npf systemicsbooklet 2014 (psoriasis)

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    N AT I O N A L P S O R I A S I S F O U ND AT I ON

    SYSTEMIC

    MEDICATIONSfor psoriasis and psoriatic arthritiincluding biologics and new oral trea

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    Psoriasis is a noncontagious, genetic disease ofthe immune system that affects the skin and/or joints. Psoriasis in the United States affects

    approximately 7.5 million Americans. Themost common form, plaque psoriasis, resultsin raised, red lesions covered by silvery whitescales. Psoriasis can be limited to a few lesionsor can involve much larger areas of skin.

    Psoriasis is considered moderate when it affects3 to 10 percent of the body. Less than 3 percentis considered mild. Psoriasis is consideredsevere when it covers more than10 percent. For most people,

    the surface area of one hand,including palm, fingers andthumb, equals about 1 percentof the skin surface. However,the severity of psoriasiscan be measured by how the

    disease affects a persons qualityof life. Psoriasis can have a seriousimpact even if it involves a small area, such asthe palms of the hands or soles of the feet.

    WHAT IS PSORIATIC ARTHRITIS?Psoriatic arthritis is a chronic inflammatorydisease of the joints and connective tissue. Upto 30 percent of people with psoriasis developpsoriatic arthritis. It is frequently diagnosedabout 10 years after the onset of psoriasis,particularly in its milder forms. Psoriaticarthritis causes pain, stiffness and swelling inand around the joints. Prompt diagnosis andtreatment can relieve pain and inf lammation,and may also possibly help prevent progressivejoint damage and loss of function. Without

    treatment, psoriatic arthritis can be disabling.Cover photo istockphoto.com/AVAVA

    Introduction to psoriasis

    and psoriatic arthritisWHAT IS PSORIASIS?

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    systemic medications

    SYSTEMIC MEDICATIONSare prescription drugs that affectthe entire body. Most people whouse them have moderate to severepsoriasis and/or psoriatic arthritis.Systemic medications are also usedby people who are not responsive to orare unable to take topical medicationsor ultraviolet (UV) light treatment.These drugs are taken by mouth inliquid or pill form or given by injection.This booklet covers several kindsof systemic medications: traditional

    systemics, which are created bycombining chemicals and have beenused for many years, and biologics, anewer class of drugs that are madefrom human or animal proteins,and new oral treatments, which are

    targeted (small molecule medications).

    1

    TRA DITIONAL SY STEMICS

    CyclosporineWhat is it and how does it work?Cyclosporine is an immunosuppressive drugthat was first used to help prevent organrejection in organ transplant patients. In1997, the U.S. Food and Drug Administration(FDA) approved Neoral (one brand name forcyclosporine) for treatment of psoriasis. Itis used for adults with severe psoriasis andotherwise normal immune systems.

    Cyclosporine suppresses the immune system

    and stops the activity of certain immune cells, which slows the growth of skin cells.

    SYSTEMIC

    MEDICATIONS

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    2 National Psoriasis Foundation

    How is it used?Cyclosporine is taken daily by mouth and isavailable as a capsule or a liquid. The liquidform must be diluted for use, preferably mixed

    with room temperature orange or apple juice

    (not grapefruit juice; see page 5 for more ondrug interactions). It should be taken on aconsistent daily schedule.

    Cyclosporine can provide rapid relief fromsymptoms. People may see some improvementin symptoms after two weeks of treatment,particularly with larger doses. However, it maytake three to four months to reach a completelevel of control.

    Extended use of cyclosporine by transplantpatients is well-established. There is lesscertainty about its long-term use for treatmentof psoriasis. The FDA recommends the drugnot be used for longer than one year becauseof potential damage to kidneys. However, there

    are no specific guidelines for how long peopleshould stay off cyclosporine if they stop andthen resume treatment. Some doctors mayprescribe the drug for more than one year,

    while others try to limit lifetime use of thedrug to one year.

    Who should not take cyclosporine?

    People whose immune systems arecompromised (for example, anyone withlymphoma or HIV infection, or anyonereceiving other immune-suppressing drugs)

    Patients with active, serious infections

    Women who are breastfeeding

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    3systemic medications

    What are the risks?People previously treated with PUVA

    (ultraviolet light A plus the light-sensitizingdrug psoralen), methotrexate or otherimmunosuppressive agents, ultravioletlight B (UVB), coal tar or radiation therapyhave an increased risk of developing skincancer when taking cyclosporine. Renal

    dysfunction, including kidney damage, isanother potential risk and increases withlength of time and amount of cyclosporinetaken. This risk is further increased in people

    with existing kidney damage. Your health careprovider will monitor your kidney function

    with blood tests before and during treatment with cyclosporine. It is possible to develophypertension while on this medication, so bloodpressure must be closely monitored.

