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Psoriasis and Psoriatic Arthritis
Developed by:Mike Crowe, PharmD, MBA, CSP, FMPA
Jonathan Clark, PharmD
Presented by:Mike Crowe , PharmD, MBA, CSP, FMPA
Speaker Disclosure
Michael Crowe has nothing to disclose.
2
Learning Objectives
At the completion of this presentation, audience members should be able to:
• Discuss the incidence and patient demographics of psoriasis and psoriatic arthritis.
• Describe the signs, symptoms, diagnosis and screening for psoriasis and psoriatic arthritis.
• Outline psoriasis and psoriatic arthritis treatment guidelines.
• Describe the appropriate pharmacologic management of psoriasis and psoriatic arthritis.
Psoriasis
Disease Overview and Presentation
3
Epidemiology
• Affects approximately 7.4 million people in the United States1
– Initial onset usually between ages 15 – 35 years
– Higher incidence in Caucasians
• Detrimental effects include:2
– High degree of morbidity
– Reduced levels of employment and income
– Reduced quality of life
– High costs for long‐term therapy1) Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad
Dermatol. 2014;70(3):512‐516. doi: 10.1016/j.jaad.2013.11.013.2) Nestle F, Kaplan D, Barker J. Psoriasis. N Engl J Med. 2009;361(5):496‐509. doi: 10.1056/NEJMra0804595.
Pathophysiology
• Plaques
– Hyperproliferation of keratinocytes
• Average turnover rate of 311 hours shortened to 36 hours1
– Abnormal skin cell differentiation
• Potential for scaling and silvery‐white patches
– Increased inflammatory cells
– Vascular changes
• Potential joint involvement (psoriatic arthritis)
1) Tsuruta D. NF‐ĸB links keratinocytes and lymphocytes in the pathogenesis of psoriasis. Recent Pat Inflamm Allergy Drug Discov. 2009;3(1):40‐48.
4
Pathophysiology
Nestle F, Kaplan D, Barker J. Psoriasis. N Engl J Med. 2009;361(5):496‐509. doi: 10.1056/NEJMra0804595.
AMPs = antimicrobial peptides; CCL = chemokine (C‐C motif) ligand; CXCL = chemokine (C‐X‐C motif) ligand; IFN = interferon; IL = interleukin ; Th1 = T helper type 1; Th17 = T helper type 17; TNF = tumor necrosis factor
Causes
• Exact etiology unknown
• Predisposing factors
– Genetics1
• Family history increases risk
– Environmental factors2,3
• Stress
• Infections
• Social characteristics– Alcohol use, smoking, obesity
• Cold, dry weather and lack of sunlight1) Nestle F, Kaplan D, Barker J. Psoriasis. N Engl J Med. 2009;361(5):496‐509. doi: 10.1056/NEJMra0804595.2) Meffert J. Psoriasis. Medscape website. emedicine.medscape.com/article/1943419‐overview. Updated November 7, 2016. Accessed February 11, 2016.3) Menter A, Gottlieb A, Feldman S, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1: overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826‐50. doi: 10.1016/j.jaad.2008.02.039.
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Exacerbating Agents
Most Common Associated Less Common
• Antimalarials (e.g., hydroxychloroquine)
• Beta blockers• Lithium
• Angiotensin‐convertingenzyme inhibitors
• Antibiotics (e.g., tetracyclines)
• Benzodiazepines• Interferons• Nonsteroidal anti‐
inflammatory drugs• Terbinafine
• Amiodarone• Cimetidine• Clonidine• Digoxin• Fluoxetine• Gemfibrozil• Gold• Imiquimod• Quinidine• Tumor necrosis factor
alpha inhibitors
Kim GK, Del Rosso JQ. Drug‐provoked psoriasis: is it drug induced or drug aggravated? J Clin Aesthet Dermatol. 2010;3(1):32‐38.
