Acta Dermato-Venereologica 99-13CompleteContent | Page 10

1224 CLINICAL REPORT Patient-reported Outcomes During Treatment in Patients with Moderate-to-severe Psoriasis: A Danish Nationwide Study Nikolai Dyrberg LOFT 1,2 , Alexander EGEBERG 1,2 , Mads Kirchheiner RASMUSSEN 3 , Lars Erik BRYLD 4 , Robert GNIADECKI 5 , Tomas Norman DAM 6 , Lars IVERSEN 3 and Lone SKOV 1,2 1 Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, 2 Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Departments of Dermatology, 3 Aarhus University Hospital, Aarhus, 4 Zealand University Hospital, Roskilde and 5 Bispebjerg Hospital, Copenhagen, and 6 Dermatology Clinic, Nykoebing Falster, Denmark The initiation and evaluation of treatment with biolo­ gics for psoriasis is based on the Psoriasis Area Seve­ rity Index (PASI) and/or Dermatological Life Quality Index (DLQI). However, these indices do not always correlate well, and changes in the DLQI do not always follow changes in the PASI. Based on data from the Da­ nish national registry (DERMBIO), this study investi­ gated the correlation between changes in PASI and DLQI in a cohort of patients with moderate-to-severe psoriasis treated with biologics or apremilast using Spearman’s rank correlation analyses. The correlation analysis of 1,677 patients, of whom 276 had available data after 5 years, showed weak-to-moderate correla­ tion between PASI and DLQI during a 5-year period and between changes in PASI and DLQI: 0.58 (p  < 0.0001) for baseline to 3 months and 0.42 (p  < 0.0001) for 3 to 12 months. The first question on “Symptoms and feelings” made up the largest proportion of the overall DLQI. The correlation between PASI and DLQI is weak- to-moderate and varies over time. Changes in PASI correlate weak-to-moderately with changes in DLQI during the first 12 months of treatment, with symp­ toms being the most important factor contributing to impaired quality of life. Key words: psoriasis; patient-reported outcomes; Psoriasis Area and Severity Index; Dermatology Life Quality Index; bio- logics. Accepted Oct 3, 2019; E-published Oct 3, 2019 Acta Derm Venereol 2019; 99: 1224–1230. Corr: Nikolai Dyrberg Loft, Department of Dermatology and Allergy, Her- lev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark. E-mail: [email protected] P soriasis is a common chronic immune-mediated in- flammatory skin disease, which confers an increased psychosocial burden (1) and impaired quality of life (2), often in a disease-severity dependent manner (3). Short-term assessment of treatment efficacy is mostly based on physician evaluation, whereby a 75% reduc- tion in the Psoriasis Area and Severity Index (PASI75) remains the current treatment goal in most guidelines for patients with moderate-to-severe psoriasis (4–7). How­ ever, some patients are not satisfied with this reduction, and a 90% improvement (PASI90) has been suggested as a clinically important endpoint, and a treatment goal doi: 10.2340/00015555-3331 Acta Derm Venereol 2019; 99: 1224–1230 SIGNIFICANCE The Danish clinical database DERMBIO collects routine information during the treatment of psoriasis with biolo- gics or small molecules. These include physicians’ evalua­ tion of severity, with the Psoriasis Area Severity Index, and the influence on patients’ lives, with the Dermatology Life Quality Index. Among 1,677 patients the correlation between Psoriasis Area Severity Index and Dermatology Life Quality Index was weak-to-moderate during a 5-year treatment period. The changes in Psoriasis Area Severity Index correlated weak-to-moderately with changes in Der- matology Life Quality Index during the first 12 months of treatment, with the strongest correlation seen during the first 3 months. Symptoms were the most important fac- tor in the Dermatology Life Quality Index. Measuring and monitoring of patients’ symptoms are important, and ad- ditional measures to capture symptoms might be beneficial in daily practice. (8–10). Indeed, patients achieving PASI90 report lower Dermatology Life Quality Index (DLQI) than patients achieving PASI75–89 (11) and patients with clear skin based on Physicians Global Assessment (PGA) report lower DLQI compared with those with almost clear skin (12). However, in smaller studies, changes in PASI during the first 3 months of treatment do not correlate fully with changes in DLQI (13, 14) and reported cor- relations between PASI and DLQI range from negligible (13, 15) to strong (16, 17). This apparent dissociation between PASI and DLQI is not yet fully elucidated, but pruritus has been shown to affect this relationship (18). We therefore investigated the relationship between changes in PASI and DLQI in a nationwide cohort of all Danish patients with psoriasis treated with biologics or novel small molecule therapies. MATERIALS AND METHODS Data sources The study was approved by the Danish Data Protection Agency (ref. HGH-2016-048, I-Suite: 04520). In Denmark, approval of an ethics committee is not required for register studies. The study was carried out in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations (19). This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2019 Acta Dermato-Venereologica.