Utility of the Dermatology Life Quality Index at initiation or switching of biologics in real-life Japanese patients with plaque psoriasis: Results from the ProLOGUE study

Abstract

Background: Plaque psoriasis significantly affects patients' health-related quality of life. To aid treatment decisions, not only objective assessment by physicians but also subjective assessment by patients is important. Objective: To assess the significance of Dermatology Life Quality Index (DLQI) evaluation at the time of biologics introduction in clinical practice in Japanese patients with plaque psoriasis. Methods: This was a single-arm, open-label, multicenter study. At baseline, Psoriasis Area and Severity Index (PASI) and DLQI scores were measured and stratified based on DLQI scores 6/5 and PASI scores 10/>10. Other patient-reported outcomes assessed included EQ-5D-5L, itch numerical rating scale (NRS), skin pain NRS, Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-8 (PHQ-8), Sleep Problem Index-II (SPI-II), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Results: Of the 73 enrolled patients, 23 had PASI scores 10. Those with PASI/DLQI scores >10/6 had a significantly higher median PASI score than those with PASI/DLQI scores >10/5 (p = 0.0125). Regardless of PASI scores (>10/10), median itch NRS and GAD-7 scores were significantly higher in patients with DLQI scores 6 than in those with DLQI scores 5 (itch NRS, p = 0.0361 and p = 0.0086, respectively; GAD-7, p = 0.0167 and p = 0.0273, respectively). Patients with PASI/DLQI scores 10/6 had significantly higher skin pain NRS (p = 0.0292) and PHQ-8 (p = 0.0255) scores and significantly lower median SPI-II scores (p = 0.0137) and TSQM-9 Effectiveness domain scores (p = 0.0178) than those with PASI/DLQI scores 10/5. Conclusion: DLQI may be useful for assessing patients' concerns that cannot be identified by PASI alone while initiating biologics or switching from other biologics in clinical practice.

Molecular Pathogenesis of Psoriasis and Biomarkers Reflecting Disease Activity

“…Psoriasis is a recurrent, persistent inflammatory skin disorder characterized by rough, reddish plaques on frequently chafed body parts, such as the extensor sites of the extremities [ 1 , 2 ]. Individuals with this condition suffer from subjective symptoms, such as itching and pain, but also from skin lesions, especially on exposed areas, such as the scalp, face, hands, and nails, which can have a prominent impact on the patients’ quality of life [ 3 , 4 , 5 , 6 ]. In fact, it has been suggested that the manifestation of psoriasis-related symptoms can trigger stigmatization, leading to social discrimination and alienation [ 7 , 8 , 9 ].…”

Itching and skin pain in real-life patients with plaque psoriasis: Baseline analysis of the ProLOGUE study

“…The burden of having both itching and skin pain in real-life patients with psoriasis has not been fully elucidated. To assess the effects of co-occurrence of itching and skin pain in real-life patients with psoriasis using multiple patient-reported outcome (PRO) instruments, we analyzed the baseline patient data of the ProLOGUE study, which assessed the effectiveness of brodalumab, a human anti-interleukin-17 receptor monoclonal antibody, in Japanese patients with plaque psoriasis (Japan Registry of Clinical Trials identifier: jRCTs031180037) [5]. This single-arm, open-label, multicenter, prospective study was conducted at 15 facilities across Japan from October 2017 to March 2020.…”

“…This single-arm, open-label, multicenter, prospective study was conducted at 15 facilities across Japan from October 2017 to March 2020. Patients (aged ≥ 18 years) who had plaque psoriasis without peripheral arthritis symptoms and who could self-administer brodalumab were included [5]. The level of itching and skin pain (during the previous 24 h) were assessed using the Itch Numeric Rating Scale (NRS) [6] and Skin Pain NRS [7] scores, respectively (0 [no itch/pain] to 10 [worst imaginable itch/pain]).…”

“…Itching and skin pain were defined as an Itch NRS score of ≥ 1 and a Skin Pain NRS score of ≥ 1, respectively. The Itch NRS score, Psoriasis Area and Severity Index (PASI) score, body surface area (BSA) involvement, and other PRO scores electronically captured before baseline medical examination [5] were compared between patients with psoriasis having both itching and skin pain and those having itching alone, based on the hypothesis that itching with skin pain poses a greater burden on patients with psoriasis than itching alone. In addition, modified severity scores for PASI components (erythema, induration, and desquamation; see Table 1 for details) were calculated and compared between the groups.…”

“…Seventy-three patients were enrolled in this study (men, 82.2%; median age, 54.0 years), and the median (quartile [Q1-Q3]) Itch NRS and Skin Pain NRS scores were 4.0 (2.0-7.0) and 1.0 (0.0-3.0), respectively [5]. Sixty-six (90.4%) patients had itching and 45 (61.6%) had skin pain, with 44 (60.3%) reporting both symptoms.…”