• Plaque type psoriasis

• Can be used as mono-therapy 1-2 times daily.
• Can be combined with other topical agents, UV light and systemic agents

• Stoughton-Cornell classification system divides steroids into 7 classes.

• Class 1 steroids: available data for 2-4 weeks of treatment
• Less potent agents: Optimal endpoint unknown
• Gradual reduction in usage recommended following clinical response; while optimal endpoint is unknown unsupervised continuous use is not recommended
• For clobetasol and halobetasol maximal weekly use should be 50 gms or less

• Highly potent agents have greater efficacy than less potent agents
• Vehicle, usage area, patient preference, patient age, and cost alter efficacy
• See Table 1 for efficacy rates.

• True efficacy and risks associated with long-term use are unknown as most clinical trials are of short duration
• Tachyphylaxis, while not demonstrated in clinical trials, may affect the long-term results achieved in a given patient.
• Combination with other topicals and variations in dosing schedules may lessen risk of long-term side effects.

• Local - skin atrophy, telangiectasias, striae, purpura, contact dermatitis, rosacea
• Systemic - hypothalamic-pituitary-adrenal axis suppression may occur with use of medium and high potency topical steroids. Unilateral or bilateral avascular necrosis of the femoral head rarely occurs.
• Increased intraocular pressure, glaucoma and cataracts have been reported with use around the eye.
• Risks increase when used with excessive frequency or duration.
• It is unknown if there is an increased risk of infection with chronic use.

• None

• Assessment of growth in children using for long term
• Regular skin checks for all patients on long term therapy to assess for atrophy

• Category C

• Unknown safety.

• Because of the increased skin surface/body mass ratio, the risks to infants and children may be higher for systemic effects secondary to enhanced absorption. Growth retardation is also a potential concern.

• Plaque type psoriasis

• Twice daily to affected areas

• In two large studies of plaque type psoriasis of the body, 70-74% of patients treated with calcitriol or calcipotriene ointment showed either 75% improvement or marked improvement to clearing as compared with 18-19% of patients treated with placebo. 60% of scalp psoriasis patients treated with calcipotriene solution showed clearance or marked improvement as compared to 17% of placebo patients.
• Combination of calcipotriene and betamethasone ointment – In a 4 week trial of patients with mild to severe plaque psoriasis - 48% of patients treated with the combination agent achieved absent or mild psoriasis, compared to 16.5% of patients treated with calcipotriene once daily, 26.3% of patients treated with betamethasone once daily, and 7.6% of patients treated with placebo. A 52 week clinical practice usage study showed 70-80% of patients achieving clear or almost clear status with no drug-related serious adverse events such as HPA axis oppression or stria when used on an as needed basis.
• Use in combination with topical corticosteroids gives added benefit.

• Irritation in lesional and peri-lesional skin that is transient.
• Reversible elevation of serum calcium – more likely to occur in patients treated with greater than 100 g/week.
• Causes photosensitivity, but no contraindications to combining with UVB phototherapy
• When using combination calcipotriene/betametasone, the side effects of high potency topical corticosteroids including HPA axis suppression, skin atrophy, among others (see above) may occasionally occur.

• Category C
• No information on excretion in breast milk and pregnant and nursing mothers were excluded from clinical studies.

• Appears to be safe

• Plaque type psoriasis

• Applied once daily.

• 50% or more improvement, seen in 63% and 50% of patients treated with tazarotene 0.1% gel and 0.05% gel used once daily for 12 weeks, compared to 31% of patients treated with vehicle.
• Overall lesional assessment of none,minimal or mild found in 40 – 51% of patients treated with tazarotene 0.1% cream and 0.05% cream used once daily for 12 weeks, compared to 25% of patients treated with vehicle.
• Best used in combination with topical corticosteroids

• Most common side effect is skin irritation in lesional and perilesional skin.
• Photosensitizing

• Pregnancy category X
• Excreted in mammalian milk, but quantity in human milk is unclear.

• No available data in psoriasis patients under age 18; for acne, approved to age 12.

• No FDA approved indications for psoriasis. Primary indications for off label use are for facial and intertriginous psoriasis.

• Applied twice daily to affected areas. No length of course is specified.

• Plaque psoriasis – not generally effective
• Intertriginous and facial psoriasis: 65% of patients treated with tacrolimus 0.1% ointment were clear or almost clear after 8 weeks of therapy compared with 31% of patients treated with placebo. 71% of the patients treated with pimecrolimus 0.1% cream were clear or almost clear after 8 weeks of therapy as compared to 21% of patients treated with placebo.

• There are no specific contraindications/adverse reactions for psoriasis.
• Most common side effect for both medications is burning and itching.
• A controversial lymphoma “black box” warning has been issued by the FDA

• Category C
• Tacrolimus and pimecrolimus are found in human milk and are not recommended for nursing mothers.

• Topical tacrolimus (0.03%) and topical pimecrolimus are approved for patients age 2 years or older for atopic dermatitis.

