Training to Increase Minority Enrollment in Lupus Clinical Trials With Community Engagement: Enhancing Lupus Clinical Trial Recruitment Through Provider and Community Health Worker Engagement.

Objective: This study evaluates the effectiveness of the Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY) program on enhancing referrals of underrepresented patients to lupus clinical trials. TIMELY leverages two existing American College of Rheumatology online educational initiatives: Materials to Increase Minority Involvement in Clinical Trials (MIMICT), a continuing medical education activity for health care providers, and the community health worker (CHW) Lupus Clinical Trials Training (LuCTT). TIMELY introduced a unique roundtable meeting format to build on the existing online educational programs and facilitate discussions between local clinical trial sites and provider and CHW participants.

Recommendations for physical activity and exercise in persons living with Systemic Lupus Erythematosus (SLE): consensus by an international task force.

Objective: This international task force aimed to provide healthcare professionals and persons living with systemic lupus erythematosus (SLE) with consensus-based recommendations for physical activity and exercise in SLE.

Methods: Based on evidence from a systematic literature review and expert opinion, 3 overarching principles and 15 recommendations were agreed on by Delphi consensus.

Results: The overarching principles highlight the importance of shared decision-making and the need to explain the benefits of physical activity to persons living with SLE and other healthcare providers.

Feasibility and Utility of a Pilot Peer Education Program to Improve Patient Engagement in Lupus Clinical Trials: Implementation and Evaluation in a Multisite Model Within a Lupus Clinical Trials Network.

Objective: To assess outcomes related to Lupus Therapeutics' Patient Advocates for Lupus Studies (LT-PALS), a peer-to-peer lupus clinical trial (LCT) education program designed to improve representation of diverse groups in LCTs. Patients with lupus and clinical trial participation experience were trained as peer educators (PALs) providing trial-agnostic education to trial-naive patients with lupus.

Methods: We used a two-arm, randomized pretest/posttest study design to evaluate outcomes related to LCT participation: knowledge, attitudes, self-efficacy, and intentions to participate in an LCT.

Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co-Expression Patterns: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial.

Objective: Obexelimab is an investigational, bifunctional, noncytolytic monoclonal antibody that binds CD19 and FcyRIIb to inhibit B cells, plasmablasts, and plasma cells. This trial evaluated the efficacy and safety of obexelimab in the treatment of patients with systemic lupus erythematosus (SLE).

Methods: During screening, patients with active, non-organ-threatening SLE received corticosteroid injections to ameliorate symptoms while immunosuppressants were withdrawn (≤10 mg/day prednisone equivalent and ≤400 mg/day hydroxychloroquine allowed).

Implications of the accuracy of diagnostic algorithms for systemic lupus on our understanding of racial disparities in pregnancy outcomes.

Objective: Disparities in pregnancy outcomes among women with SLE remain understudied, with few available racially diverse datasets. We sought to identify disparities between Black and White women in pregnancy outcomes within academic institutions in the United States.

Methods: Using the Common Data Model electronic medical record (EMR)-based datasets within the Carolinas Collaborative, we identified women with pregnancy delivery data (2014-2019) and ≥1 SLE International Classification of Diseases 9 or 10 code (ICD9/10) code.

Teratogenic medication use associated with favourable odds of contraception counselling in a cohort of women with systemic lupus erythematosus at a large tertiary academic medical centre.

Objective: SLE primarily affects women of childbearing age, who have an increased risk of pregnancy complications, especially in the setting of active disease. Contraception counselling is particularly important given the teratogenicity of some medications used for SLE treatment. Our study describes the frequency of contraception counselling provided by multiple subspecialties to women with SLE and investigates associations between teratogenic medication use and receiving contraception counselling.

A Provider-Based Approach to Address Racial Disparities in Lupus Clinical Trial Participation.

Objective: Substantial disparities exist in clinical trial participation, which is problematic in diseases such as lupus that disproportionately affect racial/ethnic minority populations. Our objective was to examine the effectiveness of an online educational course aiming to train medical providers to refer Black and Latino patients to lupus clinical trials (LCTs).

Methods: The American College of Rheumatology's Materials to Increase Minority Involvement in Clinical Trials (MIMICT) study used an online, randomized, 2-group, pretest/posttest design with medical and nursing providers of multiple specialties.

Perceived Impact of the COVID-19 Pandemic on Physical Activity Among Adult Patients With Rheumatologic Disease.

