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Psoriasis Update
Thinking About Other Ways to Treat Your Psoriasis?
Here’s what the latest research shows
Information about psoriasis treatments seems to be
everywhere these days - from magazine articles and chat rooms to
billboards and TV ads. Keeping up on the latest findings can be a
challenge. To help you reap the benefits of staying current - making
informed decisions about your treatment options and getting tips that
may make a therapy more effective for you - key findings from recent
clinical trials and case reports are summarized below. Much of this
focuses on the biologics,
a new class of medications being used to treat moderate to severe
psoriasis. Recent research also has investigated new oral therapies and
expanded existing knowledge of treatments applied to the skin.
What We’re Learning About the Biologics
In less than two years, three biologics - alefacept, efalizumab, and
etanercept - were approved by the U.S. Food and Drug Administration
(FDA) for the treatment of adults who have moderate to severe plaque
psoriasis and are candidates for phototherapy or systemic treatment.
Etanercept also has been approved for treating psoriatic arthritis.
Clinical trials continue to investigate the use of these medications in
treating psoriasis and psoriatic arthritis. Several other biologics also
are being studied in clinical trials. Two of these, adalimumab and
infliximab, may soon join the list of FDA-approved treatments for
psoriasis.
Research efforts are focusing on the biologics because of the potential
these medications may have to provide safe and effective long-term
treatment. Data shows that the biologics being used to treat psoriasis
may have a better safety profile than either cyclosporine or
methotrexate - two systemic medications approved for the treatment of
moderate to severe psoriasis. None of the biologics has shown the
potential to cause the serious kidney or liver problems that limit
long-term use of cyclosporine and methotrexate. Here are recent key
findings:
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Alefacept: More may be better for
chronic plaque psoriasis. Clinical trials continue to study dosing
- what is the optimal amount and for how long the medication should be
given. Small studies indicate that the effectiveness of alefacept in
clearing chronic plaque psoriasis increases when therapy is given once
a week for 16 weeks instead of the standard 12 weeks. Patients treated
for 16 weeks showed continued improvement, and side effects were
similar to those observed in patients taking alefacept for 12 weeks.
Side effects tend to be mild and include infections, injection-site
reactions, itching, and flu-like symptoms, such as fatigue, chills,
nausea, and muscle aches. Given these findings, some researchers favor
giving alefacept for 16 weeks to increase effectiveness; however, more
long-term data is needed to determine if this is the optimal dosage.
Another study indicates that repeated courses of alefacept are proving
safe and effective. With each additional course, the proportion of
patients responding rose, and multiple courses of alefacept did not
increase the risk of severe side effects, such as serious infection or
malignancies.
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Two cases of palmoplantar psoriasis
effectively treated with alefacept. Two patients were living with
the chronic discomfort and physical disability caused by severe
palmoplantar psoriasis because nothing they tried worked. Topical
corticosteroids, systemic corticosteroids, phototherapy, methotrexate,
cyclosporine, and other therapies all failed to alleviate the signs
and symptoms. By the time alefacept was started, the condition was
significantly affecting their ability to perform daily tasks, such as
handling paper and walking, and interfering with their work. Each
patient received 12 doses of alefacept and experienced significant
improvement. One patient said the quality of her life had greatly
improved, and she is “very happy with the results.” After eight doses,
the second patient was able to sew again. After 10 doses, she was able
to walk without pain.
Note: The results were observed in only two patients,
and these patients were not part of a clinical trial.
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Safe to begin alefacept while
gradually tapering off other therapies. Preliminary data from
ongoing clinical studies indicates that it is safe and effective to
begin alefacept while gradually tapering off another treatment for
psoriasis. Studies have looked at the safety and efficacy of alefacept
when patients are using mid- to high-potency topicals, methotrexate,
cyclosporine, phototherapy, or systemic retinoids. The data suggests
that it is safe to begin alefacept while tapering off any of these
therapies.
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Efalizumab proving safe for
continuous long-term therapy. Studies continue to look at the
safety, effectiveness, and tolerability of the biologic efalizumab,
which is meant to provide continuous long-term therapy for patients
with moderate to severe plaque psoriasis. Researchers recently
investigated the safety and patients’ ability to tolerate the
medication when treated for up to 60 continuous weeks. Results showed
that efalizumab was well tolerated in patients with moderate to severe
plaque psoriasis. New side effects were not reported, and the most
common side effects were minor flu-like symptoms, such as headache,
chills, fever, and nausea. There was no evidence of the medicine being
toxic to the organs. An ongoing clinical trial reports that patients
who had received 30 months of continuous therapy had no overall
increase in side effects and new side effects did not occur.
Additionally, there was no evidence of damage to organs caused by
continuous use. Results from these studies suggest that efalizumab can
be used as continuous therapy for long-term control in patients with
severe or chronic plaque psoriasis.
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Etanercept can be safely withdrawn
and remains effective with intermittent use. Etanercept has been
used for years to treat rheumatoid arthritis and has an excellent
safety profile when taken by these patients for extended periods of
time. Cumulative toxic effects have not been observed with long-term
use. Researchers want to know if the same holds true for patients with
severe plaque psoriasis and psoriatic arthritis — two conditions for
which etanercept was recently approved. Like efalizumab, etanercept is
prescribed for continuous long-term treatment. Recent clinical trials
have looked at what happens when etanercept is used to treat plaque
psoriasis and the medication is discontinued or used intermittently.