• The use of emollients represents an internationally accepted standard adjunctive therapeutic approach to the treatment of psoriasis

• Applied once to three times daily

• Two controlled studies of aloe vera with conflicting results

• No known contraindications

• Generally considered safe

• Generally considered safe

• No specific FDA indication

• Applied daily

• Data is limited on salicylic acid alone
• Comparator study of tacrolimus and salicylic acid vs tacrolimus alone in small study (n=24) of psoriasis pts with less than 10% BSA, revealed improved efficacy with addition of salicylic acid
• Comparator study of 408 pts with moderate - severe psoriasis treated with either mometasone and salicylic acid vs mometasone alone for 3 weeks. Psoriasis severity index measure of erythema, induration, and scaling showed the combination of mometasone furoate-salicylic acid to be more effective than mometasone furoate alone.

• Do not combine with other salicylate drugs. Systemic absorption although rare, can occur especially when applied to over 20% of body surface or in patients with abnormal hepatic or renal function. Salicylic acid decreases the efficacy of UVB phototherapy due to a filtering effect and should not be used before UVB phototherapy

• Appears to be a safe choice for the control of localized psoriasis in pregnancy

• Due to greater risk of systemic absorption and toxicity, salicylic acid should be avoided in children

• Was important component of psoriasis treatment for many years.

• Several doses are available. Now commonly used as short contact therapy starting at 1% concentration with increasing concentration over time as tolerated

• Limited placebo controlled trial data but as monotherapy, anthralin appears to have lower efficacy than more potent topical corticosteroids or vitamin D derivatives

• Most common side effects are skin irritation and staining of the skin and other touching objects. Due to skin irritation, important to avoid contact with surrounding normal skin

• Category C

• Use with caution

• Used in the treatment of psoriasis for over 100 years. Although the use of tar products for treatment of localized psoriasis has decreased over time in the US, they are still often used in other countries

• Many formulations exist

• In double blind randomized controlled trial of 324 patients with mild-moderate psoriasis comparing 1% coal tar lotion with 5% coal tar extract, there was better improvement in both PASI score and TSS (total sign score) in patients treated with 1% lotion than in 5% extract

• Often poorly tolerated by patients due to cosmetic issues including staining of clothes and tar odor.
• Other potential adverse events include irritant contact dermatitis, folliculitis, and photosensitivity.
• Coal tar is carcinogenic in animals, but in humans there are no convincing data proving carcinogenicity and epidemiologic studies fail to show increased risk of skin cancer in patients who use coal tar.

• Risk of topical coal tar used for short periods of time during pregnancy is likely to be small

• Use with caution

• Severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.

• Methotrexate is administered as a weekly single oral dose
• Doses can be increased gradually until an optimal response is achieved.
• Total dose should not ordinarily exceed 30mg per week.
• Doses should be reduced to the lowest possible amount of drug needed to achieve adequate control of psoriasis with concomitant topical therapy.
• A test dose of 2.5 – 5 mg is recommended

• Treatment can be continued for as long as is necessary provided there are no meaningful signs of liver or bone marrow toxicity with adequate monitoring.
• Folic acid supplementation 1-5mg daily by mouth, except for the day of methotrexate dosing, reduces the frequency of side effects.

• In the only placebo-controlled trial of methotrexate for psoriasis, 36% of patients treated with 7.5mg orally per week, increased as needed up to 25mg per week, reached PASI 75 after 16 weeks.

• Pregnancy
• Nursing mothers
• Alcoholism
• Alcoholic liver disease or other chronic liver disease
• Immunodeficiency syndromes
• Bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia
• Hypersensitivity to methotrexate

• Abnormalities in renal function
• Abnormalities in liver function
• Active infection
• Obesity
• Diabetes mellitus

• Elevated LFT’s - Minor elevations of LFTs are common. If elevation exceeds 2x normal, must check more frequently; if exceeds 3x normal, consider dose reduction; if exceeds 5x normal discontinue
• Anemia, aplastic anemia, leukopenia, thrombocytopenia
• Interstitial pneumonitis
• Ulcerative stomatitis
• Nausea, vomiting, diarrhea
• Malaise or fatigue
• Chills and fever
• Dizziness
• Decreased resistance to infection
• Gastrointestinal ulceration and bleeding
• Photosensitivity (“radiation recall”)
• Alopecia

• Hepatotoxic drugs such as barbiturates
• Acitretin has been used successfully in combination with methotrexate despite the potential for hepatotoxicity from both medications
• Drugs that interfere with renal secretion of methotrexate such as sulfamethoxazole, NSAIDs, and penicillins.
• Folic acid antagonists such as trimethoprim.

