Does Health-Related Quality of Life Evaluation In Psoriasis Matter? A Review of Labels of Psoriasis Products Approved By The Fda and The Ema.

PSS67 DoeS HealtH-RelateD Quality of life evaluation in PSoRiaSiS MatteR? a Review of labelS of PSoRiaSiS PRoDuctS aPPRoveD by tHe fDa anD tHe eMa Acquadro C1, Perret C1, Arnould B2 1Mapi Research Trust, Lyon, France, 2Patient-Centered Outcomes Mapi, Lyon, France Objectives: Psoriasis is a papulosquamous skin disease characterized by recurring thick, itchy and dry red patches covered with silvery scales. It has been shown that patients with psoriasis have a reduction in their quality of life similar to patients with other chronic diseases, such as ischemic heart disease and diabetes. The objective of this study was to evaluate how health-related quality of life (HRQL) was taken into consideration in the evaluation of psoriasis products approved by the FDA and the EMA since 1995. MethOds: The websites of the FDA and the EMA were explored to identify all psoriasis products approved. PROLabels was used to identify products with a PRO claim in label. All corresponding clinical reviews (FDA), and assessments reports (EMA) were reviewed for HRQL evaluation. Results: Twenty-seven products have been approved since 1995 (18 FDA, nine EMA). Six products were common to both agencies (i.e., adalimumab, apremilast, etanercept, infliximab, secukinumab, ustekinumab). For the products approved by both agencies, the same clinical studies were submitted. PRO claims were found in nine products (eight EMA, one FDA). HRQL was mentioned in the label of all EMA products (mainly, improvement in QOL), but not the FDA’s. The Dermatology Life Quality Index (DLQI) was used for all products, and the SF-36 for six products. Among the eight EMA products with a HRQL claim, five products have been also approved by the FDA. In two cases (apremilast, ustekinumab), the medical review was not available. Therefore, reasons for not including HRQL in the label could not be retrieved. For the three other products (adalimumab, infliximab, secukinumab), HRQL was not mentioned in the review. cOnclusiOns: The EMA seems to consider HRQL as a valuable endpoint in the evaluation of psoriasis products in contrast with the FDA. More harmonization between agencies might be beneficial to patients’ information.