Bierle, Dennis M.

Abstract Introduction/Objective: To assess the clinical utility of the FM/a® chemokine-cytokine assay in diagnosing fibromyalgia at an academic medical center. Methods: We performed a cross-sectional study on 50 patients diagnosed with fibromyalgia at a specialty fibromyalgia clinic between January 1, 2021 through July 31, 2021. Patients completed questionnaires and provided a venous blood sample sent to EpicGenetics, to complete the FM/a® test. Demographic, symptom, and historical data was obtained from chart review. Statistical analysis was performed. Results: Of 50 patients with a clinical diagnosis of fibromyalgia, the FM/a® test was positive in 45 (90%). Performance of the FM/a® test compared to the 2016 ACR criteria yielded an odds ratio of 3.5 with sensitivity of 0.91, specificity of 0.25. Univariate regression demonstrated an area under the curve (AUC) of 0.7337, which improved to 0.89 when adjusted for age, gender, and race. When compared to the 1990 ACR criteria, a positive FM/a® test had an odds ratio of 2.33 with sensitivity 0.92 and specificity 0.17. Univariate regression analysis demonstrated an AUC of 0.571, when adjusted for age, gender and race, AUC was similar at 0.585. Conclusion: The FM/a® test performed well overall, though inferiorly compared to the 1990 and 2016 ACR diagnostic criteria. When adjusted for age, gender, and race the test performed almost equivalently to the 2016 ACR criteria. The FM/a® test may be useful in general clinical practices to differentiate patients who are more likely to have FM.

AbstractBackgroundSolid organ transplant (SOT) recipients are at increased risk for complications from SARS‐CoV‐2 infection. Little is known regarding clinical course and outcomes of breakthrough COVID‐19 in the fully vaccinated SOT population. We sought to describe our cohort of SOT recipients who developed symptomatic breakthrough COVID‐19 after full vaccination.MethodsWe conducted a retrospective review of SOT recipients diagnosed with COVID‐19 at least 14 days after completing SARS‐CoV‐2 vaccination. Patients were analyzed according to those presenting with mild‐to‐moderate and severe COVID‐19, respectively. We described presenting characteristics, COVID‐19 therapy, and analyzed outcomes including emergency department (ED) visits, hospitalization, and intensive care unit (ICU) admission.ResultsThirty‐five patients met inclusion criteria. These had a mean age of 60.8 years and kidney transplant was the most common SOT type. Five patients presented with severe COVID‐19 at diagnosis, all requiring hospitalization without ICU admission. From the 30 patients who presented with mild‐to‐moderate infection, 28 received casirivimab–imdevimab. Four of these 28 (14.3%) had an ED visit, with one requiring hospital admission (3.4%). No patients required ICU admission.ConclusionBreakthrough COVID‐19 may occur in SOT recipients after full vaccination, though they appear to have acceptable outcomes. Anti‐spike monoclonal antibody therapy for eligible SOT patients may have mitigated clinical progression and improved the outcomes. Further study with large cohorts is warranted.

Abstract Background Breakthrough coronavirus disease 2019 (COVID-19) may occur in fully vaccinated persons. Methods We assessed the clinical outcomes of breakthrough COVID-19 in fully vaccinated individuals. Results In this cohort of 1395 persons (mean age, 54.3 years; 60% female; median body mass index, 30.7) who developed breakthrough COVID- 19, there were 107 (7.7%) who required hospitalization by day 28. Hospitalization was significantly associated with the number of medical comorbidities. Antispike monoclonal antibody treatment was significantly associated with a lower risk of hospitalization (odds ratio, 0.227; 95% confidence interval, 0.128–0.403; P < .001). The number needed to treat (NNT) to prevent 1 hospitalization was 225 among the lowest risk patient group compared with NNT of 4 among those with highest numbers of medical comorbidity. Conclusions Monoclonal antibody treatment is associated with reduced hospitalization in vaccinated high-risk persons with mild to moderate COVID-19.