• Low risk patients – at baseline, not necessary
• First biopsy: 3.5-4g; subsequent biopsies to be considered after 1.5g
• High-risk patients including history of diabetes, obesity, abnormal LFTs, excessive EtOh ingestion, chronic liver disease, family hex of heritable liver disease.
• Consider baseline biopsy or at 6 months with subsequent biopsies after 1-1.5 grams

• History and Physical Examination
• CBC and platelet count
• BUN, creatinine and LFT’s
• Liver biopsy is only indicated in patients with a history of significant liver disease
• Pregnancy test and test for HIV in selected patients.
• Consider PPD
• Consider chest x-ray if patient has underlying pulmonary disease

• CBC and platelet count at varying intervals (initially every 2-4 weeks for first few months and then every 1-3 months depending upon dosage adjustments, symptoms, and previous CBC results.
• LFT’s at monthly intervals, BUN, creatinine every 2-3 months depending on dosage adjustments, symptoms and previous blood results.
• Pregnancy test if indicated.
• Consider liver biopsy in high-risk patients including history of diabetes, obesity, abnormal LFTs, excessive EtOh ingestion, chronic liver disease, family hx of heritable liver disease
• For those without risk factors, consider liver biopsy in patients with cumulative doses of more than 3.5-4g methotrexate.
• For patients without risk factors, consider repeat liver biopsies after each subsequent 1.5g dosage, based on LFT’s, risk factors such as diabetes and obesity, or in consultation with a hepatologist.
• The aminoterminal peptide of procollagen III is used in Europe (but is generally not available in the United States) as a test for hepatic fibrosis, reducing the need for frequent liver biopsies.

• Category X
• Males and females considering conception should be off methotrexate for 3 months prior to attempting to conceive. Should pregnancy ensue prior to this time period, consider genetic counseling

• Mothers receiving methotrexate should not breast feed.

• Methotrexate is approved for the treatment of juvenile rheumatoid arthritis.
• Low dose methotrexate has been used effectively and safely in children for a variety of dermatologic and rheumatologic disorders.

• Although there are only two small controlled trials evaluating methotrexate for psoriatic arthritis that are inadequately powered to assess clinical benefit, methotrexate is often used as the primary agent to treat psoriatic arthritis.

• Adult, non-immunocompromised patients with severe, recalcitrant psoriasis (Severe is defined by the FDA as extensive or disabling plaque psoriasis; Recalcitrant is defined by the FDA as those patients who have failed to respond to at least one systemic therapy or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated)
• Some guidelines suggest use of cyclosporine in moderate to severe psoriasis
• Efficacy observed in erythrodermic psoriasis, generalized pustular psoriasis and palmoplantar psoriasis

• FDA approved for adults with severe plaque type psoriasis

• There is no FDA approved use for psoriasis

• Thiopurine methyl transferase levels are generally used to guide dosing
• One suggested daily schedule guided by results of TPMT values

Alternatively, start at 0.5mg/kg, and monitor for cytopenia. If no cytopenia, can increase dose by 0.5 mg/kg/day after 6-8 wks if necessary and increase by 0.5 mg/kg/day every 4 wks thereafter as needed. Generally dosed at 75 – 150 mg/day

• In one study 19/29 pts had >75% improvement but in another smaller study 5/10 pts had >25% improvement

• Allergy to azathioprine
• Pregnancy or attempting pregnancy
• Clinically significant active infection

• Concurrent use of allopurinol
• Prior treatment with cyclophosphamide or chlorambucil

• Bone marrow suppression
• Malignancies
  • Cutaneous (SCCs)
  • Lymphoproliferative
• Increased risk of infections
• GI: nausea, vomiting, diarrhea
• Hypersensitivity syndrome
• Pancreatitis
• Hepatitis

• Allopurinol – increased risk of pancytopenia (if using concurrently, lower azathioprine dose by 75%)
• Captopril – may increase risk of anemia and leukopenia
• Warfarin – may need an increased dose of warfarin
• Pancuronium- may need an increased dose of this for adequate paralysis
• Co-trimoxazole - increased risk of hematologic toxicity
• Rifampicin – decreases azathioprine efficacy, also hepatotoxic
• Clozapine - increased risk of agranulocytosis

• History and Physical Examination
• LFTs, CBC/diff, serum chemistry profile, urinalysis, PPD, hepatitis B and C screen.
• Pregnancy test if indicated

• CBC/diff twice/month for the first 2 months, monthly for the next 2 months, every 2 months thereafter
• LFTs monthly for the first 3 months then every 2 months thereafter
• Biannual physical examination focusing on lymph node exam and skin cancer exam (SCC’s in particular)
• Pregnancy testing if indicated

• Pregnancy Category D
• Pregnancy and breast-feeding should be avoided during treatment with azathioprine, and patients (including males) must use adequate contraception.

• No data

• A small observational cohort study suggests that azathioprine may be of value in psoriatic arthritis

• There is no FDA approved use for psoriasis in the US. Fumaric acid esters are approved in Europe.

• Starting dose -one tablet of FumadermR Increase over the next 8 weeks to a maximum of 6 tablets daily

• Multi-center, randomized, double blind placebo controlled trial of 100 pts showed that after 16 weeks fumarate treated pts reached a mean PASI 50 compared to placebo patients whose PASI was essentially changed
• Randomized, double blind controlled trial of 143 pts given either fumarates plus calcipotriol or fumarates alone found that pts given combination therapy reached PASI 50 in 3 wks vs those treated with fumarates alone reaching PASI 50 in 9 wks

• Case series of pts treated up to 14 years suggest no increased risk for infections or malignancies.
• Large, long term follow-up studies are necessary to confirm these observations.

