ABSTRACT
Sarecycline is a novel, narrow-spectrum, third generation tetracycline class antibiotic approved by the Food and Drug Administration (FDA) for the treatment of moderate-to-severe acne in patients ages nine and older. Recently, focus has increased on whether treatment responses differ in acne in skin of color. Here, we aimed to analyze the efficacy of using sarecycline in Hispanics. We report pooled post hoc analysis of efficacy data on sarecycline in Hispanics with acne from two phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trials, SC1401 and SC1402. Of 2002 patients in the pooled trials with moderate-to-severe acne, 26.9% were Hispanic. Facial inflammatory lesion counts decreased as early as week 3 by 26% (p = 0.0279), with continued reduction by 41% by week 6 (p = 0.0003), by 51% by week 9 (p < 0.0001), and by 55% by week 12 (p < 0.0001). Acne is the most common skin condition diagnosed in Hispanics, and this study illustrates a statistically significant reduction in acne in Hispanic patients with moderate-to-severe acne treated with oral sarecycline. Therefore, oral sarecycline shows promising results as a safe and effective treatment for acne in Hispanics.
ABSTRACT
Truncal acne is common, and the psychosocial burden may be underestimated as patients most often complain of facial acne. The Acne Symptom and Impact Scale (ASIS) is a 17-item patient-reported outcome (PRO) measure designed to assess the signs and impacts of acne vulgaris. ASIS has previously been validated in a prospective, non-interventional study as a reliable PRO instrument for facial acne. In a pilot study, ASIS, and an additional 10 new questions that focused on the concerns of patients (ASIS-C), were given to 10 patients with moderate-to-severe truncal acne vulgaris who received 3 months of monotherapy with oral sarecycline, a narrow-spectrum tetracycline-class antibiotic. ASIS-C questionnaires were also given to 10 acne-free control subjects. Average ASIS-C answers decreased by 4% for Signs, 15% for Impact, and 16% for Concerns in the 10 patients, with greater decreases of 5% for Signs, 20% for Impact, and 19% for Concerns in the 60% of patients whose truncal acne was clear or almost clear after 12 weeks of sarecycline treatment. In this study, sarecycline was effective in reducing the psychosocial burden associated with truncal acne based on the ASIS-C PRO measures.
ABSTRACT
OBJECTIVES: The aims of the study were to evaluate the diagnostic performance of Pediatric Early Warning Score (PEWS) to predict occult invasive bacterial infection (IBI) in well-appearing pediatric emergency department (PED) patients without known risk factors for bacterial infection and to compare PEWS to heart rate (HR) and Emergency Severity Index (ESI). METHODS: We performed a retrospective case-control analysis of febrile PED patients aged 60 days to 18 years over a 2-year period. Subjects were excluded if they were ill appearing, admitted to an intensive care unit, or had a known high-risk condition. Cases of occult IBI were included if they had a noncontaminant positive culture other than an isolated positive urine culture. Two febrile control subjects were identified for each case. Odds ratios and receiver operating characteristic curves were evaluated to determine performance characteristics of PEWS at triage and disposition, age-adjusted HR at triage and disposition, and ESI at triage. RESULTS: Compared with 178 controls, 89 cases had higher disposition PEWS, higher disposition HR, lower ESI, and higher rate of hospital admission. Disposition PEWS ≥3 (odds ratio, 2.57; 95% confidence interval, 1.08-6.18), disposition HR > 99th percentile, and ESI demonstrated increased odds of occult IBI. Area under the receiver operating characteristic curve for disposition PEWS (0.56) was similar to triage PEWS (0.54), triage HR (0.54), disposition HR (0.58), and ESI (0.65). CONCLUSIONS: Subjects with PEWS ≥3 at PED disposition have increased odds of occult IBI; however, PEWS has poor discriminative ability at all cutoffs. We cannot recommend PEWS used in isolation to predict occult IBI.
