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Applying Science to Improve the Individualized Treatment of Patients with Psoriasis Abrar Qureshi, MD, MPH Chief of the Department of Dermatology Rhode Island Hospital Chair, Department of Dermatology The Warren Alpert Medical School of Brown University
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Patient Case Studies History and Clinical Presentation
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Case #1: History A 25-year-old female presents to her primary care provider with a history of an itchy, red rash on her arms and legs for 3 months and the rash is spreading gradually. She has had a long-standing history of scalp “dandruff” and uses anti-dandruff shampoos frequently. The patient denies fever, recent illness, new exposures, or travel, and otherwise feels well. She reports that she has had a similar rash on her elbows and knees over the last couple of years that resolved in the summer months; but this time the rash has persisted. Past medical history: no previous illnesses or surgeries Family history: mother has spinal arthritis; father and siblings are healthy Social history: no tobacco use; 1-2 alcoholic drinks per week; married 6 months ago; works full time as a receptionist; has been avoiding social situations because she feels self-conscious Medications: oral contraceptive pills; over-the-counter hydrocortisone cream (0.5%) Allergies: No known drug allergies
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Case #1: Clinical Presentation Physical exam reveals small plaques with whitish or silvery scale, involving approximately 9% body surface area (BSA) Lesions are mainly on the arms and legs with some buttock involvement, but the trunk is relatively spared There are no visible nail changes, but scalp involvement is severe with thick plaques covered with a thick plate of scale There are several bleeding points where she had been scratching her scalp
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Scalp Psoriasis Photos courtesy of Abrar Qureshi, MD, MPH.
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Case #2: History A 54-year-old obese male diagnosed with chronic plaque psoriasis more than 15 years ago is seeking a consultation with a dermatologist because he recently heard of the availability of new treatments. He has been applying clobetasol ointment, which he has used intermittently over the years. The patient had been treated briefly with SC methotrexate several years ago but discontinued it because of nausea. He did get some relief from phototherapy, but he had to stop because he is not able to get away from work during the day to attend the treatment sessions. The patient denies joint pain or swelling. Past medical history: hypertension, elevated cholesterol and triglycerides; recently diagnosed with metabolic syndrome Family history: mother had colon cancer; father had coronary artery disease; no siblings Social history: current cigarette smoker (1.5 packs per day for 35 years); 1 alcoholic drink/day; married with 2 teenage children; works as an attorney in a busy firm Medications: lisinopril; atorvastatin, clobetasol ointment Allergies: penicillin SC=subcutaneous
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Case #2: Clinical Presentation Physical exam reveals moderately thick plaques covering approximately 40% BSA, with pityriasiform scale above the waist and more thick ostraceous scale below the waist There are several excoriations with hemorrhagic crusting; fingernails demonstrate distal onycholysis He sheds scale all over the exam table and surrounding floor during the visit
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Severe Plaque Psoriasis Photos courtesy of Abrar Qureshi, MD, MPH.
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Excoriated Plaque Psoriasis Photos courtesy of Abrar Qureshi, MD, MPH.
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Onycholysis Photo courtesy of Abrar Qureshi, MD, MPH.
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Interactive Question Please rate your confidence in distinguishing plaque psoriasis from other types of psoriasis. Not at all confident Somewhat confident Very confident Completely confident
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Overview of Psoriasis Chronic systemic inflammatory disorder affecting 2% of the population Manifests primarily in skin and joints Up to 30% of patients with skin disease develop psoriatic arthritis Most common form is plaque psoriasis (80% to 90% of patients) Well-demarcated erythematous patches, papules, and plaques covered by silvery scales Typically symmetric and often pruritic Most commonly involves the scalp, sacral area, extensor surfaces of elbows and knees Other types include guttate, inverse, erythrodermic, and pustular Menter A et al. J Am Acad Dermatol. 2008;58:826-850; Reich A, Szepietowski JC. Clinical aspects of itch: psoriasis. In: Carstens E, Akiyama T, editors. Itch: Mechanisms and Treatment. Boca Raton, FL: CRC Press/Taylor & Francis; 2014. Available at: www.ncbi.nlm.nih.gov/books/NBK200930/. Accessed May 12, 2016.
