MARKHAM, ON, Feb. 17 /CNW Telbec/ - Astellas Pharma Canada, Inc. has announced that it has received approval from Health Canada for a
new indication for its topical eczema therapy, Protopic® (tacrolimus ointment 0.03% and 0.1%). The new indication means that
tacrolimus ointment can be prescribed for maintenance therapy to
prevent flares and prolong flare free intervals in patients with
moderate to severe atopic dermatitis (commonly called eczema). These are individuals who experience a high
frequency of flares (≥ 5 times per year). Tacrolimus ointment, a steroid-free topical agent, is a topical calcineurin inhibitor (TCI) also indicated for the
intermittent-treatment of moderate to severe atopic dermatitis in
"We're excited to be able to offer eczema sufferers an effective option
to help prevent the chronic recurrence of eczema flares," said Michael
Tremblay, President of Astellas Pharma Canada, Inc. "Patients can now
enjoy being symptom-free for longer periods, ultimately improving their
overall quality of life, which is always our primary objective at
"This new indication is an important adjunct to our treatment
armamentarium because atopic dermatitis is in so many cases a lifelong
episodic skin disorder, and an important goal of treatment is to
prevent or delay recurrent skin exacerbations," said Dr. Harvey Lui,
MD, FRCPC, Professor and Head, Department of Dermatology and Skin
Science, Vancouver General Hospital, University of British Columbia. "While patients are typically accustomed to using this topical therapy
when they are experiencing an eczema flare, our challenge will be to
educate them and their health care providers on the new use of
tacrolimus ointment on their clear skin for preventing the flare from
Clinical Trial Results
The efficacy and safety of tacrolimus ointment in maintenance of
moderate to severe atopic dermatitis was assessed in 306 patients in
two Phase 3, multi-centre clinical trials of similar design, one in
adult patients (≥ 16 years) and one in pediatric patients (2-15 years).
Patients were randomized to apply either tacrolimus ointment (0.1%
adults; 0.03% children) or vehicle once a day, twice weekly, for
example on Mondays and Thursdays.1
Both studies showed significant benefit with twice weekly treatment with
tacrolimus ointment with regard to primary endpoint over a period of 12
months. The median number of disease exacerbations requiring a
substantial intervention (adjusted for length of time at risk) was 1.0
in the tacrolimus arm versus 5.3 in the vehicle arm (p<0.001) in the
adult study and 1.0 in the tacrolimus arm versus 2.9 in the vehicle arm
(p<0.001) in the pediatric study.
"Treating the chronic and recurring nature of atopic dermatitis has been
a source of frustration for most clinicians and patients," said Dr.
Lui. "This new approach now represents a paradigm shift in how patients
treat their eczema. Instead of reacting to their disease and treating
their flares only when they occur, now patients can take control of
their disease by applying tacrolimus twice weekly on cleared skin to
significantly reduce the number of flares and the time between flares."
About Atopic Dermatitis (Eczema)
Eczema is a relapsing, life-altering disease affecting between four to
six million Canadians nationwide2, and is characterized by painfully red, swollen, itchy, flaky skin. In
some cases the itching and redness is so serious and intense that
sufferers can scratch themselves until they bleed, increasing the risk
of secondary infection. The majority of eczema cases are diagnosed in
early childhood. While 85-90 percent of children suffering from eczema
outgrow the disease, others live with it throughout their entire lives.3 For sufferers, especially children and teenagers, the visibility of
eczema flares can lead to low self-esteem and often the inability to
interact with others.
Eczema develops as a result of a complex relationship of many known and
yet to be determined causes, including heredity, environmental
allergens, and skin irritants such as wools and fragrances. The
disease is often associated with immune system response to
environmental irritants4 and with respiratory allergies and asthma. When an immunologic
response to an allergen or irritant is triggered, white blood cells are
activated and release substances that cause inflammation. The
inflammation causes redness to appear, as well as releasing other
substances that can cause itching. It can be very difficult to resist
scratching during an eczema flare. Scratching can damage the skin,
causing more inflammatory substances to be produced that, in turn,
cause more white blood cells to respond to this reaction. This
increases the redness and itching, which makes it harder to resist
scratching.5 This is known as the itch-scratch-rash cycle. Emotional factors such as
stress can also influence and worsen the condition.
About Tacrolimus Ointment
Tacrolimus ointment, both 0.03% and 0.1% for adults and only 0.03% for
children aged 2 to 15 years, was introduced in Canada by Astellas in
2001as one of a new class of drugs called topical calcineurin
inhibitors or TCIs indicated as a second-line therapy for short and
long-term intermittent-treatment of moderate to severe atopic
dermatitis in non-immunocompromised patients. This topical
prescription therapy should be applied twice a day to treat the skin at
the site of the immune imbalance to help stop the redness and itching
of eczema inflammation. As maintenance therapy, tacrolimus ointment
0.03% and 0.1% should be applied once a day twice a week (e.g. Monday
and Thursday) to all affected areas of the skin, including the face,
neck and eyelids for preventing flares from coming back if the patient
has a high frequency of flares (≥ 5 times per year).
Tacrolimus ointment is contraindicated in patients with a history of
hypersensitivity to tacrolimus or to any other component of the
preparation. Long-term safety of topical calcineurin inhibitors has not
been established. Although a causal relationship has not been
established, rare cases of skin malignancy and lymphoma have been
reported in patients treated with topical calcineurin inhibitors,
including tacrolimus ointment (0.1% and 0.03%). Therefore, continuous
long-term use of a topical calcineurin inhibitors including tacrolimus
ointment (0.1% and 0.03%) should be avoided, and application limited to
areas of involvement with atopic dermatitis. Tacrolimus ointment is
not indicated for children less than 2 years of age. Only 0.03%
tacrolimus ointment is indicated for use in children 2-15 years of age.
The most common side effects that may be experienced by patients who use
tacrolimus ointment include skin burning (burning sensation, stinging,
soreness) or pruritus (an itch or sensation that causes the desire to
scratch); however these are localized and tend to be brief, typically
lasting a few days following the initial application of tacrolimus
ointment and decreasing as the skin heals. Other less common events
associated with tacrolimus ointment included acne, allergic reaction,
flu-like symptoms, fever, abdominal pain, increased cough, rhinitis,
diarrhea and headache. 7
Researchers agree that because the effect of ultraviolet light on skin
treated with tacrolimus ointment is unknown, patients should use safe
sun practices to avoid exposure to natural or artificial sunlight. 8
About Astellas Pharma Canada, Inc.
Astellas Pharma Canada, Inc., a Canadian affiliate of Tokyo-based
Astellas Pharma Inc., is a pharmaceutical company dedicated to
improving the health of people around the world through innovative and
reliable pharmaceutical products. Astellas was formed in 2005 through
the merger of two companies - Fujisawa and Yamanouchi. Astellas Pharma
Canada has an intense focus on five key therapeutic areas - Infectious
Disease, Immunology, Cardiology, Urology and Dermatology - and is
considered a leader in these fields. Additional corporate information
is available at www.astellas.com/ca.
1 Protopic® Product Monograph. July 2010.
2 Eczema Society of Canada. What is Eczema? Date Accessed: December 10, 2010.
3 Eczema Canada. Common Questions and Answers about Childhood Eczema. Date Accessed: December 14, 2010.
4 Eczema Society of Canada. Managing Eczema: A Treatment Guide. Date Accessed: January 24, 2011.
6 Data on file.
7 Protopic® Product Monograph. July 2010.
SOURCE Astellas Pharma Canada, Inc.
For further information:
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