Currently Viewing:
Supplements Contemporary Management of Moderate to Severe Plaque Psoriasis
Currently Reading
Contemporary Management of Moderate to Severe Plaque Psoriasis
Jashin J. Wu, MD

Contemporary Management of Moderate to Severe Plaque Psoriasis

Jashin J. Wu, MD
Some newer clinical trials have excluded patients with severe depression, any history of depression or suicidal ideation, or other psychiatric disorders, partly because of the aforementioned concerns.86,87 Many trials have used strict exclusion criteria for mental health comorbidities, including studies of adalimumab, apremilast, certolizumab, secukinumab, and ustekinumab.88 Therefore, the studied populations may not be representative of all patients with plaque psoriasis, and may underestimate psychiatric risks associated with the general use of these drugs.

Selective IL-23 Inhibitors

Selective IL-23 inhibitors are an emerging class of biologic agents for the treatment of moderate to severe plaque psoriasis.

Guselkumab

Guselkumab was recently approved for the treatment of patients with plaque psoriasis following the results of the phase 3 studies VOYAGE 1 and VOYAGE 2.60 Guselkumab is a monoclonal antibody that blocks the downstream signaling of IL-23. In the VOYAGE 1 and 2 trials,  the proportion of patients who achieved PASI 75 at Week 16 were 86% and 91%; PASI 90 was achieved by 70% and 73%; PASI 100 was achieved by 34% and 37%. In contrast, the respective rates in the active comparator (adalimumab) group at Week 16 were 69% and 73%, 47% and 50%, and 17% and 21%, respectively. VOYAGE 1 reported that at Week 48, the proportion of patients that achieved PASI 75 decreased to 88%, but increased for PASI 90 (76%) and PASI 100 (47%). The rates in the adalimumab group decreased for both PASI 75 (63%) and PASI 90 (48%), but increased for PASI 100 (23%).59,60

Tildrakizumab

Tildrakizumab and risankizumab are monoclonal antibody IL-23 inhibitors currently being evaluated in phase 3 trials for patients with moderate to severe plaque psoriasis. The FDA has accepted the biologics license application for tildrakizumab, which was filed based on results from the phase 3 reSURFACE 1 and reSURFACE 2 trials. Respective PASI 75 responders in the reSURFACE 1 and reSURFACE 2 trials were 62% and 66%, PASI 90 35% and 37%, and PASI 100 12% and 14% at Week 12 in patients receiving tildrakizumab. In comparison, patients receiving active comparator, etanercept, in the reSURFACE 2 trial were 48%, 21%, and 5%. Week 28 results from reSURFACE 1and reSURFACE that the proportion of patients receiving tildrakizumab increased for PASI 75, PASI 90, and PASI 100 to 79% and 73%, 57% in both trials, and 31% and 26%, respectively. Similarly, rates increased for PASI 75, PASI 90, and PASI 100 in the etanercept group with rates of 54%, 29%, and 11%, respectively.56

Risankizumab

Risankizumab is another anti–IL-23 monoclonal antibody. Currently, the safety and efficacy results from phase 3 trials, UltIMMa-1 and UltIMMa-2, have not been published to date.89,90 Results of the phase 2 study of risankizumab showed the proportion of patients in the risankizumab high-dose group at Week 12 that achieved PASI 75, PASI 90, and PASI 100 was 88%, 81%, and 48%, compared with 40%, 72%, and 18% response in the ustekinumab group, respectively.61

Nonbiologic Agents

Apremilast is a novel oral, nonbiologic agent that regulates inflammatory mediators through inhibition of phosphodiesterase-4.48 In the phase 3 ESTEEM-1 trial, 33% of patients with chronic plaque psoriasis who received apremilast achieved PASI 75 at Week 16 and 9.8% achieved PASI 90.48 Sixty-one percent of the patients who remained on apremilast through Week 52 achieved PASI 75 response at Week 52.48 Its toxicity profile is milder than traditional oral systemic agents; however, severe diarrhea, nausea, and vomiting can occur in the first few weeks of initiation. Apremilast also has been associated with an increased risk of depression.47 Physicians should carefully evaluate patients for depression prior to starting therapy, and closely monitor for its signs and symptoms while therapy is ongoing.47

