Evaluation of a novel autoinjector for subcutaneous self-administration of belimumab in systemic lupus erythematosus

Objective: To study self-administration and pharmacokinetics (PK) of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE). Methods: Patients previously treated with belimumab self-administered belimumab 200 mg SC weekly for 8 weeks using an autoinjector. The primary endpoint was the proportion of patients able to self-administer their first and second dose (weeks 1 and 2) in the clinic. The proportion able to self-administer at weeks 4 and 8 (clinic) and weeks 3, 5, 6, and 7 (home) were secondary endpoints. Belimumab PK, safety, and injection-site pain were assessed. Results: 91/95 patients completed the study (withdrawals: adverse events (AEs): 3; lost to follow-up: 1). 93% were female, and mean (SD) age was 44.8 (12.50) years. The majority (99%, 89/90; no attempt, n = 5) successfully self-administered belimumab SC at weeks 1 and 2 (5 had clinic staff assistance), and 98% (85/87) successfully self-administered at weeks 4 and 8. Home-administration success rates were high (93%, (81/87) at weeks 3, 5, 6, and 7). Week 8 median trough concentration was 113 µg/mL. For patients with a ≤ 1.5-week interval between IV SC administration, week-1 concentrations were higher vs. week 8 (+ 51% median) but within a range observed with IV dosing; those with a ≥ 2.5-week interval had median differences close to 0. AEs and serious AEs were low, with no deaths; pain levels were low and decreased with subsequent injections. Conclusion: Patients with SLE successfully self-administered belimumab SC using a novel autoinjector; the PK profile was stable following a switch from IV with acceptable AE and pain levels. The recommended dosing interval between IV to SC dosing is 1 – 4 weeks

Who shares wins? Understanding barriers to information sharing in managing supply chain risk.

Currently there is no universally accepted approach to supply chain risk management and assurance. To begin to shed more light on the practical operational challenges presented when considering supply chain risk mitigation through the sharing of information, this paper discusses the results of an empirical study conducted with manufacturing supply chain professionals. The study examines state-of-the-art challenges to managing risk in today's supply chains by reporting on data collected in 2021. To develop a rich picture of the challenges of information sharing in multi-tier supply chains, the authors adopted a qualitative research design. The authors conducted 14 interviews with supply chain professionals and ran two focus groups that were industry specific: one focused on the nuclear industry and the other on automotive. The study identifies contemporary practical challenges to information sharing in supply chains – specifically challenges related to data quality and the acceptance of sub-optimal normative supply chain practices, which have consequences for supplier assurance fatigue and supply chain transparency. The topical and contemporary study shows how an acceptance of the normative practices of a supply chain can have a cumulative effect on the likelihood of supply chain disruption due to shortcomings in approaches to information sharing. The notion of the acceptance of the status quo in this context has received limited research attention, and hence offers an extension to current discourse on supply chain risk and resilience

An investigation of Pseudomonas aeruginosa biofilm growth on novel nanocellulose fibre dressings

Nanocellulose from wood is a novel biomaterial, which is highly fibrillated at the nanoscale. This affords the material a number of advantages, including self-assembly, biodegradability and the ability to absorb and retain moisture, which highlights its potential usefulness in clinical wound-dressing applications. In these in vitro studies, the wound pathogen Pseudomonas aeruginosa PAO1 was used to assess the ability of two nanocellulose materials to impair bacterial growth (<48 h). The two nanocelluloses had a relatively small fraction of residual fibres (<4%) and thus a large fraction of nanofibrils (widths < 20 nm). Scanning electron microscopy and confocal laser scanning microscopy imaging demonstrated impaired biofilm growth on the nanocellulose films and increased cell death when compared to a commercial control wound dressing, Aquacel®. Nanocellulose suspensions inhibited bacterial growth, whilst UV-vis spectrophotometry and laser profilometry also revealed the ability of nanocellulose to form smooth, translucent films. Atomic force microscopy studies of the surface properties of nanocellulose demonstrated that PAO1 exhibited markedly contrasting morphology when grown on the nanocellulose film surfaces compared to an Aquacel® control dressing (p < 0.05). This study highlights the potential utility of these biodegradable materials, from a renewable source, for wound dressing applications in the prevention and treatment of biofilm development

The Effect of Self-Focused Attention and Mood on Appearance Dissatisfaction after Mirror-Gazing: An Experimental Study

Background and objectives: Self-focused attention is hypothesized to be a maintenance factor in body dysmorphic disorder (BDD). The aim of this study was to use an experimental paradigm to test this hypothesis by studying the effect of self-focused attention during mirror-gazing on appearance dissatisfaction. Methods: An experimental group design was used, in which 173 women were randomly allocated to one of three conditions before mirror-gazing for 2 min: (a) external focus of attention, (b) self-focus of attention, and (c) self-focus of attention with a negative mood induction. Results: After mirror-gazing, participants across all groups rated themselves as being more dissatisfied with their appearance. In both the self-focus conditions, there was an increase in sadness from pre to post mirror gazing, and there was a significant difference in focus of attention for participants in the self-focused, mood-induced group from pre to post manipulation, suggesting mood induction had more of an effect than focus of attention. Limitations: (1) there was no condition involving an external focus with a negative mood induction, and (2) due to the level of information provided to patients on the nature of the task, we cannot rule out demand characteristics as an influencing factor on our results. Conclusions: Self-focused attention during mirror-gazing may act indirectly to increase appearance dissatisfaction via the effect of negative mood. Further studies are required to establish the relative contribution of self-focused attention and negative mood to increases in appearance dissatisfaction as a function of mirror-gazing

Factors associated with non-utilization of postnatal care among newborns in the first 2 days after birth in Pakistan : a nationwide cross-sectional study

Background: Recent data indicated that approximately four in every ten newborns in Pakistan do not receive postnatal care (PNC) services in the first 48 hours after delivery. Objectives: This study aimed to identify factors associated with the non-utilization of PNC for newborns in Pakistan using the 2017–18 Pakistan Demographic and Health Survey (PDHS). Methods: This was a cross-sectional analytical study utilizing data from 3887 live-born newborns recorded in the 2017–18 PDHS. Non-utilization of PNC was assessed against a set of independent factors using multilevel logistic regression analysis, and the population attributable risk estimates of factors associated with non-utilization of PNC were also calculated. Results: There were 1443 newborns (37%) in Pakistan whose mothers did not utilize PNC check-ups in the first 2 days after delivery. The non-utilization of PNC was largely attributable to newborns delivered at non-health facilities 53% (47% to 59%) and those born to uneducated women 27% (13% to 38%). Adjusted analyses indicated that newborns with higher birth order and with a birth interval of more than 2 years, women who perceived their baby to be small at birth, women with no formal education and those living in regional areas of Khyber Pakhtunkhwa and Federally Administered Tribal Areas were significantly associated with non-utilization of PNC services. Conclusions: Tailored health messages by community health workers, including door-to-door visits on utilizing health facilities through pregnancy to the postnatal periods, are needed and should target places of low socioeconomic status, including educationally disadvantaged women from regional areas of Pakistan