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Objective: Latino patients are overrepresented among cases of coronavirus disease 2019 (COVID‐19) and are at an increased risk of severe disease. Prevalence of COVID‐19 in Latinos with rheumatic diseases is poorly reported. This study was undertaken to characterize COVID‐19 clinical features and outcomes in Latino patients with rheumatic diseases. Methods: We conducted a retrospective study of Latino patients with rheumatic diseases from an existing observational cohort in the Washington, DC area. Patients seen between April 1, 2020 and October 15, 2020 were analyzed in this study. We reviewed demographic characteristics, body mass index (BMI), comorbidities, and use of immunomodulatory therapies. An exploratory classification and regression tree (CART) analysis along with logistic regression analyses were performed to identify risk factors for COVID‐19 and rheumatic disease flare. Results: Of 178 Latino patients with rheumatic diseases, 32 (18%) were identified as having COVID‐19, and the incidence rate of infection was found to be 3‐fold higher than in the general Latino population. No patients required intensive care unit–level care. A CART analysis and multivariable logistic regression analysis identified a BMI of >30.35 as a risk factor for COVID‐19 (odds ratio [OR] 3.37 [95% confidence interval (95% CI) 1.5–7.7]; P = 0.004). COVID‐19 positivity was a risk factor for rheumatic disease flare (OR 4.57 [95% CI 1.2–17.4]; P = 0.02). Conclusion: Our findings indicate that Latino patients with rheumatic diseases have a higher rate of COVID‐19 compared with the general Latino population. Obesity is a risk factor for COVID‐19, and COVID‐19 is a risk factor for rheumatic disease flare. Latino patients with risk factors should be closely followed up, especially post–COVID‐19 in anticipation of disease flare. [ABSTRACT FROM AUTHOR]

The Janus kinase/signal transduction and activator of transcription (JAK-STAT) signaling pathway is implicated in the pathogenesis of inflammatory and autoimmune diseases including rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Many cytokines involved in the pathogenesis of autoimmune and inflammatory diseases use JAKs and STATs to transduce intracellular signals. Mutations in JAK and STAT genes cause a number of immunodeficiency syndromes, and polymorphisms in these genes are associated with autoimmune diseases. The success of small-molecule JAK inhibitors (Jakinibs) in the treatment of rheumatologic disease demonstrates that intracellular signaling pathways can be targeted therapeutically to treat autoimmunity. Tofacitinib, the first rheumatologic Jakinib, is US Food and Drug Administration (FDA) approved for rheumatoid arthritis and is currently under investigation for other autoimmune diseases. Many other Jakinibs are in preclinical development or in various phases of clinical trials. This review describes the JAK-STAT pathway, outlines its role in autoimmunity, and explains the rationale/pre-clinical evidence for targeting JAK-STAT signaling. The safety and clinical efficacy of the Jakinibs are reviewed, starting with the FDA-approved Jakinib tofacitinib, and continuing on to next-generation Jakinibs. Recent and ongoing studies are emphasized, with a focus on emerging indications for JAK inhibition and novel mechanisms of JAK-STAT signaling blockade. [ABSTRACT FROM AUTHOR]

Evidence of differences in bioavailability from different oral formulations of the same therapeutic agents had become obvious by the early 1960s. The consequent 40 years have produced the body of scientific belief, debate, and policy on the subject of bioequivalence. The motivating force behind many of these events has been the continued interest of the food and drug administration (FDA) to improve the manner in which these studies are conducted, the quality of the data generated from such studies, and the methods by which they are evaluated. Bioanalytical data used to support regulatory submission needs to be accurate and reproducible. In order to have confidence in the reliability of the data, it is important that the analytical method used to generate it is well characterized and fully validated. However, bioavailability assessment (BA) and bioequivalence (BE) studies are necessary in filing of the data towards the drug approval. This review article describes the methods for assessing bioavailability and bioequivalence; and bioanalytical approaches of pharmaceuticals in vivo and in vitro and also a waiver of BA/BE studies based on the biopharmaceutical classification (BCS) system. [ABSTRACT FROM AUTHOR]