Unmet Needs in the Burden of Psychiatric Morbidities

The common psychiatric comorbidities of psoriasis substantially impair QoL. It is important for clinicians to understand the true burden of these psychiatric issues, especially in patients with moderate to severe plaque psoriasis. Patients with psoriasis may perceive their mental and physical burdens to be greater than those of patients with cancer, arthritis, hypertension, heart disease, and diabetes.2 Patients believe that other people do not understand how much the disease negatively affects their lives.24

Although the frequency of psychiatric problems lessens with decreasing clinical symptoms, even patients with mild psoriasis can continue to experience substantial distress.91

Psoriasis profoundly affects QoL, even in patients who do not meet the full criteria for psychiatric illness. In a survey of over 5600 patients with psoriasis and PsA conducted by the NPF, psoriasis negatively affected the well-being of 88% of the population.37  Most patients experienced anger, helpless, embarrassment, and self-consciousness as part of their disorder. 37 Other studies’ results have demonstrated that, regardless of psoriasis severity, nearly 60% of patients believe psoriasis had a major impact on their QoL.92 Patients often report poor self-esteem and body image, as well as feeling of stigma from others.24 Uncontrolled disease impacts patients’ daily activities, work capabilities, social life, and sexual functioning.24

Psoriasis also deserves consideration as a dermatologic psychophysiological disorder. Such disorders are defined by the fact they can fluctuate in severity and may worsen in response to stress, anxiety, or depression.93 Psoriasis may be exacerbated as patients experience anxiety, embarrassment, or sadness about their disease. This promotes a vicious cycle, as emotional distress can worsen the physiological skin symptoms of the disease, further worsening their psychological impact.94

Coordination of Care for Patients With Psoriasis

It is essential that medical providers address the mental health comorbidities of patients with psoriasis. Unfortunately, depression symptoms in patients with psoriasis often go unrecognized or are inadequately treated.95 Comprehensive treatment, including mental health screenings, might lead to cost savings and benefitpatients.77 In general, European clinicians have greater awareness of the mental health burden of patients with psoriasis compared with their American colleagues. Europeans researchers have performed a number of scientific investigations of the topic.19,20,94,96-99

Various European guidelines have also moved to incorporate health-related QoL as part of general clinical assessment.95

Patients with psoriasis may benefit from specialist coordination of care to address their overall mental, emotional, and physical health.91 Patients with comorbid mental health disorders may particularly benefit from such integrated systems of care.99 When integrated multispecialty support is not available, the treating physicians must attempt to care of all aspects of a patient’s QoL.93 Providers must consider the primary symptoms of psoriasis and its potential cardiovascular and mental health comorbidities.

Many patients with psoriasis do not have their CV risk factors adequately assessed or managed. One study reported that approximately 20% of patients with moderate to severe psoriasis had undiagnosed hypertension, diabetes, or hypercholesterolemia. Moreover, 40% to 60% of patients were found not to be optimally managed for these conditions.100 Screening patients with psoriasis for such risk factors helps to identify a high proportion of individuals with potentially modifiable risk factors for CVD.101

Without multispecialty support, dermatologists may feel inadequately trained to address the mental health morbidities of the disease.93 Dermatologists must learn to screen for such problems and refer patients to psychiatrists or other mental health professionals when needed.93 Because of the increased risk of suicide, it is also essential that dermatologists screen for prior history of suicidal thoughts or present suicidality, especially in patients with severe disease.23

Many patients will need input from psychiatrists or psychologists as part of their care. Management of psycho-dermatological conditions, such as psoriasis requires that providers assess the social, familial, and occupational aspects of the condition.36 A variety of techniques are available to practitioners. For example, one study of 40 patients with psoriasis in Italy found that cognitive behavioral therapy combined with biofeedback improved PASI scores, QoL, and reduced the number of minor psychiatric disorders.98 Other prospective randomized trials’ findings have demonstrated that cognitive-behavioral approaches may be able to reduce psoriasis severity.98

Primary health providers can play a key role in care coordination. They may give support for the psychological aspects of psoriasis via referral to patient support groups, stress reduction therapy, psychologist or psychiatrist referral, or administration of psychotropic medications.36 Primary health providers should also be aware of the need for assessing cardiovascular risk factors in these patients.100