• Severe liver disease
• Severe or chronic gastrointestinal disease
• Severe or chronic kidney disease
• Malignancy or a history of malignancy
• Leukopenia and other hematologic abnormalities
• Pregnancy
• Breastfeeding

• Gastrointestinal (Abdominal cramps, nausea, diarrhea, fullness and flatulence)
• Flushing
• Malaise
• Fatigue
• Lymphopenia, leukopenia, eosinophilia
• Hepatotoxicity and elevated LFT’s
• Increased cholesterol, triglycerides
• Increased serum creatinine and potassium, and proteinuria
• Rare case reports of renal disease but none in the controlled trials

• Other fumaric acid derivatives, methotrexate, cyclosporine, immunosuppressive drugs and cytostatic drugs may potentiate toxicity
• Drugs known to cause renal dysfunction

• History and physical examination
• CBC, platelet counts
• Chemistry screen
• Urinalysis

• CBC, platelet count every other week for the first two months; monthly until month 6, and bimonthly thereafter
• Serum chemistry and urinalysis every 2 weeks for the first month, then monthly for the first 6 months and bimonthly thereafter

• Not recommended in pregnancy (no FDA pregnancy category because it is not approved in the US)
• Nursing:
• There is no data and therefore mothers receiving fumaric acid esters should not breast-feed.

• No data

• One small double blind placebo controlled trial suggested minimal efficacy as evidenced by decreased joint pain and sedimentation rate

• There is no FDA approved use for psoriasis

• Initial dose of 500 mg PO BID increasing to up to 3 g/day as tolerated.
• Weekly dose of 3 - 4.5 g/week has also been utilized

• Efficacy rates vary widely
• One study showed that 55% of 31 patients had at least a 70% reduction in PASI score (mean treatment time of 36 weeks), while another study comparing hydroxyurea to methotrexate showed a 48% reduction in PASI score after 12 weeks of hydroxyurea.

• One study found that 60% of 85 pts treated for a mean of 16 months had a complete or almost complete clearance

• Marked bone marrow depression, including leukopenia, thrombocytopenia or anemia

• Bone marrow suppression
• Gastrointestinal symptoms (stomatitis, anorexia, nausea, vomiting, diarrhea, and constipation)
• Dermatological reactions (rash, ulceration, dermatomyositis - like skin changes, alopecia)
• Dysuria may rarely occur
• Neurological disturbances limited to headache, dizziness, disorientation, hallucinations, and convulsions rarely seen
• Temporary impairment of renal tubular function accompanied by elevations in serum uric acid, BUN, and creatinine
• Fever, chills, malaise, edema, asthenia
• Elevation of hepatic enzymes
• Pulmonary fibrosis rare
• Fatal and nonfatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported in HIV-infected patients who received hydroxyurea in combination with antiretroviral agents.

• Concurrent use of hydroxyurea and other myelosuppressive agents or radiation therapy may increase the likelihood of bone marrow depression
• Hydroxyurea may raise the serum uric acid level; dosage adjustment of uricosuric medication may be necessary.

• History and Physical Examination
• Complete blood count at baseline and weekly until stable dose is achieved
• Pregnancy test if indicated

• Complete blood count at monthly intervals
• Biannual physical examination focusing on lymph node exam and skin cancer exam (SCC’s in particular)
• Pregnancy testing if indicated

• Pregnancy Category D
• Pregnancy and breast-feeding should be avoided during treatment and patients (including males) must use adequate contraception.

• No data

• No data

• There is no FDA approved use for psoriasis

• Loading dose of 100 mg/day for 3 days followed by 20 mg/day long term

• In the only randomized controlled trial of 190 pts, 24 wks of leflunomide dosed as above, led to a PASI 75 of 17% vs placebo response of 8% (p =.048)

• Not reported

• Patients with hypersensitivity to leflunomide or its metabolites

• Most common side effects include nausea, diarrhea, loss of appetite, weight loss, headache, dizziness
• Less frequent adverse reactions may include severe liver injury, including fatal outcome. Most cases of severe liver injury occur within 6 months of therapy and in pts with multiple risk factors for hepatotoxicity.
• Rare reports of pancytopenia, agranulocytosis and thrombocytopenia in patients receiving leflunomide. This occurs in patients who have been treated with methotrexate or other immunosuppressive agents, or who had recently discontinued these.

• Co-administration of leflunomide with methotrexate demonstrates no pharmacokinetic interaction between the two drugs but can lead to an increased risk of hepatotoxicity.
• When leflunomide is given with rifampin, leflunomide levels are increased

• History and Physical Examination
• CBC/diff and LFT’s.
• Pregnancy test if indicated

• Monthly complete blood count with differential and liver function tests for the first six months and then every 6 – 8 weeks
• Pregnancy testing if indicated

• Category X

• Leflunomide should not be used by nursing mothers.

