INTRODUCTION
Psoriasis is a chronic, inflammatory disease primarily affecting the skin and has been historically known to impact quality of life. Patients with uncontrolled psoriasis can experience substantial clinical symptoms leading to reduced functioning and activity that can be measured by patient-reported outcomes (PROs). Specifically, PROs in psoriasis can assess the symptoms, impact, and satisfaction experienced by a patient. Previous studies have correlated clinical measures, including the Psoriasis Area and Severity Index (PASI) and the static Physician Global Assessment (sPGA), with PROs such as the Dermatology Life Quality Index (DLQI).1,2,3
A recently published report described the primary and key secondary outcomes of a phase 4 study assessing the efficacy of etanercept in patients with moderate-to-severe plaque psoriasis who did not achieve or lost adequate clinical response or had intolerability to apremilast, in the opinion of the investigator.4 In this study, PASI 75 was achieved in 42% and 46% of etanercept patients at weeks 12 and 24, respectively while PASI 90 was achieved in 13% and 22% of patients at weeks 12 and 24, respectively. In addition, the majority of patients reported favorable PROs—66% and 57% were DLQI responders (5-point improvement in DLQI from baseline or score of 0) and 61% and 53% were satisfied/very satisfied with their psoriasis treatment at weeks 12 and 24, respectively. In addition, mean Psoriasis Symptom Inventory (PSI) scores meaningfully improved from 17 at baseline to 9 and 10 at weeks 12 and 24, respectively.
The PSI was developed in accordance with the US Food and Drug Administration guidance (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282) and measures the severity of psoriasis signs and symptoms. Briefly, the PSI is an eight-item questionnaire assessing itch, redness, scaling, burning, stinging, cracking, flaking, and pain.5,6,7 It has been used in both clinical trials8,9 and clinical practice.10,11
A recently published report described the primary and key secondary outcomes of a phase 4 study assessing the efficacy of etanercept in patients with moderate-to-severe plaque psoriasis who did not achieve or lost adequate clinical response or had intolerability to apremilast, in the opinion of the investigator.4 In this study, PASI 75 was achieved in 42% and 46% of etanercept patients at weeks 12 and 24, respectively while PASI 90 was achieved in 13% and 22% of patients at weeks 12 and 24, respectively. In addition, the majority of patients reported favorable PROs—66% and 57% were DLQI responders (5-point improvement in DLQI from baseline or score of 0) and 61% and 53% were satisfied/very satisfied with their psoriasis treatment at weeks 12 and 24, respectively. In addition, mean Psoriasis Symptom Inventory (PSI) scores meaningfully improved from 17 at baseline to 9 and 10 at weeks 12 and 24, respectively.
The PSI was developed in accordance with the US Food and Drug Administration guidance (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282) and measures the severity of psoriasis signs and symptoms. Briefly, the PSI is an eight-item questionnaire assessing itch, redness, scaling, burning, stinging, cracking, flaking, and pain.5,6,7 It has been used in both clinical trials8,9 and clinical practice.10,11