    People taking cyclosporine are also atincreased risk of developing lymphomas andother cancers not related to the skin.

    Vaccinations may be less effective while takingcyclosporine. Talk to your doctor if you plan to

    get any kind of vaccination.

    In general, women are advised not to become

    People with abnormal kidney function

    People with uncontrollable high bloodpressure

    People with cancer or a history of cancer(other than basal or squamous cell skincancers)

    People who are undergoing radiationtreatment

    People with severe gout

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    4 National Psoriasis Foundation

    pregnant while taking cyclosporine. Yourhealth care provider may recommend that youstop treatment if you do become pregnant whiletaking it.

    What are the possible side effects?

    Decreased kidney function

    High blood pressure

    High cholesterol and especially hightriglycerides (blood fats)

    Excessive hair growth

    Tingling or burning sensations in the armsor legs

    Skin sensitivity

    Increased growth of gum tissue, with

    swelling

    Flu-like symptoms

    Upset stomach

    Tiredness

    Muscle, bone or joint pain

    Neurologic symptoms including headache,tremor, etc.

    Generally, these side effects go away with a

    lower dose or if the drug is stopped.

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    What are the potential drug interactions? Your health care provider should always beaware of any medications, treatments or dietarysupplements you are using. Many medicationsinteract with cyclosporine, including certain

    antibiotics, anti-inflammatories, antifungals,gastrointestinal agents, calcium channelblockers and anticonvulsants.

    Over-the-counter (OTC) medications such asaspirin and ibuprofen can also interact withcyclosporine. These interactions can affect themetabolism of the drug, causing you to haveeither too much or too little of the drug in

    your bloodstream.

    Avoid drinking grapefruit juice or eatinggrapefruit while taking cyclosporine becauseit can increase the level of the drug in yourbloodstream. Eating a potassium-rich diet whileon cyclosporine can raise your potassium toomuch. Talk with your health care provider about

    the amount of potassium-rich foods such asbananas, tomatoes, raisins and carrots that isadvisable for you while taking cyclosporine.

    St. Johns wort, a popular dietary supplementused for treating depression, can reduce the

    blood level of cyclosporine in transplant patients.It is not clear if the dose of cyclosporine used intreating psoriasis would be affected by takingSt. Johns wort. Talk with your health careprovider if you are taking St. Johns wort.

    Can cyclosporine be used along withother treatments?

    You can use cyclosporine along with the topical vitamin D drugs, Dovonex and Vectical (genericnames calcipotriene and calcitriol), as well

    as topical corticosteroids. All of these topicaltreatments are safe and effective for severechronic plaque psoriasis. Once using a topical

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    along with cyclosporine leads to improvement, you may need a lower dose of cyclosporine. Thislessens the risk of side effects.

    Your health care provider may recommendalternating cyclosporine with other forms of

    treatment to manage psoriasis better. This iscalled rotational therapy.

    Normally doctors do not prescribe cyclosporinefor people using PUVA, UVB therapy,methotrexate or other immunosuppressiveagents. Cyclosporine can increase the skinssensitivity to the sun, so protect your skin whilein the sun. Methotrexate

    What is it and how does it work?Methotrexate is in a class of medicationsknown as antimetabolites. It was initially usedto treat cancer. Methotrexate was found to beeffective in clearing psoriasis in the 1950s and

    was approved for this use by the FDA in the

    1970s. It is usually sold as a generic. The dosesadministered for cancer are considerablyhigher than those given for psoriasis andpsoriatic arthritis.

    Methotrexate is prescribed for adults with

    severe psoriasis or adults with psoriaticarthritis.

    Methotrexate acts by suppressing the immunesystem and thereby stopping the inflammatoryresponse that can lead to psoriasis andpsoriatic flares. Controlled studies havenot unequivocally proven the efficacy ofmethotrexate to treat psoriatic arthritis.

    How is it used?