• No data

• In the only randomized controlled study of 190 pts with psoriasis and psoriatic arthritis, 59% of pts treated with leflunomide vs 30% of placebo pts were responders by the PsARC

• There is no FDA approved use for psoriasis

• 1.0 – 1.5 gm orally two times per day

• 47% mean reduction in PASI at 12 weeks in 23 patients with psoriasis treated with 1.0-1.5 gm bid
• 47% mean reduction in PASI at 6 weeks in 11 psoriasis patients treated with 1 gm bid for 3 weeks then 0.5 gm bid for 3 more weeks

• No data

• Hypersensitivity to mycophenolate mofetil, mycophenolic acid

• GI side effects (diarrhea, nausea/vomiting, abdominal cramps). These occur early and decrease with continued use.
• Hematologic (leukopenia is most common; anemia, thrombocytopenia)
• Genitourinary (urgency, frequency, dysuria, sterile pyuria).
• Increased incidence of viral, bacterial and mycobacterial infections
• Progressive multifocal leukoencephalopathy
• Hypercholesterolemia, hypophosphatemia, hyperkalemia, hypokalemia
• Fever and myalgias
• Headache, insomnia
• Peripheral edema
• Hypertension
• Patients taking mycophenolate mofetil should not be given live attenuated virus vaccines

• Antacids containing aluminum and magnesium
• Calcium and iron
• Cholestyramine
• Antibiotics including cephalosporins, fluoroquinolones, macrolides, penems, penicillins, sulfonamides inhibit enterohepatic recirculation and decrease mycophenolate mofetil levels
• High dose salicylates
• Phenytoin
• Xanthine bronchodilators
• Probenecid
• Acyclovir, ganciclovir, valganciclovir

• History and Physical Examination
• CBC, platelet counts
• Chemistry screen, LFT’s
• Pregnancy test if indicated

• CBC, platelet count weekly x1 month; then every 2 weeks for 2 months; then monthly thereafter.
• Monthly chemistry panel and LFT’s
• Biannual physical examination focusing on lymph node exam and skin cancer exam (SCC’s in particular)
• Pregnancy testing if indicated

• Pregnancy Category D
• Pregnancy and breast-feeding should be avoided during treatment and patients (including males) must use adequate contraceptive precautions.

• No data

• Case reports suggest improvement

• There is no FDA approved use for psoriasis

• In psoriasis, initial dose of 500 mg PO BID increased to up to 3 -4 g/day as tolerated.

• As long as needed. There are no known cumulative toxicities.

• Efficacy rates not well characterized. In the only randomized controlled trial, 8 wks of 3- 4 g/day sulfasalazine led to moderate improvement (global improvement of 30-59%) in 7/17 assessable sulfasalazine pts compared to 1/27 assessable placebo pts)

• Not reported

• Patients with intestinal or urinary obstruction, patients with porphyria, patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates.

• Anorexia, headache, gastrointestinal symptoms (including nausea, vomiting, and gastric distress) and oligospermia can occur in up to one third of patients
• Less frequent reactions include skin rash, pruritus, urticaria, fever, hemolytic anemia, and cyanosis, which may occur in one in 1/30 patients or less.

• Reduced absorption of folic acid and digoxin

• History and physical examination
• CBC/diff and LFT’s
• Pregnancy test if indicated

• CBC/diff and LFT’s every other week for the first three months. During the second three months, CBC/diff and LFT’s monthly and thereafter once every three months.
• Urinalysis and renal function tests should be done periodically
• Pregnancy testing if indicated

• Category B

• Sulfonamides are excreted in the milk. In the newborn, they compete with bilirubin for binding sites on the plasma proteins and may thus cause kernicterus.

• No data

• In the largest trial of sulfasalazine for psoriatic arthritis, after 36 weeks of treatment with 2 gm/day, 58% of pts given sulfasalazine compared to 45% of pts given placebo achieved PsARC

• There is no FDA approved use for psoriasis

• 0.05 – 0.15 mg/kg

• Unknown

• Efficacy rates are poorly characterized. Pts dosed at 0.05 mg/kg showed no difference from placebo at 3 wks. When dosed at 0.10 – 0.15 mg/kg, by 9 wks there was a statistically significant improvement in PASI compared to placebo

• Not reported

• Patients with hypersensitivity to tacrolimus or its metabolites.

• Most common side effects include tremor, headache, nausea, diarrhea, hypertension and abnormal renal function tests
• Less common side effects include hyperglycemia, hyperkalemia, elevated LFTs, anemia, leukocytosis, dyspnea, fever, arthralgias, edema, diabetes, insomnia, paresthesias,

• Numerous drug interactions as tacrolimus is metabolized by cytochrome P450 system
• Do not give tacrolimus and cyclosporine together

• History and Physical Examination
• CBC/diff, renal and LFT’s.
• Pregnancy test if indicated

• Blood pressure
• Serum chemistry
• Renal function
• Liver function
• Pregnancy testing if indicated

• Category C

• Tacrolimus should not be used by nursing mothers.

• No data

• Case reports suggest improvement

• There is no FDA approved use for psoriasis

• Start at 80 mg two times per week. Increase by 20 mg every 2-4 weeks. Maximum dose is 160 mg 3 times per week.