Types of Psoriasis
• Plaque psoriasis
– Affects 85 – 90% of patients1
– Thick, erythematous, sharply marginated lesions
• Silvery‐white scales often involved
• Symmetrical and stable
– Common sites: scalp, trunk, buttocks, and limbs
– May experience pain, fever, chills, and/or pruritus2,3
1) Nestle FO, et al. N Engl J Med 2009;361:496‐509.2) Griffiths CE, Christophers E, Barker JN, et al. A classification of psoriasis vulgaris according to phenotype. Br J Dermatol. 2007;156(2):258‐262. doi: 10.1111/j.1365‐2133.2006.07675.x.3) Yosipovitch G, Goon A, Wee J, et al. The prevalence and clinical characteristics of pruritus among patients with extensivepsoriasis. Br J Dermatol. 2000;143(5):969‐973.
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Types of Psoriasis• Guttate psoriasis
– Affects up to 10% of patients1
• Tends to occur in individuals younger than 30 years2
• May be associated with streptococcal infections
– Presentation includes several red droplike lesions on the trunk and limbs2
• Inverse psoriasis
– Usually occurs with other forms of psoriasis
– Highly erythematous lesions in intertriginous areas (e.g., axilla, genitals, between buttocks, submammary region)
• Minimal scaling due to moist locations
1) Menter A, Gottlieb A, Feldman S, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1: overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826‐50. doi: 10.1016/j.jaad.2008.02.039.2) Guttate psoriasis. National Psoriasis Foundation website. psoriasis.org/about‐psoriasis/types/guttate. Accessed February 11, 2017. 3) Langley R, Drueger G, Griffiths, C. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64(suppl 2):18‐23. doi: 10.1136/ard.2004.033217.
Types of Psoriasis• Erythrodermic psoriasis
– Affects approximately 3% of patients• Generally occurs in those with unstable plaque psoriasis
– Most severe type with large amounts of skin shedding• Can lead to itching, pain, infection, pneumonia, hypothermia, and congestive heart failure1,2
• Pustular psoriasis
– Usually appears as white blisters and may be severe• Symptoms include malaise, fever, diarrhea, and lab value abnormalities
– Typically occurs on a cyclical basis and affects the palms of the hands and soles of the feet3
– May be triggered by local irritants, pregnancy, medications, infections, and systemic glucocorticoid withdrawal4
1) About psoriasis. National Psoriasis Foundation website. psoriasis.org/about‐psoriasis. Accessed February 11, 2017.2) Erythrodermic psoriasis. National Psoriasis Foundation website. psoriasis.org/about‐psoriasis/types/erythrodermic. Accessed February 11, 2017.3) Pustular psoriasis. National Psoriasis Foundation website. psoriasis.org/about‐psoriasis/types/pustular. Accessed February 11, 2017. 4) Morrison AO. Overview of pustular psoriasis. Medscape website. emedicine.medscape.com/article/1108220‐overview. Updated January 26, 2017. February 11, 2017.
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Comorbidities
• Patients with psoriasis are at increased risk of developing metabolic syndrome and cardiovascular disease
• Patients with psoriasis have a higher incidence of other autoimmune diseases (e.g., multiple sclerosis, Crohn’s disease) and skin cancer
• Potential for physical and mental disabilities
– Dermatology Life Quality Index (DLQI)
Menter A, Gottlieb A, Feldman S, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1: overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826‐50. doi: 10.1016/j.jaad.2008.02.039.
Psoriatic Arthritis
Differentiation and Classification
8
Presentation• Inflammatory arthropathy associated with psoriasis, joint pain, stiffness, and inflammation1,2
– Enthesitis and dactylitis
• Up to 42% of patients with psoriasis may develop psoriatic arthritis
– Nail involvement may place patients at higher risk for joint involvement3
1) Luba KM, Stulberg DL. Chronic plaque psoriasis. Am Fam Physician. 2006;73(4):636‐644. 2) Gottlieb A, Korman N, Gordon K, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 2: psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008;58(5):851‐864. doi:10.1016/j.jaad.2008.02.040.3) Menter A, Gottlieb A, Feldman S, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1: overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826‐50. doi: 10.1016/j.jaad.2008.02.039.