Managed health providers are also needed to help ensure that patients get access to the most appropriate treatments for them. Such cost/benefit calculations must consider the varying direct costs of treatment options. However, they must also weigh the costs of AEs, decreased work productivity, and inadequately treated disease and disease morbidities on the overall economic burden.102 At this time, we lack good data on many of these outcomes, and high-quality studies of long-term cost effectiveness are needed to help inform decision making.102

Conclusion

Psoriasis is a source of significant psychological strain and physical discomfort for patients.2 Treatment goals in the management of psoriasis continue to emerge. With the availability of newer and more effective treatments, researchers and clinicians are beginning to use higher standards to assess patient’s therapeutic goals.44 Direct and indirect financial and personal costs of the disease are quite substantial both for individuals and for society as a whole.32 Many of these costs result from the commonly associated disease comorbidities, which include CVD, obesity, PsA, and psychiatric disorders such as depression, which exert considerable personal and financial strain on society.2,32 Yet some practitioners continue to underestimate the severity and prevalence of mental health comorbidities.95 Managed care providers also need to incorporate updated criteria to provide more comprehensive analyses of the full impacts of psoriasis-related costs.31

Over time, we will gain a better understanding of how best to address the needs of patients with psoriasis in terms of their physical, emotional, and mental health.

Author affiliations: Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA.
Funding source: This publication was sponsored by Ortho Dermatologics.
Author disclosures: Dr Wu reports serving as an investigator for and receiving grants from AbbVie, Inc; Amgen, Inc; Eli Lilly and Company; Janssen Pharmaceutical; Novartis International AG; and Regeneron Pharmaceuticals, Inc.
Authorship information: Concept and design; analysis and interpretation of data; critical revision of the manuscript for important intellectual content; administrative, technical or logistic support; and supervision.
Address correspondence to: E-mail: jashinwu@gmail.com
 
