Development of rapid, reliable and novel severity measures for psoriasis and eczema

Physician global assessment (PGA) and body surface area (BSA) have long been used to rapidly assess psoriasis patients' disease severity in both clinical practice and trials. Psoriasis area and severity index (PASI) in patients with psoriasis and the Eczema area and severity index (EASI) in patients with atopic eczema are effective but time-consuming and many dermatologists may not find PASI and EASI feasible while evaluating patients in a clinical setting. Developing rapid and effective tools to assess disease severity and response to treatment is of paramount importance. Historically, researchers have attempted to establish methods for developing a rapid, reliable, and valid physician reported outcome (PRO) for psoriasis or eczema that could be used in clinical practice.1, 2 However, the studies shows variation in the correlation coefficients depending on the severity and duration of the disease. We believe that we have developed such a PRO for both PASI and EASI, namely the G2-PASE (Gulliver-Gestalt-psoriasis area severity estimate) and G2 -EASE (Gulliver-Gestalt-eczema area severity estimate) (see Table 1). We considered both a Gestalt BSA and a PGA with a constant (which is arbitrary and may be corrected in the future) to determine the PRO of G2-PASE or G2-EASE. The correlation between PASI and G2-PASE and EASI and G2-EASE was determined using a sample of 100 patients with G2-PASI and 77 with G2-EASE. The data is then validated using a second random sample of 100 and 77 patients, respectively, for the G2-PASE and G2-EASE. The products of Gestalt PGA and BSA were calculated using the appropriate multiplier for G2-PASE and G2-EASE (see Table 1). Correlation coefficients, Cronbach's alpha reliability tests3 and area under the receiver operating characteristic curve (ROC AUC) were used to ascertain the association between PASI and G2-PASE, as well as between EASI and G2-EASE (see Table 2). In both the first and second samples, there is a strong correlation between PASI and G2-PASE, with correlation coefficients of 0.90 (p value 0.00) and 0.82 (p value 0.00), respectively. Overall, excellent reliability was determined using Cronbach's α (0.91 and 0.89). G2-EASE was calculated in a similar manner utilising gestalt BSA and PGA, with a correlation coefficient of 0.95 (p value 0.000) for the first sample and 0.92 (p value 0.000) for the second sample. Cronbach's α values of 0.97 and 0.95 indicated excellent reliability for G2-EASE. AUC values are determined to be 1 (p = 0.00) for all data sets utilised in the study, indicating that the newly adopted tools are highly reliable. Further statistical analysis with a larger data set can be performed to establish the validity of newly developed PRO's. Our plan is to conduct additional validation of data with larger cohorts to strengthen the scientific foundations for G2-PASE and G2-EASE. Based on preliminary data, we conclude that G2-PASE and G2-EASE are both rapid and reliable clinician-reported outcomes effective of estimating PASI and EASI scores using the product of PGA and gestalt BSA with acceptable constants. W. P. Gulliver: Research idea and development of indices; data collection; research design; manuscript write-up and review; manuscript submission; overall supervision. O. P. Yadav: Data validation; statistical data analysis; manuscript write-up and editing. S. Gulliver: Project administration; manuscript editing; review. M. Cousens: Data compilation; manuscript editing. Funding is not available for this study. W. P. Gulliver: Relationships with commercial interests: Grants/research support: AbbVie, Amgen, Eli Lilly, Novartis, Pfizer. Honoraria for Ad Boards/Invited Talks/Consultation: AbbVie, Actelion, Amgen, Arylide, Bausch Health, Boehringer, Celgene, Cipher, Eli Lilly, Galderma, Janssen, LEO Pharma, Merck, Novartis, PeerVoice, Pfizer, Sanofi-Genzyme, Tribute, UCB, Valeant. Other: Clinical trials (study fees): AbbVie, Asana Biosciences, Astellas, Boerhinger-Ingleheim, Celgene, Corrona/National Psoriasis Foundation, Devonian, Eli Lilly, Galapagos, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, UCB. The remaining authors declare no conflict of interest. Data available on request due to privacy/ethical restrictions. Not applicable. Data available on request due to privacy/ethical restrictions.

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