ABSTRACT
Background: Kidney transplant recipients (KTR) remain at risk for severe COVID-19 because of emerging SARS-CoV-2 variants and impaired antibody response to COVID-19 vaccines. There is an urgent need for effective vaccination and pre-exposure prophylaxis. In December 2021, the FDA issued an emergency use authorization of tixagevimab/ cilgavimab for pre-exposure prophylaxis of COVID-19 in moderately-severely immunocompromised individuals. In PROVENT, tixagevimab/cilgavimab resulted in 83% relative risk reduction in incidence of symptomatic COVID-19, but only 3% of subjects received immunosuppressive medications and <1% had immunosuppressive disease. We report safety and tolerability of tixagevimab/cilgavimab in KTR at our center. Method(s): 40 doses initially allocated to KTR. We designed an online questionnaire to assess therapy tolerability. 28/38 KTR who received therapy responded. Result(s): Patient characteristics of 38 KTR who received tixagevimab/cilgavimab are listed (Table 1a). Negative Anti-S antibody documented in 54.1% patients, with 17(85%) testing negative after three vaccines. 28 KTR completed the survey and authorized use of their deidentified data. Most patients, 81.5%, reported tolerating tixagevimab/cilgavimab "Very Well" (Table 1b). The most common symptom was fatigue, moderate in 25% and mild in 29%. Other symptoms were less frequent, <15%. Conclusion(s): Tixagevimab/cilgavimab was generally "very well" tolerated. Additional data substantiating safety and tolerability of tixagevimab/cilgavimab over a longer observation period and with more study participants should help increase confidence in a pre-exposure prophylaxis strategy and offer a safety net for kidney transplant recipients and others at risk for severe COVID-19.
ABSTRACT
Background: Kidney transplant recipients (KTRs) are risk for severe complications from COVID-19 illness due to immunosuppression. Predating COVID-19 vaccines our center reported AKI in 39% & death in 13% of KTRs. Here we describe the impact of COVID-19 on allograft & patient outcomes in KTRs with & without COVID-19 vaccination. We also compare outcomes in KTRs with & without response (SARS-CoV2 spike/anti-S antibody) to COVID-19 vaccine. Method(s): This is a retrospective cohort analysis of 142 KTRs identified with COVID-19 illness between 7/1/21 and 2/10/22. We collected data on patient demographics, COVID19 vaccine doses, anti-S levels & clinical outcomes including graft dysfunction, hospitalization, ICU admission & death. Result(s): Of 142 KTRs in our cohort, 113 (80%) were fully vaccinated (+/-booster) and 29 (20%) were un or partially vaccinated. 60 of 113 vaccinated KTRs were tested for anti-S levels between COVID19 vaccination & illness: 68% tested positive and 32% negative for anti-S Ab. Allograft dysfunction & hospitalization were less frequent in fully vaccinated vs unvaccinated KTRs (Fig.1). There was no difference between the two in terms of ICU admission and death (22 vs 18%, p=0.7). Among vaccinated KTRs, there was a trend towards less graft dysfunction in positive vs. negative anti-S (15% vs. 33% p=0.15). No differences were observed between anti-S levels and hospitalization (23% vs 26% p=0.7), ICU admission (11 vs 60% p=0.07) and death (11 vs 20% p=0.65). Conclusion(s): In our cohort, kidney allograft dysfunction and hospitalization was less common vaccinated vs unvaccinated KTRs with COVID-19. Additionally, there is a trend towards lower graft dysfunction in those with positive anti-S Ab. No significant differences were observed in death and ICU admissions with vaccination or positive anti-S. Vaccination to COVID-19 and maintaining positive anti-S Ab (with boosters or monoclonal Ab) are important in preventing graft dysfunction and hospitalization following COVID-19.
ABSTRACT
Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, on KTR remains unknown. We aimed to determine the impact of COVID-19 illness on kidney graft function including graft loss and characterize Long COVID (LC) symptoms in KTR. Method(s): Clinical data were extracted from an established registry of KTR diagnosed with COVID-19 between February 2020 to April 2022. A LC symptom questionnaire was developed and distributed. KTR that self-reported COVID-19 associated symptoms >=2 months were considered to have Long COVID (LC). Result(s): Of the 121 post COVID-19 KTR, 15 (12%) developed graft dysfunction defined as an increase in serum creatinine >0.3 mg/dL. Characteristics of KTR stratified as with and without graft dysfunction are shown in Table 1. Urine albumin/creatinine ratio was higher in the group with dysfunction and 2 (1.6%) KTR lost their allografts as well. Four (18%) reported LC symptoms and the frequency of LC symptoms among the first 22 questionnaire respondents are shown in Figure 1. Conclusion(s): Both allograft injury and LC symptoms are frequent among KTR. Identification of risk factors for long-term complications post COVID-19 and development of mechanism-based interventions may mitigate post COVID-19 sequalae in KTR.
