The 5-point Investigator’s Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials

References

• Langley RG, Ellis CN. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment, and Lattice System Physician’s Global Assessment. J Am Acad Dermatol. 2004;51:563–9
   PubMed Web of Science ®Google Scholar
• Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64:ii65–8
   PubMed Web of Science ®Google Scholar
• Fredriksson T, Pettersson U. Severe psoriasis – oral therapy with a new retinoid. Dermatologica. 1978;157:238–44
   PubMedGoogle Scholar
• Puzenat E, Bronsard V, Prey S, et al. What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature. J Eur Acad Dermatol Venereol. 2010;24:10–6
   PubMed Web of Science ®Google Scholar
• Robinson A, Kardos M, Kimball AB. Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI): why do both? A systematic analysis of randomized controlled trials of biologic agents for moderate to severe plaque psoriasis. J Am Acad Dermatol. 2012;66:369–75
   PubMed Web of Science ®Google Scholar
• Naldi L, Svensson A, Diepgen T, et al. European dermato-epidemiology network. Randomized clinical trials for psoriasis 1977-2000: the EDEN survey. J Invest Dermatol. 2003;120:738–41
   PubMed Web of Science ®Google Scholar
• Spuls PI, Lecluse LLA, Poulsen MLNF, et al. How good are clinical severity and outcome measures for psoriasis? Quantitative evaluation in a systematic review. J Invest Dermatol. 2010;130:933–43
   PubMed Web of Science ®Google Scholar
• Pinosky DG. Clinical assessment of the safety and efficacy of lorazepam, a new benzodiazepine derivative, in the treatment of anxiety. J Clin Psychiatry. 1978;39:24–9
   PubMed Web of Science ®Google Scholar
• Rao DB, Georgiev EL, Paul PD, et al. Cyclandelate in the treatment of senile mental changes: a double-blind evaluation. J Am Geriatr Soc. 1977;25:548–51
   PubMed Web of Science ®Google Scholar
• Day RO, Furst DE, Dromgoole SH, et al. Relationship of serum naproxen concentration to efficacy in rheumatoid arthritis. Clin Pharmacol Ther. 1982;31:733–40
   PubMed Web of Science ®Google Scholar
• Roth SH. A comparison of benoxaprofen and sulindac in patients with rheumatoid arthritis and osteoarthritis. Eur J Rheumatol Inflamm. 1982;5:258–69
   PubMedGoogle Scholar
• Katz HI, Gross E, Buxman M, et al. A double-blind, vehicle-controlled paired comparison of halobetasol propionate cream on patients with plaque psoriasis. J Am Acad Dermatol. 1991;25:1175–8
   PubMed Web of Science ®Google Scholar
• Nijsten T, Looman CW, Stern RS. Clinical severity of psoriasis in last 20 years of PUVA study. Arch Dermatol. 2007;143:1113–21
   PubMed Web of Science ®Google Scholar
• Heydendael VM, Spuls PI, Opmeer BC, et al. Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis. N Engl J Med. 2003;349:658–65
   PubMed Web of Science ®Google Scholar
• Duffin KC, Gottlieb AB. Outcome measures for psoriasis severity: a report from the GRAPPA 2012 annual meeting. J Rheumatol. 2013;40:1423–4
   PubMed Web of Science ®Google Scholar
• Gottlieb AB, Armstrong AW. Psoriasis outcome measures: a report from the GRAPPA 2012 annual meeting. J Rheumatol. 2013;40:1428–33
   PubMed Web of Science ®Google Scholar
• Dermatologic and Ophthalmic Drugs Advisory Committee 49th Meeting 1998: Food and Drug Administration, Department of Health and Human Services, Public Health Service, March 20, 1998. Washington, DC: Miller Reporting Company, Inc.; 1998
   Google Scholar
• European Medicines Agency. London, England: Committee for Medicinal Products for Human Use. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis; 18 November 2004; [about 18 screens]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf. Accessed April 5, 2013
   Google Scholar
• Berth-Jones J, Grotzinger K, Rainville C, et al. A study examining inter- and intrarater reliability of three scales for measuring the severity of psoriasis: Psoriasis Area and Severity Index, Physician’s Global Assessment and Lattice System Physician’s Global Assessment. Br J Dermatol. 2006;155:707–13
   PubMed Web of Science ®Google Scholar
• Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349:2014–22
   PubMed Web of Science ®Google Scholar
• Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2007;56:31.e1–15
   PubMed Web of Science ®Google Scholar
• 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;58:106–15
   PubMed Web of Science ®Google Scholar
• Papp KA, Tyring S, Lahfa M, et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005;152:1304–12
   PubMed Web of Science ®Google Scholar
