Avacincaptad pegol in geographic atrophy secondary to age-related macular degeneration: a profile of its useZhuang-Yan, Amy; Blair, Hannah A.
doi: 10.1007/s40267-024-01097-2pmid: N/A
Avacincaptad pegol (IZERVAYTM), a complement C5 inhibitor, is a promising new treatment option for patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). In phase 2/3 (GATHER1) and phase 3 (GATHER2) trials in adults with non-center point involving GA secondary to AMD, monthly intravitreal injection of avacincaptad pegol demonstrated a significant reduction in GA lesion growth rate over a period of 12 months. There were no significant differences in the mean change in best-corrected visual acuity (BCVA) and low-luminance BCVA between the avacincaptad pegol and sham groups. Avacincaptad pegol was generally well tolerated, with the most common adverse reactions being conjunctival hemorrhage, increased intraocular pressure, blurred vision, and choroidal neovascularization. Preliminary data from the 24-month analyses of GATHER2 have shown continued efficacy up to 24 months.
Treat atopic dermatitis during pregnancy with safe and effective therapiesZhuang-Yan, Amy
doi: 10.1007/s40267-024-01088-3pmid: N/A
The complex hormonal and immunological changes that occur during pregnancy can lead to the development of specific skin conditions, of which atopic dermatitis, now referred to as atopic eruption of pregnancy (AEP), is the most common. AEP typically presents before the third trimester and is characterized by eczematous or prurigo skin lesions that predominantly involve the flexures, extremities and/or trunk. Management options for AEP include topical treatments, phototherapy and systemic therapies. Novel therapies have been developed for the treatment of atopic dermatitis and further studies of their use in pregnant people will be useful.
Glucocorticoid-induced osteoporosis—from molecular mechanism to clinical practiceHsu, Chueh Hsuan; Hsu, Chueh Lin; Langley, Ashley; Wojcik, Caroline; Iraganje, Elysee; Grygiel-Górniak, Bogna
doi: 10.1007/s40267-024-01079-4pmid: N/A
Glucocorticoids (GCs) are essential and effective medications commonly prescribed to patients with autoimmune disorders and inflammatory diseases. However, they often adversely affect bone health, including a rapid bone mineral density reduction and an increased bone fracture rate. An estimated 30% of long-term GC users develop secondary osteoporosis [glucocorticoid-induced osteoporosis (GIO)], whereas the measurement and prevention for GC-treated patients are sometimes clinically overlooked in clinical practice. Fortunately, many guidelines for GIO-related fracture risk assessment have been established, and several new drugs that benefit primary osteoporosis patients may also serve as potential GIO therapeutic options. Because of the broad application of GCs in clinical practice and the growing prevalence of GIO, increasing with the dose and time of GC administration, awareness of GIO development is crucial for implementing preventive therapy promptly and effectively. In this paper, we discuss the pathomechanisms of GIO and bone health problems depending on the method and route of GC administration in various groups of patients. Various treatment regimens are broadly analyzed, highlighting the most crucial aspects and new therapeutic options.
Evaluation of the Med Safety mobile app for reporting adverse events in Burkina FasoOuoba, Joël; Haro-Lankoandé, Sougrimani; Nacoulma, Aminata P.; Merle, Corinne Simone Collette; Hennig, Branwen Johanna; Fofana, Souleymane; Kaboré, Lassané; Ouédraogo, Emile; Sawadogo, Ruth; Samadoulougou, Sekou; Kirakoya-Samadoulougou, Fati
doi: 10.1007/s40267-024-01078-5pmid: N/A
IntroductionSmartphone applications (apps) for pharmacovigilance present an opportunity for integration as cost-effective healthcare service intervention into basic healthcare services in low-resource settings. This study aimed to (i) evaluate the implementation of the Med Safety app in Burkina Faso, and (ii) compare the characteristics of the reports sent by the Med Safety app with those sent on paper form.MethodsThe study had two components: (i) a cross-sectional online survey assessing the Med Safety app, and (ii) a retrospective analysis comparing the characteristics of the Med Safety reports with those of the paper form, received by the National Pharmacovigilance Centre of Burkina Faso (CNVPS), from January 1, 2021 to December 31, 2022. We evaluated the success of the implementation of the Med Safety intervention using measures of acceptability, usefulness and feasibility. This assessment involved a set of 14 items rated on a 4-point Likert scale. Acceptability, feasibility, and usefulness were determined based on achieving a total score higher than the mean. Subsequently, we computed the proportion of participants whose overall score for all items exceeded the mean. Continuous and categorical variables were compared using the Wilcoxon rank-sum test and the Chi2 test, respectively. The significance level of the statistical test was set at 5%.ResultsThe survey participation rate was 51.9% (160/308). Half of the respondents were in the 35-44 age group (50.6%), and participants were predominantly male (71.9%). The Med Safety app was acceptable, feasible, and useful to 58.1% of respondents. The most useful features of the app were “reporting” (53.1%), “news” (13.6%) and “watch list” (12.4%). During the period, a total of 1,472 reports were received, including 357 (24.3%) through Med Safety and 1,115 (75.7%) through the paper form. The reports of adverse events following immunization received at the CNVPS numbered 974 (66.2%), these were related to COVID-19 vaccines, with 256 (26.3%) through the Med Safety and 718 (73.7%) through the paper form. The median time to submit the reports to the CNVPS was 159 (IQR 59–187) days for the Med Safety and 166 (IQR 107–281) days for the paper form (p < 0.001).ConclusionIn Burkina Faso, the Med Safety was found to be acceptable, useful, and feasible by users surveyed. In addition, and compared to the paper form, the app reduces the time to submit a report, and with increase in use, the reporting timeframe could be further improved.