The Static Physician’s Global Assessment of Genitalia: A Clinical Outcome Measure for the Severity of Genital Psoriasis

August 2017 | Volume 16 | Issue 8 | Original Article | 793 | Copyright © August 2017

Joseph F. Merola MD MMSc,a Alison Potts Bleakman PhD,b Alice B. Gottlieb MD PhD,c Alan Menter MD,d April N. Naegeli PhD,b Robert Bissonnette MD MS FAAD FRCPC,e Lyn Guenther MD FRCPC,f John Sullivan MBBS MS,g Kim Meeuwis MD PhD,h Kyoungah See PhD,b and Kristina Callis Duffin MD MSi

aDepartment of Dermatology and Medicine, Division of Rheumatology, Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, USA bEli Lilly and Company, Indianapolis, IN, USA cDepartment of Dermatology, New York Medical College at Metropolitan Hospital, New York, NY, USA dDepartment of Dermatology, Baylor University Medical Center, Dallas, TX, USA eInnovaderm Research, Montreal, QC, Canada fThe Guenther Dermatology Research Centre, London, ON, Canada gDepartment of Medicine, UNSW, Sydney, New South Wales, Australia hDepartment of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands iDepartment of Dermatology, University of Utah, Salt Lake City, UT, USA

Table 3Medicines Agency recommend including a Physician’s Global Assessment as an efficacy endpoint for psoriasis clinical trials.24-27 The sPGA-G was developed as a collaborative effort between academic and clinical dermatologists and Eli Lilly and Company as an efficacy outcome measure for clinical trials in patients with genital psoriasis. The sPGA-G emphasizes erythema during assessment given the erythematous clinical presentation of genital psoriasis and because erythema is considered the most significant physical characteristic by patients with genital psoriasis.13 Because the sPGA-G was designed to evaluate psoriasis affecting the genitalia, it does not assess adjacent body regions such as the perianal area. It also does not assess secondary features of genital psoriasis such as erosion, fissures, and secondary candidiasis.7 In clinical practice, HCPs should still consider the impact of these additional features and body sites when treating patients with genital psoriasis. In this study, there was a high degree of concordance between raters and assessors using the sPGA-G. However, there are limitations to these analyses. For example, the number of experts in the area of genital psoriasis is currently small. In addition, the availability of high quality photographs of genital psoriasis that have the required patient consent for use in training materials is limited. Moreover, photographs may limit the ability of raters to fully assess physical characteristics as compared to a physical examination. In summary, genital psoriasis is a common and often overlooked manifestation of psoriasis yet to be studied in a large-scale clinical trial. It is essential that reliable outcome measures for genital psoriasis are available for use as clinical trial endpoints. The sPGA-G scale was developed as a collaboration between clinical, academic, and industry experts to address this unmet need. The results presented here indicate that the sPGA-G should be considered a well-defined outcome measure in the clinical assessment of the severity of genital psoriasis, present in up to 60% of psoriasis patients.5

DISCLOSURES

J. F. Merola is a consultant/advisor for Biogen IDEC, AbbVie, Amgen, Eli Lilly and Company, Novartis, Pfizer, Janssen, UCB, Kiniksa, and Momenta and Mallinckrodt; is on the advisory board for Biogen IDEC, AbbVie, Amgen, Eli Lilly and Company, Novartis, Pfizer, Janssen, UCB, Kiniksa, and Momenta and Mallinckrodt; is a speaker for AbbVie, is an investigator for Biogen IDEC, Amgen, Pfizer, and Boehringer Ingelheim; has received grant support from Biogen IDEC; and has a licensed outcome measure for AbbVie. A.B. Gottlieb is a consultant/advisory board member for Am- gen, Astellas, Akros, Centocor (Janssen), Celgene, Bristol Myers Squibb, Beiersdorf, Abbot Labs (Abbvie),TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dermipsor, Incyte, Pfizer, Cante, Eli Lilly and Company, Coronado, Vertex, Karyopharm, CSL Behring Biotherapies for Life, Glaxo Smith Kline, Xenoport, Catabasis, Meiji Seika Pharma,Takeda, Mitsubishi, Tanabe Pharma Development America, Genentech, Baxalta, Kineta One, KPI Therapeutics, Crescendo Bioscience, Aclaris, Amicus, Reddy labs, Valeant, Dermira, and Allergan. Dr Gottlieb also received research/educational grants from Centocor (Janssen), Amgen, Abbott (Abbvie), Novartis, Celgene, Pfizer, Eli Lilly and Company, Levia, Merck, Xenoport, Dermira, and Baxalta. A. Menter is an advisory board member for AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly and Company, Janssen