• Reich K, Nestle FO, Papp K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicenter, double-blind trial. Lancet. 2005;366:1367–74
   PubMed Web of Science ®Google Scholar
• Saurat JH, Stingl G, Dubertret L, et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008;158:558–66
   PubMed Web of Science ®Google Scholar
• Gordon KB, Langley RG, Gottlieb AB, et al. A phase III, randomized, controlled trial of the fully human IL-12/23 mAb briakinumab in moderate-to-severe psoriasis. J Invest Dermatol. 2012;132:304–14
   PubMed Web of Science ®Google Scholar
• Gottlieb AB, Leonardi C, Kerdel F, et al. Efficacy and safety of briakinumab vs. etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011;165:652–60
   PubMed Web of Science ®Google Scholar
• Griffiths CE, Strober BE, van de Kerkhof P, et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med. 2010;362:118–28
   PubMed Web of Science ®Google Scholar
• Kimball AB, Gordon KB, Langley RG, et al.; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008;144:200–7
   PubMed Web of Science ®Google Scholar
• Leonardi CL, Kimball AB, Papp KA, et al.; PHOENIX 1 study investigators. 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;371:1665–74
   PubMed Web of Science ®Google Scholar
• 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 randomized, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371:1675–84
   PubMed Web of Science ®Google Scholar
• Strober BE, Crowley JJ, Yamauchi PS, et al. Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011;165:661–8
   PubMed Web of Science ®Google Scholar
• Hueber W, Patel DD, Dryja T, et al.; Rheumatoid Arthritis Study Group. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci Transl Med. 2010;2:52ra72
   PubMed Web of Science ®Google Scholar
• Leonardi C, Matheson R, Zachariae C, et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. New Engl J Med. 2012;366:1190–9. Study protocol (online supplement). Available from NEJM.org [last accessed 5 Apr 2013]
   PubMed Web of Science ®Google Scholar
• Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II dose-ranging study. Br J Dermatol. 2013;168:412–21
   PubMed Web of Science ®Google Scholar
• Papp K, Leonardi C, Menter A, et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. New Engl J Med. 2012;366:1181–9
   PubMed Web of Science ®Google Scholar
• Rich P, Sigurgeirsson B, Thaci D, et al. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. Br J Dermatol. 2013;168:402–11
   PubMed Web of Science ®Google Scholar
• FDA: Dermatologic and Ophthalmic Drugs Advisory Committee: briefing document for ustekinumab (CNTO 1275). Silver Springs, MD: Food and Drug Administration; 2008. Available from: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4361b1-02-centocor.pdf. Accessed April 5 2013
   Google Scholar
• Mrowietz U, Kragballe K, Reich K, et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011;303:1–10
   PubMed Web of Science ®Google Scholar
• Langley RG, Strober BE, Gu Y, et al. Benefit-risk assessment of tumour necrosis factor antagonists in the treatment of psoriasis. Br J Dermatol. 2010;162:1349–58
   PubMed Web of Science ®Google Scholar
• Data on File, Novartis
   Google Scholar
• Gottlieb AB, Griffiths CE, Ho VC, et al.; for the Multi-Centre Investigator Group. Oral pimecrolimus in the treatment of moderate to severe chronic plaque-type psoriasis: a double-blind, multicenter, randomized, dose-finding trial. Br J Dermatol. 2005;152:1219–27
   PubMed Web of Science ®Google Scholar
• Menter A, Gottlieb A, Feldman SR, 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;58:826–50
   PubMed Web of Science ®Google Scholar
• Pathirana D, Ormerod AD, Saiag P, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol. 2009;23:1–70. Erratum in: J Eur Acad Dermatol Venereol. 2010;24:117–8
   PubMed Web of Science ®Google Scholar
• Smith CH, Anstey AV, Barker JNWN, et al. British Association of Dermatologists’ guidelines for biologic interventions for psoriasis 2009. Br J Dermatol. 2009;161:987–1019
   PubMed Web of Science ®Google Scholar
• Canadian Psoriasis Guidelines Committee: Canadian guidelines for the management of plaque psoriasis. Toronto, Ontario: Canadian Psoriasis Guidelines Committee; 2009. Available from: http://www.dermatology.ca/wp-content/uploads/2012/01/cdnpsoriasisguidelines.pdf. Accessed April 4 2013
   Google Scholar
• Papp K, Gulliver W, Lynde C, et al.; for the Canadian Psoriasis Guidelines Committee. Canadian guidelines for the management of plaque psoriasis: overview. J Cutan Med Surg. 2011;15:210–9
   PubMed Web of Science ®Google Scholar