• Open label trial of 14 pts treated with pulse dosing followed by maintenance dosage (120 mg twice a week to 160 mg three times per week). Of 11 pts who became longer term responders, 6/11 showed a response after 2-4 weeks

• 76 patients followed for over one month. At 24 months, 58% were effectively maintained.
• Has been safely used up to 145 months
• Another study showed 14/18 patients had 90% improvement

Generalized psoriasis (including guttate) unresponsive to topicals

• BB:
  • Initial dosing according to skin type (20-60 mJ/cm²) or MED (50% of MED).
  • Subsequent dosage increase by 5-30 mJ/cm² or 25% or less of the initial MED.
  • Treatment 3-5 times weekly.
• NB:
  • Initial dosing according to skin type (130 to 400 mJ/cm²) or MED (50% of MED).
  • Subsequent dosage increase by 15- 65 mJ/cm² or 10% or less of the initial MED.
  • Treatment 3-5 times weekly.

• BB:
  • Initial improvement often occurs within 4 weeks of therapy
  • A single course is 20-25 treatments
  • Maintenance therapy may prolong remission
• NB:
  • Response observed at 8 to 10 treatments.
  • A single course is 15 to 20 treatments.
  • Maintenance therapy may prolong remission.

• BB:
  • Average of 20-25 treatments to induce clearance
• NB:
  • More effective than BB-UVB, clearance within 2 weeks may be seen.
  • Average of 15-20 treatments to achieve clearance

• BB: Remission rate of 5% after 1 year
• NB: Remission rate of 38% after 1 year

• Patients with known lupus erythematosus, or xeroderma pigmentosum

• Patients with skin types I and II who tend to burn easily
• Those with a history of arsenic intake or previous treatment with ionizing radiation therapy
• Those with a history of melanoma or multiple non-melanoma skin cancers
• Those with any medical condition that is severe enough that the patient cannot tolerate heat or prolonged standing in the light box.

• Acute:
• Erythema
• Pruritus
• Burning

• Photo-aging, lentigines, telangectasias
• Theoretical risk of photo-carcinogenesis.
• Advise use of protective goggles and genital shields during treatment

• Cautious use with other photosensitizing medications.
• When used in conjunction with systemic retinoids, the dose of both retinoids and UVB may need to be lowered.

• Full body skin check before initiation of therapy.

• Regular full skin exam to monitor signs of photo-aging, pigmentation and cutaneous malignancies.

• Generally considered safe (expert opinion)

• Generally considered safe (expert opinion)

• No adequate study. May be used with caution in individuals younger than 18 years of age.

• No studies

• Adult and Pediatric Patients with Mild, Moderate or Severe Psoriasis with less than 10% BSA involvement.

• Initial dose depends on the individual’s skin type (including formal MED testing), plaque characteristics and thickness. (500 to 900 mJ/cm² for the XTRAC ®)
• Subsequent doses adjusted according to clinical response and/or side effects.

• Dosing 2-3x a week until the patient is clear, usually an average of 10-12 treatments are needed.

• Initial response within 8-10 treatments depends on multiple factors such as device utilized, protocol used, lesion characteristics and site.

• Mean remission times of 3.5 – 6 months

• In patients with photosensitivity disorders.

• Erythema
• Hyperpigmentation
• Blistering, particularly with higher doses.

• May need to lower dosing based upon presence of photosensitizing medications (Note: the action spectrum of most photosensitizing medications is in the UVA range)

• None

• For efficacy and for burning

• No studies in pregnancy have been performed but expert opinion is that it is safe

• No studies in nursing mothers have been performed but expert opinion is that it is safe to be used.

• No large scale studies in children have been performed but expert opinion is that it is safe to be used.

• No studies

• Adults with generalized psoriasis who are resistant to topical therapy.

• 8-methoxypsoralen (Oxsoralen Ultra), 0.4-0.6 mg/kg, taken 1-2 hour before exposure to UVA.
• Other available forms of psoralen include 5-methoxypsoralen and trimethylpsoralen
• UV protective eye wear should be worn when outdoors for 12 hours post-ingestion
• Treatment 2-3 times weekly.

• Initial improvement frequently seen within 1 month of therapy
• A single course is 20-25 treatments
• May be repeated as indicated.

• 89% clearing with an average of 25 treatments in the US and 20 treatments in Europe
• 11.6 weeks to clear in US studies compared to 5.3 weeks to clear in European studies

• Once clearance has been achieved, maintenance treatment may or may not be used
• Remission times: 3-12 months.

• Patients with known lupus erythematosus, porphyria, or xeroderma pigmentosum

• In patients with skin types I and II who tend to burn easily
• Those with a history of arsenic intake or previous treatment with ionizing radiation therapy
• Those with a history of melanoma or multiple non-melanoma skin cancers
• Those with any medical condition that is severe enough that the patient cannot tolerate heat or prolonged standing in the light box
• Those with severe liver disease that could lead to toxic levels of psoralens
• Possibly those who have been treated with cyclosporine or methotrexate
• Patients who are pregnant or nursing.