  1. Menter A, Gottlieb A, Feldman SR, , et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826-850.
  2. Menter A, Korman NJ, et al. 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.
  3. 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.20111.013.
  4. Armstrong AW. Psoriasis. JAMA Dermatol. 2017;153(9):956. doi: 10.1001/jamadermatol.2017.2103
  5. Wu JJ, No DJ, Amin M. BSA75, BSA90, and BSA100: new clinical tools for measuring improvement in psoriasis. Cutis. 2017;99(6):418.
  6. Armstrong AW, Siegel MP, Bagel J, et al. From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis. J Am Acad Dermatol. 2017;76(2):290-298. doi: 10.1016/j.jaad.20110.017.
  7. Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013;149(10):1180-1185. doi: 10.1001/jamadermatol.2013.5264.
  8. Carvalho AV, Romiti R, Souza CD, Paschoal RS, Milman LM, Meneghello LP. Psoriasis comorbidities: complications and benefits of immunobiological treatment. An Bras Dermatol. 2016;91(6):781-789. doi: 10.1590/abd1806-4841.20165080.
  9. Furue M, Tsuji G, Chiba T, Kadono T. Cardiovascular and metabolic diseases comorbid with psoriasis: beyond the skin. Intern Med. 2017;56(13):1613-161 doi:10.2169/internalmedicine.56.8209.
  10. Kimball AB, Robinson D Jr, Wu Y, et al. Cardiovascular disease and risk factors among psoriasis patients in two US healthcare databases, 2001-2002. Dermatology.2008;217(1):27-37. doi: 10.1159/000121333.
  11. Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB, Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol. 2006;55(5):829-835. doi:10.1016/j.jaad.2006.08.040.
  12. Armstrong EJ, Harskamp CT, Armstrong AW. Psoriasis and major adverse cardiovascular events: a systematic review and meta-analysis of observational studies. J Am Heart Assoc. 2013;2(2):e000062. doi: 10.1161/JAHA.113.000062.
  13. Noe MH, Shin DB, Wan MT, Gelfand JM. Objective measures of psoriasis severity predict mortality: a prospective population-based cohort study. J Invest Dermatol. 2017. doi: 10.1016/j.jid.2017.07.841.
  14. Bremmer S, Van Voorhees AS, Hsu S, et al. Obesity and psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol.2010;63(6):1058-1069. doi: 10.1016/j.jaad.2009.09.053.
  15. Armstrong AW, Harskamp CT, Armstrong EJ. The association between psoriasis and obesity:
    a systematic review and meta-analysis of observational studies. Nutr Diabetes. 2012;2:e54.
    doi: 10.1038/nutd.2012.26.
  16. Wee CC, Davis RB, Huskey KW, Jones DB, Hamel MB. QoL among obese patients seeking weight loss surgery: the importance of obesity-related social stigma and functional status. J Gen Intern Med. 2013;28(2):231-238. doi:10.1007/s11606-012-2188-0.
  17. Qureshi AA, Choi HK, Setty AR, Curhan GC. Psoriasis and the risk of diabetes and hypertension: a prospective study of US female nurses. Arch Dermatol. 2009;145(4):379-382. doi: 10.1001/archdermatol.2009.48.
  18. Kerschbaumer A, Fenzl KH, Erlacher L, Aletaha D. An overview of psoriatic arthritis - epidemiology, clinical features, pathophysiology and novel treatment targets. Wien Klin Wochenschr. 2016;128(21-22):791-795. doi: 10.1007/s00508-016-1111-9.
  19. Dowlatshahi EA, Wakkee M, Arends LR, Nijsten T. The prevalence and odds of depressive symptoms and clinical depression in psoriasis patients: a systematic review and meta-analysis. J Invest Dermatol. 2014;134(6):1542-1551. doi : 10.1038/jid.2013.508.
  20. Dominguez P, Han J, Li T, Ascherio A, Qureshi A. Depression and the risk of psoriasis in US women.
    J Eur Acad Dermatol Venereol
    . 2013;27(9):1163-1167. doi: 10.1111/j.1468-3083.2012.04703.x.
  21. Connor CJ, Liu V, Fiedorowicz JG. Exploring the physiological link between psoriasis and mood disorders. Dermatol Res Pract. 2015;2015:409637. doi: 10.1155/2015/409637.
  22. Hayes J, Koo J. Psoriasis: depression, anxiety, smoking, and drinking habits. Dermatol Ther. 2010;23(2):174-180. doi: 10.1111/j.1529-8019.2010.01312.x.
  23. Singh S, Taylor C, Kornmehl H, Armstrong AW. Psoriasis and suicidality: A systematic review and meta-analysis. J Am Acad Dermatol. 2017;77(3):425-440.e2. doi: 10.1016/j.jaad.2017.05.019.
  24. Bhosle MJ, Kulkarni A, Feldman SR, Balkrishnan R. QoL in patients with psoriasis. Health Qual Life Outcomes. 2006;4:35. doi: 10.1186/1477-7525-4-35.