Psoriatic Arthritis vs. Rheumatoid Arthritis
Characteristic Psoriatic Arthritis Rheumatoid Arthritis
Psoriasis Yes Uncommon
Peripheral disease Asymmetric Symmetric
Stiffness In the morning and/or with immobility
In the morning and/or with immobility
Female to male ratio 1:1 3:1
Enthesitis Yes No
High titer rheumatoid factor (RF) No Yes
Human leukocyte antigen (HLA) association
CW6, B27 DR4
Nail lesions Yes No
Subcutaneous nodules Less common More common
Ocular involvement Less common More common
1) Gottlieb A, Korman N, Gordon K, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 2: psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008;58(5):851‐864. doi:10.1016/j.jaad.2008.02.040.2) Hammadi AA. Psoriatic arthritis. Medscape website. emedicine.medscape.com/article/2196539‐overview#showall. Updated January 21, 2016. Accessed February 10, 2017.
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Onset
• Psoriatic symptoms tend to precede arthritis symptoms in 60 – 80% of cases1
– Usually within 10 years
• Psoriatic arthritis is underdiagnosed
– Estimated that one‐third of patients with psoriasis are undiagnosed2
• Diagnosis is often delayed
1) Hammadi AA. Psoriatic arthritis. Medscape website. emedicine.medscape.com/article/2196539‐overview#showall. Updated January 21, 2016. Accessed February 10, 2017.2) Hampton T. Psoriatic arthritis: early diagnosis matters. MedPage Today website. medpagetoday.com/resource‐center/Psoriasis‐psoriatic‐arthritis/early‐diagnosis/a/46125. Published June 3, 2014. Accessed February 11, 2017.
Classification
• Classification Criteria for Psoriatic Arthritis (CASPAR)
– Established inflammatory articular disease and at least 3 points from the following features
Feature Points
Current psoriasis 2
History of psoriasis without current symptoms 1
Family history of psoriasis without current symptoms 1
History or current symptoms of dactylitis 1
Juxta‐articular new‐bone formation 1
Negative test result for rheumatoid factor 1
Nail dystrophy 1
Boyd T, Kavanaugh A. Novel treatment concepts in psoriatic arthritis. Rheum Dis Clin N Am. 2015;41(4):739‐754. doi: 10.1016/j.rdc.2015.07.011.
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Psoriasis and Psoriatic Arthritis
Treatment and the Pharmacist’s Role
Treatment Considerations
• Treatment regimens may change over time
• Primary goal: skin normalization
• Other goals:
– Itch relief
– Reduction of flares
– Managing adverse effects
– Improving quality of life
• The first step after diagnosis is determining the severity of the disease
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Disease Severity
American Academy of Dermatology (AAD) definitions:
• Mild psoriasis
– Less than 5% body surface area (BSA) affected
• Moderate psoriasis
– Greater than or equal to 5%, but less than 10% BSA affected
• Severe psoriasis
– Greater than or equal to 10% BSA affected
Mentor A, Korman NJ, Elmets CA, et al.; American Academy of Dermatology Work Group. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6: guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case‐based presentations and evidence‐based conclusions. J Am Acad Dermatol. 2011;65(1):137‐174. doi:10.1016/j.jaad.2010.11.055.
Rule of Nines
Modified from: The human body in anatomical position.© Osteomyoamare (https://commons.wikimedia.org/wiki/File:Anatomical_Position.png). CC‐BY‐3.0
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Disease Severity Evaluation Tools
• Psoriasis Area and Severity Index (PASI)– Commonly used in clinical trials
– Score ranges from no disease (0) to maximal disease (72)
– 75% improvement in the PASI score (PASI 75) frequently required of biologic agents prior to FDA approval
• Physician’s Global Assessment (PGA)– Focus on overall psoriasis severity
– 7‐point scale ranging from clear skin (0) to severe disease (6)
• Subjective measures used in clinical practice
Menter A, Gottlieb A, Feldman S, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1: overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826‐50. doi: 10.1016/j.jaad.2008.02.039.
