Introduction: COVID-19 is an acute respiratory viral infection that threatens people worldwide, including people with rheumatic disease, although it remains unclear to what extent various antirheumatic disease therapies increase susceptibility to complications of viral respiratory infections. Objective: The present study undertakes a scoping review of available evidence regarding the frequency and severity of acute respiratory viral adverse events related to antirheumatic disease therapies. Methods: Online databases were used to identify, since database inception, studies reporting primary data on acute respiratory viral infections in patients utilizing antirheumatic disease therapies. Independent reviewer pairs charted data from eligible studies using a standardized data abstraction tool. Results: A total of 180 studies were eligible for qualitative analysis. While acknowledging that the extant literature has a lack of specificity in reporting of acute viral infections or complications thereof, the data suggest that use of glucocorticoids, JAK inhibitors (especially high-dose), TNF inhibitors, and anti-IL-17 agents may be associated with an increased frequency of respiratory viral events. Available data suggest no increased frequency or risk of respiratory viral events with NSAIDs, hydroxychloroquine, sulfasalazine, methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, or apremilast. One large cohort study demonstrated an association with leflunomide use and increased risk of acute viral respiratory events compared to non-use. Conclusion: This scoping review identified that some medication classes may confer increased risk of acute respiratory viral infections. However, definitive data are lacking and future studies should address this knowledge gap. (C) 2020 Elsevier Inc. All rights reserved.
OBJECTIVE:This study aimed to analyze the concerns and health-related behaviors in patients with vasculitis during the early phase of the coronavirus disease 2019 (COVID-19) pandemic in North America.METHODS:Patients with vasculitis in North America were invited to complete an online survey through the Vasculitis Patient-Powered Research Network in collaboration with the Vasculitis Foundation and the Relapsing Polychondritis Foundation. Questions focused on concerns and behaviors related to doctors' visits, tests, medication, and telehealth use. Factors affecting their concern and health-related behaviors were determined.RESULTS:Data from 662 patients were included: 90% of patients were White, 78% were women, 83% expressed moderate or high levels of concern about COVID-19, and 87% reported that their vasculitis moderately or extremely affected their level of concern. Older age, female sex, lung disease, and immunosuppression were associated with greater concern. Doctors' visits, laboratory tests, and other tests were avoided by 66%, 46%, and 40% of patients, respectively. Younger age, urban location, higher income, higher concern levels, and prednisone use (>10 mg/day) were associated with greater likelihood of avoiding visits or tests. Ten percent of patients on immunosuppressive therapy stopped their medication. Twenty-nine percent patients on rituximab avoided an infusion. Forty-four percent of patients had telehealth visits; more visits were reported for younger patients, for patients on glucocorticoids, and in Canada versus the United States.CONCLUSION:During the COVID-19 pandemic, patients with vasculitis have high levels of concern and exhibit potentially harmful health-related behaviors. Health care use varies across different demographic groups and geographic regions. Specific strategies are warranted to facilitate engagement of these patients with the health care system during the pandemic.
OBJECTIVE:Patients with coronavirus disease 2019 (COVID-19) can progress to a state of unregulated inflammation called cytokine storm syndrome (CSS). We describe formation and operation of a COVID-19 multidisciplinary consultation service that was allowed to individualize treatment for critically ill patients with COVID-19 during the pandemic.METHODS:Institutional experts from different subspecialties formed a COVID-19 CSS task force at Montefiore Medical Center, Bronx, NY. They agreed on a set of four clinical and six laboratory parameters that can help early identify COVID-19 CSS. We describe the formation and implementation of the COVID-19 task force. The case series description of the COVID-19 CSS consultation cohort highlights consultation volume, baseline characteristics, clinical and laboratory parameters, and how biologic treatments were allocated to these patients.RESULTS:Between April 4,2020, and May 7,2020, the COVID-19 CSS task force was formed, consisting of adult and pediatric rheumatologists and allergy and immunology physicians. The task force evaluated a total of 288 patients, of whom 197 (68%) were male, the median (interquartile range [IQR]) age was 62 (51-70) years, 122 (42%) were Hispanic, and 88 (31%) were Black or African American. The common presenting symptoms in all referred patients were dyspnea (85%) and diarrhea (80%). Thirty-one patients who received biologic therapy were younger, with a median (IQR) age of 53 (32-63) years, as opposed to 62.5 (52-70) years in the nonbiologic group (P = 0.008). A higher proportion receiving biologics was in the critical care setting (26 [84%] vs 151 [59%]; P = 0.006).CONCLUSION:To the best of our knowledge, this is the first multidisciplinary collaborative effort to provide individualized patient recommendations for evaluation and treatment of patients with COVID-19 who may have CSS. This working model helped to devise an approach that may have identified patients who were most likely to benefit from biologic therapy in the absence of evidence-based guidelines.