  25. Dunbar JA, Reddy P, Davis-Lameloise N, et al. Depression: An important comorbidity with metabolic syndrome in a general population. Diabetes Care. 2008;31(12):2368-2373. doi:10.2337/dc08-0175.
  26. Egede LE. Major depression in individuals with chronic medical disorders: prevalence, correlates and association with health resource utilization, lost productivity and functional disability. Gen Hosp Psychiatry. 2007;29(5):409-416.
  27. Husni ME, Merola JF, Davin S. The psychosocial burden of psoriatic arthritis. Semin Arthritis Rheum. 2017;47(3):351-360. doi: 10.1016/j.semarthrit.2017.05.010.
  28. Dommasch ED, Li T, Okereke OI, et al. Risk of depression in women with psoriasis: a cohort study.
    Br J Dermatol. 2015;173(4):975-980. doi:10.1111/bjd.14032.
  29. Wu JJ, Penfold RB, Primatesta P, et al. The risk of depression, suicidal ideation and suicide attempt in patients with psoriasis, psoriatic arthritis or ankylosing spondylitis. J Eur Acad Dermatol Venereol. 2017;31(7):1168-1175. doi: 10.1111/jdv.14175.
  30. Lewinson RT, Vallerand IA, Lowerison MW, et al. Depression Is associated with an increased risk of psoriatic arthritis among patients with psoriasis: a population-based study. J Invest Dermatol. 2017;137(4):828-835. doi: 10.1016/j.jid.2016.11.032. 
  31. Evans C. Managed care aspects of psoriasis and psoriatic arthritis. Am J Manag Care. 2016;22(suppl 8):s238-s243.
  32. Brezinski EA, Dhillon JS, Armstrong AW. Economic burden of psoriasis in the United States:
    a systematic review. JAMA Dermatol. 2015;151(6):651-658. doi: 10.1001/jamadermatol.2014.3593.
  33. Armstrong AW, Zhao Y, Herrera V, Li Y, Bancroft T, Hull M, Altan A. Drivers of healthcare costs among the costliest patients with psoriasis over three years in a United States health plan. J Drugs Dermatol. 2017;16(7):651-658.
  34. Feldman SR, Tian H, Gilloteau I, Mollon P, Shu M. Economic burden of comorbidities in psoriasis patients in the United States: results from a retrospective U.S. database. BMC Health Serv Res. 2017;17(1):337. doi: 10.1186/s12913-017-2278-0.
  35. Korman NJ, Zhao Y, Pike J, Roberts J. Relationship between psoriasis severity, clinical symptoms, QoL and work productivity among patients in the USA. Clin Exp Dermatol. 2016;41(5):514-521. doi: 10.1111/ced.12841.
  36. Koo J, Lebwohl A. Psycho dermatology: the mind and skin connection. Am Fam Physician. 2001;64(11):1873-1878.
  37. Armstrong AW, Schupp C, Wu J, Bebo B. QoL and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003-2011. PloS One. 2012;7(12):e52935-e52011. doi: 10.1371/journal.pone.0052935.
  38. Spuls PI, Lecluse LL, Poulsen ML, Bos JD, Stern RS, Nijsten T. How good are clinical severity and outcome measures for psoriasis?: quantitative evaluation in a systematic review. J Invest Dermatol. 2010;130(4):933-943. doi: 10.1038/jid.2009.391.
  39. Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64 (Suppl 2):ii65-ii68; discussion ii69-ii73. doi: 10.1136/ard.2004.031237.
  40. Puig L. PASI 90 response: the new standard in therapeutic efficacy for psoriasis. J Eur Acad Dermatol Venereol. 2015;29(4):645-648. doi: 10.1111/jdv.12817.
  41. Ahn CS, Gustafson CJ, Sandoval LF, Davis SA, Feldman SR. Cost effectiveness of biologic therapies for plaque psoriasis. Am J Clin Dermatol. 2013;14(4):315-326. doi: 10.1007/s40257-013-0030-z.
  42. Duffin KC, Papp KA, Bagel J, et al. Evaluation of the Physician Global Assessment and Body Surface Area Composite Tool for assessing psoriasis response to apremilast therapy: results from ESTEEM 1 and ESTEEM 2. J Drugs Dermatol. 2017;16(2):147-153.
  43. Menter A, Korman NJ, Elmets CA, 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(4):643-659. doi: 10.1016/j.jaad.2008.12.032
  44. Menter A, Korman NJ, Elmets CA, 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):451-485.
  45. Manalo IF, Gilbert KE, Wu JJ. Time to raise the bar to Psoriasis Area Severity Index 90 and 100.
    J Drugs Dermatol. 2015;14(10):1086-1088.
  46. Gu T, Shah N, Deshpande G, Tang DH, Eisenberg DF. Comparing biologic cost per treated patient across indications among adult US managed care patients: a retrospective cohort study. Drugs Real World Outcomes. 2016;3(4):369-381. doi: 10.1007/s40801-016-0093-2.
  47. Otelza [package insert]. Summit, New Jersey: Celgene Corporation; 2014.
