about
1% of 933 patients treated with Enbrel compared with 1% of 414 placebo
-
treated patients.(3)


Twenty
-
three (23) maligna
ncies were reported in patients with plaque psoriasis treated with ENBREL in
double blind and open
-

label studies of up to 15 months involving 1,261 patients treated with ENBREL.(3)


Psoriasis affects 5.1 million people in Europe. The most common form of
psoriasis is plaque psoriasis
(psoriasis vulgaris), which occurs in approximately 80% of all patients with psoriasis. In plaque psoriasis,
it is likely that a response in the immune system causes the skin cells to grow quickly, resulting in plaques
or lesi
ons. These lesions are reddish and thick with silvery white scales that are loose and easily removed
by scratching.(16,17)


The most common symptom associated with psoriasis is dry, flaky scaling of the skin, which is
experienced by nearly 95% of patients
. Itching and skin redness are the other two most prominent
symptoms.(18)


###


Wyeth Pharmaceuticals markets ENBREL outside North America. ENBREL was discovered by Immunex,
now part of Amgen (NASDAQ: AMGN), and jointly developed with Wyeth Pharmaceutica
ls. The two
companies co
-
promote ENBREL in North America.


Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care,
cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, onc
ology,
vaccines and nutritional products. Wyeth is one of the world's largest research
-
driven pharmaceutical and
health care products companies. It is a leader in the discovery, development, manufacturing, and
marketing of pharmaceuticals, vaccines, biotec
hnology products and nonprescription medicines that
improve the quality of life for people worldwide. The Company's major divisions include Wyeth
Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.


1. Elewski B, Strober B, Tyring S,

et al. Etanercept 50 mg once weekly sustains safety and efficacy for 96
weeks in plaque psoriasis patients. 15th Congress, European Academy of Dermatology and Venereology,
4
-
8 October 2006. Poster 950757


2. Data on file, Wyeth Pharmaceuticals, Inc.; Cli
nical Study Report 20030115. Final report: an open
-
label,
long
-
term extension study to assess the safety of etanercept in the treatment of psoriasis in adult
subjects. 28 November 2005


3. Enbrel Summary of Product Characteristics/Patient Information Leaf
let, Wyeth Pharmaceuticals


4. Data on file, Wyeth Pharmaceuticals, Inc.; IMS Health, MIDAS via Dataview Analyzer, 4Q05, based on
audited sales


5. Draft SmPC for PFS


6. Data on file, Amgen. Clinical Study Report 20030117. A phase 3 multicenter study t
o assess the
efficacy and safety of etanercept 50 mg twice weekly in psoriasis. 24 February 2006


7. Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N
Engl J Med. 2003;349:2012
-
2020


8. Gottlieb AB, Gordo
n KB, Weng AT, et al. Etanercept can safely be withdrawn from patients with
psoriasis and re
-
establishes disease control on retreatment. Poster presented at the 10th International
Psoriasis Symposium; June 10
-
13, 2004; Abstracts: 110
-
111; Toronto, Canada


9. Humira Summary of Product Characteristics, Abbott Laboratories


10. Raptiva Summary of Product Characteristics, Genentec Inc/Serono


11. Remicade Summary of Product Characteristics, Centocor Pharmaceuticals


12. Data on file, Wyeth Pharmaceuticals I
nc.; Clinical Study Report 56504. A comparative
pharmacokinetic study to compare subcutaneous (SC) administration of two 25
-
mg reconstituted
etanercept injections to a single SC 50
-
mg liquid etanercept injection in healthy volunteers: final report. 12
May
2004


13. Wyeth Pharmaceuticals, Inc. ENBREL (etanercept) Core Claims Directive, Psoriasis: 2004. 2006
Version3


14. Christophers E. Psoriasis
-
epidemiology and clinical spectrum. Clin Exper Derm. 2001;26;314
-
320


15. Lebwohl M. Psoriasis. Lancet. 2003;3
61:1197
-
1204


16. Fitzpatrick TB, Johnson RA, Wolff K, et al. Psoriasis and ichthyosiform dermatoses. In: Color Atlas
and Synopsis of Clinical Dermatology: Common and Serious Diseases. 4th ed. New York, NY: McGraw
-
Hill;2001;50
-
83


17. Peters BP, Weissman

FG, Gill MA. Pathophysiology and treatment of psoriasis. AM J Health
-
Syst
Pharm. 2000;57:645
-
659


18. Krueger G, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: results of a 1998
National Psoriasis Foundation patient
-
membership surve
y. Arch Dermatol. 2001;137:280
-
284


For further information please visit:

http://www.wyeth.com/


Article URL:
http://www.medicalnewstoday.com/medicalnews.php?newsid=53536