• Acute:
  • Nausea and vomiting are common
  • Dizziness and headache are rare
  • Erythema (peaks at 48-96 hrs)
  • Pruritus
  • Tanning (starts 1 wk after PUVA)
  • Blisters, photo-onycholysis, melanonychia
• Chronic:
  • Photo-carcinogenesis (SCC, BCC and possible melanoma)
  • Increased risk of photo-carcinogenesis in Caucasians with skin types 1-3 after 200 treatments. This risk not present for non-Caucasians.
  • Photo-aging and lentigines are common, especially in patients of skin types 1-3 and are cumulative UVA dose dependent

• Caution when the patient is taking other photosensitizing medication
• Should decrease the UVA dose by one-third if patient is started on oral retinoids while receiving PUVA.

• Skin cancer screening
• Eye examination. However, recent evidence demonstrates no increased risk of cataract in patients who receive PUVA.
• If indicated by history:
  • ANA panels (anti-Ro/La antibodies)
  • Liver enzymes

• Regular full skin exam due to potential increased risk of photo-carcinogenesis in Caucasians.
• In patients who are non-compliant with eye protection, yearly eye exam

• Category C

• Contraindicated for a period of 24 hours after ingesting psoralen

• No studies. May be used with caution in individuals younger than 18 years of age

• No studies

• Topical PUVA for adults with psoriasis of palms and soles.
• Bath PUVA for adults and children with generalized psoriasis.

• Topical:
  • Use 0.1% 8-methoxypsoralen in emollient and treat 2-3 times per week.
  • Apply 30 minutes before UVA
  • Start at 0.25 – 0.5 J/cm², increase by 0.25 – 0.5 J/cm²
• Bath:
  • 50mg of 8-methoxypsoralen (Oxsoralen Ultra) in 100L water
  • 20-30 min pre-exposure
  • Schedule similar to oral PUVA

• May take 30 treatments to have noticeable response
• A single course usually is 30-40 treatments
• May be repeated as indicated

• Clinically is beneficial

• Once clearance has been achieved, maintenance treatment may be used
• Remission 3-12 months

• Patients with known lupus erythematosus, porphyria, or xeroderma pigmentosum

• In patients with skin types I and II who tend to burn easily
• Those with a history of arsenic intake or previous treatment with ionizing radiation therapy
• Those with a history of melanoma or multiple non-melanoma skin cancers
• Patients who are pregnant or nursing.

• Acute: Erythema, blistering, hyperpigmentation
• Chronic: No increased risk of skin cancer demonstrated

• None

• None

• For efficacy and monitor for burning

• Category C

• No data available

• Safe provided patient can follow instructions, however no systemic absorption studies have been performed

• No studies 

• moderate to severe psoriasis.

• 15 mg every week given as an intramuscular injection for 12 weeks, with a 12 week follow-up non-treatment period

• 21% of patients achieved a PASI 75 at week 14

• Associated with long remissions in a subset of responders.
• Prior response to alefacept is a likely marker of future treatment response. Thus, patients responding to the first course of therapy may be treated long-term with repeated 12-week courses of alefacept – at a minimum of 24 week intervals.

• Excellent safety profile in clinical trials.

• CD4 count

• Biweekly CD4 count required
• Hold dose for counts <250

• Category B

• HIV infection

• moderate - severe psoriasis

• 45 mg of ustekinumab at baseline, 4 weeks and every 12 weeks in those < 100 kg, and 90 mg of ustekinumab at the same intervals for those > 100 kg.

• PASI 75 in 67% at 12 weeks.

• PASI 75 maintained in 87% of patients at 52 weeks who attained PASI 75 at week 12.

• Occasional injection site reactions.
• Rare reports of serious infections and malignancies including skin cancers.
• Rare reports of major adverse cardiovascular events (MACE).

• PPD is required
• LFT, CBC and hepatitis profile

• Periodic history and physical examination recommended while on treatment.
• Yearly PPD, and periodic CBC and LFT.

• Category B

• moderate/severe psoriatic arthritis, moderate to severe psoriasis, adult and juvenile rheumatoid arthritis (as young as age 4), ankylosing spondylitis, and Crohn’s disease.

• 80mg the first week, 40 mg the second week, followed by 40mg every other week given subcutaneously.

• 80% of patients achieve PASI 75 at 12 weeks.

• 68% of patients achieve PASI 75 at 60 weeks.
• Small percentage of patients lose efficacy with continued use.

• Moderately painful injection site reactions are noted.
• Rare reports of serious infections (i.e., tuberculosis and opportunistic infections) and malignancies.
• There are rare reports of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS as well as exacerbation of and new onset of CHF.

• PPD is required.
• Liver function tests, CBC, and hepatitis profile.

• Periodic history and physical exam are recommended while on treatment.
• Consider a yearly PPD, and periodic CBC and liver function studies.

• Category B.

• moderate to severe psoriasis, moderate/severe psoriatic arthritis, adult and juvenile rheumatoid arthritis (as young as age 4), and ankylosing spondylitis.

• 50mg twice weekly given subcutaneously for 3 months followedby 50 mg once weekly.