    Methotrexate is taken once a week, either bymouth or by injection. It is usually taken orally,

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    either in pill or liquid form. The liquid form maybe mixed with fruit juice. It can be taken in asingle dose or in three doses taken at 12-hourintervals over a period of 24 hours.

    Sometimes a test dose of methotrexate is given

    first to see if a person tolerates the drug. If itis tolerated, the dosage is increased graduallyto achieve clearance. Once the skin is clear,the dose may be gradually reduced to thelowest level capable of maintaining reasonableimprovement. However, some may not taperoff the medication if it is effective and welltolderated. If a few stubborn lesions remain,a doctor will usually not increase the dose ofmethotrexate. Instead, another treatment, suchas a topical, may be added to clear remaining

    lesions. Improvement from methotrexateusually begins within three to six weeks ofstarting the drug. It may take up to six monthsto achieve the highest degree of improvement.

    Who should not take methotrexate?

    People with alcoholism, alcoholic liverdisease or other chronic liver diseases suchas cirrhosis and hepatitis B and C

    People with immunodeciency syndromes

    Pregnant or nursing women

    Women (or their male partners) planning apregnancy

    People with active peptic ulcers

    People with signicant liver or kidneyabnormalities

    People with an active infectious disease

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    What are the risks?The main risk of long-term methotrexatetreatment is liver damage. A small numberof people, estimated to be 1 in 200, developreversible liver scarring. After they stoptaking methotrexate, their liver will return

    to normal. This is a potential risk after anindividual has reached a lifetime accumulationof 1.5 grams (g) of methotrexate. How long ittakes an individual to reach 1.5 g depends onseveral factors, including his/her treatmentschedule and whether she/he takes any breaks

    from the drug. In rare instances, some peopledevelop irreversible cirrhosis. The risk canbe minimized by monitoring for liver toxicityat regular intervals and by avoidingmedications that are known to be toxic tothe liver.

    In people with a risk factor for liver disease,doctors may perform a liver biopsy to testfor liver damage or consult with a specialistonce a lifetime accumulation of anywherefrom1.5 g to 3 g has been reached. In abiopsy, a thin needle is inserted throughthe skin to obtain a small sample of livertissue. If significant liver damage is shown,methotrexate is usually discontinued.

    A liver biopsy may need to be repeated at

    regular intervals. However, some healthcareproviders do not recommend biopsies for

    People with pre-existing blood problemssuch as underdevelopment of bone marrow,low white blood cell count, low platelets orsignicant anemia, should use methotrexate

    with caution

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    Nausea

    Tiredness

    Difculty sleeping

    Lightheadedness

    Mouth ulcers

    Vomiting

    Headache

    patients without elevated risks for liver damage.

    The risk of liver damage increases if a persondrinks alcohol, has abnormal kidney function,is obese, has diabetes or has had prior liver

    disease.

    People who take methotrexate need to haveregular blood tests to ensure that the drug isbeing safely processed by the body, and that theliver, blood or bone marrow is not negativelyaffected. Methotrexate can cause a reduced

    white blood cell count, which can increase therisk of infection.

    Pregnancy should be avoided if either partner

    is taking methotrexate. Men should be offmethotrexate at least three months beforea couple tries to conceive. Women should

    wait at least four months after stoppingmethotrexate to become pregnant. Studies havedemonstrated harmful effects of methotrexate

    on fetal development. What are the possible side effects?

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    These side effects are generally manageable with careful monitoring and patient education.

    However, severe nausea or mouth ulcers canindicate that the dose is too high. In rareinstances, some serious side effects may occur

    years after the drug is used, including certaintypes of cancer, such as lymphoma, and bone

    marrow toxicity.

    Taking folic acid can decrease the severity ofside effects of methotrexate during treatment.Talk with your health care provider aboutrecommendations for folic acid supplements.

    What are the potential druginteractions?

    Your health care provider should always beaware of any medications, therapies or dietarysupplements you are using. This is especiallyimportant when taking methotrexate.

    Some over-the-counter (OTC) medications forinflammation or pain (including aspirin andibuprofen) may increase the side effects of

    methotrexate.

    Easy bruising and bleeding

    Fever

    Diarrhea with blood in the stool

    Chills

    Sensitivity to sunlight

    Burning sensation in lesions

    Hair loss

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    Some oral antibiotics can interfere with theabsorption of methotrexate. Penicillin canreduce clearance of the drug from the kidneys.Talk to your health care provider before takingany of these drugs while taking methotrexate.

