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1.
Nephrol Dial Transplant ; 2022 Oct 28.
Article in English | MEDLINE | ID: covidwho-2107546

ABSTRACT

BACKGROUND: With accruing case reports on de novo or relapsing glomerular diseases (GD) following different severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, we evaluated the risk of GD following BNT162b2 and CoronaVac vaccines. METHODS: A modified self-controlled case series analysis was conducted using anonymized, territory-wide SARS-CoV-2 vaccination records in Hong Kong. All Hong Kong residents aged 18 years or above with outcomes of interest were included. Outcomes of interest were GD, proteinuria or hematuria within 42 days following each dose of SARS-CoV-2 vaccines. Incidence per 100 000 doses of SARS-CoV-2 vaccines administered was calculated, and incidence rate ratios (IRRs) were estimated using conditional Poisson regression with seasonality adjustment. RESULTS: Between 23 February 2021 and 31 March 2022, 4062 patients had an incident diagnosis of GD, proteinuria or hematuria, with 2873 of them being vaccinated during the observation period. The incidences of the composite events 1-41 days after vaccination were 3.7 (95% CI 3.1-4.4) per 100 000 doses of BNT162b2 administered, and 6.5 (95% CI 5.7-7.5) per 100 000 doses CoronaVac administered. There was no significant increase in the risks of composite events following the first (BNT162b2: IRR = 0.76, 95% CI 0.56-1.03; CoronaVac: IRR = 0.92, 95% CI 0.72-1.19), second (BNT162b2: IRR = 0.92, 95% CI 0.72-1.17; CoronaVac: IRR = 0.88. 95% CI 0.68-1.14) or third (BNT162b2: IRR = 0.39. 95% CI 0.15-1.03; CoronaVac: IRR = 1.18. 95% CI 0.53-2.63) dose of SARS-CoV-2 vaccines. CONCLUSIONS: There was no evidence of increased risks of de novo or relapsing GD with either BNT162b2 or CoronaVac vaccines.

2.
American Journal of Transplantation ; 22(Supplement 3):965, 2022.
Article in English | EMBASE | ID: covidwho-2063547

ABSTRACT

Purpose: Primary focal segmental glomerulosclerosis (FSGS) recurs after kidney transplantation (KT) in 30-50% of recipients with a median time of 1.5 months post- KT. Recurrence is associated with early graft loss in 60% of cases. The aim of this study is to assess the efficacy of pre-emptive therapeutic plasma exchange (TPE) and rituximab for the prevention of FSGS recurrence post-KT. Method(s): This single-center, retrospective study included patients receiving KT for primary FSGS between May 2016 and August 2021. Living-donor KT recipients received three sessions of TPE prior to scheduled transplant. Recipients of both living and deceased donor KT received 3 postoperative sessions of TPE followed by one dose of 375 mg/m2 rituximab with or without intravenous immune globulin (IVIG) 0.5 g/kg. Recipients underwent protocol biopsy at one month to screen for FSGS recurrence. The primary endpoint was a composite for disease recurrence including proteinuria (>=1 g/day) or/and biopsy-proven FSGS within one month. Result(s): 54 patients received KT for FSGS during the study period using the TPE/ rituximab protocol. 5 patients (9%) experienced FSGS recurrence within one month of transplant. A total of 10 patients (19%) were found to have disease recurrence within a year, with median (IQR) time to recurrence of 37 days (27-66). White race and history of hypertension were independent risk factors for recurrence, whereas African American race and diabetes were associated with a reduced risk of recurrence. 31 patients (57%) also received IVIG prior to discharge due to concerns for hypogammaglobulinemia. There were 18 documented infections in 13 patients (24%) within 3 months of transplant. Patients who received IVIG had significantly fewer cases of infection (3 cases: 1 viral and 2 COVID-19) compared to patients who did not receive IVIG (15 cases: 4 bacterial, 9 viral, 1 fungal, and 1 COVID-19), p<0.001. At one year, 9 patients (19%) had biopsy-proven rejection (5 acute cellular rejection, 1 antibody-mediated rejection, and 3 mixed rejection). There were no instances of graft loss or mortality observed at one year. Conclusion(s): The utilization of plasma exchange and rituximab may prevent early disease recurrence of FSGS without significant rates of infection, graft loss, or mortality.