• 49% of patients given 50 mg twice weekly achieved a PASI 75 at 12 weeks
• 34% of patients given 25 mg twice weekly achieved a PASI 75 at 12 weeks.

• 54% of patients whose dose was decreased from 50 mg twice weekly to 25 mg twice weekly achieved a PASI 75 at 24 weeks
• 45% of patients whose dose remained at 25 mg twice weekly achieved a PASI 75 at 24 weeks.

• Mildly pruritic injection site reactions may occur.
• Rare cases of serious infections (i.e.,. tuberculosis) and malignancies.
• There are also rare cases of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS, as well as exacerbation and new onset of CHF.

• PPD, LFT, and CBC

• Periodic history and physical exam are recommended while on treatment.
• Consider yearly PPD, and periodic CBC and liver function studies

• Category B.

• Sepsis

• severe psoriasis, moderate/severe psoriatic arthritis, adult rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis and Crohn’s disease.

• 5mg/kg dose infusion schedule at weeks 0, 2, 6 and then every 6-8 weeks. Dose and interval of infusions may be adjusted as needed.

• 80% of patients achieved a PASI 75 at week 10
• 50% PASI improvement noted by 2nd week.

• 61% of patients achieved a PASI 75 at week 50.

• Infusion reactions and serum sickness can occur - more commonly in patients who have developed antibodies.
• The incidence of infusion reactions may be reduced by concurrent administration of methotrexate.
• Rare cases of serious infections (i.e., tuberculosis) and malignancies including hepatosplenic T-cell lymphoma (in children).
• There are rare reports of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS as well as exacerbation of and new onset of CHF.

• PPD is required.
• LFT’s, CBC, and hepatitis profile.

• Periodic history and physical exam are recommended while on treatment.
• Consider a yearly PPD, and periodic CBC and liver function studies.

• Category B

• Infliximab at doses of greater than 5 mg/kg should not be given to patients with New York Heart Association Functional Class Type 3 or 4 CHF.

• Moderate/severe psoriatic arthritis, moderate/severe psoriasis, adult and juvenile rheumatoid arthritis (as young as age 4), ankylosing spondylitis, and adult Crohn’s disease.

• 40mg every other week subcutaneously

• ACR 20 at week 12 is 58%

• Moderately painful injection site reactions are noted.
• Rare reports of serious infections (i.e., tuberculosis and opportunistic infections) and malignancies.
• There are rare reports of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS as well as exacerbation of and new onset of CHF.

• Moderate/severe psoriatic arthritis, moderate to severe psoriasis, adult and juvenile rheumatoid arthritis (as young as age 4), and ankylosing spondylitis.

• 25mg twice weekly or 50 mg once weekly given subcutaneously

• ACR 20 at 12 weeks is 59%

• Mildly pruritic injection site reactions may occur.
• Rare cases of serious infections (i.e.,. tuberculosis) and malignancies.
• There are also rare cases of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS, as well as exacerbation and new onset of CHF.

• PPD, LFT, and CBC

• Periodic history and physical exam are recommended while on treatment.

• moderate - severe psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis

• 50 mg every 4 weeks subcutaneously.

• ACR 20 - 51% at wk 14.

• Occasional injection site reactions.
• Rare reports of serious infections and malignancies.
• Although there are rare reports of drug-induced reversible side effects including lupus without CNS or renal complications, cytopenias, multiple sclerosis, and exacerbation as well as new onset congestive heart failure with the other three TNF inhibitors, there have been no reports of these reactions with golimumab to date. However, golimumab is a TNF inhibitor and it should be used cautiously.

• PPD is required
• LFT and CBC

• Periodic history and physical examination recommended while on treatment.
• Consider a yearly PPD, and periodic CBC and LFT.

• Category B

• Moderate/severe psoriatic arthritis, severe psoriasis, adult rheumatoid arthritis, ankylosing spondylitis, and Crohn’s disease (pediatric and adult).

• 5mg/kg given intravenously at weeks 0, 2, 6 and then every 6 - 8 weeks. Dose and interval of infusions may be adjusted as needed.

• ACR 20 at week 14 is 58%

• Infusion reactions and serum sickness can occur - more commonly in patients who have developed antibodies.
• The incidence of infusion reactions may be reduced by concurrent administration of methotrexate.
• Rare cases of serious infections (i.e., tuberculosis) and malignancies including hepatosplenic T-cell lymphoma (in children). There are rare reports of drug-induced, reversible side effects including lupus without renal or CNS complications, cytopenias, MS as well as exacerbation of and new onset of CHF.

• PPD is required.
• LFT’s, CBC, and hepatitis profile.

• Periodic history and physical exam are recommended while on treatment.
• Consider a yearly PPD, and periodic CBC and liver function studies.

• Salicylates
• Naproxen
• Ibuprofen
• Indomethocin
• Phenylbutazone

• Trimethoprim/sulfamethoxazole
• Sulfonamides
• Penicillins
• Ciprfloxacin

• Barbiturates
• Colchicine
• Dipyramidole
• Ethanol
• Phenytoin
• Sulfonylureas
• Furosemide
• Thiazide diuretics