    Drinking alcohol while on a course ofmethotrexate is not recommended because itincreases the chance of liver damage. Drugscontaining trimethoprim and sulfamethoxazole(such as Septra or Bactrim) must be avoided

    while on methotrexate. The interaction of thesedrugs and methotrexate can be fatal.

    On rare occasions, sensitivity to light can occureven when methotrexate is taken several days

    after exposure to ultraviolet light. This is calleda sunburn recall.

    Can it be used with other treatments?Methotrexate is sometimes rotated with othertreatments such as PUVA, Soriatane (acitretin),

    cyclosporine or a biologic. Rotation maydecrease side effects.

    Methotrexate can be used with PUVA or UVBto reduce the amount of ultraviolet light neededto clear the skin. In unresponsive cases of

    generalized pustular psoriasis, methotrexatehas been used with Soriatane. It has also beenused with biologics to prevent resistance andincrease response to both medications.

    Soriatane (acitretin)What is it and how does it work?Soriatane (acitretin) is an oral retinoid, whichis a synthetic form of vitamin A. Syntheticretinoids were approved in the United Statesin the 1980s. Soriatane is the only oral retinoid

    approved by the FDA specifically for treatingpsoriasis. Isotretinoin, another oral retinoid, issometimes used instead of Soriatane to treat

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    psoriasis (see page 16 for more about thistreatment).The exact way that Soriatane works to controlpsoriasis is unknown. In general, retinoidsaffect how cells regulate their behavior.

    Retinoids help control the multiplication of cells,including the speed at which skin cells willgrow and shed from the skins surface, whichspeeds up in psoriasis.

    How is it used?Soriatane comes in 10 milligram (mg), 17.5 mgand 25 mg capsules. The prescribed dose istaken once a day and should be taken with food.Several factors determine the correct dosagefor each person, including the type of psoriasis.

    Dosage may be reduced after symptomsimprove, depending on the persons response.Ordinarily, retinoid treatment is stopped whenlesions have cleared significantly. When lesionsor other symptoms reappear, the drug may be

    restarted.

    Soriatane tends to work slowly for plaquepsoriasis. Psoriasis may worsen before clearingbegins. After eight to 16 weeks of treatment, theskin lesions usually improve. It may take up to

    six months for the drug to reach its peak effect.Soriatane rarely clears psoriasis alone and

    works best in combination with phototherapy.

    Soriatane is approved for use in adults withsevere psoriasis. The Soriatane label supportsuse of the drug for plaque, guttate, pustular,erythrodermic and palmoplantar psoriasis.Soriatane is helpful in people with psoriasisprone to skin cancers such as squamous cellcarcinoma.

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    What are the risks?The most serious risk with Soriatane is the riskof severe birth defects in developing fetusesif a woman has the drug in her body duringpregnancy. Soriatane can remain in the body

    for many months, so it should not be taken forthree years before pregnancy. Because of therisk of birth defects, women of childbearingpotential must have two negative pregnancytests before starting Soriatane. They must usetwo effective forms of birth control at least one

    month before beginning treatment, while onthe drug and for three years after stoppingtreatment. Women who become pregnantduring the three years following treatmentshould seek the advice of a doctor whospecializes in high-risk pregnancies.

    Progestin-only birth control pills may not work while taking Soriatane, so women should notuse them as a primary form of birth control.

    People should not donate blood duringtreatment and for three years after

    Pregnant women or women who mightbecome pregnant during treatment

    Women who are breastfeeding

    People with severe liver or kidney disease

    People who repeatedly show a high level offat in the blood that cannot be controlled bymedications

    People who are allergic to or havehypersensitivity to retinoids

    Who should not take Soriatane?

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    These side effects, and others, seem to be dosedependent. They tend to go away after stopping

    the medication or reducing the dosage.

    Hair loss

    Chapped lips and dry mouth

    Dry skin and dry eyes

    Bleeding gums and nose bleeds

    Increased sensitivity to sunlight

    Peeling ngertips and nail changes

    Sticky skin sensation

    Changes in blood fat level

    Depression

    Aggressive thoughts or thoughts ofself- harm

    Headache

    Joint pain

    Decreased night vision

    Elevated liver enzymes

    stopping treatment. Donated blood couldexpose pregnant women to Soriatane.

    What are the possible side effects?

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    What are the potential druginteractions?