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Guttate Psoriasis Photo courtesy of Abrar Qureshi, MD, MPH.
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Photos courtesy of Abrar Qureshi, MD, MPH. Inverse Psoriasis
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Erythrodermic Psoriasis Photos courtesy of Abrar Qureshi, MD, MPH.
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Pustular Psoriasis Photo courtesy of Abrar Qureshi, MD, MPH.
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Immunopathogenesis of Plaque Psoriasis DC=dendritic cell; PSORS1=psoriasis susceptibiity 1; IL=interleukin; TNF=tumor necrosis factor. Gaspari AA, Tyring S. Dermatol Ther. 2015;28:179-193; Nestle FO et al. N Eng J Med. 2009;361:496-509. Disease initiation Environmental trigger TNF-α IL-6 IL-1β TNF-α IL-6 IL-1β Psoriatic plaque Keratinocyte activation and proliferation Tc17 IL-17A IL-17F IL-22 IL-23 TNF-α IL-2 IFN-γ Genetic predisposition Disease maintenance Naïve T cell Angiogenesis Neutrophils Activation IL-17A IL-17F IL-22 IL-12
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Assessment and Classification of Psoriatic Disease Severity Armstrong AW et al. JAMA Dermatol. 2013;149:1180-1185; Menter A et al. J Am Acad Dermatol. 2008;58:826-250; Spuls PI et al. J Invest Dermatol. 2010;130:933-943; Both H et al. J Invest Dermatol. 2007;127:2726-2739; Mrowietz U et al. Arch Dermatol Res. 2011;303:1-10. Psoriasis Area and Severity Index (PASI) Assessments Classifications of severity Percentage of BSA involved Location/distribution of lesions (eg, hands, feet, face, genitals) Impact on psychological factors and quality of life Mild disease: <3% BSA Moderate disease: 3%–10% BSA Severe disease: >10% BSA Mild disease: BSA ≤ 10 and PASI ≤ 10 and DLQI ≤ 10 Moderate-to-severe disease: (BSA >10 or PASI >10) and DLQI >10 Lesion characteristics including erythema, scaling, induration Dermatology Life Quality Index (DLQI) BSA
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Comorbid Conditions Associated with Psoriasis Cardiovascular disease Metabolic syndrome and its individual components (ie, hypertension, obesity, impaired glucose regulation, and low HDL levels) Malignancies including lymphoma, melanoma, and nonmelanoma skin cancer Autoimmune diseases (eg, inflammatory bowel disease, multiple sclerosis) Psychiatric conditions including anxiety and depression HDL=high-density lipoprotein. Menter A et al. J Am Acad Dermatol. 2008;58:826-250.
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Patient Case Studies Assessment and Plan
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Case #1: Assessment and Plan Preliminary assessment This patient’s presentation is consistent with moderately severe plaque psoriasis The history suggests initial scalp disease with recent and worsening skin involvement Patient is motivated to treat and agrees to be adherent with topical therapy Plan Apply topical calcipotriene and betamethasone dipropionate (solutions to scalp and ointments to the body) once daily to affected areas; avoid applying to face or around eyes Follow up in 4 weeks
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Case #2: Assessment and Plan Preliminary assessment This patient is presenting with severe inadequately treated chronic plaque psoriasis for many years, complicated by comorbid obesity, hypertension, and dyslipidemia Plan Follow up in 2 weeks to review results of lab tests and to discuss treatment options
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Psoriasis Treatment Modalities UVB=ultraviolet B; UVA=ultraviolet A; PUVA=psoralen plus ultraviolet A. Menter A et al. J Am Acad Dermatol. 2011;65:137-174. Corticosteroids Vitamin D analogs Retinoids Calcineurin inhibitors Anthralin Coal tar UVB UVA PUVA Traditional agents Biologics Small molecules +/- +/- +/-
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Severity of Disease Guides Selection Among Treatment Modalities Menter A et al. J Am Acad Dermatol. 2008;58:826-250; Menter A et al. J Am Acad Dermatol. 2009;60:643-659; Menter A et al. J Am Acad Dermatol. 2010;62:114-135. Yes No Topical agents +/- Yes No Plaque psoriasis diagnosed Signs/symptoms of psoriatic arthritis? Severity of disease? Moderate to severe Mild Effective? Systemic pharmacotherapy Phototherapy Continue current therapy +/- Phototherapy
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Interactive Question How would you rate your knowledge of the mechanisms of action of currently available systemic therapies for psoriasis? Very low Fair, but I need to learn more Sufficient, but I could learn more I think I know all I need to know
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Systemic Pharmacotherapies for Psoriasis
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Traditional Systemic Treatment Options Menter A et al. J Am Acad Dermatol. 2009;61:451-485.
