A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus.

OBJECTIVE: To explore long-term safety and tolerability of anifrolumab 300 mg compared with placebo in patients with systemic lupus erythematosus (SLE) who completed a Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP) trial and enrolled in the placebo-controlled 3-year long-term extension (LTE) study (ClinicalTrials.gov identifier: NCT02794285). METHODS: In the blinded LTE study, patients continued anifrolumab 300 mg, switched from anifrolumab 150 mg to 300 mg, or were re-randomized from placebo to receive either anifrolumab 300 mg or to continue placebo, administered every 4 weeks. Primary comparisons in the LTE study were between patients who received anifrolumab 300 mg or placebo throughout the TULIP and LTE studies. For rare safety events, comparisons included patients who received any anifrolumab dose during TULIP or LTE. When exposure differed, exposure-adjusted incidence rates (EAIRs) per 100 patient-years were calculated. RESULTS: In the LTE study, EAIRs of serious adverse events (SAEs) were 8.5 with anifrolumab compared with 11.2 with placebo; likewise, EAIRs of AEs leading to treatment discontinuation were 2.5 versus 3.2, respectively. EAIRs of non-opportunistic serious infections were comparable between groups (3.7 with anifrolumab versus 3.6 with placebo). Exposure-adjusted event rates of COVID-related AEs, including asymptomatic infections, were 15.5 with anifrolumab compared with 9.8 with placebo. No COVID-related AEs occurred in fully vaccinated individuals. EAIRs of malignancy and major acute cardiovascular events were low and comparable between groups. Anifrolumab was associated with lower cumulative glucocorticoid use and greater mean improvement in the SLE Disease Activity Index 2000, compared with placebo. CONCLUSION: This LTE study represents the longest placebo-controlled clinical trial performed in SLE to date. No new safety findings were identified in the LTE study, supporting the favorable benefit-risk profile of anifrolumab for patients with moderate-to-severe SLE receiving standard therapy.

Health information use by patients with systemic lupus erythematosus (SLE) pre and during the COVID-19 pandemic.

OBJECTIVE: We conducted an international survey of patients with SLE to assess their access, preference and trust in various health information sources pre-COVID-19 and during the COVID-19 pandemic. METHODS: Patients with SLE were recruited from 18 observational cohorts, and patients self-reporting SLE were recruited through five advocacy organisations. Respondents completed an online survey from June 2020 to December 2021 regarding the sources of health information they accessed in the 12 months preceding (pre-11 March 2020) and during (post-11 March 2020) the pandemic. Multivariable logistic regressions assessed factors associated with accessing news and social media post-11 March 2020, and self-reporting negative impacts from health information accessed through these sources. RESULTS: Surveys were completed by 2111 respondents; 92.8% were female, 76.6% had postsecondary education, mean (SD) age was 48.8 (14.0) years. Lupus specialists and family physicians were the most preferred sources pre-11 March 2020 and post-11 March 2020, yet were accessed less frequently (specialists: 78.5% pre vs 70.2% post, difference -8.3%, 95% CI -10.2% to -6.5%; family physicians: 57.1% pre vs 50.0% post, difference -7.1%, 95% CI -9.2% to -5.0%), while news (53.2% pre vs 62.1% post, difference 8.9%, 95% CI 6.7% to 11.0%) and social media (38.2% pre vs 40.6% post, difference 2.4%, 95% CI 0.7% to 4.2%) were accessed more frequently post-11 March 2020 vs pre-11 March 2020. 17.2% of respondents reported negative impacts from information accessed through news/social media. Those outside Canada, older respondents or with postsecondary education were more likely to access news media. Those in Asia, Latin America or younger respondents were more likely to access social media. Those in Asia, older respondents, males or with postsecondary education in Canada, Asia or the USA were less likely to be negatively impacted. CONCLUSIONS: Physicians, the most preferred and trusted sources, were accessed less frequently, while news and social media, less trusted sources, were accessed more frequently post-11 March 2020 vs pre-11 March 2020. Increasing accessibility to physicians, in person and virtually, may help reduce the consequences of accessing misinformation/disinformation.

Characteristics and Outcomes of COVID-19 Patients Admitted to Intensive Care Units in a Large Health System in Western Pennsylvania.