    Your health care provider should always beaware of any medications, therapies orsupplements you are using. Avoid dietary

    supplements that have vitamin A. Soriataneis related to vitamin A, and taking vitamin Acould add to any side effects Soriatane mightcause.

    Women of childbearing age who use Soriatanemust not drink or eat anything containingalcohol during treatment and for two monthsafter treatment is stopped. Consuming alcoholcan cause Soriatane to stay in your body longer,

    which increases the risk of birth defects if a

    woman becomes pregnant.

    Soriatane can reduce the effectiveness ofphenytoin, a common drug for epilepsy, whentaken concurrently.

    Soriatane should not be taken concurrently with tetracycline, an antibiotic, since bothmedications can cause increased pressureon the brain, which can have seriousconsequences.

    Can it be used with other treatments?Soriatane is most effective for treatingpsoriasis when used in combination

    with phototherapy rather than by itself.Combination therapy can speed clearing andhelp reduce the amount of phototherapy neededto clear symptoms. This reduces the risks andside effects of both treatments.

    Soriatane is sometimes used with the biologicdrugs Enbrel and Remicade to achieve clearing

    of psoriasis. Soriatane may also be prescribedin rotation with other systemic medications,such as cyclosporine or methotrexate.

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    OTHER SYSTEMIC MEDICATIONSThe following systemic medications are notapproved by the FDA for the treatment of

    psoriasis or psoriatic arthritis. However, somedoctors prescribe them off-labela commonand accepted medical practice.

    Antimalarial therapy Antimalarial therapy is sometimes used to treatpsoriatic arthritis. Certain antimalarial drugsmay trigger psoriasis symptoms in some people,so its advisable to talk with your health careprovider about this treatment option.

    HydroxyureaHydrea is an oral cancer medication that,in the late 1960s, was found to be effectivefor psoriasis. Although not as effective asmethotrexate, it is less likely to cause liverdamage with long-term use. While fewer people

    will have an acceptable response than withmethotrexate, Hydrea can produce significantimprovement in stable plaque psoriasis inabout half of those who tolerate it. The majorside effect of Hydrea is bone marrow toxicity.If this develops, it can occur quite rapidly, so

    close monitoring is important, especially in thefirst several months. Long-term use has beenassociated with skin cancer.

    IsotretinoinIsotretinoin is an oral retinoid (a synthetic formof vitamin A) that was approved as a treatmentfor severe cystic acne in 1982. Some doctorshave used it successfully to treat pustularpsoriasis. Generally, it is not as effective asSoriatane for plaque psoriasis.

    Isotretinoin has many side effects similar to

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    Soriatane (see discussion of Soriatane on page11). The most common side effects are eye andlip dryness and nosebleeds. Bone spurs andhair loss occur to a lesser degree. Isotretinoinleaves the body much faster than Soriatane,

    and some doctors consider it safer for womenof childbearing potential. However, it also cancause severe birth defects if a woman becomespregnant while the drug is in her system.

    Women of childbearing potential who takeisotretinoin should use reliable birth controlone month before treatment, during treatmentand for at least one month after stoppingtreatment.

    Mycophenolatemofetil (Cellcept)

    Mycophenolatemofetil has been used to preventorgan transplant rejection. It has also beenused for treatment of several inflammatory orautoimmune skin diseases and liver diseasessuch as hepatitis. It can be used in combination

    with cyclosporine, and some doctors use it

    when tapering patients off cyclosporine. Manydoctors believe that it is not very effective asa stand-alone treatment for psoriasis. It cansuppress the immune system, so people with acompromised immune system should not take it.

    Nonsteroidal anti-inammatory drugs(NSAIDs)NSAIDs can help relieve the pain, swellingand stiffness of psoriatic arthritis. They areavailable in over-the-counter and prescriptionstrengths. Examples of over-the-counterNSAIDs include aspirin, ibuprofen (Advil,Motrin) and naproxen sodium (Aleve). If youare taking frequent doses of one of theseNSAIDs to control your arthritis, you may needto move to prescription-strength medications.

    Talk to a rheumatologist about the bestoptions to control your symptoms and prevent

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    permanent joint damage.Sulfasalazine (Azuldine)

    A combination anti-inf lammatory andantibiotic, sulfasalazine is sometimes usedto treat psoriatic arthritis. It is generally

    regarded as being only modestly effectivefor plaque psoriasis. Many doctors thinkthat methotrexate is more effective thansulfasalazine. However, sulfasalazines sideeffects tend to be less dangerous. Therefore,trying this medication may be worthwhilefor some. Many people cannot toleratesulfasalazine because of an allergy to sulfaor because of side effects, including nausea,

    vomiting and loss of appetite.

