Introduction: With newer biologics, the achievement of complete skin clearance has become an attainable treatment goal for patients with plaque psoriasis. We evaluate how improvements in Psoriasis Area and Severity Index (PASI) responses, particularly at incremental improvements approaching complete skin clearance (PASI 100), translate into improvements in health-related quality of life (HRQoL) and patient-perceived symptoms.
Methods: Data from the BE RADIANT phase 3b trial (NCT03536884) and its open-label extension (OLE), pooled across all study visits and treatments over 16 weeks (randomised patients) and 2 years (patients entering the OLE), were analysed using mixed-effects logistic regression models. Proportions of patients achieving a Dermatology Life Quality Index (DLQI) of 0/1, DLQI item scores of 0, and Psoriasis Symptoms and Impacts Measure (P-SIM) item scores of 0 for itching, scaling, and skin pain at specific PASI improvement levels were estimated.
Results: Seven hundred and forty-three patients were randomised to treatment; 654 entered the OLE. Using 16-week pooled data, there were incremental improvements in the proportions of patients estimated by our model to achieve DLQI 0/1 with PASI 100 compared with 95% (PASI = 95%) and 90% (PASI = 90%) improvements in PASI (93.0%, 89.3%, and 83.8% achieving DLQI 0/1, respectively). Estimated proportions achieving DLQI item scores of 0 had the greatest increases at higher PASI improvement levels for Items 1 (itchy, sore, painful, or stinging skin), 2 (embarrassment), and 4 (choice of clothing). Estimated proportions of patients achieving P-SIM = 0 were also higher for PASI 100 (itching: 61.7%; scaling: 82.2%; skin pain: 96.9%) than for PASI = 95% (50.8%; 72.3%; 95.7%) and PASI = 90% (39.8%; 59.5%; 94.0%). Similar benefits of incremental PASI improvements were estimated using 2-year data.
Conclusions: Complete skin clearance translated into the greatest benefits to HRQoL and patient-perceived symptoms, over and above skin clearance between 90% and 100%, highlighting the importance of targeting PASI 100 as a treatment outcome for patients with psoriasis.
Trial Registration Number: NCT03536884. Complete skin clearance is associated with the greatest benefits to health-related quality of life and perceived symptoms for patients with psoriasis: KeyResults and Conclusions (MP4 72828 kb).
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http://dx.doi.org/10.1007/s13555-024-01261-6 | DOI Listing |
Clin Pharmacokinet
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Clinical Pharmacology and Quantitative Science, Genmab, Plainsboro, NJ, USA.
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Int J Mycobacteriol
October 2024
Department of Pulmonary Medicine, Medical College, Baroda and SSGH, Vadodara, Gujarat, India.
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View Article and Find Full Text PDFSemin Plast Surg
November 2024
Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas.
Mohs micrographic surgery (MMS) is a tissue-sparing skin cancer resection technique that involves 100% margin analysis. This procedure is performed in the outpatient setting under local anesthesia by dermatologic surgeons who act as both the surgeon and the pathologist. The technique allows for prompt reconstruction immediately after cancer clearance and offers the highest cure rate for many skin malignancies, including basal and squamous cell carcinoma, as well as more rare tumors.
View Article and Find Full Text PDFJ Pharm Health Care Sci
December 2024
Department of Clinical Pharmacokinetics, Graduate School of Medical Sciences, Kanazawa University, 13-1 Takara-Machi, Kanazawa, 920-8641, Japan.
Background: In the dose titration of transdermal fentanyl to prevent unrelieved pain, it is important to consider not only dose adjustment, but also the titration period, which is influenced by the time required to reach the steady state. Many patients with cancer pain experience comorbidities that might affect the skin properties and influence transdermal absorption. We hypothesized that skin changes due to diabetes mellitus (DM) would affect the titration period of transdermal fentanyl.
View Article and Find Full Text PDFDrug Metab Pharmacokinet
November 2024
Department of Clinical Pharmacokinetics, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan; Department of Hospital Pharmacy, University Hospital, Kanazawa University, Kanazawa, Japan; AI Hospital/Macro Signal Dynamics Research and Development Center, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan. Electronic address:
A retrospective study and an animal study were conducted to investigate factors affecting the transdermal fentanyl dose to achieve adequate pain relief in patients switched from other opioids. In the retrospective study, patient factors were included as gender, age, body mass index (BMI), and serum albumin concentration. In obese (BMI ≥25) patients, the post-titration dose of transdermal fentanyl was significantly lower than in normal (BMI 18.
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