RESUMO
INTRODUCTION: Patients with psoriasis report pruritus as their most bothersome symptom. Tapinarof cream 1% once daily demonstrated significant efficacy versus vehicle and was well tolerated in adults with mild to severe plaque psoriasis in two 12-week trials: PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980). Here, we present patient-reported pruritus outcomes from these trials. METHODS: Outcomes included a Peak Pruritus Numerical Rating Scale (PP-NRS) score of 0 or 1 (itch-free state); Dermatology Life Quality Index (DLQI) itch item scores; and Psoriasis Symptom Diary (PSD) itch item scores. RESULTS: Analyses included 683 tapinarof- and 342 vehicle-treated patients. At baseline, mean pruritus scores were similar across trials with only 7-11% of patients reporting an itch-free state. At week 12, the proportion of tapinarof-treated patients achieving an itch-free state was 50% in both trials compared with 32% (P = 0.0007) and 27% (P < 0.0001) in the vehicle groups. Improvements were apparent at the earliest assessments with continued improvement over the course of the trials. There were rapid and statistically significant improvements in the proportion of patients with a ≥ 4-point improvement in PP-NRS for tapinarof-treated patients versus vehicle from week 2 with 68% vs 46% (P = 0.0004) and 60% vs 31% (P = 0.0001) at week 12 achieving a response in each trial. Significantly greater reductions in itch with tapinarof versus vehicle were also demonstrated at week 12 for DLQI itch item 1 (P = 0.0026 and P < 0.0001), PSD item 1 (both P < 0.0001), and PSD item 2 (both P < 0.0001). CONCLUSION: Tapinarof was highly efficacious in reducing pruritus across multiple patient-reported outcome measures, with rapid, statistically significant, and clinically meaningful improvements. The high proportion of patients achieving the treatment target of an itch-free state at week 12 (50%) is a noteworthy clinical outcome for a non-steroidal topical cream in the treatment of mild to severe plaque psoriasis. TRIAL REGISTRATION: Clinical trial registration information: NCT03956355, NCT03983980.
RESUMO
BACKGROUND: Emergency department (ED) visits for opioid overdose continue to rise. Evidence-based harm reduction strategies for opioid use disorder (OUD), such as providing home naloxone, can save lives, but ED implementation remains challenging. METHODS: The researchers aimed to increase prescribing of naloxone to ED patients with OUD and opioid overdose by employing a model for improvement methodology, a multidisciplinary team, and high-reliability interventions. Monthly naloxone prescribing rates among discharged ED patients with opioid overdose and OUD-related diagnoses were tracked over time. Interventions included focused ED staff education on OUD and naloxone, and creation of electronic medical record (EMR)-based work-aids, including a naloxone Best Practice Advisory (BPA) and order set. Autoregressive interrupted time series was used to model the impact of these interventions on naloxone prescribing rates. The impact of education on ED staff confidence and perceived barriers to prescribing naloxone was measured using a published survey instrument. RESULTS: After adjusting for education events and temporal trends, ED naloxone BPA and order set implementation was associated with a significant immediate 21.1% increase in naloxone prescribing rates, which was sustained for one year. This corresponded to increased average monthly prescribing rates from 1.5% before any intervention to 28.7% afterward. ED staff education had no measurable impact on prescribing rates but was associated with increased nursing perceived importance and increased provider confidence in prescribing naloxone. CONCLUSIONS: A significant increase in naloxone prescribing rates was achieved after implementation of high-reliability EMR work-aids and staff education. Similar interventions may be key to wider ED staff engagement in harm reduction for patients with OUD.