Objective: The objective of this cross-sectional study was to investigate the impact of the COVID-19 pandemic on physical activity (PA) levels of patients with rheumatic and musculoskeletal diseases (RMDs) and to examine factors associated with decreased PA.

Methods: A sample of adult patients with RMDs (n = 7,776) was identified through electronic medical records from an academic health care system in North Carolina. Invitations to participate in an online survey were sent between July 2020 and September 2020 to assess self-reported changes in PA during the COVID-19 pandemic.

The Disparities in Patient Portal Use Among Patients With Rheumatic and Musculoskeletal Diseases: Retrospective Cross-sectional Study.

Background: During the COVID-19 pandemic, the shift to virtual care became essential for the continued care of patients. Individuals with rheumatic and musculoskeletal diseases (RMDs) especially require frequent provider visits and close monitoring. To date, there have been limited studies examining inequities in health technology use among patients with RMDs.

Trial of Anti-BDCA2 Antibody Litifilimab for Cutaneous Lupus Erythematosus.

Background: Blood dendritic cell antigen 2 (BDCA2) is a receptor that is exclusively expressed on plasmacytoid dendritic cells, which are implicated in the pathogenesis of lupus erythematosus. Whether treatment with litifilimab, a humanized monoclonal antibody against BDCA2, would be efficacious in reducing disease activity in patients with cutaneous lupus erythematosus has not been extensively studied.

Methods: In this phase 2 trial, we randomly assigned adults with histologically confirmed cutaneous lupus erythematosus with or without systemic manifestations in a 1:1:1:1 ratio to receive subcutaneous litifilimab (at a dose of 50, 150, or 450 mg) or placebo at weeks 0, 2, 4, 8, and 12.

EMBRACE: One Small Story in Lupus-One Giant Challenge in Clinical Trials.

Clinical trials of novel therapeutics in the United States have not been adequately representative of diverse populations, particularly racial and ethnic minorities. The challenges and consequences of underrepresentation in clinical trial recruitment are exemplified by the case of belimumab, a biologic treatment for systemic lupus erythematosus (SLE), a disease that is more prevalent in patients of Black African ancestry and of Hispanic/Latino ethnicity than in other patient populations. Although belimumab was found to be effective in phase 2 and 3 clinical trials in the general population, post hoc analyses of efficacy data in patients of Black African ancestry showed inconsistent results.

ACT for Lupus: Pilot Feasibility and Acceptability Study of a Novel Web-Based Acceptance and Commitment Therapy Program for Patients With Lupus.

Objective: Acceptance and commitment therapy (ACT) has demonstrated effectiveness in addressing symptoms of anxiety and depression, frequently experienced by patients with systemic lupus erythematosus (SLE). The goal of this pilot study was to develop and assess the feasibility and acceptability of a novel web-based ACT skills training program tailored for patients with lupus: ACT for Lupus. The program served as a complementary approach to support the management of symptoms and stressors during the COVID-19 pandemic.

Association of Lupus Nephritis Histopathologic Classification With Venous Thromboembolism-Modification by Age at Biopsy.

Introduction: Lupus nephritis (LN) is an independent risk factor for venous thromboembolism (VTE). The risk of VTE has not been analyzed by International Society of Nephrology/Renal Pathology Society or World Health Organization LN class. Study goals were to measure VTE incidence in an LN patient cohort, to evaluate associations between VTE and LN class, and to investigate factors modifying associations between VTE and LN class.

Phase III/IV, Randomized, Fifty-Two-Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus.

Objective: Enrollment of patients of Black African ancestry with systemic lupus erythematosus (SLE) in phase II and phase III of the belimumab trials was not reflective of the racial distribution observed in the lupus population. This study was undertaken to assess the efficacy and safety of intravenous (IV) belimumab plus standard therapy in patients of self-identified Black race.

Methods: EMBRACE (GSK Study BEL115471; ClinicalTrials.

Pilot study of an internet-based pain coping skills training program for patients with systemic Lupus Erythematosus.

Background: Patients with Systemic Lupus Erythematosus (SLE) often experience pain and other symptoms that negatively impact quality of life. Interventions that enhance the use of behavioral and cognitive coping strategies may lead to improved outcomes among patients with SLE. Pain coping skills training (PCST) programs have been shown to improve outcomes among patients with other rheumatic conditions, but there have been no trials of PCST among patients with SLE.

Mortality and adverse events of special interest with intravenous belimumab for adults with active, autoantibody-positive systemic lupus erythematosus (BASE): a multicentre, double-blind, randomised, placebo-controlled, phase 4 trial.