3.
American Journal of Transplantation ; 22(Supplement 3):1066-1067, 2022.
Article in English | EMBASE | ID: covidwho-2063520

ABSTRACT

Purpose: Adverse events of a novel mRNA vaccine are not well described in Kidney Transplant Recipients(KTR), especially the risk of immune activation or recurrent glomerulonephritis(GN), which has been described in native GN after COVID-19 vaccines. Method(s): In this single-center prospective study, 147 KTR were enrolled after informed consent and administered 2 doses of Pfizer/BioNTech vaccine 21 days apart. Follow-up was 3 weeks after Dose2. Result(s): Mean age of KTR was 51 years;55.1% male;65.3% Chinese, 19% Malay, 11.6% Indian;69.5% Living donor, 29.9% Deceased donor, 0.7% Pancreas-kidney transplants;71.5% had biopsy-proven or presumptive chronic GN(CGN), 12.9% diabetic nephropathy, 15.6% other causes. 11(7.5%) KTR had delayed Dose2 administered at median 29 days(range 24-93) after Dose1. 7(4.8%)were delayed due to renal events: rise in creatinine(n=3), or proteinuria(n=2), or both creatinine and proteinuria with allograft biopsy showing acute T-cell and antibody-mediated rejection(n=1), new BK viraemia(n=1). Other reasons were possible anaphylaxis(n=1), intercurrent infection(n=2), and inability to attend due to quarantine(n=1). 27 KTR had new microhaematuria(MH) after Dose1;9 persisted after Dose2. Additional 18 had new MH after Dose2. Of 45 KTR with new MH, 7 had underlying IgAN, 5 had other biopsy-proven-CGN and 22 had presumed CGN, suggesting 34/45 with possible immune activation. 12 KTR had new onset proteinuria (rise in urine protein:creatinine ratio (UPCR) <=30 to >30mg/mmol);5/7 who developed a rise after Dose1 remained elevated;additional 5 had a rise after Dose2. 7 KTR had rise in proteinuria from UPCR <=100 to >100mg/mmol. Conclusion(s): Subclinical changes in allograft monitoring parameters are frequent after COVID-19 mRNA vaccines with up to 40.1% of KTRs showing rises in creatinine, proteinuria or new MH. Although overt recurrent GN and acute rejection are infrequent, high vigilance and monitoring for these occurrences should be undertaken in KTRs receiving mRNA vaccines.

4.
American Journal of Transplantation ; 22(Supplement 3):948, 2022.
Article in English | EMBASE | ID: covidwho-2063503

ABSTRACT

Purpose: Currently there are no UNOS guidelines regarding the selection criteria required for simultaneous heart-kidney transplant recipients (SHKT). As of 2018 our center has begun performing these dual transplants for appropriate candidates. We report on the criteria devised to guide SHKT candidate selection at our institution and the subsequent clinical outcomes. Method(s): This is a single center, retrospective study of 26 patients who received SHKT at our institution from Dec 2018 to Oct 2021. A multidisciplinary team composed of heart and kidney transplant medical and surgical members determined appropriate recipient-donor SHKT candidate pairs. Selection criteria for SHKT was established by our kidney transplant group and included an evaluation for chronic kidney disease (CKD) or evidence of acute kidney injury (AKI) with a prolonged course or requiring renal replacement therapy (RRT). The surgery was conducted according to our institution's standardized protocols. The majority of patients received IL2-RA and methylprednisolone induction therapy, and all patients received triple immunosuppression therapy with prednisone, mycophenolate mofetil and tacrolimus. Adjustments in long term therapy were made in collaboration between the heart and kidney transplant teams. Result(s): From Dec 2018 to Oct 2021, 26 patients underwent SHKT at our institution. 24 patients (92%) carried a diagnosis of chronic kidney disease (CKD) as defined as an eGFR <60 ml/min/1.73m2 for at least 90 days on at least two separate tests. Clinical risk factors for CKD, the presence of proteinuria, and renal imaging data were also taken into consideration when determining a diagnosis of CKD. Two patients (8%) carried a diagnosis of stage III AKI for at least 4 weeks and required renal replacement therapy during their hospital course. Of our 26 patients, one patient received a DCD donor and 12 patients (46%) received hepatitis C donors. 25 patients (96%) received induction therapy with IL2-RA. During the first 3 months post-transplant, the only patient who received ATG had 7 severe infections;11 patients (44%) and 13 patients (52%) who received IL2 -RA had no infections and <= 4 mild infections, respectively. One patient died due to COVID 19 pneumonia complicated by multisystem organ failure. For a median follow up period of 410 (187-707) days, 8% patients in the IL2-RA induction cohort experienced a 2R/3A heart rejection, 8% patients remained on HD due to primary kidney graft nonfunction, and the survival rate was 96%. Conclusion(s): UNOS guidelines regarding selection criteria for SHKT are an important next step in the care of heart transplant candidates with kidney disease, particularly as the number of SHKT performed yearly increase. Compared to the literature, our data supports the use of standardized criteria for SHKT selection and the use of IL2- RA as an induction strategy with excellent patient survival.