    6-Thioguanine6-Thioguanine is an oral medication approvedfor treating certain types of leukemia. It iseffective for plaque psoriasis and has beenused to treat pustular psoriasis. 6-Thioguaninerequires close medical supervision to watch

    for potential severe side effects, includingsuppression of bone marrow. Most people whouse it feel that it works as often and as well asmethotrexate.

    BIOLOGIC TREATMENTSThe biologics are a newer class of prescriptionmedications for treating psoriasis and psoriaticarthritis. They are administered by injectioninto the skin or muscle or through intravenous(IV) infusion.

    What are they and how do they work? A biologic is a drug or vaccine that comesfrom living sources, such as human or animalproteins. Biologics have been around for more

    than 100 years. However, they have been usedfor just a little over a decade for psoriasis and

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    by selectively targeting the cytokinesinterleukin-12 (IL-12) and interleukin-23 (IL-23). These proteins are believed to play arole in psoriasis and psoriatic arthritis, andare thought to promote the accumulation of

    psoriatic disease-causing T cells. By preventingthese two proteins from attaching to cells inthe body, Stelara reduces inflammation andimproves psoriatic disease symptoms for manypeople who take it.

    How are they used?Biologics are administered by injection or byintravenous (IV) infusion. Stelara is injectedsubcutaneously (just under the skin) in adoctors office, or by self-injection. Typically,

    people give themselves injections of Cimzia,Enbrel, Humira and Simponi at home in amanner similar to that used by people withdiabetes giving themselves insulin injections.Remicade is given through IV infusion in adoctors office or an infusion center.

    Doctors are most likely to recommend biologicsfor people with moderate to severe cases ofpsoriasis and psoriatic arthritis who havenot responded to other treatments. They offeranother option for those who cannot take some

    medications because of side effects. Biologicscan be very effective in improving psoriasisand psoriatic arthritis. Three drugsEnbrel,Humira and Remicadehave been shown inclinical trials to decrease progressive jointdamage in psoriatic arthritis.

    Who should not take biologics? People whose immune systems are already

    signicantly compromised

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    What are the risks?Biologics for psoriasis and psoriatic arthritisare still relatively new and their overall safetyis still being evaluated. People consideringtreatment with biologics should talk withtheir doctor about the short- and long-term

    side effects and risks, which should be weighed carefully against the risks of othertreatment options.

    Because biologics suppress the immune system,people taking them could be at an increasedrisk of infection. If they notice any sign of aninfection, they should contact their doctorright away.

    Drugs that suppress the immune system can

    increase the risk of some types of cancer. As aresult, various studies have looked at a possible

    Individuals with active infections

    People with active tuberculosis or witha positive TB test who have not beentreated with a course of isoniazid (INH) as

    recommended by the American ThoracicSociety

    People with multiple sclerosis or a rst-degree relative with multiple sclerosisshould avoid TNF alpha blockers

    People with congestive heart failure,including those whose symptoms rank class3 or 4 in the New York Heart Association(NYHA) classication of heart failure should

    avoid TNF alpha blockers

    People who have recently received a livevaccine

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    link between biologic therapy and lymphomasand skin cancer, but data are inconclusive.Biologics have not been tested in patients withinternal malignancies.

    The risks of biologics for pregnant womenor developing fetuses have not been studiedcomprehensively. TNF-Alpha blockers can beprescribed for a pregnant or nursing womanif the medical need is clear and the doctor andpatient make the decision together.

    What are the possible side effects?The side effects for biologic medications vary.Common side effects for TNF-alpha blockersinclude:

    Abdominal pain

    Upper-respiratory infections

    Headache

    Flu-like symptoms

    Injection-site reactions (such as swelling,itch or rash) for self-injected biologics

    Side effects for IL-12/23 blockers like Stelarainclude:

    Headache

    Fatigue or tiredness

    Respiratory infections

    Hypersensitivity reactions

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    The side effects of biologics are generally mildand in most cases do not cause people to stoptaking the medication. You should tell yourhealth care provider about any side effect thatbothers you or does not go away.

