As the Moderna (mRNA-1273) and Pfizer/BioNTech (BNT162b2) vaccines become available to patients with autoimmune diseases and SLE, practitioners will have to inform them about the safety and efficacy of these vaccines. Here we discuss the challenges of applying vaccine data to patients with autoimmune diseases and the evidence available in the literature that may help in the decision process.
Objectives Systemic lupus erythematosus (SLE) affects the joints in up to 95% of patients. The diagnosis and evaluation of SLE arthritis remain challenging in both practice and clinical trials. Frequency domain optical imaging (FDOI) has been previously used to assess joint involvement in inflammatory arthritis. The objective of this study was to evaluate FDOI in SLE arthritis. Methods Ninety-six proximal interphalangeal (PIP) joints from 16 patients with SLE arthritis and 60 PIP joints from 10 age-matched, gender-matched and race/ethnicity-matched controls were examined. A laser beam with a wavelength of 670 nm, 1 mm in diameter and intensity modulated at 300 MHz and 600 MHz was directed onto the dorsal surface of each joint, scanning across a sagittal plane. The transmitted light intensities and phase shifts were measured with an intensified charge-coupled device camera. The data were analysed using Discriminant Analysis and Support Vector Machine algorithms. Results The amplitude and phase of the transmitted light were significantly different between SLE and control PIPs (p<0.05). Receiver operating characteristic (ROC) analysis of cross-validated models showed an Area Under the ROC Curve (AUC)of 0.89 with corresponding sensitivity of 95%, specificity of 79%, and accuracy of 80%. Conclusion This study is the first evaluation of optical methods in the assessment of SLE arthritis; there was a statistically significant difference in the FDOI signals between patients with SLE and healthy volunteers. The results show that FDOI may have the potential to provide an objective, user-independent, evaluation of SLE PIP joints arthritis.
Objective There is a lack of data on the use of telemedicine (TM) in SLE. SLE outcome measures remain complex, and clinicians and clinical trialists have raised concerns about the accuracy of virtual disease activity measures. This study evaluates the level of agreement between virtual SLE outcome measures and face-to-face (F2F) encounter. Here, we describe the study design, virtual physical examination protocol and demographics for the first 50 patients evaluated. Methods and analysis This is an observational, longitudinal study of 200 patients with SLE with varying levels of disease activity from 4 academic lupus centres serving diverse populations. Each study participant will be evaluated at a baseline and a follow-up visit. At each visit, participants are evaluated by the same physician first via a videoconference-based TM and then a F2F encounter. For this protocol, virtual physical examination guidelines relying on physician-directed patient self-examination were established. SLE disease activity measures will be completed immediately after the TM encounter and repeated after the F2F encounter for each visit. The degree of agreement between TM and F2F disease activity measures will be analysed using the Bland-Altman method. An interim analysis is planned after the enrolment of the first 50 participants. Ethics and dissemination This study has been reviewed by the Columbia University Medical Center Institutional Review Board (IRB Protocol #: AAAT6574). The full results of this study will be published after the final data analysis of 200 patients. The abrupt shift to TM visits due to the COVID-19 pandemic disrupted clinical practice and clinical trials. Establishing a high level of agreement between SLE disease activity measures obtained with videoconference TM and F2F at the same time point, will allow for improved assessment of disease activity when F2F data cannot be acquired. This information may guide both medical decision-making and provide reliable outcome measures for clinical research.
Coronavirus disease-2019 (COVID-19) elicits a range of different responses in patients and can manifest into mild to very severe cases in different individuals, depending on many factors. We aimed to establish a prediction model of severe risk in COVID-19 patients, to help clinicians achieve early prevention, intervention and aid them in choosing effective therapeutic strategy. We selected confirmed COVID-19 patients who were admitted to First Hospital of Changsha city between 29 January and 15 February 2020 and collected their clinical data. Multivariate logical regression was used to identify the factors associated with severe risk. These factors were incorporated into the nomogram to establish the model. The ROC curve, calibration plot and decision curve were used to assess the performance of the model. A total of 228 patients were enrolled and 33 (14.47%) patients developed severe pneumonia. Univariate and multivariate analysis showed that shortness of breath, fatigue, creatine kinase, lymphocytes and h CRP were independent factors for severe risk in COVID-19 patients. Incorporating age, chronic obstructive pulmonary disease (COPD) and these factors, the nomogram achieved good concordance indexes of 0.89 [95% confidence interval (CI) 0.832–0.949] and well-fitted calibration plot curves (Hosmer–Lemeshow test: P = 0.97). The model provided superior net benefit when clinical decision thresholds were between 15% and 85% predicted risk. Using the model, clinicians can intervene early, improve therapeutic effects and reduce the severity of COVID-19, thus ensuring more targeted and efficient use of medical resources.
Acute esophageal necrosis, or “black esophagus,” is a rare but severe condition characterized by circumferential black necrotized esophageal mucosa with an abrupt transition at the gastroesophageal junction. The “two-hit” hypothesis suggests that an initial ischemic insult predisposes the esophageal mucosa to further injury from luminal acid exposure or medications. We present the first documented case of tacrolimus-induced acute esophageal necrosis without preceding hemodynamic instability in a liver transplant recipient, which resolved with discontinuation of tacrolimus and transition to cyclosporin.