American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 5.

OBJECTIVE: To provide guidance to rheumatology providers on the use of COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious diseases specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9-point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. RESULTS: Despite a paucity of direct evidence, statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines, including supplemental/booster dosing, in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. CONCLUSION: These guidance statements are intended to provide direction to rheumatology health care providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients.

American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 4.

OBJECTIVE: To provide guidance to rheumatology providers on the use of COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9-point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. RESULTS: Despite a paucity of direct evidence, statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines, including supplemental/booster dosing, in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. CONCLUSION: These guidance statements are intended to provide direction to rheumatology health care providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients.

American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3.

OBJECTIVE: To provide guidance to rheumatology providers on the use of coronavirus disease 2019 (COVID-19) vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID-19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9-point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. RESULTS: Despite a paucity of direct evidence, 74 draft guidance statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID-19 vaccines in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. CONCLUSION: These guidance statements, made in the context of limited clinical data, are intended to provide direction to rheumatology health care providers on how to best use COVID-19 vaccines and to facilitate implementation of vaccination strategies for RMD patients.

Variables Associated With Perceived Risk of Contracting SARS-CoV-2 Infection During the COVID-19 Pandemic Among Patients With Systemic Rheumatic Diseases.

OBJECTIVE: The aim of this study was to assess patients' perceived risk of contracting SARS-CoV-2 at the peak of the pandemic in NYC in terms of their systemic rheumatic disease and medications. METHODS: With the approval of their rheumatologists, patients were interviewed by telephone and were asked about their perceived risk of contracting SARS-CoV-2 considering their rheumatic condition and whether medications increased this risk. Patients also completed surveys assessing beliefs about medication and multidimensions of physical/mental well-being. Information about current medications and rheumatologist-initiated changes in medications during the pandemic were reported by patients and verified from medical records. RESULTS: One hundred twelve patients (86% women; mean age, 50 years; 81% White, 15% Latino) with diverse diagnoses were enrolled. Fifty-four percent thought they were at "very much greater risk" of COVID-19 because of their rheumatic condition, and 57% thought medications "definitely" put them at greater risk. In multivariable analysis, the perception of "very much greater risk" was associated with greater belief that rheumatic disease medications were necessary, worse physical function, chronic pulmonary comorbidity, and more anxiety. In a separate model, the perception that medications "definitely" caused greater risk was associated with White race, not taking hydroxychloroquine, rheumatologists initiating change in medications, more anxiety, and taking biologics and corticosteroids. CONCLUSIONS: Patients' perceived increased risk of contracting SARS-CoV-2 was associated with beliefs about their rheumatic disease, medications, comorbidity, and anxiety. Clinicians should be aware of patients' perceptions and foster self-management practices that will alleviate anxiety, minimize exposure to the virus, and optimize systemic rheumatic disease outcomes.

Modifications in Systemic Rheumatic Disease Medications: Patients' Perspectives During the Height of the COVID-19 Pandemic in New York City.

OBJECTIVE: Concerns about severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection may have led to changes or discontinuation of immunosuppressive medications among patients with systemic rheumatic disease. Our goal was to assess patients' perspectives regarding medication modifications and deviations from planned uses during the height of the pandemic. METHODS: Adult patients of 13 rheumatologists at an academic center with physician-diagnosed rheumatic disease and prescribed disease-modifying medications were interviewed by telephone and asked open-ended questions about the impact of SARS-CoV-2 on their medications. Responses were analyzed using content and thematic analyses to generate categories that described patterns of medication modification. RESULTS: A total of 112 patients (mean age 50 years, 86% women, 34% non-White race or Latino ethnicity) with diverse diagnoses (30% lupus, 26% rheumatoid arthritis, 44% other) who were taking various medications were enrolled. Patients reported clinically relevant issues that were iteratively reviewed to generate unique categories of medication modification: medications and increased or decreased risk of SARS-CoV-2 infection; role of hydroxychloroquine; maintaining medication status quo; role of glucocorticoids; increasing or decreasing existing medications in relation to clinical disease activity; postponing infusions; and medication plan if infected by SARS-CoV-2. Some modifications were suboptimal for disease control but were made to mitigate infection risk and to minimize potential harm when patients were unable to obtain laboratory tests and physical examinations due to cessation of in-person office visits. CONCLUSION: During the height of the pandemic, substantial medication modifications were made that, in some cases, were temporizing measures and deviations from planned regimens. Future studies will assess short- and long-term sequelae of these medication modifications.

Impact of COVID-19 on patients with rheumatic complications of cancer immunotherapy: results of a registry survey.

