Efficacy of Tocilizumab in Patients Hospitalized with Covid-19.

BACKGROUND: The efficacy of interleukin-6 receptor blockade in hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving mechanical ventilation is unclear. METHODS: We performed a randomized, double-blind, placebo-controlled trial involving patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92%. Patients were randomly assigned in a 2:1 ratio to receive standard care plus a single dose of either tocilizumab (8 mg per kilogram of body weight) or placebo. The primary outcome was intubation or death, assessed in a time-to-event analysis. The secondary efficacy outcomes were clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline, both assessed in time-to-event analyses. RESULTS: We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women. The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% confidence interval [CI], 0.38 to 1.81; P = 0.64), and the hazard ratio for disease worsening was 1.11 (95% CI, 0.59 to 2.10; P = 0.73). At 14 days, 18.0% of the patients in the tocilizumab group and 14.9% of the patients in the placebo group had had worsening of disease. The median time to discontinuation of supplemental oxygen was 5.0 days (95% CI, 3.8 to 7.6) in the tocilizumab group and 4.9 days (95% CI, 3.8 to 7.8) in the placebo group (P = 0.69). At 14 days, 24.6% of the patients in the tocilizumab group and 21.2% of the patients in the placebo group were still receiving supplemental oxygen. Patients who received tocilizumab had fewer serious infections than patients who received placebo. CONCLUSIONS: Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide. (Funded by Genentech; ClinicalTrials.gov number, NCT04356937.).

2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases.

OBJECTIVE: To provide evidence-based recommendations on the use of vaccinations in children and adults with rheumatic and musculoskeletal diseases (RMDs). METHODS: This guideline follows American College of Rheumatology (ACR) policy guiding management of conflicts of interest and disclosures and the ACR guideline development process, which includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. It also adheres to the Appraisal of Guidelines for Research and Evaluation (AGREE) criteria. A core leadership team consisting of adult and pediatric rheumatologists and a guideline methodologist drafted clinical population, intervention, comparator, outcomes (PICO) questions. A review team performed a systematic literature review for the PICO questions, graded the quality of evidence, and produced an evidence report. An expert Voting Panel reviewed the evidence and formulated recommendations. The panel included adult and pediatric rheumatology providers, infectious diseases specialists, and patient representatives. Consensus required ≥70% agreement on both the direction and strength of each recommendation. RESULTS: This guideline includes expanded indications for some vaccines in patients with RMDs, as well as guidance on whether to hold immunosuppressive medications or delay vaccination to maximize vaccine immunogenicity and efficacy. Safe approaches to the use of live attenuated vaccines in patients taking immunosuppressive medications are also addressed. Most recommendations are conditional and had low quality of supporting evidence. CONCLUSION: Application of these recommendations should consider patients' individual risk for vaccine-preventable illness and for disease flares, particularly if immunosuppressive medications are held for vaccination. Shared decision-making with patients is encouraged in clinical settings.

2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases.

OBJECTIVE: To provide evidence-based recommendations on the use of vaccinations in children and adults with rheumatic and musculoskeletal diseases (RMDs). METHODS: This guideline follows American College of Rheumatology (ACR) policy guiding management of conflicts of interest and disclosures and the ACR guideline development process, which includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. It also adheres to the Appraisal of Guidelines for Research and Evaluation (AGREE) criteria. A core leadership team consisting of adult and pediatric rheumatologists and a guideline methodologist drafted clinical population, intervention, comparator, outcomes (PICO) questions. A review team performed a systematic literature review for the PICO questions, graded the quality of evidence, and produced an evidence report. An expert Voting Panel reviewed the evidence and formulated recommendations. The panel included adult and pediatric rheumatology providers, infectious diseases specialists, and patient representatives. Consensus required ≥70% agreement on both the direction and strength of each recommendation. RESULTS: This guideline includes expanded indications for some vaccines in patients with RMDs, as well as guidance on whether to hold immunosuppressive medications or delay vaccination to maximize vaccine immunogenicity and efficacy. Safe approaches to the use of live attenuated vaccines in patients taking immunosuppressive medications are also addressed. Most recommendations are conditional and had low quality of supporting evidence. CONCLUSION: Application of these recommendations should consider patients' individual risk for vaccine-preventable illness and for disease flares, particularly if immunosuppressive medications are held for vaccination. Shared decision-making with patients is encouraged in clinical settings.