5.
American Journal of Transplantation ; 22(Supplement 3):1101, 2022.
Article in English | EMBASE | ID: covidwho-2063496

ABSTRACT

Purpose: Immunomodulatory and anti-inflammatory properties have been hypothesized for native vitamin D (nVD). Very little is reported about nVD and risk of Sars- CoV-2 infection (COV) in renal transplant (RTx). In a cohort of renal transplanted patients (RTxp) we retrospectively evaluated: a) nVD status in patients with (COV+) and without (COV-) COV infection;b) the impact of nVD status on severity of COV. Method(s): The study includes 61 COV+ in whom nVD status was available in the year before the infection, and 122 COV- matched 1:2 for age (53[45-64]years), gender (M=60.7%), RTx vintage (7[2-15]years), presence of diabetes (18%), arterial hypertension (85%) and cardiac symptomatic disease (3%). Renal function, 24-h proteinuria, mineral metabolism (MM) parameters were evaluated at 1, 6 and 12 months before COV whereas nVD status was considered as the mean 25-OH-VD levels at the same timepoints. Severity of COV was based on the need for hospitalization (HOSP+: 27/61, 44.3%) and death (D+: 6/61, 9.8%). Result(s): a) nVD levels were significantly lower in COV+ than in COV- (19[12-26] ng/mL and 23[16-30] ng/mL, respectively, p=0.01). No differences in the other biochemical parameters were found. The COV discriminative power of nVD status was evaluated by ROC curve (AUC 0.61, 95% CI 0.54-0.68, p=0.01), with a value of 25-OHVD 23.9 ng/mL showing the best discriminative power (sensibility 72%, specificity 47%).b) nVD levels showed a trend towards lower values in HOSP+COV+ than HOSP-COV+ (17[8-25] ng/mL vs 20[14-26] ng/mL) and in D+COV+ than D-COV+ (13[6-23] ng/mL vs 20[13-26] ng/mL), although these differences did not reach the statistical significance (p=0.1 and p=0.2, respectively). Conclusion(s): With the limitations of the retrospective nature of the study and the small sample size, our data report that:COV+ showed lower nVD levels in the year preceding the infection compared to controls with similar main demographic features and comorbid conditionsNo differences were found in renal function, proteinuria, and other MM parameters between the two groupsNo association was found between nVD levels in the year preceding the infection and COV severity.

6.
American Journal of Transplantation ; 22(Supplement 3):1062-1063, 2022.
Article in English | EMBASE | ID: covidwho-2063409