  48. Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015;73(1):37-49. doi: 10.1016/j.jaad.2015.03.049.
  49. Feldman SR, Goffe B, Rice G, et al. The challenge of managing psoriasis: unmet medical needs and stakeholder perspectives. Am Health Drug Benefits. 2016;9(9):504-513.
  50. Ekelund M, Mallbris L, Qvitzau S, Stenberg B. A higher score on the dermatology life quality index, being on systemic treatment and having a diagnosis of psoriatic arthritis is associated with increased costs in patients with plaque psoriasis. Acta Derm Venereol. 2013;93(6):684-688. doi: 10.2340/00015555-1591.
  51. Strober B, Papp KA, Lebwohl M, et al. Clinical meaningfulness of complete skin clearance in psoriasis. J Am Acad Dermatol. 2016;75(1):77-82.e7. doi: 10.1016/j.jaad.2016.03.026.
  52. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomized, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665-1674. doi: 10.1016/S0140-6736(08)60725-4.
  53. Leonardi CL, Powers JL, Matheson RT, et al; Etanercept Psoriasis Study Group. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349(21):2014-2022.
  54. Reich K, Nestle FO, Papp K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet. 2005;366(9494):1367-1374.
  55. Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-2 Study Group. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. doi: 10.1056/NEJMoa1512711.
  56. Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017;390(10091):276-288. doi: 10.1016/S0140-6736(17)31279-5.
  57. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis–results of two phase 3 trials. N Engl J Med. 2014;371(4):326-338. doi: 10.1056/NEJMoa1314258.
  58. Lønnberg AS, Zachariae C, Skov L. Targeting of interleukin-17 in the treatment of psoriasis. Clin Cosmet Investig Dermatol.. 2014;7:251-259. doi: 10.2147/CCID.S67534.
  59. Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431. doi: 10.1016/j.jaad.2016.11.042. 
  60. Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-423. doi: 10.1016/j.jaad.2016.11.041.
  61. Papp KA, Blauvelt A, Bukhalo M, et al. Risankizumab versus ustekinumab for moderate-to-severe plaque psoriasis. N Engl J Med. 2017;376(16):1551-1560. doi: 10.1056/NEJMoa1607017.
  62. Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541-551. doi: 10.1016/S0140-6736(15)60125-8.
  63. Papp KA, Reich K, Paul C, et al. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 201;175(2):273-286. doi: 10.1111/bjd.14493.
  64. Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318-1328. doi: 10.1056/NEJMoa1503824.
  65. Enbrel [package insert]. Thousand Oaks, CA: Amgen; 2017.
  66. Remicade [package insert]. Horsham, PA: Janssen Biotech, Inc; 2013.
  67. Humira [package insert]. North Chicago, IL: AbbVie Inc; 2017.
  68. Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58(1):106-115.
  69. Stelara [package insert]. Thousand Oaks, CA: Janssen Biotech, Inc; 2014.
  70. Papp KA, Langley RG, Lebwohl M, et al; PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a andomized, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625):1675-1684. doi: 10.1016/S0140-6736(08)60726-6.
  71. Cosentyx [package insert]. East Hanover, NJ: Novartis Pharmaceutical Corporation; 2017.
  72. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  73. Siliq [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals; 2017.
  74. Tremfya [package insert]. Horsham, PA: Janssen Biotech, Inc; 2017.
  75. Menter A, Thaçi D, Wu JJ, et al. Long-term safety and effectiveness of adalimumab for moderate to severe psoriasis: results from 7-year interim analysis of the ESPRIT Registry. Dermatology and Therapy. 2017;7(3):365-381. doi:10.1007/s13555-017-0198-x.
  76. Tyring S, Gottlieb A, Papp K, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomized phase III trial. Lancet. 2006;367(9504):29-35.
  77. Menter A, Augustin M, Signorovitch J, et al. The effect of adalimumab on reducing depression symptoms in patients with moderate to severe psoriasis: a randomized clinical trial. J Am Acad Dermatol. 2010;62(5):812-818. doi: 10.1016/j.jaad.2009.07.022.
  78. Amjevita [package insert]. Thousand Oaks, CA: Amgen Inc; 2016.
  79. Cyltezo [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.;2017.
  80. Erelzi [package insert]. Princeton, NJ: Sandoz Inc; 2016.
  81. Inflectra [package insert]. Incheon, Republic of Korea: Celltrion, Inc; 2016.