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Objective: To determine the optimal time for SARS-CoV-2 mRNA vaccination, after infusion with anti-CD20 therapy, in patients with multiple sclerosis and neuromyelitis optica spectrum disorder (MS/NMOSD) as there are currently no guidelines. Background: To achieve adequate immunity against SARS-CoV-2, mRNA vaccines (BNT162b2 or mRNA-1273) stimulate B and T cells. Therefore, it is imperative to ensure MS/NMOSD patients on anti-CD20 therapy have enough B cells to produce antibodies at the time of vaccination. Design/Methods: This was a retrospective study at Rutgers New Jersey Medical School, Newark. We identified all MS/NMOSD patients on anti-CD20 therapy (Ocrelizumab or Rituximab) who received a SARS-CoV-2 mRNA vaccine. Some of these patients were not on the standard, biannual dosing schedule due to treatment guideline modifications made during the pandemic. Antibody response to the SARS-CoV-2 spike protein was checked at least 4 weeks after the second dose of the vaccine. Results: We analyzed 23 vaccinated MS/NMOSD patients on anti-CD20 therapy (87% on Ocrelizumab and 13% on Rituximab). Patients were divided into two groups: those who developed antibodies after vaccination (52%) and those who did not (48%). There was no significant difference between the two groups in age, gender, MS type, expanded disability status scale, type of anti-CD20 therapy, and brand of vaccine. However, there was statistical significance in the interval between infusion and vaccination between the groups (p-value -0.03;9.2±3.9 vs 6.2±3.1months). Additionally, none of these patients had a relapse. Conclusions: The mean interval between infusion and vaccination was 9.2 months in those that developed antibodies and 6.2 months in those that did not. Patients on anti-CD20 therapy may mount an immune response when vaccinated if the time between infusion and vaccination is extended beyond 6 months. The main limitation of this study was the variable timing in the collection of CD19 counts.
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Objective: To investigate whether there is an association between Myasthenia Gravis (MG) and COVID-19 vaccination. Background: New onset or exacerbation of MG after vaccination was previously reported. Design/Methods: The reporting rate of MG cases after COVID-19 vaccination was compared to that of MG after all other vaccinations in 3 time periods: the vaccine period (December 2020- July 2021);the pre-vaccine pandemic period (April 2020-November 2020) and pre-pandemic period (January 2019-August 2019). Self-controlled case series analysis and case-centered analysis were used. Six weeks after vaccination was defined as the risk period for possible causeeffect relationship. For self-controlled case analysis, the risk period was followed by one month of washout and another six weeks of control monitoring. Results: 77 and 3 cases with MG after COVID-19 vaccination and all other vaccinations were reported during the vaccine period respectively. The reporting rate of MG after COVID-19 vaccination was significantly higher than the reporting rate of MG after other vaccines (4 vs 0.1 per 10 million p< 0.00001). However, the reporting rate was within the incidence range expected in the general population. Two cases of MG after vaccination were reported during pandemic period and none in the pre-pandemic period. Using self-controlled and case centered analyses, there is a significant difference in the reporting rate of MG after COVID-19 vaccination between the risk period and control period (92.2% vs 2.6-3.9% p<0.00001). The reporting rate of MG after COVID-19 vaccination was not significantly different between Johnson and Johnson, Moderna and Pfizer vaccines. Conclusions: There is no significant increase in reporting rate of MG after COVID-19 vaccination. Although the reporting rate of MG after COVID-19 vaccination was significantly higher during the risk period compared to the control period, a non-reported or undiagnosed concomitant COVID-19 infection, other triggering factors or non-adherence to medications cannot be excluded;this could account for the observed increase.