ABSTRACT

Purpose: Emerging SARS-CoV-2 variants may be associated with a higher risk of breakthrough infections compared to wild-type (WT) virus in kidney transplant recipients (KTRs). The purpose of this study was to evaluate antiviral immune responses against WT and Delta (B.1.617.2) variant of SARS-CoV-2 after 3 doses of SARS-CoV-2 mRNA vaccines in KTRs. Method(s): We conducted a multicenter prospective cohort study of adult KTRs who received 3 doses of BNT162b2 or mRNA-1273. Blood samples were collected from KTRs before and 4 weeks after the 3rd vaccine dose. Sera from pre-pandemic healthy controls (HCs) and pre-pandemic kidney transplant control patients (KCs) were used for comparison. A Luminex-based multiplex assay was used to measure anti-spike antibodies for the WT, Alpha, Beta, Gamma and Delta variants of SARSCoV- 2. A surrogate virus neutralization test was used to assess neutralization against the WT and Delta variant. Patients were also monitored for rejection using several non-invasive biomarkers. Result(s): 54 KTRs were enrolled in the study. The median age was 63, 44% were female and the median time post-transplantation was 42 months. 94% received BNT162b2 vaccine. After the 3rd vaccine dose, there was a significant increase in anti-spike antibody MFIs against the WT, Alpha, Beta, Gamma and Delta variants (Fig. 1A, p<0.0001 for all). For comparison, all pre-pandemic HCs and KCs had a negative result for anti-spike antibody levels (Fig. 1B). Prior to the 3rd vaccine dose, 29% of KTRs had anti-spike antibodies against the WT compared to only 2% against the Delta variant (Fig. 1C, p=0.0001). After the 3rd vaccine dose, 67% of KTRs had anti-spike antibodies against the WT compared to 25% against the Delta variant (p<0.0001, Fig. 1D). Differences between WT and other variants are shown in Figure 1C-D. After the 3rd vaccine dose, there was a 2.1-fold and 2.5-fold increase in the percentage of KTRs with neutralizing responses against the WT and Delta variant respectively (p<0.0001 for both). There was no significant change in serum creatinine, proteinuria, or donor-derived cell-free DNA levels after vaccination. No episodes of rejection occurred during follow-up. Conclusion(s): Two doses of SARS-CoV-2 mRNA vaccines in KTRs are associated with minimal anti-spike antibody response directed against the Delta variant of SARS-CoV-2. After the third dose, a quarter of KTRs developed anti-spike antibodies directed against the Delta variant of SARS-CoV-2.

7.
Chest ; 162(4):A2237, 2022.
Article in English | EMBASE | ID: covidwho-2060915

ABSTRACT

SESSION TITLE: Unique Inflammatory and Autoimmune Complications of COVID-19 Infections SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/19/2022 12:45 pm - 1:45 pm INTRODUCTION: ANCA-associated vasculitis (AAV) is a systemic disease that causes inflammation of small vessels in various organs, such as the lungs, kidneys, and nervous system. We report a case of AAV following SARS-CoV-2 infection. CASE PRESENTATION: A 64-year-old female from Albania with no known medical history, presented with intermittent low-grade hemoptysis and fever for 1 week prior to admission. She had chills, myalgias, fatigue, and poor appetite 6 weeks prior. On arrival, she was febrile (101F), and hypoxic (Spo2 92% on 3L O2). Labs were significant for anemia [Hb 6.8 g/dl], acute kidney injury (AKI) [Cr 2.5 mg/dl]. She was found to be Positive for Sars-CoV-2 by PCR. Chest X-Ray showed patchy bilateral airspace opacities with peripheral and lower lobe predominance, concerning for atypical pneumonia (Fig 1). Urinalysis was significant for proteinuria (2+) and hematuria (2+). CT (Computed Tomography) thorax showed extensive bilateral airspace disease (dense consolidations and ground-glass opacities) favoring multifocal infection and mediastinal lymphadenopathy(Fig 2). Due to the chronicity of her symptoms and atypical imaging for viral pneumonia, other diagnoses were explored including bacterial superinfection, Tuberculosis, and autoimmune disease. Sputum studies were negative for infections including Acid Fast Bacilli. Workup revealed elevated Antimyeloperoxidase antibodies (MPO) and positive COVID-19 Ig G. She was started on methylprednisolone 1g for AAV. Renal biopsy revealed pauci-immune glomerulonephritis with features of cellular crescent consistent with microscopic polyangiitis (Fig 3). Follow-up CT chest showed improved airspace abnormalities and mediastinal lymphadenopathy. After induction therapy with Rituximab was initiated, she continued to recover and was discharged home. DISCUSSION: The pathogenesis of AAV is believed to be an aberrant pathogenic autoimmune response that follows an initial insult which can include infections. SARS-CoV-2 has been associated with the emergence of autoimmune diseases in susceptible patients(1). The proposed mechanism is linked to elevated levels of circulating neutrophil extracellular traps (NETs) observed in covid infection. These NETS are covered with proteins including neutrophilic enzymes which can activate complement pathways causing tissue destruction and vasculitis. The diagnosis of new-onset AAV can be challenging in COVID-19 patients as symptoms and clinical manifestations of both diseases can overlap. AAV should be considered strongly in patients who are currently infected or have been infected with SARS-CoV-2 and present with atypical or non-resolving pneumonia and other organ involvement such as AKI to avoid permanent organ damage. CONCLUSIONS: The presence of non-resolving or atypical pneumonia and AKI in a patient with SARS-CoV-2 should prompt evaluation of immunological markers to assess or rule out AAV for early diagnosis and treatment. Reference #1: Caso F, Costa L, Ruscitti P, Navarini L, Del Puente A, Giacomelli R, Scarpa R. Could Sars-coronavirus-2 trigger autoimmune and/or autoinflammatory mechanisms in genetically predisposed subjects? Autoimmun Rev. 2020;19(5):102524. doi: 10.1016/j.autrev.2020.102524 DISCLOSURES: No relevant relationships by Tarik Al-Bermani No relevant relationships by Anant Jain No relevant relationships by Ian Kaplan No relevant relationships by Alina Kifayat No relevant relationships by Lisa Paul