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Therapeutic Targets of Current Biologics and Small Molecules *Approved by FDA for use in psoriatic arthritis; not approved for use in plaque psoriasis. All other agents listed are approved by FDA for use in both plaque psoriasis and psoriatic arthritis, except for ixekizumab, which is currently FDA-approved for use in plaque psoriasis only. PDE-4=phosphodiesterase 4. Menter A et al. J Am Acad Dermatol. 2008;58:826-250; Cimzia [package insert]. Smyrna, GA: UCB, Inc., 2015; Simponi [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2016; Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2014; Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016; Cosentyx [package insert]. East Hanover, NJ: Novartis Pharmaceutical Corp; 2016; Otezla [package insert]. Summit, NJ: Celgene Corp; 2015.
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TNF Inhibition in Psoriasis Gaspari AA, Tyring S. Dermatol Ther. 2015;28:179-193; Nestle FO et al. N Eng J Med. 2009;361:496-509; Narahari S et al. The Dermatologist. 2012;20:38-43. TNF-α Pleotropic, proinflammatory cytokine Released from keratinocytes, T cells, macrophages, mast cells, dermal dendritic cells Leads to recruitment, migration and activation of T cells Causes keratinocyte hyperproliferation, vascular changes, inflammation and subsequent tissue damage TNF inhibitors
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IL-12/IL-23 Inhibition in Psoriasis *Ustekinumab is a human monoclonal antibody directed against the p40 subunit of IL-12 and IL-23. Gaspari AA, Tyring S. Dermatol Ther. 2015;28:179-193; Nestle FO et al. N Eng J Med. 2009;361:496-509; Kofoed K et al. Acta Derm Venereol. 2015;95:133-139; Elyoussfi S et al. Rheumatol Int. 2016;36:603-612. Ustekinumab* IL-12 Heterodimeric pleiotropic cytokine (p40 and p35 subunits) Produced by dendritic cells, macrophages, and B cells Multiple effects on T cells and natural killer cells IL-23 Heterodimeric pleiotropic cytokine (p40 and p19 subunits) Released by dendritic cells Essential for Th17 lymphocyte differentiation
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IL-17A Inhibition in Psoriasis *Ixekizumab is a humanized IgG4 monoclonal antibody against IL-17A; †Secukinumab is a fully human IgG1ĸ monoclonal antibody against IL-17A. Gaspari AA, Tyring S. Dermatol Ther. 2015;28:179-193; Nestle FO et al. N Eng J Med. 2009;361:496-509. Ixekizumab* Secukinumab† IL-17A One of 6 members of the IL-17 family Involved in psoriasis immunopathogenesis at the keratinocyte level Produced by Th17 and Tc17 cells Proinflammatory effects on keratinocytes, macrophages, and endothelial cells Induces expression of neutrophil, T-cell, and dendritic-cell chemokines
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PDE-4 Inhibition in Psoriasis *Proinflammatory cytokines affected by PDE-4 inhibition are indicated with red text. Gaspari AA, Tyring S. Dermatol Ther. 2015;28:179-193; Nestle FO et al. N Eng J Med. 2009;361:496-509; Kofoed K et al. Acta Derm Venereol. 2015;95:133-139; Schafer PH et al. Br J Pharmacol. 2010; 159:842-855.  cAMP Apremilast
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Systemic Biologics and Small Molecules in Late-Stage Development for Plaque Psoriasis Campa M et al. Dermatol Ther. 2016;6:1-12; Kofoed K et al. Acta Derm Venereol. 2015;95:133-139; Valeant announces FDA acceptance of BLA submission for brodalumab in moderate-to-severe plaque psoriasis [news release]. Laval, Quebec. Valeant Pharmaceuticals International, Inc. January 25, 2016. http://ir.valeant.com/news-releases/2016/01-25-2016-130634702. Accessed July 1, 2016; Pfizer receives complete response letter from FDA for oral XELJANZ (tofacitinib citrate) supplemental new drug application for moderate to severe chronic plaque psoriasis [news release]. New York, NY. Pfizer Inc. October 14, 2015. http://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_complete_response_letter_from_fda_for_ oral_xeljanz_tofacitinib_citrate_supplemental_new_drug_application_for_moderate_to_severe_chronic_plaque_psoriasis. Accessed July 1, 2016; Clincaltrials.gov; accessed July 1, 2016.