Psoriasis Treatment Options
Topical
Creams & Ointments Phototherapy
Systemic
Traditional Oral Agents Biologics
1) Menter A, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 3. J Am Acad Dermatol. 2009; 60(40):643‐656.2) Menter A, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1. J Am Acad Dermatol. 2008;58:826‐50
Targeted Oral Agents
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Treatment Guidelines
American Academy of Dermatology Decision Tree for the Treatment of Psoriasis and Psoriatic Arthritis
Anti‐TNF = tumor necrosis factor inhibitor; MTX = methotrexate; PsA = psoriatic arthritis. *Patients not physically limited by PsA should not automatically begin therapy with an anti‐TNF agent. †Patients with limited disease that does not improve should not automatically begin systemic therapy because the risk of systemic therapy may outweigh the risks of the disease.
Adapted from Menter A, Gottlieb A, Feldman S, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1: overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826‐850. doi: 10.1016/j.jaad.2008.02.039.
Nonpharmacologic Therapy
• Support groups and counseling
• Hygienic practices
– Avoid harsh soaps and detergents
– Use fragrance‐free soaps
– Use lukewarm water when showering or bathing
• Phototherapy with ultraviolet (UV) light
– Antiproliferative and anti‐inflammatory effects
– Usually reserved for patients with less than 10% BSA involvement or pregnant women
– Avoid in patients with a history of skin cancer
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Nonpharmacologic Therapy
• Photochemotherapy (PUVA)
– Psoralens (e.g., methoxsalen) administered topically or orally before exposure to UVA light
– Contraindicated in pregnancy1
• Emollients
– Prevent evaporation from deep layers of the skin
– Should be applied topically 1 to 3 times a day2
1) Menter A, Korman N, Elmets C, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2009; 62(1):114‐131. doi:10.1016/j.jaad.2009.08.026.2) Menter A, Korman N, Elmets C, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009; 60(40):643‐656. doi:10.1016/j.jaad.2008.12.032.
Pharmacologic Treatments
Topical therapy
• Patient preference and adherence is key
• Fingertip unit (FTU) useful for application1
• MonotherapyMild to Moderate Psoriasis
• Combination therapySevere Psoriasis
1) Menter A, Korman N, Elmets C, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009; 60(40):643‐656. doi:10.1016/j.jaad.2008.12.032.
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Pharmacologic Treatments
Calcineurin inhibitors
Corticosteroids
Keratolytics
Retinoids
Vitamin D analogs
Coal tar
Anthralin
Topical Therapies
Pharmacologic TreatmentsTraditional systemic therapies
Agent Indication(s) Typical Dose Adverse Effects Counseling Points
Acitretin (Soriatane®)
Severe plaque psoriasis
25 – 50 mg/day (lower doses may be used)
Hypervitaminosis A, hyperlipidemia, hepatotoxicity, gastrointestinal (GI) intolerance
Take with a meal, do not consume alcohol, do not donate blood
Cyclosporine (Neoral®)
Severe, recalcitrant plaque psoriasis
2.5 – 4 mg/kg/day in 2 divided doses (dose may be reduced)
Hypertension, elevated lipids, GI intolerance, headache, gingival hyperplasia, hair growth
Long‐term therapy not recommended due to risk of malignancy, no live vaccinations
Methotrexate (TrexallTM)
Severe, recalcitrant, disabling psoriasis
7.5 – 25 mg once weekly; increase by 2.5 mg every 2 – 4 weeks until response (do not exceed 30 mg/week)
Myelosuppression, hepatotoxicity, nausea, vomiting, stomatitis, malaise, headaches, pulmonary toxicity
Avoid use in breastfeeding women and within 3 months of pregnancy for both men and women
1) Menter A, Korman N, Elmets C, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009; 61(3):451‐480. doi:10.1016/j.jaad.2009.03.027.
2) Soriatane [package insert]. Research Triangle Park, NC: Stiefel Laboratories, Inc.; 2015.
3) Neoral [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2015.