8.
Chest ; 162(4):A2217-A2218, 2022.
Article in English | EMBASE | ID: covidwho-2060912

ABSTRACT

SESSION TITLE: Autoimmune Diseases Gone Wild: Rare Cases of Pulmonary Manifestations SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/18/2022 01:35 pm - 02:35 pm INTRODUCTION: Post-Covid-19 Multisystem Inflammatory Syndrome (MIS) is a severe hyperinflammatory syndrome associated with either the acute or recovery phase of covid-19 infection affecting multiple organ systems requiring hospitalization. This syndrome has been described in both children (MIS-C) and adults (MIS-A). Several case reports and systematic reviews have reported an association between post-covid-19 MIS-A and several autoimmune diseases. CASE PRESENTATION: We herein report a case of a 27-year-old female with no known chronic medical condition and a non-contributory family history who was diagnosed with post-covid-19 multisystem inflammatory syndrome in adults (MIS-A). She presented with generalized partial thickness erythematous skin ulcerations with tender blistering and painful erosion of her mucus membranes (oral and vaginal mucosa). This was diagnosed as Steven Johnsons syndrome. She was pulsed with intravenous methylprednisone. During this therapy, she progressed to severe acute respiratory distress syndrome (ARDS) requiring mechanical ventilation (fig 1). Bronchoscopy revealed mild pulmonary hemorrhage fig 2a&b). Serological testing heralded a new onset systemic lupus erythematosus in light of positive antinuclear antibodies, anti Ds DNA and anti Smith antibodies. Her course was complicated by significant proteinuria and an active renal cast suggestive of lupus nephritis. This necessitated further treatment for active lupus. She was successfully extubated and discharged home. DISCUSSION: We arrived at the diagnosis of post-covid-19 multisystem inflammatory syndrome in adults (MIS-A) in light of her presenting with fever, hypotension, persistent sinus tachycardia and new onset atrial fibrillation), acute pancreatitis, acute kidney injury, elevation in transaminases, new onset skin rash, elevated inflammatory markers and a recent history of positive SARS-CoV-2 infection. Covid-19 has been reported to induce wide spread vasculitis resulting in MIS-A or MIS-C by triggering type 3 hypersensitivity (1). Also, multiple case reports and systemic reviews have reported a direct association between MIS-A and several autoimmune diseases including SLE, SJS (2). The patient recovered with high dose corticosteroid and supportive therapy indicating her severe ARDS was most likely due associated to SJS, SLE and MIS-A. Clinicians should also keep in mind that SARS-CoV-2 PCR swab may be negative at the time patient presents with symptoms of MIS-A as the infection might have occurred about 4-5weeks prior just as in our patient(3) CONCLUSIONS: We cannot underscore enough the importance of clinicians having a high index of suspicion for this syndrome in patients with acute or recent covid-19 infection, with or without a positive PCR covid-19 test. Early involvement of a multidisciplinary approach and appropriate management is essential to mitigate morbidity and mortality in these patients. Reference #1: Roncati L, Ligabue G, Fabbiani L, Malagoli C, Gallo G, Lusenti B, et al. Type 3 hypersensitivity in COVID-19 vasculitis. Clin Immunol Orlando Fla. 2020 Aug;217:108487. Reference #2: Gracia-Ramos AE, Martin-Nares E, Hernández-Molina G. New Onset of Autoimmune Diseases Following COVID-19 Diagnosis. Cells [Internet]. 2021 Dec 20 [cited 2022 Mar 22];10(12):3592. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8700122/ Reference #3: Morris SB. Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection — United Kingdom and United States, March–August 2020. MMWR Morb Mortal Wkly Rep [Internet]. 2020 [cited 2022 Mar 22];69. Available from: https://www.cdc.gov/mmwr/volumes/69/wr/mm6940e1.htm DISCLOSURES: No relevant relationships by Isaac Ikwu No relevant relationships by Anthony Lyonga Ngonge No relevant relationships by Alem Mehari No relevant relationships by Noordeep Panesar no disclosure on file for Vis al Poddar;No relevant relationships by Emnet Yibeltal

