Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...

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IMPORTANCE Advanced liver fibrosis is a precursor to cirrhosis, a leading cause of mortality. People with severe psoriasis are at risk for liver disease, but our understanding of advanced fibrosis in individuals with psoriasis is limited.OBJECTIVES To describe the prevalence of and evaluate the clinical factors associated with advanced liver fibrosis in people with severe psoriasis. DESIGN, SETTING, AND PARTICIPANTS The Co-morbidities in Severe Psoriasis study, a prospective observational cohort study in a large center serving London and Southeast England, was conducted from October 18, 2012, to April 2, 2015; 400 adults with severe psoriasis (Psoriasis Area Severity Index score, Ն10) were recruited from outpatient clinics. Statistical analysis was conducted from October 2, 2016, to March 3, 2017. MAIN OUTCOMES AND MEASURES The primary outcome was a diagnosis of advanced liver fibrosis determined by transient elastography, a noninvasive criterion standard test. Clinical factors evaluated included psoriasis-specific and metabolic indices, alcohol use, and methotrexate exposure. RESULTSOf 400 patients recruited (108 women and 289 men; mean [SD] age, 49.5 [13] years), 333 had a successful transient elastography scan and were included in final analysis. Forty-seven patients (14.1%; 95% CI, 10.4%-17.9%) had advanced liver fibrosis as diagnosed by transient elastography. The clinical factors that produced the best-fit model for advanced fibrosis were central obesity (waist circumference), insulin resistance, aspartate aminotransferase level, platelet count, psoriasis disease severity, and reduced alcohol use (R 2 = 0.54). CONCLUSIONS AND RELEVANCEFindings from this study suggest that advanced fibrosis is common in severe psoriasis. Abdominal obesity (by waist circumference) and insulin resistance were associated with the presence of advanced fibrosis. Longitudinal work to characterize the hepatic sequelae of central obesity, insulin resistance, and inflammation as well as the influence of systemic drugs (methotrexate and biologics) will inform future personalized therapeutic decision-making.

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BackgroundThe Disease Activity Score including 28 joint count (DAS-28) is the most widely used outcome measure in RA. However, despite evidence that metatarsophalangeal (MTP) joints are often the first joints affected in RA, DAS-28 score does not incorporate them.ObjectivesOur study aimed to investigate the correlation between DAS-28 assessment and objective evidence of active joint inflammation using the US examination of both hands and feet, including wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and MTP joints.MethodsA retrospective study was conducted, including 87 patients who were referred to the US clinic for an examination of their hands and feet in the last 6 months (46 patients with RA and 43 controls - patients with other inflammatory or degenerative arthropathies). Information about demographics, disease duration, current treatment, inflammatory markers, and DAS-28 scores was captured. The US OMERACT criteria were used for grading synovial hypertrophy, and assessing for the presence of Power Doppler (PD) signal, erosions and osteophytes. Statistical analysis methods included T-test, Mann-Whitney U test, Z score for proportions and Spearman's correlation coefficients.ResultsIn the RA group, DAS-28 had a weakly positive correlation with the cumulative PD scores of their hands and feet joints (R=0.14, P=0.02), but did not correlate with PD score of MTP joints (R=0.03, P=0.09). In the control group, DAS-28 did not correlate significantly with either the total PD scores of feet (R=0.42, P=0.26) or hands and feet joints (R=0.5, P=0.25). Sensitivity of US examination of hands alone compared to hands and feet was 74.3% for the RA group, while the sensitivity of US feet to detect the presence of PD was 59.2% when compared to the US of both hands and feet.ConclusionsWe found that DAS-28 correlated poorly with objective evidence of inflammation as detected by US of the hands and feet, and this correlation was lost when only the presence of inflammation in the feet was taken into consideration. Further validation of our results in a larger study including patients stratified based on the disease duration might help understand which patient subgroups are more likely to have their disease activity significantly under-evaluated using DAS-28 outcome measure.Disclosure of InterestNone declared