Evaluation of Patient-Reported Outcomes with Etanercept in Moderate to Severe Plaque Psoriasis Patients After Therapy With Apremilast
April 2020 | Volume 19 | Issue 4 | Original Article | 378 | Copyright © April 2020
Published online March 6, 2020
Jerry Bagel MD, Bradley S. Stolshek MD, Yue Yang MD, Gregory Kricorian MD, Leon Kircik MD
aPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ bAmgen Inc., Thousand Oaks, CA cIcahn School of Medicine, Mount Sinai, New York, NY; Indiana Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC; DermResearch, PLLC, Louisville, KY
Patients with moderate-to-severe psoriasis can have symptoms resulting in significant impact on patient-reported outcomes (PROs). The effect of etanercept (ETN) in moderate-to-severe psoriasis patients who previously received apremilast (APR) was studied, including impact on PRO endpoints. Methods:
In this multicenter, open-label, single-arm, phase 4 estimation study, patients with moderate-to-severe psoriasis who did not have adequate response to APR in the opinion of the investigator received ETN 50mg subcutaneous (SC) twice weekly for 12 weeks, followed by ETN 50mg SC once weekly for an additional 12 weeks. Analysis was conducted for PROs directly and by the Psoriasis Area and Severity Index (PASI) achievement thresholds. Results:
Of the 80 patients enrolled, the Psoriasis Symptom Inventory (PSI; total and individual items) had substantial improvement at weeks 12 and 24. Improvement in PSI total score (percent; mean [SD]) in patients who achieved PASI 50, -75, and -90 at week 12 was 57% (30), 67% (24), and 83% (18), respectively and at week 24 was 56% (40), 68% (29), and 80% (25). DLQI responders by PASI 50, -75, and 90 achievements were 69%, 68%, and 90%, respectively, at week 12 and 68%, 77%, and 82% at week 24. The percent of patients reported being “very satisfied” or “satisfied” with treatment at week 12 was 79%, 81%, and 100%, respectively, and at week 24 was 77%, 86%, and 88%. Conclusion:
Patient-reported symptoms are important outcomes to consider in psoriasis management. ETN provided benefits in patients who did not have adequate response with APR, with improvements seen in both psoriasis symptoms and patient impact. Clinical Trial Number
: NCT02749370 J Drugs Dermatol. 2020;19(4): doi:10.36849/JDD.2020.4910
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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