Title: Outcome Measures of Psoriasis in Clinical Trials: An Overview
Authors: Satyapal Singh, Rajendra Prasad, J.S. Tripathi3, N.P. Rai
DOI: http://dx.doi.org/10.18535/jmscr/v4i2.34
Psoriasis is a common chronic inflammatory dermatological disorder resulting from interactions between genetic pre-disposition and triggering environmental factors. It affects approximately 1-3% of the population and poses a lifelong burden on those, affected. Psoriasis typically follows a relapsing and remitting course. It can occur at any age, although is uncommon in children (0.71%) but the majority of cases occur before 35 years. Psoriasis is associated with arthritis in a significant proportion of patients (reported in one study at 13.8%). Usually the psoriasis is not life threatening but it can be life ruining due to its visibility. In clinical trials, several outcome measures have been used to assess the severity of psoriasis. The common outcome measures include PASI (psoriasis area and severity index)score, Psoriasis Life Stress Inventory (PLSI), Psoriasis disability index (PDI), The National Psoriasis Foundation Psoriasis Score (NPF-PS),Physician Global Assessment (PGA), Self-Administered PASI (SAPASI), Simplified PASI (SPASI), Psoriasis Assessment Severity Score (PASS), Psoriasis Log-Based Area and Severity Index (PLASI), Psoriasis Exact Area and Severity Index (PEASI) and Beer Sheva Psoriasis Severity Score (BPSS). Among these, the PASI score is most popular and commonly used in clinical trials. To assess the quality of life in the patients of psoriasis the DLQI (dermatologic life quality index) is most commonly used in clinical trials. Several such instruments have been developed and continue to be developed to provide an assessment of the severity of the skin lesions. Since the skin lesions of psoriasis have an impact on quality of life of patients, there has been growing recognition of the need to measure the impact of the disease on quality of life along with the severity of the lesions. KEYWORDS: Psoriasis, outcome measures, PASI, DLQI, Quality of life. 1. Farber EM, Nall ML. The natural history of psoriasis in 5,600 patients. Dermatologica. 1974; 148:1–18. 2. Dr. Satyapal Singh, Prof. N.P. Rai.Co-morbidites with Psoriasis – A Review. Sangyaharan, 2015; 18(1): 76-85. 3. Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T: Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Invest DermatolSympProc 2004, 9:136–139. 4. Zachariae R, Zachariae H, Blomqvist K, Davidsson S, Molin L, Mørk C, Sigurgeirsson B: Quality of life in 6479 Nordic patients with psoriasis. Br J Dermatol 2002, 146:1006–1016. 5. Fredriksson T, Pettersson U: Severe psoriasis-oral treatment with a new retinoid. Dermatologica 1978, 157:238–244. 6. Krueger GG, Feldman SR, Camisa C, Duvic M, Elder JT, Gottlieb AB, Koo J, Krueger JG, Lebwohl M, Lowe N, Menter A, Morison WL, Prystowsky JH, Shupack JL, Taylor JR, Weinstein GD, Barton TL, Rolstad T, Day RM: Two considerations for patients with psoriasis and their clinicians: What defines mild, moderate, and severe psoriasis? What constitutes aclinically significant improvement when treating psoriasis? J Am AcadDermatol 2000, 43:281–285. 7. Sampogna F, Sera F, Abeni D: IDI Multipurpose Psoriasis Research on Vital Experiences (IMPROVE) Investigators: Measures of clinical severity, quality of life, and psychological distress in patients with psoriasis: a cluster analysis. J Invest Dermatol 2004, 122:602–607. 8. Chren MM, Weinstock MA: Conceptual issues in measuring the burden ofskin diseases. J Invest DermatolSympProc 2004, 9:97–100.Williams HC: Applying trial evidence back to the patient. Arch Dermatol2003, 139:1195–1200. 9. Chren MM, Lasek RJ, Quinn LM, Mostow EN, Zyzanski SJ: Skindex, a quality of life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol 1996, 107:707–713. 10. Morgan M, McCreedy R, Simpson J, Hay RJ: Dermatology Quality of LifeScales-a measure of the impact of skin disease. Br J Dermatol 1997, 136:202–206. 11. McKenna SP, Cook SA, Whalley D, Doward LC, Richards HL, Griffiths CE, VanAssche D: Development of the PSORIQoL, a psoriasis-specific measure of quality of life designed for use in clinical practice and trials. Br J Dermatol 2003, 149:323–331. 