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Patient Case Studies Follow-up Visit #1
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Case #1: Follow-up Visit 4 Weeks Later Since her last visit, the patient has been using her topical treatments as prescribed After some initial improvement, her rash has become more extensive and now involves her back and abdomen She is becoming increasingly concerned about the appearance of her skin because she is planning a tropical vacation to celebrate her first wedding anniversary in a couple of months On exam, the plaques are somewhat thinner and the scales have improved The scalp is unchanged and new plaques have developed on the patient’s back
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Interactive Question From the options provided below, please select an appropriate systemic treatment for this patient (choose only one): Retinoid (acitretin) Immunosuppressant (cyclosporine or methotrexate) TNF inhibitor (adalimumab, etanercept, or infliximab) IL-12/IL-23 inhibitor (ustekinumab) IL-17A inhibitor (ixekizumab or secukinumab) PDE-4 inhibitor (apremilast) Other (including combination therapy) _________________
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Case #2: Follow-up Visit 2 Weeks Later The patient returns to discuss his treatment options There have been no interval changes The results of the laboratory tests that were ordered at the last visit are as follows: CBC normal BUN/creatinine ratio slightly elevated ALT: 72 AST normal Hepatitis B and C serologies normal Interferon-gamma release assay positive ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea nitrogen; CBC=complete blood count.
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Interactive Question From the options provided below, please select an appropriate systemic treatment for this patient (choose only one): Retinoid (acitretin) Immunosuppressant (cyclosporine or methotrexate) TNF inhibitor (adalimumab, etanercept, or infliximab) IL-12/IL-23 inhibitor (ustekinumab) IL-17A inhibitor (ixekizumab or secukinumab) PDE-4 inhibitor (apremilast) Other (including combination therapy) _________________
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Patient-Related Considerations For Individualized Treatment of Psoriasis Disease severity and impact on quality of life Lifestyle and personal preferences Comorbid conditions Risk factors for adverse effects of therapy (eg, active or latent infection) Response to previous therapy Menter A et al. J Am Acad Dermatol. 2008;58:826-850.
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Considerations For Individualized Treatment of Psoriasis with Traditional Systemic Therapies GI=gastrointestinal; IM=intramuscular. Menter A et al. J Am Acad Dermatol. 2009;61:451-485.
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Considerations For Individualized Treatment of Psoriasis with Biologics and Small Molecules *Approved by FDA for use in psoriatic arthritis; not approved for use in plaque psoriasis. All other agents listed are approved by FDA for use in both plaque psoriasis and psoriatic arthritis, except for ixekizumab, which is currently FDA-approved for use in plaque psoriasis only. IV=intravenous; URTI: upper respiratory infection. Menter A et al. J Am Acad Dermatol. 2008;58:826-250; Strober BE et al. J Am Acad Dermatol. 2016 Feb 4 [Epub ahead of print]. Thaci E et al. J Am Acad Dermatol. 2015;400-409; Cimzia [package insert]. Smyrna, GA: UCB, Inc., 2015; Simponi [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2016; Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2014; Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016; Cosentyx [package insert]. East Hanover, NJ: Novartis Pharmaceutical Corp; 2016; Otezla [package insert]. Summit, NJ: Celgene Corp; 2015.