Background: Belimumab is approved for the treatment of active systemic lupus erythematosus (SLE). Although clinical trials showed a favourable benefit-risk profile, numerical differences in the incidence of mortality and adverse events of special interest (AESIs) have been reported. We assessed the frequency of these events in patients with SLE receiving belimumab or placebo plus standard therapy.

Rise and Fall: Hydroxychloroquine and COVID-19 Global Trends: Interest, Political Influence, and Potential Implications.

Objective: The coronavirus disease 2019 (COVID-19) pandemic has led to rapid research and reporting on potential preventatives and treatments for the disease, including the drug hydroxychloroquine (HCQ). Despite a lack of robust evidence to support the use of HCQ for treatment of COVID-19, it was publicly endorsed and received widespread media coverage and public interest. The purpose of this report is to describe and contextualize the surges in public interest, demand, and adoption of HCQ for treatment of COVID-19 and outline implications for future public health policy and practice.

Increasing Ancestral Diversity in Systemic Lupus Erythematosus Clinical Studies.

Non-White people are more likely to develop systemic lupus erythematosus (SLE) yet are underrepresented in SLE clinical trials. The efficacy and safety of drugs may be influenced by ancestry, and ancestrally diverse study populations are necessary to optimize treatments across the full spectrum of patients. However, barriers to entry into clinical trials are amplified in non-White populations.

Quantification of citrullinated histones: Development of an improved assay to reliably quantify nucleosomal H3Cit in human plasma.

Background: Recent data propose a diagnostic and prognostic capacity for citrullinated histone H3 (H3Cit), a marker of neutrophil extracellular traps (NETs), in pathologic conditions such as cancer and thrombosis. However, current research is hampered by lack of standardized assays.

Objectives: We aimed to develop an assay to reliably quantify nucleosomal H3Cit in human plasma.

Types of paraproteinemia in patients with multiple myeloma: A cross-sectional study.

Objective: To determine the types of paraproteins in patients with multiple myeloma in a tertiary care setting.

Methods: The cross-sectional study was conducted at the Liaquat National Hospital, Karachi, from November 2015 to May 2016, and comprised patients with multiple myeloma selected using consecutive, non-probability sampling technique. Detailed history was taken and immunofixation assay was conducted to assess the type of paraproteins in the patients.

Clinician's Perceptions of a CME Activity to Increase Knowledge of Vaccination in Adults with Chronic Inflammatory Conditions.

Objective: Annual influenza and pneumococcal vaccination rates remain suboptimal in patients with systemic lupus erythematosus despite their higher risk of infections and related complications. The CDC identified lack of knowledge about vaccine guidelines among adult patients and their providers as the most substantial barrier to vaccination coverage. As specialists working with particularly affected populations, rheumatologists, allergists, and immunologists can advise patients regarding gaps in recommended vaccinations.

Association of Lupus Nephritis With Coronary Artery Disease by ISN/RPS Classification: Results From a Large Real-world Lupus Population.

Objective: Patients with systemic lupus erythematosus (SLE) are at an increased risk for developing coronary artery disease (CAD). Several studies suggest that the presence of lupus nephritis (LN) is independently associated with CAD. The purpose of our study was to assess whether the presence of LN is independently associated with CAD in our patient population and whether this association varies by class of LN.

The State of Lupus Clinical Trials: Minority Participation Needed.

In the United States, the reported prevalence of lupus is 100,000 to 500,000 patients. Lupus disproportionately affects minority populations, including African Americans and Latinos, and the associated health disparities are substantial. Women are at a higher risk of lupus than men and lupus prevalence is the highest in African Americans and Latinos compared to non-Hispanic whites.

Evaluation of a novel autoinjector for subcutaneous self-administration of belimumab in systemic lupus erythematosus .

Objective: To study self-administration and pharmacokinetics (PK) of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE).

Methods: Patients previously treated with belimumab self-administered belimumab 200 mg SC weekly for 8 weeks using an autoinjector. The primary endpoint was the proportion of patients able to self-administer their first and second dose (weeks 1 and 2) in the clinic.

Sustained unresponsiveness to peanut in subjects who have completed peanut oral immunotherapy.

Background: Although peanut oral immunotherapy (OIT) has been conclusively shown to cause desensitization, it is currently unknown whether clinical protection persists after stopping therapy.

Objective: Our primary objective was to determine whether peanut OIT can induce sustained unresponsiveness after withdrawal of OIT.

Methods: We conducted a pilot clinical trial of peanut OIT at 2 US centers.