Psoriasis (cont.)
What injections or infusions are available?
The newest category of psoriasis drugs are called biologics. All biologics modulate (adjust) and sometime suppress (quiet) the immune system that is overactive in psoriasis. Currently available biologic drugs include alefacept (Amevive), adalimubab
(Humira), infliximab (Remicade), etanercept (Enbrel), and ustekinumab. Newer drugs are in development and may be on the market in the near future. As this class of drugs
is fairly new, ongoing monitoring and adverse effect reporting continues and long-term safety continues to be monitored. Although previously available, efalizumab (Raptiva) was removed from the U.S. market in early 2009 due to reported safety concerns for the development of a serious brain infection, progressive multifocal leukoencephalopathy (PML). Individuals still taking Raptiva should contact their health-care professional to discuss risks and benefits of treatment with this drug.
Some biologics are self-injections for home use, while others are intramuscular injections or intravenous infusions in the physician's office.
Biologics have some screening requirements such as a tuberculosis screening
test (TB skin test or PPD test) and other labs prior to starting therapy.
As with any drug, side effects are possible with all biologic drugs. Common
potential side effects include mild local injection-site reactions (redness and
tenderness). There is concern of serious infections and potential malignancy
with nearly all biologic drugs.
Precautions include patients with known or suspected hepatitis B or C
infection, active tuberculosis, and possibly HIV/AIDS. As a general
consideration, these drugs may not be an ideal choice for patients with a
history of cancer and patients actively undergoing cancer therapy.
In particular, there may be an increased association of lymphoma in patients
taking biologics. It is not at all certain if this association is directly
caused by these drugs. In part, this is because it is known that certain
diseases like rheumatoid arthritis or psoriasis may be associated with an
inherent increase in the overall risk of some infections and malignancies.
Biologics are expensive medications ranging in price from several to tens of
thousands of dollars per year per person. Their use may be limited by
availability, cost, and insurance approval. Not all insurance drug plans may
fully cover these drugs for all conditions. Patients need to check with their
insurance and may require a prior authorization request for coverage approval.
Some of the biologics manufacturers have patient-assistance programs to help
with financial issues.
The choice of the right medication for your condition depends on
many medical factors. Additionally, convenience of receiving the medication and
lifestyle may be factors in choosing the right biologic medication.
Currently, the four main classes of biologic drugs for psoriasis are:
1. TNF-alpha blockers (tumor necrosis factor),
2. drugs that block T-cell activation and the movement of T-cells,
3. drugs that decrease the number of activated T-cells, and
4. drugs that interfere with interleukin chemical messengers of inflammation.
TNF blockers
TNF blockers include Enbrel (etanercept), Remicade (infliximab) and Humira
(adalimumab). TNF-alpha blocking drugs may have an advantage of treating
psoriatic arthritis and psoriasis skin disease. Their disadvantage is that some
patients may notice a decrease in the effectiveness of TNF-alpha blocking drugs over
months to years.
TNF blockers are generally not used in patients with demyelinating
(neurological) diseases like multiple sclerosis, congestive heart failure, or
patients with severe overall low blood counts called pancytopenia.
The major side effect of these class of drugs is suppression of the immune
system. Because of the increased risk of infections while on these drugs,
patients should promptly report fevers or signs of infection to their
physicians. Minor side effects have included autoimmune conditions like lupus
or flares in lupus. Additionally, it is best to avoid any live vaccines while
using TNF blockers.
- Enbrel (etanercept) is a self-injectable medication for home use. It is
injected via a small needle just under the skin, called subcutaneous injection.
It is usually dosed once or twice week by patients at home after training with
their physician or the nursing staff. Sometimes a higher loading dose is used
for the first 12 weeks and then it is "stepped down" to half the dose after the
first 12 weeks. Enbrel has the advantage of at least 16 years of clinical use
and long-term experience.