4) Methotrexate [package insert]. Eatontown, NJ: West‐Ward Pharmaceuticals Corporation; 2016.
16
Pharmacologic Treatments
Traditional systemic therapies
Agent Indication(s) Typical Dose Adverse Effects Counseling Points
Leflunomide (Arava®)
Not FDA‐approved for PsO or PsA; limited data in PsA
Loading dose 100 mg/day for 3 days; maintenance dose up to 20 mg/day
Myelosuppression, hepatotoxicity, nausea, vomiting, stomatitis, malaise, headaches, pulmonary toxicity
Avoid use in pregnancy and nursing
Sulfsalazine (Azulfidine®)
Not FDA‐approved for PsO or PsA
500 mg twice daily; may increase up to 3 –4 g/day as tolerated
Headache, GI intolerance, anorexia, allergic reaction
Breastfed newborns have risk of kernicterus
Tacrolimus (Prograf®)
Not FDA‐approved for PsO or PsA
0.05 – 0.15 mg/kg/day; appropriate duration of treatment is unknown
Nephrotoxicity, hypertension, elevated lipids, GI intolerance, headache, gingival hyperplasia, hair loss
Avoid use while breastfeeding
1) Menter A, Korman N, Elmets C, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009; 61(3):451‐480. doi:10.1016/j.jaad.2009.03.027.
2) Arava [package insert]. Bridgewater, NJ: Sanofi‐aventis U.S. LLC; 2016.
3) Azulfidine [package insert]. New York, NY: Pharmacia and Upjohn Company; 2014.
4) Prograf [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; 2015.
GI = gastrointestinal; PsA = psoriatic arthritis; PsO = psoriasis
Pharmacologic Treatments
• Biologic therapies
– Generally reserved for moderate to severe psoriasis when other therapies are inadequate or contraindicated1
– Usually monotherapy, unless used in combination with traditional systemic therapy for psoriatic arthritis
1) Menter A, Gottlieb A, Feldman S, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1: overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826‐50. doi: 10.1016/j.jaad.2008.02.039.
17
Biologic Therapies
Highly effective
Well tolerated
Few drug interactions
Cost
Prior authorization
Administration route
Biologic Therapies
• Safety considerations
– Contraindicated in patients with active, serious infections
– Screen for tuberculosis and hepatitis
– Practice good hygiene
– Increased risk of infections
• May discontinue biologic use during infection treatment
– Vaccinations should be up‐to‐date
• Avoid live vaccinations while on biologic therapy
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Biologic Therapies
• Counseling
– Injection site and infusion reactions
• Patients may experience pain, irritation, or rash
• Rotate injection sites and allow the product to warm to room temperature prior to administration
– Ensure full dose is administered before withdrawal of an injection device and dispose appropriately
– Do not rub the injection site
– Response to therapy may take up to 12 weeks, depending on the product
Biologic Therapies
• Tumor necrosis factor (TNF)
– Proposed to stimulate synthesis of several inflammatory cytokines
– Patients with psoriasis have elevated TNF levels
• Degree of elevation corresponds with the PASI score1
Menter A, Gottlieb A, Feldman S, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1: overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826‐50. doi: 10.1016/j.jaad.2008.02.039.
19
Biologic Therapies
• TNF inhibitors
– Adalimumab (Humira®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), and infliximab (Remicade®)
– Warnings and Precautions
• Hepatitis B
• Moderate to severe heart failure
• Multiple sclerosis
• Tuberculosis
– Potential for decreased efficacy over time
Biologic Therapies
• Ustekinumab (Stelara®)1
– IL‐12 and IL‐23 inhibitor
– Most common adverse effects are infection, fatigue, and headache
• Secukinumab (Cosentyx®)2
– IL‐17A inhibitor
– Most common adverse effects are nasopharyngitis, headache, upper respiratory tract infection, and diarrhea
1) Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2016.
2) Cosentyx [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016.
