Objective To compare the efficacy of abatacept to placebo for giant cell arteritis (GCA). Methods In this multicenter trial, patients with newly-diagnosed or relapsing GCA were treated with abatacept 10 mg/kg IV on days 1, 15, 29, week 8, together with prednisone. At week 12, patients in remission underwent a double-blinded randomization to continue monthly abatacept or switch to placebo. Patients in both study arms received a standardized prednisone taper with discontinuation of prednisone at week 28. Patients remained on their randomized assignment until meeting criteria for early termination or until 12 months after enrollment of the last patient. The primary endpoint was duration of remission (relapse-free survival). Results Forty-nine eligible patients with GCA were enrolled and treated with prednisone and abatacept; forty-one reached the week 12 randomization and underwent a blinded randomization to abatacept or placebo. Prednisone was tapered using a standardized schedule reaching 20 mg daily at week 12 with discontinuation in all patients at week 28. The relapse-free survival at 12 months was 48% for those receiving abatacept and 31% for those receiving placebo (p=0.049). A longer median duration of remission was seen with abatacept (9.9 months) compared to placebo (3.9 months, p=0.023). There was no difference in the frequency or severity of adverse events between treatment arms, including infection. Conclusions In patients with GCA the addition of abatacept to a treatment regimen with prednisone reduced the risk of relapse and was not associated with a higher rate of toxicity compared to prednisone alone.
Objective To compare the efficacy of abatacept to placebo for the treatment of Takayasu’s arteritis (TAK). Methods In this multicenter trial, patients with newly-diagnosed or relapsing TAK were treated with abatacept 10 mg/kg IV on days 1, 15, 29, week 8, together with prednisone. At week 12, patients in remission underwent a double-blinded randomization to continue monthly abatacept or switch to placebo. Patients in both study arms received a standardized prednisone taper, reaching 20 mg daily at week 12 with discontinuation of prednisone at week 28 and remained on their randomized assignment until meeting criteria for early termination or until 12 months after enrollment of the last patient. The primary endpoint was duration of remission (relapse-free survival). Results Thirty-four eligible patients with TAK were enrolled and treated with prednisone and abatacept; 26 reached the week 12 randomization and underwent a blinded randomization to abatacept or placebo. The relapse-free survival at 12 months was 22% for those receiving abatacept and 40% for those receiving placebo (p= 0.853). Treatment with abatacept in patients with TAK enrolled in this study was not associated with a longer median duration of remission (abatacept 5.5 months, placebo 5.7 months). There was no difference in the frequency or severity of adverse events between treatment arms, including infection. Conclusions In patients with TAK the addition of abatacept to a treatment regimen with prednisone did not reduce the risk of relapse.
The COVID-19 pandemic is presenting a disproportionate impact on minorities in terms of infection rate, hospitalizations and mortality. Many believe Artificial Intelligence (AI) is a solution to guide clinical decision making for this novel disease, resulting in the rapid dissemination of under-developed and potentially biased models, which may exacerbate the disparities gap. We believe there is an urgent need to enforce the systematic use of reporting standards and develop regulatory frameworks for a shared COVID-19 data source to address the challenges of bias in AI during this pandemic. There is hope that AI can help guide treatment decisions within this crisis yet given the pervasiveness of biases, a failure to proactively develop comprehensive mitigation strategies during the COVID-19 pandemic risks exacerbating existing health disparities.
Background: HIV programmes in sub-Saharan Africa (SSA) require information about HIV among key populations to ensure equitable and equal access to HIV prevention and treatment. Surveillance has been conducted among female sex workers (FSW), men who have sex with men (MSM), people who inject drugs (PWID), and transgender populations, but is not systematically included in national HIV estimates. We consolidated existing KP surveys to create national-level estimates of key population size, HIV prevalence, and ART coverage for mainland SSA. Methods: Key population size estimates (KPSE), HIV prevalence, and ART coverage data from 38 countries from 2010-2021 were collated from existing databases, deduplicated, and verified against primary sources. We used Bayesian mixed-effects regression to spatially smooth KPSE, and regressed subnational key population HIV prevalence and ART coverage against age/sex/year/province-matched total population estimates. Findings: We extracted 1449 unique KPSE datapoints, 1181 HIV prevalence datapoints, and 242 ART coverage datapoints. Countries had data for a median of five of the twelve population/outcome stratifications. Across countries, a median of 1.44% of urban women were FSW (interquartile range [IQR] 0.83-1.89%); 0.60% of urban men were MSM; and 0.16% of urban adults injected drugs (IQR 0.14-0.24%). HIV prevalence in all key populations was higher than matched total population prevalence. ART coverage was correlated with, but lower than, total population ART coverage. Across SSA, key populations were estimated as 1.1% (95%CI 0.7-1.9%) of the population but 5.1% (95%CI 3.2-10.3%) of all PLHIV aged 15-49 years. Interpretation: Key populations in sub-Saharan experience disproportionate HIV burden and somewhat lower ART coverage, underscoring need for focused prevention and treatment services. However, large heterogeneity and incomplete data availability limit precise estimates for programming and monitoring trends. Future efforts should focus on integrating and strengthening key population surveys and routine data within national HIV strategic information systems.
Loperamide produces both QRS and QT prolongation at supra-therapeutic dosing. A blood loperamide concentration of 210 ng/mL is among the highest concentrations reported. Supra-therapeutic dosing of loperamide is promoted on multiple drug-use websites and online forums as a treatment for opioid withdrawal, as well as for euphoric effects. With the current epidemic of prescription opioid abuse, toxicity related to loperamide, an opioid agonist that is readily available without a prescription is occurring more frequently. It is important for clinicians to be aware of the potentially life-threatening toxicity related to loperamide abuse in order to provide proper diagnosis, management and patient education.
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