Telemedicine in Adult Rheumatology: In Practice and in Training.

Many rheumatology providers, including fellows-in-training, responded to the immediate need for maintaining patient access to care via telerheumatology during the COVID-19 pandemic. The rapidity of this transition did not permit an intentional approach to integrating fellow education and training into virtual patient care. Virtual patient care has since become an integrated, and perhaps, an embedded part of rheumatology practice that will likely endure beyond the COVID-19 pandemic. Thus, the development of best practices in telerheumatology, including those for fellow education and training as these new entrants prepare to enter our workforce, will benefit the entire specialty. In this work, we seek to describe current models for training learners in virtual patient care, characterize existing barriers to virtual care models, and offer strategies to integrate telerheumatology into curriculum development and training.

Nonradiographic axial spondyloarthritis.

Non-radiographic axial spondyloarthritis (nr-axSpA) is a complex disease process that is part of the spectrum of axial spondyloarthritis (axSpA). This article reviews the current state of the literature as the understanding of this disease spectrum expands. The conceptual history and terminology, genetics, and epidemiology are reviewed. The clinical manifestations, diagnostic approach, and measures of disease activity are examined. Finally the current treatment modalities and recommendations and the research agenda for nr-axSpA are reviewed. With the advent of new criteria, the disease spectrum can be studied in a systematic manner. These data have enriched our knowledge that reflects an earlier or milder form of disease on a spectrum same as that of ankylosing spondylitis (or radiographic axSpA). We learned how patients present in this stage and that despite an unacceptable delay in diagnosis (regardless of the stage), the burden of disease is high and unremitting. nr-axSpA clinical trials have been somewhat heterogeneous (with variable inclusion criteria) but have nevertheless shown considerable efficacy with tumor necrosis factor inhibitors and flare on withdrawal of therapy.

Screening via CT angiogram after traumatic cervical spine fractures: narrowing imaging to improve cost effectiveness. Experience of a Level I trauma center.

OBJECT: Screening for vertebral artery injury (VAI) following cervical spine fractures is routinely performed across trauma centers in North America. From 2002 to 2007, the total number of neck CT angiography (CTA) studies performed in the Medicare population after trauma increased from 9796 to 115,021. In the era of cost-effective medical care, the authors aimed to evaluate the utility of CTA screening in detecting VAI and reduce chances of posterior circulation strokes after traumatic cervical spine fractures. METHODS: A retrospective review of all patients presenting with cervical spine fractures to Northeast Ohio's Level I trauma institution from 2002 to 2012 was performed. RESULTS: There was a total of 1717 cervical spine fractures in patients presenting to Northeast Ohio's Level I trauma institution between 2002 and 2012. CTA screening was performed in 732 patients, and 51 patients (0.7%) were found to have a VAI. Fracture patterns with increased odds of VAI were C-1 and C-2 combined fractures, transverse foramen fractures, and subluxation of adjacent vertebral levels. Ten posterior circulation strokes were identified in this patient population (0.6%) and found in only 4 of 51 cases of VAI (7.8%). High-risk fractures defined by Denver Criteria, VAI, and antiplatelet treatment of VAI were not independent predictors of stroke. CONCLUSIONS: Cost-effective screening must be reevaluated in the setting of blunt cervical spine fractures on a case-by-case basis. Further prospective studies must be performed to elucidate the utility of screening for VAI and posterior circulation stroke prevention, if identified.