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Biologic Therapies• Ixekizumab (Taltz®)1
– IL‐17A inhibitor
– Most common adverse effects are injection site reactions, upper respiratory tract infections, nausea, and tinea infections
• Brodalumab (Siliq®)2
– IL‐17A inhibitor
– Most common adverse effects are arthralgia, nasopharyngitis, upper respiratory tract infection, and headache
– Black box warning and REMS program for suicidal ideation and behavior
1) Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
2) Tong Y, Peranteau AJ, Nawas Z, Tyring SK. A Review of Brodalumab, an IL‐17 Receptor Antagonist, for Moderate‐to‐Severe PlaquePsoriasis. Skin Therapy Lett. 2017; 22(1):1‐6.
Targeted Oral Therapies
• Apremilast (Otezla®)
– cAMP specific phosphodiesterase‐4 (PDE4) inhibitor
– Most common adverse effects are diarrhea, nausea, headache, and upper respiratory tract infection1
– Dose titrated over 5 days to avoid gastrointestinal intolerance; adjust dose for renal impairment
– Increased risk of depression and weight loss
– Avoid strong CYP450 inducers (e.g., rifampin)
– Pregnancy category C; avoid nursing
1) Otezla [package insert]. Summit, NJ: Celgene Corporation; 2016.
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Biologic and Targeted Oral Therapies
Agent Target Indications* Route and Dosing
Adalimumab
(Humira®)TNF PsO, PsA
• Subcutaneous injection
• PsO: 80 mg initially, then 40 mg every other week
starting one week later
• PsA: 40 mg every other week
Apremilast
(Otezla®)PDE4 PsO, PsA
• Oral tablet
• 30 mg twice daily after completion of 5‐day
titration dosing:
Day 1: 10 mg in AM
Day 2: 10 mg in AM, 10 mg in PM
Day 3: 10 mg in AM, 20 mg in PM
Day 4: 20 mg in AM, 20 mg in PM
Day 5: 20 mg in AM, 30 mg in PM
1) Humira [package insert]. North Chicago, IL: AbbVie Inc.; 2016.
2) Otezla [package insert]. Summit, NJ: Celgene Corporation; 2016.
AM = morning; PM = evening; PDE4 = phosphodiesterase 4; PsA = psoriatic arthritis; PsO = plaque psoriasis; TNF = tumor necrosis factor. *Only FDA‐approved indications for PsO and PsA are presented in this table.
Biologic and Targeted Oral Therapies
Agent Target Indications* Route and Dosing
Brodalumab
(Siliq®)IL‐17A Refractory PsO
• Subcutaneous injection
• 210 mg at Weeks 0, 1, and 2 followed by 210 mg
every 2 weeks
Certolizumab
pegol
(Cimzia®)
TNF PsA
• Subcutaneous injection
• 400 mg initially and at Week 2 and 4, followed by
200 mg every other week; for maintenance
dosing, 400 mg every 4 weeks can be considered
Etancercept
(Enbrel®)TNF PsO, PsA
• Subcutaneous injection
• PsO: 50 mg twice weekly for 3 months, followed
by 50 mg once weekly
• PsA: 50 mg once weekly with or without
methotrexate
1) Siliq [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals; 2017.
2) Cimzia [package insert]. Smyrna, GA: UCB, Inc.; 2017.
3) Enbrel [package insert]. Thousand Oaks, CA: Immunex Corporation; 2016.
IL‐17A = interleukin‐17A; PsA = psoriatic arthritis; PsO = plaque psoriasis; TNF = tumor necrosis factor.*Only FDA‐approved indications for PsO and PsA are presented in this table
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Biologic and Targeted Oral Therapies
Agent Target Indications* Route and Dosing
Golimumab
(Simponi®)TNF PsA
• Subcutaneous injection
• 50 mg once a month
Infliximab
(Remicade®)TNF PsO, PsA
• Intravenous infusion
• 5 mg/kg at Weeks 0, 2, and 6, then every 8 weeks
Ixekizumab
(Taltz®)IL‐17A PsO
• Subcutaneous injection
• 160 mg at Week 0, followed by 80 mg at Weeks 2,
4, 6, 8, 10, and 12, then 80 mg every 4 weeks
1) Simponi [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2017.