-
Remicade (infliximab) is an intravenous (IV) medication strictly for
physician office or special infusion medical center use. It is dosed
specifically based on your weight. It is currently not for home use or self-injection. It is injected slowly over time via a small needle into a vein. It
may usually be dosed once a week. There have been reports of antibodies to this
drug in patients taking it for some time. These antibodies may cause a greater
drug-dose requirement for achieving disease improvement or failure to improve.
The IV route may be more time-consuming, requiring physician during the
infusions. Remicade has the advantage of fast disease response and good potency.
-
Humira (adalimumab) is a self-injectable medication for home use. It is
injected via a small needle just under the skin as a subcutaneous dose. It is
usually dosed once every other week, totaling 26 injections in one year. Dosing
is individualized and should be discussed with your physician. Sometimes a
higher loading dose is used for the first dose (80 mg) and then it is continued
at 40 mg every other week. It may give results as soon as one to two weeks of therapy. Humira has the advantage of at least 11 years of clinical use and long-term
experience.
Drugs that block T-cell activation and the movement of T-cells
- Raptiva (efalizumab) blocks both T-cell activation and the movement of
T-cells into the skin. As noted above, Raptiva was withdrawn by the manufacturer from the U.S. market in April 2009 following a black-box warning issued in late 2008 by the U.S. Food and Drug Administration. (FDA). Raptiva may continue to be available in other countries.
It is dosed specifically based on your weight. Labs are
required before starting injections and weekly for the 12 weeks of therapy.
Injections are placed just under the skin (subcutaneous) and may be given in
the physician's office or at home.
Raptiva seems to work well over several years without losing its
effectiveness, therefore having the advantage of "staying power." Raptiva may
cause flares of arthritis in some patients. Raptiva may also cause a decrease or drop in the platelet (blood-clotting element) count. Platelet counts are usually checked before starting and periodically (often quarterly) while patients continue Raptiva.
As with other biologics, live vaccines are not advised while patients are taking Raptiva. It is usually best to have any required vaccines weeks before starting therapy.
As with all biologics, Raptiva has been associated with possible infections and malignancy (cancer). The relative risk of these two side effects is fairly low. The most serious reported side effect in patient taking Raptiva was the onset of progressive multifocal leukoencephalopathy (PML) in several patients. PML is a rare, potentially fatal, severe neurologic disorder which is thought to be caused by a particular viral infection of brain. PML usually occurs in individuals whose immune system is weakened or suppressed and leads to permanent loss of brain function. Symptoms of PML include unusual weakness, visual changes, loss of coordination, difficulty speaking, and personality changes.
Drugs that decrease the number of activated T-cells
- Amevive (alefacept) decreases the number of available activated T-cells
that play a role in causing psoriasis. It is given intramuscularly (injected in
the muscle) usually in the physician's office and given once a week for 12
weeks. Many patients may see improvement in their symptoms that lasts
approximately 12 months (more or less). Amevive may not be uniformly effective
for all patients, and some patients improve more than others. The average time to maximum improvement for many patients is about 14 weeks.
Amevive should generally not be used in patients with HIV infections as the
drug causes a decrease in the CD4 cells (part of the immune system that HIV also
attacks).
Also, because of the immune-system suppression, Amevive may not be a good
choice in patients with active cancer or infection. As Amevive is one of the two currently available drugs that inhibits T cells directly, there may be a potential concern for immunosuppression and increased susceptibility to infections including PML. The risks and benefits of treatment with biologics need to be assessed for each individual.
Drugs that interfere with interleukin mechanisms
- Ustekinumab is the newest biologic injectable medication used to modulate
the immune system. It is an interleukin-12/23 human monoclonal antibody.
Ustekinumab targets chemical messengers in the immune system involved in skin
inflammation and skin-cell production. This drug is planned to be dosed
subcutaneously (just under the skin) once a quarter (every three months). It has
been very promising with very good clearance rates in the clinical trials thus
far. A major advantage may be the convenience of a quarterly medication. The
concerns for infection and malignancy may be similar to the other biologics.
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