Abstract Background Bamlanivimab and casirivimab-imdevimab are authorized for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in high-risk patients. We compared the outcomes of patients who received these therapies to identify factors associated with hospitalization and other clinical outcomes. Methods Adult patients who received monoclonal antibody from 19 November 2020 to 11 February 2021 were selected and divided into those who received bamlanivimab (n = 2747) and casirivimab-imdevimab (n = 849). The 28-day all-cause and COVID-19–related hospitalizations were compared between the groups. Results The population included 3596 patients; the median age was 62 years, and 50% were female. All had ≥1 medical comorbidity; 55% had multiple comorbidities. All-cause and COVID-19–related hospitalization rates at 28 days were 3.98% and 2.56%, respectively. After adjusting for medical comorbidities, there was no significant difference in all-cause and COVID-19–related hospitalization rates between bamlanivimab and casirivimab-imdevimab (adjusted hazard ratios [95% confidence interval], 1.4 [.9–2.2] and 1.6 [.8–2.7], respectively). Chronic kidney, respiratory and cardiovascular diseases, and immunocompromised status were associated with higher likelihood of hospitalization. Conclusions This observational study on the use of bamlanivimab and casirivimab-imdevimab in high-risk patients showed similarly low rates of hospitalization. The number and type of medical comorbidities are associated with hospitalizations after monoclonal antibody treatment.

Objective To develop and implement criteria for description of post COVID syndrome based on analysis of patients presenting for evaluation at Mayo Clinic Rochester between November 2019 and August 2020. Methods A total of 465 patients with a history of testing positive for COVID-19 were identified and their medical records reviewed. After a thorough review, utilizing the DELPHI methods by an expert panel, 42 (9%) cases were identified with persistent central sensitization (CS) symptoms persisting after the resolution of acute COVID-19, herein referred to as Post COVID syndrome (PoCoS). In this report we describe the baseline characteristics of these PoCoS patients. Results Among these 42 PoCoS patients, the mean age was 46.2 years (median age was 46.5 years). Pain (90%), fatigue (74%), dyspnea (43%), and orthostatic intolerance (38%) were the most common symptoms. The characteristics of an initial 14 patients were utilized for the development of clinical criteria via a modified Delphi Method by a panel of experts in central sensitization disorders. These criteria were subsequently applied in the identification of 28 additional cases of suspected PoCoS. A 2-reviewer system was used to analyze agreement with using the criteria, with all 28 cases determined to be either probable or possible cases by the reviewers. Inter-reviewer agreement using these proposed defining criteria was high with a Cohen’s alpha of .88. Conclusions Here we present what we believe to be the first definitional criteria for Post COVID syndrome. These may be useful in clinical phenotyping of these patients for targeted treatment and future research.

AbstractBackgroundBamlanivimab and casirivimab-imdevimab are authorized for emergency use treatment of mild to moderate coronavirus disease 2019 (COVID-19) in patients at high risk for developing severe disease or hospitalization. Their safety and efficacy have not been specifically evaluated in solid organ transplant recipients.MethodsWe retrospectively reviewed solid organ transplant recipients who received monoclonal antibody infusion for COVID-19 at Mayo Clinic sites through January 23, 2021. Outcomes included emergency department visit, hospitalization, mortality, and allograft rejection.ResultsSeventy-three patients were treated, most commonly with bamlanivimab (75.3%). The median age was 59 years, 63% were male, and the median Charlson comorbidity index was 5. Transplant type included 41 kidney (56.2%), 13 liver (17.8%), 11 heart (15.1%), 4 kidney-pancreas (5.5%), 2 lung (2.7%), 1 heart-liver, and 1 pancreas. Eleven (15.1%) patients had an emergency department visit within 28 days of infusion, including 9 (12.3%) who were hospitalized for a median of 4 days. One patient required intensive care unit admission for a nonrespiratory complication. No patients required mechanical ventilation, died, or experienced rejection. Ten adverse events occurred, with 1 seeking medical evaluation. Hypertension was associated with hospital admission (P < .05), while other baseline characteristics were similar. The median time from symptom onset to antibody administration was 4 days in nonhospitalized patients compared with 6 days among hospitalized patients (P < .05).ConclusionsMonoclonal antibody treatment has favorable outcomes with minimal adverse effects in solid organ transplant recipients with mild to moderate COVID-19. Earlier administration of monoclonal antibody therapy appears to be more efficacious.