2) Remicade [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2017.
3) Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
IL‐17A = interleukin‐17A; PsA = psoriatic arthritis; PsO = plaque psoriasis; TNF = tumor necrosis factor.*Only FDA‐approved indications for PsO and PsA are presented in this table
Biologic and Targeted Oral Therapies
Agent Target Indications* Route and Dosing
Secukinumab
(Cosentyx®)IL‐17A PsO, PsA
• Subcutaneous injection
• PsO: Recommended dosage is 300 mg at Weeks 0, 1, 2, 3,
and 4 followed by 300 mg every 4 weeks; for some patients,
a dose of 150 mg may be acceptable
• PsA: For patients with coexistent moderate to severe PsO,
use the dosage and administration for PsO; for others,
administer with or without a loading dosage. Recommended
dosage:
• With a loading dosage: 150 mg at Weeks 0, 1, 2, 3, and
4, then every 4 weeks thereafter
• Without a loading dosage: 150 mg every 4 weeks
• If a patient continues to have active psoriatic arthritis,
consider a dosage to 300 mg per dose
1) Cosentyx [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016.
IL‐17A = interleukin‐17A; PsA = psoriatic arthritis; PsO = plaque psoriasis.*Only FDA‐approved indications for PsO and PsA are presented in this table.
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Biologic and Targeted Oral Therapies
Agent Target Indications* Route and Dosing
Ustekinumab
(Stelara®)IL‐12/23 PsO, PsA
• Subcutaneous injection
• PsO: For patients weighing ≤100 kg (220 lbs), the
recommended dose is 45 mg initially and 4 weeks later,
followed by 45 mg every 12 weeks. Use 90 mg per dose for
patients greater than 100 kg.
• PsA: 45 mg initially and 4 weeks later, followed by 45 mg
every 12 weeks. Use 90 mg per dose for patients with
coexistent moderate to severe PsO weighing >100 kg.
1) Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2016.
IL‐17A = interleukin‐17A; PsA = psoriatic arthritis; PsO = plaque psoriasis.*Only FDA‐approved indications for PsO and PsA are presented in this table.
Treatment Selection
Mentor A, Korman NJ, Elmets CA, et al.; American Academy of Dermatology Work Group. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6: guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case‐based presentations and evidence‐based conclusions. J Am Acad Dermatol. 2011;65(1):137‐174. doi:10.1016/j.jaad.2010.11.055.
Mild psoriasis
• First line: topical therapies, phototherapy
• Second line: short term use of systemic therapies
Moderate or severe psoriasis
• First line: systemic agents, phototherapy, photochemotherapy, biologics
Psoriasis with physically‐limiting psoriatic arthritis
• First line: anti‐TNF agent +/‐methotrexate
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Treatment Selection
• Caveats in AAD recommendations for moderate to severe psoriasis
– Golimumab not recommended for patients without psoriatic arthritis
– Ustekinumab is second line for adult patients with psoriatic arthritis, in combination with methotrexate
– The latest AAD treatment guidelines were published before approval of apremilast, certolizumab pegol, ixekizumab, secukinumab, and brodalumab for psoriatic conditions
Mentor A, Korman NJ, Elmets CA, et al.; American Academy of Dermatology Work Group. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6: guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case‐based presentations and evidence‐based conclusions. J Am Acad Dermatol. 2011;65(1):137‐174. doi:10.1016/j.jaad.2010.11.055.
Pharmacist’s Role
• Ensure optimal drug therapy selection
• Educate patients on:
– Potential adverse effects and mitigation strategies
– Proper dosing and administration
– Potential drug interactions
– Efficacy expectations
– Adherence
– Contraindications
– Appropriate vaccinations
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Conclusion
• Pharmacists are in a favorable position to educate patients and increase their probability of success with therapy for psoriasis and psoriatic arthritis
• Pharmacist support can influence adherence, efficacy, adverse effect management, and overall health outcomes
Thank you!