    Can they be used with other treatments? All of the current biologics can and have beenused with other psoriasis treatments, suchas phototherapy or topicals. Enbrel, Humira,Remicade, Stelara and Simponi are safe andeffective when taken with methotrexate. Somepeople have seen success using Soriatane

    with different biologics. TNF alpha blockersshould be avoided in conjunction with otherbiologics such as those used for rheumatoid

    arthritis. They should be used with caution with other immune suppressing drugs suchas cyclophosphamide, azothioprine and6-mercaptopurine. Talk to your health careprovider about whether using any othertreatments with a biologic is right for you.

    Cimzia (certolizumab pegol)

    FDA-approved for treating psoriaticarthritis, rheumatoid arthritis and Crohnsdisease

    Patients should be screened for latenttuberculosis (TB) before starting Cimzia

    Patients give themselves an injection underthe skin every other week

    Drug is taken continuously to maintainresults

    May reduce the progression of joint damage

    and improves quality of life

    Occasional blood tests are recommended

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    Enbrel (etanercept)

    FDA-approved for treating psoriasis,psoriatic arthritis, juvenile idiopathicarthritis, rheumatoid arthritis and

    ankylosing spondylitis

    Patients should be screened for latenttuberculosis (TB) before starting Enbrel

    Patients give themselves an injection underthe skin once or twice a week

    Drug is taken continuously to maintainresults

    May reduce the progression of joint damageand improves quality of life

    Occasional blood tests are recommended

    Humira (adalimumab)

    FDA-approved for treating psoriasis, psoriaticarthritis, ankylosing spondylitis, crohnsdisease, ulcerative colitis and rheumatoid

    arthritis

    Patients should be screened for latenttuberculosis before starting Humira

    Patients give themselves an injection underthe skin, usually every other week

    May reduce the progression of joint damage

    Occasional blood tests are recommended

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    25systemic medications

    FDA-approved for psoriasis, psoriaticarthritis, rheumatoid arthritis, ulcerativecolitis, ankylosing spondylitis and Crohns

    disease

    Patients should be screened for latenttuberculosis before starting Remicade

    Administered by three infusions in a doctorsofce during the rst six weeks of treatment

    Later infusions repeated every eight weeks

    May reduce the progression of joint damage

    Blood tests are recommended on aregular basis

    Remicade (iniximab)

    Simponi (golimumab)

    FDA-approved for treating psoriatic arthritis,ankylosing spondylitis and rheumatoidarthritis

    Patients should be screened for latent

    tuberculosis before starting Simponi

    Patients give themselves an injection underthe skin once per month

    May reduce the progression of joint damage

    Blood tests are recommended on aregular basis

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    26 National Psoriasis Foundation

    NEW ORA L TREATMENTOtezla is a new oral treatment option for treatingpsoriatic arthritis. Unlike earlier oral disease-modifying antirheumatic drugs for psoriatic

    arthritis, this oral medication selectively targetsmolecules inside immune cells. By adjusting thecomplicated processes of inf lammation withinthe cell, this treatment corrects the overactiveimmune response that causes inflammationin people with psoriatic arthritis, leading to

    improvement in joint tenderness and swelling.

    Otezla (apremilast)What is it and how does it work?Otezla treats psoriatic arthritis by regulatinginflammation within the cell. It inhibits anenzyme known as phosphodiesterase 4, orPDE4. PDE4 controls much of the inflammatoryaction within cells, which can affect the level ofinflammation associated with psoriatic arthritis.

    How is it used?Otezla is available as a 30 (mg) tablet taken by

    FDA-approved for treatment of psoriasisand psoriatic arthritis in adults 18 years

    and older

    Patients should be screened for latenttuberculosis before starting Stelara

    Given by injection at the doctors ofce or athome on week zero, week four, then every three months

    Stelara (ustekinumab)

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    27systemic medications

    mouth. Otzela dosing begins with a five day startperiod, where the dosage will gradually increaseuntil the recommended dose of 30 milligramstwice daily is reached. Otezla is designed to betaken continuously to maintain improvement.

    Who should not take Otezla? The safety and effectiveness of Otezla in peopleunder 18 years of age has not been established.

    Additionally, the dose of Otezla should bemodified or reduced in people with severerenal impairment. Nursing women should usecaution when taking Otezla. People with a knownsevere allergic reaction to this treatment or itscomponents should not take Otezla.