  82. Renflexis [package insert]. Kenilworth, NJ: Merck & Co. Inc; 2017.
  83. Langley RG, Feldman SR, Han C, et al. Ustekinumab significantly improves symptoms of anxiety, depression, and skin-related QoL in patients with moderate-to-severe psoriasis: Results from a randomized, double-blind, placebo-controlled phase III trial. J Am Acad Dermatol. 2010;63(3):457-65. Doi: 10.1016/j.jaad.2009.09.014.
  84. Center for Drug Evaluation and Research. Summary Review. [Brodalumab]. 2017.
  85. Lebwohl MG, Papp KA, Marangell LB, et al. Psychiatric adverse events during treatment with brodalumab: analysis of psoriasis clinical trials. J Am Acad Dermatol. 2017;S0190-9622(17)32256-32259. doi:10.1016/j.jaad.2017.08.024.
  86. A study of ixekizumab (LY2439821) in participants with moderate-to-severe plaque psoriasis naive to systemic treatment. clinicaltrials.gov/ct2/show/NCT02634801. Updated December 4, 2017. Accessed August 24, 2017.
  87. A study of KHK4827 (brodalumab) in subjects with moderate to severe psoriasis in Korea. clinicaltrials.gov/ct2/show/NCT02982005. Updated June 8, 2017. Accessed August 24, 2017.
  88. Wu JJ, Feldman SR, Koo L, et al. Epidemiology of mental health comorbidity in psoriasis [published online November 10, 2017]. J Dermatolog Treat. 2017;1-9. doi: 10.1080/09546634.2017.1395800.
  89. BI 655066 (risankizumab) compared to placebo and active comparator (ustekiinumab) in patients with  moderate to severe chronic plaque psoriasis. clinicaltrials.gov/ct2/show/NCT02684370. Updated December 5, 2017. Accessed November 13, 2017.
  90. BI 655066 (risankizumab) compared to placebo and active comparator (ustekiinumab) in patients with moderate to severe chronic plaque psoriasis. clinicaltrials.gov/ct2/show/NCT02684357. Updated December 5, 2017. Accessed November 13, 2017.
  91. Basavaraj KH, Navya MA, Rashmi R. Relevance of psychiatry in dermatology: present concepts. Indian J Psychiatry. 2010;52(3):270-275. doi:10.4103/0019-5545.70992.
  92. Stern RS, Nijsten T, Feldman SR, et al.  Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Investig Dermatol Symp Proc. 2004;9(2):136-139.
  93. Connor CJ. Management of the psychological comorbidities of dermatological conditions: practitioners’ guidelines. Clin Cosmet Investig Dermatol. 2017;10:117-132. doi: 10.2147/CCID.S111041.
  94. Ferreira BI, Abreu JL, Reis JP, Figueiredo AM. Psoriasis and associated psychiatric disorders: a systematic review on etiopathogenesis and clinical correlation. J Clin Aesthet Dermatol. 2016;9(6):36-43.
  95. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatology and Therapy. 2013;3(2):117-130. doi: 10.1007/s13555-013-0031-0.
  96. Dalgard FJ, Gieler U, Tomas-Aragones L, et al. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries.J Invest Dermatol. 2015;135(4):984-991. doi: 10.1038/jid.2014.530.
  97. Owczarek K, Jaworski M. QoL and severity of skin changes in the dynamics of psoriasis. Postepy Dermatol Alergol. 2016;33(2):102-108. doi: 10.5114/pdia.2015.54873.
  98. Piaserico S, Marinello E, Dessi A, Linder MD, Coccarielli D, Peserico A. efficacy of biofeedback and cognitive-behavioral therapy in psoriatic patients A single-blind, randomized and controlled study with added narrow-band ultraviolet B therapy. Acta Derm Venereol. 2016;96(217):91-95. doi: 10.2340/00015555-2428.
  99. Schmitt J, Wozel G, Garzarolli M, Viehweg A, Bauer M, Leopold K. Effectiveness of interdisciplinary vs. dermatological care of moderate-to-severe psoriasis: a pragmatic andomized controlled trial. Acta Derm Venereol. 2014;94(2):192-197. doi: 10.2340/00015555-1697.
  100. Kimball AB, Szapary P, Mrowietz U, et al. Underdiagnosis and undertreatment of cardiovascular risk factors in patients with moderate to severe psoriasis. J Am Acad Dermatol. 2012;67(1):76-85. doi: 10.1016/j.jaad.2011.06.035.
  101. Rutter MK, Kane K, et al. Primary care-based screening for cardiovascular risk factors in patients with psoriasis. Br J Dermatol. 2016;175(2):348-356. doi: 10.1111/bjd.14557.
  102. Zhang W, Islam N, Ma C, Anis AH. Systematic review of cost-effectiveness analyses of treatments for psoriasis. Pharmacoeconomics. 2015;33(4):327- 40. doi: 10.1007/s40273-014-0244-9.
PDF
 
Copyright AJMC 2006-2020 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up