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Case #1: Assessment and Treatment Considerations Worsening plaque psoriasis despite combination topical therapy Psychological distress/impaired quality of life Up to 79% of patients report psoriasis has an overall negative impact on their lives Scalp involvement Scalp is involved in up to 80% of patients with psoriasis Topical therapy is most commonly used and is often effective Systemic therapies are used for recalcitrant cases The scalp is considered equivalent to the rest of the integument; modifications in the therapeutic regimen are generally not necessary for scalp-specific treatment Pregnancy potential Discuss contraception Consider pregnancy risk category Consider referral to dermatologist Krueger G et al. Arch Dermatol. 2001;137:280-284; Guenther L. Skin Therapy Lett. 2015;20:5-7; Nguyen CM et al. J Drugs Dermatol. 2016;15:272-276; Strober BE et al. Dermatol Ther. 2012;2:1; Menter A et al. J Am Acad Dermatol. 2008;58:826-850; Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2014; Cosentyx [package insert]. East Hanover, NJ: Novartis Pharmaceutical Corp; 2016; Otezla [package insert]. Summit, NJ: Celgene Corp; 2015; Weigle N, McBane S. Am Fam Physician. 2013;87:626-633.
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Case #2: Assessment and Treatment Considerations Chronic severe plaque psoriasis with nail involvement Nail disease (psoriatic onychodystrophy) affects 35%50% of patients with plaque psoriasis and up to 90% of patients with psoriatic arthritis All currently available targeted biologics and small molecules have been shown to improve psoriatic onychodystrophy in clinical trials Multiple comorbidities and risk factors Cigarette smoking Metabolic syndrome (obesity, high triglycerides, hypertension) Elevated liver enzyme Non-alcoholic fatty liver disease has been associated with psoriasis, independently of other risk factors including metabolic syndrome Latent TB All available biologics are associated with an increased risk of TB infection or reactivation TB=tuberculosis. Menter A et al. J Am Acad Dermatol. 2008;58:826-850; Strober BA et al. Dermatol Ther. 2012;2:1; Rich P et al. Br J Dermatol. 2014;170:398-407; Paul C et al. J Eur Acad Dermatol Venereol. 2014;28:1670-1675. Rich P et al. J Am Acad Dermatol. 2016;74:134-142; Langley RG et al. J Eur Acad Dermatol Venereol. 2015;29:1763-1770; Mantovani A et al. Int J Mol Sci. 2016;17(2); Sivamani RK et al. Clinic Rev Allerg Immunol. 2013;44:121-140.
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Recommendations for Screening and Management of Latent and Active TB Infection in Patients Requiring Biologic Therapy CXR=chest x-ray; IGRA=interferon gamma release assay; BCG=Bacillus Calmette-Guérin; TST= tuberculin skin test. Cantini F et al. Autoimmun Rev. 2015;14:503-509. BCG-unvaccinated BCG-vaccinated TST and IGRA IGRA Annual screening with TST and/or IGRA if at high risk for TB exposure CXR TST negative and IGRA negative Annual screening with IGRA if at high risk for TB exposure Preventive therapy for LBTI + TB education Active TB management Start or resume biologic agent after 1 month of LBTI therapy or after completion of treatment for active TB TST and/or IGRA positive No active TB Active TB IGRA positive IGRA negative
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Psoriasis and Cardiovascular Disease Estimated excess of 11,500 (95% CI, 1169 to 24,407) major adverse cardiovascular events in the United States each year Chronic and uncontrolled inflammation from psoriatic disease may be related to endothelial dysfunction that increases cardiovascular risk Systemic therapies for psoriasis (eg, methotrexate and TNF inhibitors) have been associated with reductions in cardiovascular events RR=relative risk; CI-confidence interval; NS=not significant Armstrong EJ et al. J Am Heart Assoc. 2013;2:e000062. Strober BE et al. Dermatol Ther. 2012;2:1. Wu JJ et al. Arch Dermatol. 2012;148:1244-1250; Ahlehoff O et al. J Eur Acad Dermatol Venereol. 2015;29:1128-1134; Hugh J et al. J Am Acad Dermatol. 2014;70:168-177. Psoriasis is associated with an increased risk of major cardiovascular events