12. Both H, Essink-Bot ML, Busschbach J, Nijsten T: Critical review of genericand dermatology-specific health-related quality of life instruments. J Invest Dermatol 2007, 127:2726–2739. 13. Bronsard V, Paul C, Prey S, Puzenat E, Gourraud PA, Aractingi S, Aubin F, BagotM, Cribier B, Joly P, Jullien D, Le Maitre M, Richard-Lallemand MA, Ortonne JP: What are the best outcome measures for assessing quality of life in plaque type psoriasis? A systematic review of the literature. J EurAcad Dermatol Venereol 2010, 24:17–22. 14. Chren MM: Understanding research about quality of life and other healthoutcomes. J Cutan Med Surg 1999, 3:312–316. 15. Eedy DJ, Griffiths CE, Chalmers RJ et al. (2009) Care of patients with psoriasis: an audit of U.K. services in secondary care. British Journal of Dermatology. 160: 557–64. 16. Finlay AY, Khan GK, Luscombe DK, Salek MS. Validation of Sickness Impact Profile and Psoriasis Disability Index in Psoriasis. Br J Dermatol 1990;123:751–6. 17. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) – a simple practical measure for routine clinical use. ClinExpDermatol 1994;19:210–16. 18. Gupta MA, Gupta AK. The Psoriasis Life Stress Inventory: a preliminary index of psoriasis-related stress. Acta Derm Venereol 1995;75:240–3. 19. Kirby B, Fortune DG, Bhushan M, et al. The Salford Psoriasis Index: an holistic measure of psoriasis severity. Br J Dermatol 2000;142:728–32. 20. Lebwohl M, Christophers E, Langley R, et al. An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol 2003;139:719–27. 21. Papp K, Bissonnette R, Krueger JG, et al. The treatment of moderate to severe psoriasis with a new anti-CD11a monoclonal antibody. J Am Acad Dermatol 2001;45:665–74..]. However, unlike PASI, none of these instruments has achieved broad approval. 22. Dr. Singh Satyapal, Prof. Rai NP. Co-morbidites with Psoriasis –A Review. Sangyaharan Shodh, 2015; 18(1): 76-85. 23. See Feldman SR, Krueger GG (2005) Psoriasis assessment tools in clinical trials. Annals of Rheumatic Disease 64 (Suppl. 2): ii65–ii68. 24. Fredriksson T, Pettersson U (1979) Oral treatment of pustulosispalmo-plantaris with a new retinoid, Ro 10–9359. Dermatologica 158:60–4. 25. Fredriksson T, Pettersson U. Severe psoriasis – oral therapy with a new retinoid. Dermatologica 1978;157: 238–44. 26. Satyapal Singh, P S Byadgi, N P Rai. Clinical evaluation of virechan therapy and haridradivati and oil for the management of kitibhkushtha (psoriasis). Int.J.Res. Ayurveda Pharm, 2013, 4(2):207-211. 27. Ochen Schmitt, Gottfried Wozel. The Psoriasis Area and Severity Index Is the Adequate Criterion to Define Severity in Chronic Plaque-Type Psoriasis. Dermatology 2005;210:194–199. 28. Feldman SR. A quantitative definition of severe psoriasis for use in clinical trials. J Dermatol Treat 2004;15:27–9. 29. Jacobson CC, Kimball AB. Rethinking the Psoriasis Area and Severity Index: the impact of area should be increased. Br J Dermatol 2004;151:381–7. 30. Sampogna F, Sera F, Abeni D. Measures of clinical severity, quality of life, and psychological distress in patients with psoriasis: a cluster analysis. J Invest Dermatol 2004;122:602–7. 31. Va de Kerkhof PC. The Psoriasis Area and Severity Index and alternative approaches for the assessment of severity: persisting areas of confusion. Br J Dermatol 1997; 137:661–2. 32. Ashcroft DM, Li Wan PA, Williams HC, Griffiths CE. Quality of life measures in psoriasis: a critical appraisal of their quality. J Clin Pharm Ther 1998;23:391–8. 33. Ashcroft DM, Wan Po AL, Williams HC, Griffiths CE. Clinical measures of disease severity and outcome in psoriasis: a critical appraisal of their quality. Br J Dermatol 1999;141:185–91. 34. Monali J Bhosle1, AmitKulkarni, Steven R Feldman and Rajesh Balkrishnan. Quality of life in patients with psoriasis. Health and Quality of Life Outcomes 2006, 4:35]. 35. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) - a simple practical measure for routine clinical use. Clin ExpDermatol. 1994;19:210-6.]. 36. Lewis V, Finlay AY. 10 years’ experience of the Dermatology Life Quality Index (DLQI). J InvestigDermatolSympproc 2004; 9: 169–180. 37. Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994–2007: a comprehensive review of validation data and clinical results. br J Dermatol 2008; 159: 997–1035.]. 38. Andrew Y Finlay. Quality of Life Indices. Indian J DermatolVenereolLeprol, 2004;70:143-48. 