[an error occurred while processing this directive]
PsoriasisNet Article
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:
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.
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.
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.
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.
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.
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:
Each biologic is different. Failure of one biologic does not indicate that others will not be effective.
Long-term safety cannot be assessed from current data. Concerns about developing serious infections and malignancies exist.
Most biologics do not deliver quick resolution but can provide gradual long-term control.
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.
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
Two oral therapies are proving effective in clinical trials for treating
moderate to severe plaque psoriasis:
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.
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.
Reference:
Balkrishnan B., et al., “Electronic monitoring of medication adherence in skin
disease: results of a pilot study.” Journal of the American Academy of
Dermatology. 2003 October;49(4):651-4.

An educational program brought
to you by the American Academy of Dermatology.