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Objective: To investigate whether there is an relationship between Miller Fisher Syndrome (MFS) and COVID-19 vaccination Background: MFS was rarely reported after COVID-19 vaccination. Design/Methods: The reporting rate of MFS cases after COVID-19 vaccination was compared to the rate after all other vaccinations in 3 time periods: COVID-19 vaccination (December 2020 - July 2021);COVID-19 pandemic outside the vaccination time period (April 2020-November 2020) and the time outside of COVID-19 vaccination and the pandemic (January 2019-August 2019). Self-controlled case series analysis and case-centered analysis was used. Six weeks after vaccination was defined as the risk period of possible association. Results: 12 cases after COVID-19 vaccination and 1 case from all other vaccinations were reported during the vaccine period. The reporting rate of MFS after COVID-19 vaccination (0.62 per 10 million vaccinations) was significantly higher than the rate after other vaccinations (0.04 per 10 million vaccinations) p<0.05. Both reporting rates are within the incidence range expected in the general population. No cases of MFS were reported during the pandemic period and 2 cases of MFS were reported outside the pandemic period. Using self-controlled and case centered analyses, there was a significant difference in the reporting rate of MFS after COVID-19 vaccination between the risk period and control period (91.6% vs 0-8,3% p<0.00001). The reporting rate of MFS after each vaccine used in USA (Johnson & Johnson, Pfizer and Moderna) was within the expected incidence range and there was no significant difference between them. Conclusions: There is no association between MFS and COVID-19 vaccination. Although the reporting rate MFS after COVID-19 was significantly higher during the risk period compared to control period, and compared to the rate of other vaccines, the number of reported cases was low and within the expected incidence range. Furthermore, cases of MFS related to COVID-19 infection or other triggering factors cannot be excluded.
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Background: Procalcitonin is a widely used test to distinguish bacterial infections from viral infections, but its level is influenced by kidney function. The normal range of procalcitonin levels in end-stage renal disease (ESRD) patients on hemodialysis (HD) is not well established. In this study, we evaluated the relationship between Procalcitonin and inflammatory markers and outcomes in ESRD outpatients on HD. Methods: We recruited 71 ESRD outpatients on HD from October 1st 2019 to December 15th 2019 and measured their procalcitonin levels prior to dialysis. We evaluated whether procalcitonin levels were associated with clinical characteristics, laboratory parameters, and future hospitalizations and infections. Results: In this cohort, the median procalcitonin level was 0.38 ng/mL with an interquartile range of 0.23 ng/mL and 0.54 ng/mL. The distribution of procalcitonin values are found in Fig. 1A. African Americans had a significantly higher procalcitonin level than non-African Americans (P=0.02, Wilcoxon rank sum test). ESRD outpatients who had hypertension, diabetes mellitus, or HIV did not have significantly higher procalcitonin levels than those who did not (P> 0.05). Procalcitonin levels were positively correlated with CRP (r=0.57, P<0.001) (Fig. 1B) and negatively correlated with albumin (r=-0.28, P=0.02) (Fig. 1C). Procalcitonin levels were not correlated with Kt/V, white blood cell count, and ferritin levels (P>0.05). ESRD outpatients who developed infections or who were hospitalized did not have significantly higher initial procalcitonin levels than those who did not (P>0.05). Conclusions: Procalcitonin levels are correlated with inflammatory markers such as CRP and albumin, suggesting its potential use to identify ESRD on HD at high risk for complications, especially in the era of COVID-19. (Figure Presented).
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Background: Kidney graft recipients receiving immunosuppressive therapy may be at heightened risk for Covid-19 and adverse outcomes. We aimed to study how practice patterns and outcomes changed before and after the peak incidence of cases in New York City. Methods: We reviewed 68 consecutive adult kidney graft recipients from our center diagnosed with SARS-CoV-2 from March 13, 2020 to May 25, 2020. We compared outcomes of those treated from March 13 until the apex of infections on April 14 (Phase 1), and those treated from April 15th to May 25, 2020 (Phase 2). Results: Characteristics of both Phase 1 and Phase 2 patients are described in Table 1. Inflammatory markers were lower in the second phase as was patient mortality. Changes in management strategies between the two phases are highlighted in Figure 2. Graft loss occurred in 4 patients (6%) and there were 5 deaths (7%). Conclusions: Data from our study suggest that management strategies of immunosuppressed patients changed over the course of the Covid-19 Pandemic in New York City, including less use of hydroxychloroquine, and increased use of novel agents such as remdesivir. Additional data are needed to better understand if the decrease in patient mortality during the second phase is attributable to better management or lower inflammatory response in the setting of Covid-19 illness.