Objective To characterize patients with systemic lupus erythematosus (SLE) affected by coronavirus disease 2019 (COVID-19) and to analyze associations of comorbidities and medications on infection outcomes. Methods Patients with SLE and reverse transcriptase-polymerase chain reaction-confirmed COVID-19 were identified through an established New York University lupus cohort, query of 2 hospital systems, and referrals from rheumatologists. Data were prospectively collected via a web-based questionnaire and review of medical records. Data on baseline characteristics were obtained for all patients with COVID-19 to analyze risk factors for hospitalization. Data were also collected on asymptomatic patients and those with COVID-19-like symptoms who tested negative or were not tested. Statistical analyses were limited to confirmed COVID-19-positive patients. Results A total of 226 SLE patients were included: 41 with confirmed COVID-19, 19 who tested negative for COVID-19, 42 with COVID-19-like symptoms who did not get tested, and 124 who remained asymptomatic without testing. Of the SLE patients with confirmed COVID-19, hospitalization was required in 24 (59%) and intensive care unit-level of care in 4, and 4 died. Hospitalized patients tended to be older, nonwhite, Hispanic, have higher body mas index (BMI), history of nephritis, and at least 1 comorbidity. An exploratory (due to limited sample size) logistic regression analysis identified race, presence of at least 1 comorbidity, and BMI as independent predictors of hospitalization. Conclusion In general, the variables predictive of hospitalization in our SLE patients were similar to those identified in the general population. Further studies are needed to understand additional risk factors for poor COVID-19 outcomes in patients with SLE.
Background: Guselkumab (GUS), a fully human monoclonal antibody, selectively binds and blocks interleukin-23. VOYAGE 1 and VOYAGE 2 are two ongoing Phase 3, randomized, double-blind, placebo (PBO)/active comparator-controlled clinical trials of GUS in patients (pts) with moderate-to-severe psoriasis (PsO). Objectives: This post-hoc analysis reports pooled results through 4 years among a subgroup of moderate-to-severe PsO pts with self-reported psoriatic arthritis (PsA) at baseline. Methods: 1829 pts were randomized to GUS 100 mg at Weeks (Wks) 0, 4, and 12, then every 8 wks (q8wk); PBO at Wks 0, 4, and 12, GUS at Wks 16 and 20 then q8wk; or adalimumab (ADA) 80 mg at Wk 0, 40 mg at Wk 1, then 40 mg q2wk until Wk 47 (VOYAGE 1) or Wk 23 (VOYAGE 2). In VOYAGE 1, all pts received open-label GUS 100 mg q8wk during Wks 52-204. VOYAGE 2 incorporated a randomized withdrawal study design, followed by open-label GUS during Wks 76-204. Pooled subgroup analyses using the combined GUS group were conducted based on self-reported PsA status at baseline. Efficacy based on Investigator Global Assessment (IGA) score and Psoriasis Area and Severity Index (PASI) response was assessed using prespecified treatment failure rules (nonresponder status for all time points after discontinuing due to lack of efficacy, worsening of PsO, or use of a prohibited treatment). Results: For pooled VOYAGE 1 and VOYAGE 2 pts (N=1721), combined GUS and ADA to GUS response rates at Wks 100, 156, and 204 were: PASI 90 80.6%, 80.0%, and 80.4%; PASI 100 50.1%, 49.9%, and 52.2%; IGA 0/1 83.6%, 83.3%, and 81.7%; and IGA 0 54.3%, 52.9%, and 53.9, respectively. In the pooled subgroup analysis of pts with and without PsA, response rates were similar across the Wk 100, Wk 156, and Wk 204 evaluations (Table). Rates of adverse events through Wk 204 were comparable for pts with PsA vs those without PsA at baseline. Conclusion: Among GUS-treated pts with moderate-to-severe PsO with and without self-reported PsA at baseline, stable, durable, and high levels of skin responses, as well as comparable safety outcomes, through 4 years were observed. Table. Pooled GUS Response Rates Without PsA at Baseline With PsA at Baseline Wk 100 Wk 156 Wk 204 Wk 100 Wk 156 Wk 204 N=1301 N=1239 N=1191 N=289 N=276 N=264 PASI 90 1049 (80.6%) 1001 (80.8%) 964 (80.9%) 233 (80.6%) 211 (76.4%) 206 (78.0%) PASI 100 648 (49.8%) 631 (50.9%) 635 (53.3%) 149 (51.6%) 125 (45.3%) 125 (47.3%) N=1300 N=1235 N=1189 N=288 N=276 N=264 IGA 0/1 1086 (83.5%) 1042 (84.4%) 979 (82.3%) 241 (83.7%) 217 (78.6%) 208 (78.8%) IGA 0 702 (54.0%) 664 (53.8%) 649 (54.6%) 160 (55.6%) 135 (48.9%) 134 (50.8%) Acknowledgments: None Disclosure of Interests: Kristian Reich Grant/research support from: Janssen Research & Development, LLC, Jan Dutz Grant/research support from: Janssen Research & Development, LLC, Peter Foley Grant/research support from: Janssen Research & Development, LLC, Diamant Thaçi Grant/research support from: Janssen Research & Development, LLC, Ronald Vender Grant/research support from: Janssen Research & Development, LLC, Michael Song Employee of: Janssen Research & Development, LLC, Megan Miller Employee of: Janssen Research & Development, LLC, Yin You Employee of: Janssen Research & Development, LLC, Shu Li Employee of: Janssen Research & Development, LLC, Yaung-Kaung Shen Employee of: Janssen Research & Development, LLC, April Armstrong Grant/research support from: Janssen Research & Development, LLC