9.
Chest ; 162(4):A856, 2022.
Article in English | EMBASE | ID: covidwho-2060709

ABSTRACT

SESSION TITLE: COVID-Related Critical Care Cases SESSION TYPE: Case Reports PRESENTED ON: 10/19/2022 11:15 am - 12:15 pm INTRODUCTION: We present a case of rapidly progressive glomerulonephritis in a patient with granulomatosis with polyangiitis and COVID-19 pneumonia. CASE PRESENTATION: A 72 year old man presented to the hospital with shortness of breath, fatigue, fevers, and malaise. Chest x-ray showed bilateral lower lobe infiltrates consistent with COVID-19 pneumonia and creatinine of 1.57, elevated from baseline of 1.30. He was diagnosed with COVID-19 pneumonia and admitted to the Intensive Care Unit due to acute hypoxic respiratory failure and worsening acute kidney injury. Past medical history was significant for granulomatosis with polyangiitis (GPA) with recurrent deep venous thromboses and splenic infarct. Warfarin was held due to supratherapeutic INR on admission. COVID-19 drug therapy was initiated, including baricitinib, remdesivir and decadron. Creatinine began to rise significantly and renal ultrasound was ordered but showed no hydronephrosis or acute abnormality of the kidneys. There was no improvement with administration of fluids, and hemodialysis was initiated due to worsening creatinine with a peak of 12.09 and a strong suspicion for rapidly progressive glomerulonephritis (RPGN) in the setting of GPA. High-dose steroid therapy was started and daily hemodialysis was continued. Patient required transfer to a tertiary care center for multifactorial shock where he continued to receive dialysis therapy. Patient eventually required mechanical ventilation and ultimately expired. DISCUSSION: GPA is an autoimmune small and medium vessel vasculitis most often associated with anti-neutrophil cytoplasmic antibodies (c-ANCA). Without treatment, GPA has a high mortality rate due to systemic vasculitis. Treatment of GPA includes immunosuppressive therapies like rituximab or cyclophosphamide. Environmental and infectious processes are thought to cause GPA. Viruses have also been shown to cause GPA with two such cases documented with SARS-CoV-2. Our case illustrates a patient with known previously GPA who developed RPGN in the setting of COVID-19. RPGN can lead to rapid loss of renal function in GPA and can be the initial presentation of the disease process. However, care must be taken as often the presentation of GPA lung sequela may mimic those of COVID-19, including dyspnea, hemoptysis, and radiographic changes. Obtaining ANCA autoantibodies as well as a urinalysis showing proteinuria can help distinguish GPA and guide clinical judgment in starting high-dose steroid therapy early in renal failure due to RPGN in the setting of COVID-19. CONCLUSIONS: COVID-19 in patients with GPA can trigger renal failure due to RPGN. Reference #1: Bressler MY, Pathak N, Cervellione K, et al. New Onset Granulomatosis with Polyangiitis Associated with COVID-19. Case Rep Dermatol Med. 2021. Reference #2: Hasan MR, Sakibuzzaman M, Tabassum T, Moosa SA. A Case of Granulomatosis with Polyangiitis (Wegener's Granulomatosis) Presenting with Rapidly Progressive Glomerulonephritis. Cureus. 2019. Reference #3: Lutalo PM, D'Cruz DP. Diagnosis and classification of granulomatosis with polyangiitis (aka Wegener's granulomatosis). J Autoimmun. 2014. DISCLOSURES: No relevant relationships by Kristin Davis No relevant relationships by Charles Peng