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Interactive Question Which of the following tools/measures do you use to assess response to systemic therapy in your patients with psoriasis? (Please select all that apply) BSA only Psoriasis Area and Severity Index (PASI) Dermatology Life Quality Index (DLQI) Physician Global Assessment (PGA) Patient-reported satisfaction Other _________________
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Treatment Goals for Moderate-to-Severe Psoriasis Ultimate goal is to achieve complete skin clearance Assess response to systemic therapy after induction phase (16–24 weeks) and at regular intervals during maintenance phase Mrowietz U et al. Arch Dermatol Res. 2011;303:1-10. Change in PASI  75 DLQI > 5 Continue current therapy Change in PASI < 75 and  50 Change in PASI < 50 DLQI ≤ 5 Modify treatment regimen Adjust dose Add another therapy (combination therapy) Transition to another therapy
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Strategies to Optimize Systemic Therapy: Combination Therapy Potential Indications for Systemic Combination Therapy Inadequate efficacy of monotherapies (potential for additive or synergistic efficacy) Tolerability concerns (dose of individual agents may be reduced) Complications or comorbidities (eg, psoriatic arthritis, cardiovascular disease) Bridging treatment in patients switching between systemic therapies Potential for intermittent or continuous use during long-term treatment for relapsing disease Tailoring therapy to meet individual patients’ needs Evidence and Recommendations for Combination Therapy Experience with combination therapy is greater for psoriatic and rheumatoid arthritis than psoriasis Methotrexate or acitretin can be added to a biologic monotherapy A TNF inhibitor + methotrexate (5–15 mg/week) is safe and increases long-term efficacy Data on combining traditional systemic therapies with non-TNF biologics are limited Combined use of cyclosporine and a biologic raises safety concerns Optimal safety monitoring for combination therapy has not been determined Monitoring interval should be defined by the agent with the most stringent monitoring criteria Cather JC, Crowley JJ. Am J Clin Dermatol. 2014;15:467-478; Mrowietz U et al. J Eur Acad Dermatol Venereol. 2014;28:438-453.
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Patient Case Studies Follow-up Visit #2
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Case #1: Follow-up Visit 3 Months Later The patient returns after 3 months of treatment Her skin is much improved However, she has recently noticed some painful swelling of her toes
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Dactylitis Photo courtesy of Abrar Qureshi, MD.
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Case #1: Assessment and Considerations Plaque psoriasis well controlled on current therapy New joint manifestations Dactylitis (‘‘sausage digit’’) is a common characteristic of psoriatic arthritis Combination of enthesitis of the tendons and ligaments and synovitis involving entire digit Associated with radiologic findings May require modification of treatment regimen Consider referral to specialist Gottlieb A et al. J Am Acad Dermatol. 2008;58:851-864.
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Case #2: Follow-up Visit 18 Months Later The patient had been doing well on the prescribed therapy However, approximately 18 months later, he experiences a flare
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Case #2: Assessment and Considerations Loss of response/management of chronic disease Development or worsening of psoriasis may occur during anti-TNF treatment Switching to a therapy with a different mechanism of action may be beneficial Collamer AN et al. Arthritis Rheum. 2008;59:996-1001; Fagerli KM et al. Ann Rheum Dis. 2013;72:1840-1844.
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Summary Psoriasis is a multisystem inflammatory disorder While local therapy is a mainstay of treatment for psoriasis, systemic therapy may be required to achieve treatment goals Improved understanding of the dysregulated immune response characteristic of psoriasis has allowed for development of a number of systemic therapies that target specific mediators involved in the immunopathogenesis of the disease Optimal treatment depends on accurate assessment of disease severity and consideration of patient-specific factors that may affect treatment decisions