An evaluation of anifrolumab for use in adults with systemic lupus erythematosus.

INTRODUCTION: Type 1 interferons play a key role in the pathogenesis of systemic lupus erythematosus (SLE). An important clinical question is whether inhibiting the type 1 interferon pathway reduce the disease activity in SLE patients. This review evaluates the safety and efficacy of the monoclonal antibody against the type 1 interferon alpha receptor, anifrolumab, in patients with SLE. AREAS COVERED: Key terms (SLE, type 1 interferon, anifrolumab) were used to query the PubMed database for phase 1, 2 and 3 clinical trials of anifrolumab for SLE patients. Phase 1 studies showed anifrolumab has non-linear pharmacokinetics and the optimal safe dose is 300 mg given intravenously every four weeks. The MUSE (phase 2) and the TULIP-2 (phase 3) trials showed that anifrolumab when added to standard therapy significantly reduced disease activity in SLE patients. Common adverse events associated with anifrolumab were upper respiratory and urinary infections as well as shingles. EXPERT OPINION: Anifrolumab is an exciting new therapeutic for SLE patients. Additional analyses of the combined TULIP-1 and TULIP-2 datasets as well as future studies with anifrolumab will generate yet more data in SLE. No doubt anifrolumab will be studied in other diseases where type I interferons play an important role.

Comparison of Pain Severity and Management in Burn and Nonburn Trauma Patients.

Burn injuries are generally considered to be among the most painful. However, there is little evidence to support this. It is also unknown if pain management in burn patients differs from patients with other sources of pain. We compared pain severity among patients presenting to emergency departments (EDs) across the United States with burn and nonburn injuries using data generated from the National Hospital Ambulatory Care Survey. Multivariate analyses was performed to determine the association between predictor variables and pain severity as well as pain management in the ED. Of the estimated 527 million ED visits between 2010 and 2013, 2.1 million were due to burns and 128 million were due to nonburn trauma. Mean (SE) initial pain scores by patient group were burns 6.3 (0.27), nonburn trauma 5.4 (0.04), and nontrauma 4.8 (0.04), P < .001. Mean (95% confidence interval) pain scores by specific type of injury were burns 6.4 (5.9-6.9), fractures 6.7 (6.6-6.9), dislocations 6.7(6.3-7.1), and sprains/strains 6.8 (6.7-6.9), P < .001. Pain scores were higher for males and increased with age. Adjusted for age and gender, burns had the smallest effect of all types of injuries on pain score except for open wounds, contusions, and crush injuries. Patients with fractures and dislocations were more likely to receive an opioid than burn patients after adjusting for pain severity. We conclude that pain severity due to burns is no greater than due to dislocations, fractures, and sprains/strains and that burn patients are less likely to receive opioid and nonopioid analgesics than fractures and dislocations.

Topical antibiotic ointment versus silver-containing foam dressing for second-degree burns in swine.

OBJECTIVES: Second-degree burns are very common but their management is controversial. These burns may be treated with either topical antimicrobial agents or advanced occlusive dressings; however, there is no established treatment comparator for preclinical studies. This study was designed to determine which of two commonly used comparator therapies (a silver-containing advanced dressing or a topical antibiotic ointment) resulted in faster reepithelialization and less scarring. The hypothesis was that second-degree burns treated with a topical antimicrobial ointment would heal faster and with less scarring than those treated with a silver-containing occlusive foam dressing in a porcine model. METHODS: Deep partial-thickness burns were created on the flanks of three anesthetized female domestic pigs (20 to 25 kg) using a 150-g aluminum bar preheated in 80°C water bath and applied to the skin for 20 seconds using a force of 2 kg. The burn eschars were excised 48 hours later with an electric dermatome set at a depth of 0.75 mm. The wound beds were treated with a thin layer of triple-antibiotic petrolatum-based ointment (changed three times weekly) or a silver-containing foam dressing (changed once weekly). Full-thickness punch biopsies were obtained at 9, 11, 14, 16, 18, and 21 days for determination of percentage complete wound reepithelialization and at 28 days for measurement of scar depth. RESULTS: At all dressing changes the wounds treated with the topical antibiotic appeared moist, while those treated with the silver-based dressings appeared dry. At day 21 all wounds treated with the ointment were completely reepithelialized, while only 55% of those treated with the silver dressing were reepithelialized (p < 0.001). Scar depth at day 28 was also significantly less in wounds treated with the topical antibiotic ointment (4.3 mm vs. 5.1 mm, difference = 0.7 mm; 95% confidence interval [CI] = 0.1 to 1.4 mm). There was less scar contraction in wounds treated with the topical antibiotic compared with the silver-based dressing (mean ± SD = 25.0% ± 14.6% vs. 38.9% ± 16.9%, difference = 13.9%; 95% CI = 5.7% to 22.0%). CONCLUSIONS: In this model of excised deep partial-thickness burns, a triple-antibiotic ointment enhanced reepithelialization and reduced scar depth and contraction compared with a silver-based foam dressing. This triple-antibiotic ointment should be considered as a control for studies evaluating novel topical burn therapies.