Importance Despite growing literature, there is still limited understanding of factors that can predict outcomes in coronavirus disease 2019 (COVID-19) patients who require intensive care. Objective To evaluate the characteristics of COVID-19 patients admitted to the intensive care unit (ICU) and identify their associations with outcomes. Background There are limited data on the outcomes in COVID-19 patients in Pennsylvania. Design Retrospective study Setting Intensive care units in an academic health system in Western Pennsylvania. Participants Patients with reverse transcriptase-polymerase chain reaction (RT-PCR)-confirmed COVID-19 admitted to ICUs as direct admission or transfers from regular floors between March 1, 2020, and April 30, 2020. Main outcome(s) and measure(s) The primary outcome was inpatient mortality. Secondary outcomes included complications during ICU stay, hospital length of stay, discharge disposition, and the need for oxygen at discharge. Categorical variables are described as frequencies and continuous variables as median with interquartile range (IQR). Regression modeling was used to identify the predictors of inpatient mortality in these patients. P-value <0.05 was considered statistically significant. Analysis was performed using Stata version 15.1 (StataCorp, College Station, Texas). Results The cohort included 58 consecutive patients, with a median age of 62 years (IQR 54-73), 63.8% of which were male. On presentation, constitutional symptoms were the most common (91.4%), followed by lower respiratory tract symptoms (87.9%). Tachypnea (65.5%) and hypoxia (67.2%) were the most common abnormal vital signs at presentation. Common comorbidities were cardiovascular disease (74.1%), obesity (53.5%), and diabetes (39.7%). The median Acute Physiology and Chronic Health Evaluation (APACHE) score on admission to ICU was 11 (IQR 8.5-17.5). The major complications included acute respiratory distress syndrome (ARDS) 50.0%, shock 41.4%, and acute kidney injury 41.4%. The proportion of patients who underwent mechanical ventilation, required vasopressors, or were on renal replacement therapy were 58.6%, 41.4%, and 10.3%, respectively. Overall mortality was 32.8%. Age, Charlson-comorbidity index, tachypnea, lymphopenia at presentation, high APACHE score, shock, ARDS, mechanical ventilation, and steroid use were significantly associated with mortality. Of the patients who survived their ICU stay, 63.2% were discharged home and 44.7% had a new oxygen requirement at discharge. Conclusion and relevance Our study reports high mortality in COVID-19 patients requiring ICU care in Western Pennsylvania. Identifying factors associated with poor prognosis could help risk-stratify these patients. Prospective studies are needed to assess whether early risk stratification and triaging result in improved outcomes.

Perspectives of Health Care Providers in an Integrated Health Care Delivery Network on Inpatient Electronic Consultation (e-Consult) Use During the COVID-19 Pandemic.

A large academic hospital system (Allegheny Health Network) introduced inpatient electronic consultations (e-Consults) during the COVID-19 crisis. Providers were invited to complete an anonymous survey on their perceptions of e-Consults. Descriptive statistics were used to analyze Likert-scale data. Cronbach's alpha was used to assess internal consistency. Ninety-five providers completed the survey. Requesting and consulting providers agreed that e-Consults were easy to use (100% and 96.2%, respectively). Both groups also concurred that e-Consults either decreased or did not significantly impact their workload (81% and 74%, respectively) and that training was appropriate (77.8% and 86.8%, respectively). The advantage and barrier selected most frequently by specialists was "timelier completion of the consult versus in-person" and "inadequate information to complete the consult," respectively. The disadvantage selected most frequently by requesting physicians was "lack of communication between providers." Open-ended comments were categorized into themes. Concerns were raised regarding whether provider-provider communication via this platform offered enough information to make recommendations compared to traditional encounters. The perceived benefits and barriers of e-Consults should be further explored with the goal of improving patient care delivery and provider satisfaction.

Coronavirus Disease-2019: Implication for the care and management of patients with systemic lupus erythematosus.

Systemic lupus erythematosus is a chronic remitting-relapsing autoimmune disease that affects multiple organ systems. In this article we discuss aspects in the management of lupus patients that are particularly relevant during the current SARS-CoV-2 pandemic. We speculate that lupus patients might be more susceptible for a more severe COVID-19 disease course and emphasize the importance of maintaining remission in lupus patients. We discuss the critical role hydroxychloroquine plays in the management of lupus patients and suggest considering the psychosocial implications of the current pandemic on lupus care.