Acta Dermato-Venereologica 99-12CompleteContent | Page 11

CLINICAL REPORT 1085 Quality of Life in Psoriasis Vulgaris: Use of the ItchyQoL Question­ naire in a Secukinumab Phase III Trial in Patients with Psoriasis Vulgaris Sonja STÄNDER 1 , Sabine STEINKE 2 , Matthias AUGUSTIN 3 , Dieter METZE 2 , Karin LOSER 2 , Daniel BAEUMER 4 , Christian SIEDER 4 and Thomas LUGER 1 Department of Dermatology and Center for Chronic Pruritus, University Hospital Münster, 2 Department of Dermatology, University Hospital Münster, 3 Institute for Health Services Research in Dermatology and Nursing, Hamburg, and 4 Novartis Pharma GmbH, Nürnberg, Germany 1 Chronic pruritus is a bothersome symptom in psoria- sis vulgaris and can profoundly reduce quality of life (QoL). In this exploratory analysis of the PSORITUS study, the impact of pruritus on QoL in 130 subjects with moderate-to-severe psoriasis was assessed using the ItchyQoL questionnaire. The majority of patients (n  =  127) had to scratch their itchy skin regularly, which led to painful skin and frustration (mean  ±  stan- dard deviation; SD ItchyQoL scores; 4.50  ±  0.56; 3.80  ±  1.09 and 4.20  ±  0.87, respectively). Changes in either temperature or season led to worsening of itching in most of the patients (n  = 126; mean  ±  SD ItchyQoL score; 3.80  ±  1.02). Many patients felt asha- med (n  = 125) or embarrassed (n  = 127) due to their itchy skin (mean  ±  SD ItchyQoL scores; 3.90  ±  1.26 and 3.40  ±  1.19, respectively). The results demonstrated the ItchyQoL questionnaire as a validated tool respon- sive to treatment for detailed insights into chronic pru- ritus in patients with psoriasis. Key words: itch; ItchyQoL questionnaire; pruritus; psoriasis vulgaris; quality of life. Accepted Aug 6, 2019; E-published Aug 6, 2019 Acta Derm Venereol 2019; 99: 1085–1090. Corr: Sonja Ständer, Department of Dermatology and Center for Chronic Pruritus, University Hospital Münster, Von-Esmarch-Strasse 58, DE- 48149 Münster, Germany. E-mail: [email protected] P soriasis vulgaris, or plaque-type psoriasis, is the most common clinical presentation of psoriasis, a chro- nic, disabling, and complex inflammatory disease that primarily affects the skin (1). The estimated worldwide prevalence of psoriasis is 2–3% (2); and approximately 20–44% of patients experience moderate-to-severe forms (3, 4). Pruritus, or itch, is one of the most bothersome symptoms of psoriasis, affecting 60–90% of patients (5–7) and, if lasting for at least 6 weeks, pruritus is defined as chronic by the International Forum for the Study of Itch (IFSI) (8). In Germany, psoriasis was reported in 2.18% of patients in a cross-sectional study, of whom 38.7% had chronic pruritus. Pruritus can considerably compromise the quality of life (QoL) of patients with psoriasis (e.g. through sleep deprivation) and often has serious psycho- logical implications, including depression and suicidal ideation (6, 9, 10). SIGNIFICANCE Pruritus is one of the most common and bothersome symp- toms of psoriasis and can be of varying intensity, affecting 60–90% of patients with psoriasis. Pruritus has a large im- pact on patients’ quality of life and can significantly alter their psychosocial well-being. For the first time, in this ex- ploratory analysis of the PSORITUS study, the impact of pruritus on quality of life in patients with psoriasis has been described using the ItchyQoL questionnaire. The results provide detailed insights into the aspects of quality of life impacted by pruritus in psoriasis. Since chronic pruritus affects QoL, specific and vali- dated questionnaires can provide important information on its impact on patients’ QoL and also on the efficacy and safety of treatment, thus enabling physicians to refine patient management. In addition to the Dermatology Life Quality Index (DLQI) questionnaire, which is commonly used to assess impairment of QoL, there are several other generic health-related QoL (HRQoL) instruments which are used for patients with dermatoses. However, disease- specific QoL tools provide a deeper understanding of the impact of treatments and disease on QoL than with generic tools (11). The ItchyQoL, as the first pruritus- specific QoL instrument, was developed in 2008 and can be applied to patients with pruritus independent of the underlying disease (12). To date, insufficient data on the use of the ItchyQoL instrument in clinical practice or trials is available for psoriasis. We report here the baseline characteristics from an exploratory analysis of the PSORITUS study performed to assess the impact of treatment on pruritus in patients with psoriasis using the ItchyQoL questionnaire. METHODS PSORITUS (Secukinumab study in PSOriasis exploring pruRITUS intensity and lesional biomarkers) was an exploratory, Phase IIIb study conducted at 19 centres in Germany. The study had a 16- week open-label run-in phase, followed by a 16-week randomized, placebo-controlled drug withdrawal phase. Subjects (≥ 18 years) diagnosed with chronic moderate-to-severe psoriasis (Psoriasis Area and Severity Index (PASI) score > 10) of at least 6 months prior to baseline and pruritus intensity ≥ 30 on a 100-point visual analogue scale (VAS, the worst itch within a recall period of 24 h) This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2019 Acta Dermato-Venereologica. doi: 10.2340/00015555-3275 Acta Derm Venereol 2019; 99: 1085–1090