39. Hongbo Y, Thomas CL, Harrison MA, Salek MS and Finlay AY. Translating the science of quality of life into practice: What do dermatology life quality index scores mean? J Invest Dermatol 2005; 125:659-64]. 40. Finlay AY. Quality of life measurement in dermatology: Apractical guide. Br J Dermatol 1997;136:305-14. 41. Finlay AY. Quality of Life Indices. Indian J DermatolVenereolLeprol 2004;70:143-48. 42. ramsay B, O regan M. A survey of social and psychological effect of psoriasis. Br J Dermatol, 1988: 118: 195-201 ]. 43. GUPTA MA, GUPTA AK HEBERMAN HF. PSORIASIS AND psychiatry: an update. Gen hosp psychiatry, 1987; 9: 157-166]. 44. Satyapalsingh*, J.S. Tripathi, N.P. Rai. An overview of Ayurvedic& contemporary approaches to Psychodermatology. The Journal of Phytopharmacology 2014; 3(4): 286-299. 45. Finlay AY, Kelley SE. psoriasis- an index of disability. Clinical expdermatol, 1987; 12: 8-11. 46. Finlay AY, Kelley SE. psoriasis- an index of disability. Clinical expdermatol, 1987; 12: 8-11]. 47. Madulika A gupta, aditya k gupta. The psoriasis life stress inventory : a preliminary index of psoriasis related stress. Actadermvenereol (stockh), 1995; 75:240-243] 48. Finlay AY, Coles EC: The effect of severe psoriasis on the quality of life of 369 patients. Br J Dermatol 1995, 132:236–244.]. 49. Zehui He, Chuanjian Lu, AihuaOu, Jiqian Fang, Dongmei Wang, Jingwen Deng, Zhongzhao Zhang and Jingjie Yu. Reliability and validity of the Chinese version of the Psoriasis Disability Index (PDI) in Chinese patients with psoriasis. Health and Quality of Life Outcomes 2012, 10:37; 1-7. 50. Arnon D. Cohen, Dina Van-Dijk, LechaimNaggan and Daniel A. Vardy. Factor Analysis of the Beer Sheva Psoriasis Severity Score (BPSS). MAJ 2008;10:419–423.] 51. Cohen AD, Van-Dijk D, Naggan L, Vardy DA. Effectiveness of climatotherapy at the Dead Sea for Israeli patients with psoriasis vulgaris. A community oriented study introducing "Beer Sheva Psoriasis Severity Score." J Dermatol Treat 2005;16:308. 52. Carlin CS, Callis KP, Krueger GG. Efficacy of acitretin andcommercial tanning bed therapy for psoriasis. Arch Dermatol2003;139:459-64. 53. Dafna D. Gladman, Philip J. Mease, Gerald Krueger, Désirée M.F.M. Van Der Heidje, Christian Antoni, Philip S. Helliwell, Arthur F. Kavanaugh, Peter Nash, Christopher T. Ritchlin, C. Vibeke Strand, And William Taylor. Outcome Measures in Psoriatic Arthritis. The Journal of Rheumatology 2005; 32(11): 2262-2269. 54. Paul C, Bushmakin AG, Cappelleri JC, Mallbris L, Mamolo C. Do Patients and Physicians Agree in Their Assessment of the Severity of Psoriasis? Insights from Tofacitinib Phase 3 Clinical Trials. . J DermatologClin Res, 2015; 3(3): 1048]. 55. Gottlieb AB, Chaudhari U, Baker DG et al. (2003) The National Psoriasis Foundation Psoriasis Score (NPF-PS) system versus the Psoriasis Area Severity Index (PASI) and Physician’s Global Assessment (PGA): a comparison. J Drugs Dermatol 2:260–6]. 56. Fleischer AB Jr, Rapp SR, Reboussin DM et al. (1994) Patient measurement of psoriasis disease severity with a structured instrument. J Invest Dermatol, 102:967–9. 57. Fleischer AB Jr, Feldman SR, Rapp SR et al. (1996) Disease severity measures in a population of psoriasis patients: the symptoms of psoriasis correlate with self-administered psoriasis area severity index scores. J Invest Dermatol 107:26–9. 58. Louden BA, Pearce DJ, Lang W et al. (2004) A simplified psoriasis area severity index (SPASI) for rating psoriasis severity in clinic patients. Dermatol Online J 10:7. 59. Harari M, Shani J, Hristakieva E et al. (2000) Clinical evaluation of a more rapid and sensitive Psoriasis Assessment Severity Score (PASS), and its comparison with the classic method of Psoriasis Area and Severity Index (PASI), before and after climatotherapy at the Dead-Sea. Int J Dermatol 39:913–8.] 60. Phyllis I. Spuls, Lidian L.A. Lecluse, Marie-Louise N.F. Poulsen, Jan D. Bos, Robert S. Stern, Tamar Nijsten. How Good Are Clinical Severity and Outcome Measuresfor Psoriasis?: Quantitative Evaluation in a SystematicReview. Journal of Investigative Dermatology, (2010); 130,: 933–943. 61. Jacobson CC, Kimball AB (2004) Rethinking the psoriasis area and severityindex: the impact of area should be increased. Br J Dermatol 151:38,1–7.Abstract
References