Results show that when etanercept is discontinued the psoriasis
gradually relapses in approximately three months. Withdrawal is well
tolerated and does not cause a severe flare. Beginning treatment again
does not diminish the effectiveness nor increase side effects.
Researchers conclude that while etanercept has been used continuously
to treat rheumatic conditions, data suggests that rotating or
intermittently using etanercept to treat plaque psoriasis can be safe
and effective.
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Etanercept responses similar among
patients with varying treatment histories. Researchers recently
studied how patients who have received other psoriasis therapies, such
as methotrexate, cyclosporine, acitretin, psoralen with ultraviolet-A
radiation (PUVA), and ultraviolet B radiation (UVB), respond to
etanercept. Before being treated with etanercept all patients
underwent a washout of systemic medications, stopped phototherapy
treatments for at least 4 weeks, and agreed not to use topical
medications for at least 2 weeks. Researchers classified these
patients’ overall response to etanercept as “excellent.” Patients who
had more severe psoriasis at the time the study began responded
equally as well as patients with less severe psoriasis. At week 24,
improvements ranged from 58% to 65%, and there was no significant
difference among patients who had been treated with other psoriasis
therapies.
If You are Considering a Biologic
Anyone considering treatment with a biologic should know:
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Each biologic is different. Failure of
one biologic does not indicate that others will not be effective.
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Long-term safety cannot be assessed
from current data. Concerns about developing serious infections and
malignancies exist.
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Most biologics do not deliver quick
resolution but can provide gradual long-term control.
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Biologics work by suppressing the
immune system, so these medications are usually not suitable for
patients with chronic infections, a history of malignancies, or
certain conditions, such as multiple sclerosis.
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Data suggests that the biologics may
activate some chronic conditions that are in remission, such as
tuberculosis (TB). The FDA recommends that patients be screened for TB
before beginning treatment with infliximab or adalimumab. A patient
also may be screened for TB before another biologic is prescribed if
the patient has an increased risk of developing TB.
New Oral Therapies for Plaque
Psoriasis
Three oral therapies are proving effective in clinical trials for
treating moderate to severe plaque psoriasis:
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Fumaric acid ester therapy is
one of the most commonly prescribed oral treatments for psoriasis in
Germany. Introduced almost 30 years ago, it has been used to treat
patients with severe plaque psoriasis. Common side effects are
flushing and gastrointestinal problems, such as diarrhea, abdominal
pain, and nausea. More serious side effects, such as kidney disorders,
decreased white blood cell count, and osteoporosis have been reported.
Gastrointestinal problems tend to resolve over time; however, in a
recent study, 31 of the 83 patients discontinued treatment because of
these common side effects. A new formulation appears to offer improved
tolerance, making gastrointestinal problems rare.
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Oral pimecrolimus, a medication
that modifies the patient’s immune response, has shown dramatic
results in clinical trials. Patients have responded with favorable
Psoriasis Area and Severity Index (PASI) scores. PASI scores are
measurements used in clinical trials to assess clearing. The higher
the PASI score, the more clearing seen. In a 28-day study, more than
60% of patients with moderate to severe plaque psoriasis achieved a
PASI 50, 50% achieved a PASI 75, and 40% achieved a PASI 90. These
results support the need for further studies to evaluate the safety
and effectiveness of oral pimecrolimus in treating moderate to severe
plaque psoriasis.
“Use as Directed” Key to Effectiveness
of Topical Medications
If your dermatologist has ever prescribed a topical medication, you’ve
probably heard, “Be sure to apply this as prescribed.” In real life this
straightforward instruction can be difficult to follow. Applying the
medication as prescribed can be time-consuming, messy, inconvenient, and
sometimes it just slips your mind.
However, dermatologists continue to stress the importance of using
medication exactly as prescribed because research shows that a majority
of treatment failures are caused by patients not using the medication as
prescribed. Many studies have been conducted to find out just how often
patients apply prescribed medication. Most of these studies have weighed
ointment tubes and asked patients to record their usage at home. While
compliance problems were found, researchers believed more accurate
measurement was needed to assess how patients really used topical
medications.
A more recent study monitored patients’ usage by fitting a bottle cap
with a microprocessor that could record the date and time of each
opening. Ten patients with psoriasis who were already enrolled in
another study and using topical medication were instructed to apply a
psoriasis medication twice a day and keep a log of their use. The
researchers found that not one patient actually achieved 100% compliance
over the one-week period and the electronic cap indicated a greater
number of missed doses than did the patients’ logs. While larger studies
are needed, the study does reinforce the point that patients do not use
medication as prescribed. It is estimated that 30% to 40% of medications
taken for chronic conditions are not taken as prescribed and the cost of
non-compliance in the United States alone exceeds $100 billion annually.
If you are using a topical medication, you may want to make a resolution
to use it as prescribed in order to gain maximum benefit. If using the
medication as prescribed is a problem, be sure to let your dermatologist
know. Without compliance, there is a significant chance that the
treatment will not work.
Talk with a Dermatologist
Should you consider any of the therapies described above, be sure to
discuss this with a dermatologist. As new therapies for skin conditions
emerge, dermatologists are typically the first to learn about these.
Dermatologists’ in-depth knowledge of the skin, various treatment
options for psoriasis, and the outcome of these treatments make them
uniquely qualified to treat psoriasis.
Information contained in this article was presented during
lectures and in posters displayed at the American Academy of
Dermatology’s summer scientific meeting, ACADEMY ’04.
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