Background The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal antibody therapies are not established. This study aimed to identify factors impacting the decision to consent for monoclonal antibody therapies and assess the differences in clinical outcomes of patients who accepted compared to those who declined these therapies. Methods This retrospective cohort study enrolled 2820 adult patients who were offered monoclonal antibody therapies, bamlanivimab and casirivimab-imdevimab, for COVID-19 at Mayo Clinic in the Midwest between 11/19/2020 and 12/31/2020. The primary endpoint is the decision to accept or decline monoclonal antibody treatment. Secondary endpoints were patient-level factors that could have impacted the decision to accept treatment (age, gender, race, ethnicity, primary language spoken, and medical comorbidities). The main clinical endpoint was hospitalization within 28 days of COVID-19 diagnosis. Results 59.1% (n = 1669) chose to accept monoclonal antibody therapy, and 40.9% (n = 1151) chose to decline the offer for treatment. Patients were more likely to accept treatment if they were non-Hispanic White, English speaking, identified a spouse or life partner, had a religious affiliation, and possessed more medical comorbidities. Overall, 28-day hospitalization rate was 2.6% (n = 72/2820) and was higher among those who declined (3.3%) than those who accepted monoclonal antibody therapy (2.0%; Rate Ratio = 0.62, 95% Confidence Interval, 0.39-0.98). Conclusions Despite having more comorbidities, patients who accepted monoclonal antibody treatments had a lower rate of hospitalization compared to patients who declined treatment. Several social and cultural factors were associated with the decision to decline therapy, including race, language, ethnicity, and lack of social support. These findings can inform public health efforts to reduce social disparities in the treatment of COVID-19 and increase utilization of monoclonal antibody therapies in high risk populations.

Abstract Background Residents of nursing homes and long‐term care facilities are at increased risk for severe coronavirus disease‐19 (COVID‐19) but may not be able to access monoclonal antibody therapies offered at outpatient infusion centers due to frailty and logistical issues. We describe a mobile monoclonal antibody infusion program for patients with COVID‐19 in skilled nursing facilities and provide descriptive data on its outcomes. Design Retrospective cohort study. Setting Collaboration between Mayo Clinic and skilled nursing facilities in Southeast Minnesota was developed to administer anti‐spike monoclonal antibodies under the FDA Emergency Use Authorization. Participants Seventy five residents of skilled nursing facilities at high risk of COVID‐19 complications. Exposure Emergency use treatment with bamlanivimab and casirivimab–imdevimab. Measurements Hospitalization and medically attended visits. Results The mobile infusion unit, staffed by Mayo Clinic Infusion Therapy registered nurses and supported by the skilled nursing facility staff, infused anti‐spike monoclonal antibodies to 45 of 75 patients (average age, 77.8 years) in December 2020. The infusions occurred at an average of 4.3 days after COVID‐19 diagnosis. Fourteen days after infusion, there were no deaths, two emergency department visits, and three hospitalizations, for a combined event rate of 11.1%. There was one reported adverse event. Conclusion The implementation of a mobile infusion unit embedded in a collaborative process resulted in rapid infusion of monoclonal antibodies to high‐risk COVID‐19 patients in skilled nursing facilities, who would otherwise be unable to access the novel therapies. The therapies were well tolerated and appear beneficial. Further study is warranted to explore the scalability and efficacy of this program.

Controversy exists regarding the use of dose capping of weight-based unfractionated heparin (UFH) infusions in obese and morbidly obese patients. The primary objective of this study was to compare time to first therapeutic activated partial thromboplastin time (aPTT) in hospitalized patients receiving UFH for acute venous thromboembolism (VTE) among three body mass index (BMI) cohorts: non-obese (< 30 kg/m 2 ), obese (30–39.9 kg/m 2 ), and morbidly obese (⩾ 40 kg/m 2 ). In this single-center, retrospective cohort study, patients were included if they ⩾ 18 years of age, had a documented VTE, and were on an infusion of UFH for at least 24 hours. Weight-based UFH doses were calculated using actual body weight. A total of 423 patients met the inclusion criteria, with 230 (54.4%), 146 (34.5%), and 47 (11.1%) patients in the non-obese, obese, and morbidly obese cohorts, respectively. Median times to therapeutic aPTT were 16.4, 16.6, and 17.1 hours in each cohort. Within 24 hours, the cumulative incidence rates for therapeutic aPTT were 70.7% for the non-obese group, 69.9% for the obese group, and 61.7% for the morbidly obese group (obese vs non-obese: HR = 1.02, 95% CI: 0.82–1.26, p = 0.88; morbidly obese vs non-obese: HR = 0.87, 95% CI: 0.62–1.21, p = 0.41). There was no significant difference in major bleeding events between BMI groups (obese vs non-obese, p = 0.91; morbidly obese vs non-obese, p = 0.98). Based on our study, heparin dosing based on actual body weight without a dose cap is safe and effective.