Immune checkpoint inhibitors (ICI) block negative regulatory molecules, such as CTLA-4, PD-1 and PD-L1, in order to mount an antitumor response. T cells are important for antiviral defense, but it is not known whether patients with cancer treated with ICI are more or less vulnerable to viral infections such as COVID-19. Furthermore, immunosuppressive treatment of immune-related adverse events (irAE) may also impact infection risk. Rheumatic irAEs are often persistent, and can require long-term treatment with immunosuppressive agents. The aim of this study was to determine the incidence of COVID-19 infection and assess changes in ICI and immunosuppressive medication use among patients enrolled in a prospective rheumatic irAE registry during the height of the COVID-19 pandemic. On April 16 2020, following the 'surge' of COVID-19 infections in the New York Tri-State area, we sent a 23-question survey to 88 living patients enrolled in a single institutional registry of patients with rheumatic irAE. Questions addressed current cancer and rheumatic irAE status, ICI and immunosuppressant medication use, history of COVID-19 symptoms and/or diagnosed infection. A follow-up survey was sent out 6 weeks later. Sixty-five (74%) patients completed the survey. Mean age was 63 years, 59% were female, 70% had received anti-PD-(L)1 monotherapy and 80% had had an irAE affecting their joints. Six patients (10%) had definite or probable COVID-19, but all recovered uneventfully, including two still on ICI and on low-to-moderate dose prednisone. Of the 25 on ICI within the last 6 months, seven (28%) had their ICI held due to the pandemic. In patients on immunosuppression for irAE, none had changes made to those medications as a result of the pandemic. The incidence of COVID-19 was no higher in patients still on ICI. Ten percent of rheumatic irAE patients developed COVID-19 during the NY Tri-state 'surge' of March-April 2020. Oncologists held ICI in a quarter of the patients still on them, particularly women, those on anti-PD-(L)1 monotherapy, and those who had had a good cancer response. The incidence of COVID-19 was no higher on patients still on ICI. None of the patients on disease-modifying antirheumatic drugs or biological immunosuppressive medications developed COVID-19.

Impact of COVID-19 on vulnerable patients with rheumatic disease: results of a worldwide survey.

OBJECTIVE: There is emerging evidence that COVID-19 disproportionately affects people from racial/ethnic minority and low socioeconomic status (SES) groups. Many physicians across the globe are changing practice patterns in response to the COVID-19 pandemic. We sought to examine the practice changes among rheumatologists and what they perceive the impact to be on their most vulnerable patients. METHODS: We administered an online survey to a convenience sample of rheumatologists worldwide during the initial height of the pandemic (between 8 April and 4 May 2020) via social media and group emails. We surveyed rheumatologists about their opinions regarding patients from low SES and racial/ethnic minority groups in the context of the COVID-19 pandemic. Mainly, what their specific concerns were, including the challenges of medication access; and about specific social factors (health literacy, poverty, food insecurity, access to telehealth video) that may be complicating the management of rheumatologic conditions during this time. RESULTS: 548 rheumatologists responded from 64 countries and shared concerns of food insecurity, low health literacy, poverty and factors that preclude social distancing such as working and dense housing conditions among their patients. Although 82% of rheumatologists had switched to telehealth video, 17% of respondents estimated that about a quarter of their patients did not have access to telehealth video, especially those from below the poverty line. The majority of respondents believed these vulnerable patients, from racial/ethnic minorities and from low SES groups, would do worse, in terms of morbidity and mortality, during the pandemic. CONCLUSION: In this sample of rheumatologists from 64 countries, there is a clear shift in practice to telehealth video consultations and widespread concern for socially and economically vulnerable patients with rheumatic disease.

Rheumatic Disease-Related Symptoms During the Height of the COVID-19 Pandemic.

BACKGROUND: Systemic rheumatic diseases are characterized by diverse symptoms that are exacerbated by stressors. QUESTIONS/PURPOSES: Our goal was to identify COVID-19-related stressors that patients associated with worsening rheumatic disease symptoms. METHODS: With approval of their rheumatologists, patients at an academic medical center were interviewed with open-ended questions about the impact of COVID-19 on daily life. Responses were analyzed with qualitative methods using grounded theory and a comparative analytic approach to generate categories of stressors. RESULTS: Of 112 patients enrolled (mean age 50 years, 86% women, 34% non-white or Latino, 30% with lupus, 26% with rheumatoid arthritis), 2 patients had SARS-CoV-2 infection. Patients reported that coping with challenges due to the pandemic both directly and indirectly worsened their rheumatic disease symptoms. Categories associated with direct effects were increased fatigue (i.e., from multitasking, physical work, and taking precautions to avoid infection) and worsening musculoskeletal and cognitive function. Categories associated with indirect effects were psychological worry (i.e., about contracting SARS-COV-2, altering medications, impact on family, and impact on job and finances) and psychological stress (i.e., at work, at home, from non-routine family responsibilities, about uncertainty related to SARS-CoV-2, and from the media). Patients often reported several effects coalesced in causing more rheumatic disease symptoms. CONCLUSION: Coping with the COVID-19 pandemic was associated with rheumatic disease-related physical and psychological effects, even among patients not infected with SARS-CoV-2. According to patients, these effects adversely impacted their rheumatic diseases. Clinicians will need to ascertain the long-term sequelae of these effects and determine what therapeutic and psychological interventions are indicated.