    What are the risks?In clinical trials, 10 percent of people takingOtezla reported unexplained weight loss of 5 to10 percent during the trial. It is recommendedthat people taking Otezla have their weightmonitored regularly. Treatment with Otezla is

    associated with an increase in adverse reactionsof depression. People experiencing worsening ofmood while taking Otezla should contact theirdoctor.

    What are the possible side effects?In clinical trials, the most common side effects

    were diarrhea, nausea and headache, whichoccurred in the first two weeks and tended tolessen with continued treatment.

    Can Otezla be used with other treatments?Otezla can be used with other treatments. Inclinical trials, no significant impacts wereobserved when 30 mg of Otezla was taken witheither oral birth control, ketoconazole (antifungal

    medication), or methotrexate. Taking a CYP450inducer treatment (such as rifampin, a medicationused to treat tuberculosis) at the same time as

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    Thanks to diligent scientic research,todays treatments are providing a widerange of safe and effective optionsfor people with psoriasis and psoriaticarthritis. And the search continues to ndsafer and even more effective treatments.

    The National Psoriasis Foundation tracksthe movement of drugs for psoriasisand psoriatic arthritis from preliminarystudies through the three phases of clinicaltrials as required by the U.S. Food andDrug Administration. This informationis compiled, along with that from othersources, and entered into our drug

    research pipeline.

    To learn more about research and upcomingtreatments visit www.psoriasis.org/drug-pipline

    28 National Psoriasis Foundation

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    29systemic medications

    Were here for you. At the National Psoriasis Foundation, ourpriority is giving you the information andservices you need to take control of yourpsoriasis and/or psoriatic arthritis, whilefunding research to find a cure.

    RESEARCH Finding a cure for psoriasis and psoriaticarthritis is our highest priority. Were working

    for you by:

    Funding promising new studies through ourDiscovery and Translational grants programs

    Increasing the number of scientists doingresearch through our Medical Fellowshipprogram

    Hosting the worlds largest collection ofpsoriasis DNA for genetic research

    ADVOCACY

    Were ensuring that people with psoriasis andpsoriatic arthritis have a say in the policies thataffect their lives. Join us as we:

    Work to increase federal funding for psoriasis

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    30 National Psoriasis Foundation

    and psoriatic arthritis research

    Improve access to health care for patients

    HEA LTH EDUCATION

    National Psoriasis Foundation is your one-stopshop for news and information about psoriasisand psoriatic arthritis. Visit www.psoriasis.orgto learn more about:

    The latest treatment information andresearch updates

    Health events in your area

    CONNECTION Sometimes the best resource to managepsoriasis and psoriatic arthritis is anotherperson with your condition. Share information

    and get support from:

    TalkPsoriasis.org, the largest onlinecommunity for people affected by psoriasisand psoriatic arthritis

    Psoriasis One to One mentor program

    LE ARN MORE

    Find more information and resources at www.psoriasis.org.

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    31systemic medications

    Were here for you.

    At the National Psoriasis Foundation, our

    priority is giving you the information andservices you need to take control of yourpsoriasis and/or psoriatic arthritis, whilefunding research to find a cure.

    RESEARCH Finding a cure for psoriasis and psoriatic

    Become a member of the NationalPsoriasis Foundation and get thetools and information you needto manage your psoriasis and/orpsoriatic arthritis. As a member,youll receive a full year of Psoriasis

    Advance magazine as well as otherbenets and services designed tohelp you live well with psoriaticdiseases.

    Yes, I want to join the National PsoriasisFoundation. Please send me a bill for $35.For faster service, join online at www.psoriasis.orgor call 800.723.9166.

    Get Psoriasis Advance andmorewith your membership.

    Join for $35.

    Name

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    NOTES

    32 National Psoriasis Foundation

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    National Psoriasis Foundation is a 501 (c) (3) charitable organization governedby a volunteer Board of Trustees and advised on medical issues by a volunteerMedical Board.

    National Psoriasis Foundation educational materials are reviewed by membersof our Medical Board and are not intended to replace the counsel of a physician.

    National Psoriasis Foundation does not endorse any medications, productsor treatments for psoriasis or psoriatic arthritis and advises you to consult aphysician before initiating any treatment.

    2014 National Psoriasis Foundation May 2014National Psoriasis Foundation6600 SW 92nd Ave., Suite 300, Portland, OR 97223-7195800.723.9166 | get nfo psor as s org | www psor as s org

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