10.
Chest ; 162(4):A604, 2022.
Article in English | EMBASE | ID: covidwho-2060645

ABSTRACT

SESSION TITLE: COVID-19 Co-Infections SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/19/2022 12:45 pm - 1:45 pm INTRODUCTION: SARS-CoV-2 has been associated with co-infecting pathogens, such as bacteria, viruses, and fungi. Little has been reported about community acquired atypical bacterial co-infections with SARS-CoV-2. We present a case of a patient with recent COVID-19 pneumonia and diagnosis of Legionella and Mycoplasma pneumonia, in addition of E. coli and C. perfringens bacteremia, that emphasizes SARS-CoV-2 impact in human immunity and the need to consider community acquired infections. CASE PRESENTATION: A 64-year-old male with history of hypertension, alcohol use disorder, iron deficiency anemia, and recent COVID-19 pneumonia presented to the ED with shortness of breath, dark urine, and increased confusion. The patient was admitted to the hospital a week prior with COVID-19 pneumonia and acute kidney injury. He received dexamethasone, remdesivir, and IV fluids. After 8 days, he was discharged home. Upon evaluation, he was afebrile and normotensive, but tachycardic, 129/min, on 4 L of nasal cannula sating 100%. On exam, the patient was oriented only to person and had decreased breath sounds bilaterally. Labs revealed an elevated WBC, 15.3 K/mcL, with left shift, low Hgb, 7.8 g/dL, with low MCV, 61 fL, increased BUN/Cr, 56 mg/dL and 2.8 mg/dL, and an abnormal hepatic panel, AST 121 U/L, ALT 45 U/L, alkaline phosphatase 153 U/L. Ammonia, GGT, CPK and lactic acid were within normal range;but the D-dimer and procalcitonin were elevated, 4618 ng/mL and 25.12 ng/mL, respectively. A urinalysis showed gross pyuria, positive leukocyte esterase and mild proteinuria. CT head showed no acute abnormalities, but the chest X-Ray revealed a hazy opacity in the left mid and lower lung, followed by a CT chest that demonstrated peripheral and lower lobe ground glass opacities and a CT abdomen that showed right sided perinephric and periureteral stranding. Given increased risk for thromboembolism, a VQ scan was done being negative for pulmonary embolism. The patient was admitted with acute metabolic encephalopathy, acute kidney injury, transaminitis, pyelonephritis and concern for hospital acquired pneumonia. Vancomycin, cefepime and metronidazole were ordered. HIV screen was negative. COVID-19 PCR, Legionella urine antigen and Mycoplasma IgG and IgM serologies were positive. Blood cultures grew E. coli and C. perfringens. Infectious Disease and Gastroenterology were consulted. The patient was started on azithromycin and a colonoscopy was done showing only diverticulosis. After an extended hospital course, the patient was cleared for discharge, without oxygen needs, to a nursing home with appropriate follow up. DISCUSSION: Co-infection with bacteria causing atypical pneumonia and bacteremia should be considered in patients with recent or current SARS-CoV-2. CONCLUSIONS: Prompt identification of co-existing pathogens can promote a safe and evidence-based approach to the treatment of patients with SARS-CoV-2. Reference #1: Alhuofie S. (2021). An Elderly COVID-19 Patient with Community-Acquired Legionella and Mycoplasma Coinfections: A Rare Case Report. Healthcare (Basel, Switzerland), 9(11), 1598. https://doi.org/10.3390/healthcare9111598 Reference #2: Hoque, M. N., Akter, S., Mishu, I. D., Islam, M. R., Rahman, M. S., Akhter, M., Islam, I., Hasan, M. M., Rahaman, M. M., Sultana, M., Islam, T., & Hossain, M. A. (2021). Microbial co-infections in COVID-19: Associated microbiota and underlying mechanisms of pathogenesis. Microbial pathogenesis, 156, 104941. https://doi.org/10.1016/j.micpath.2021.104941 Reference #3: Zhu, X., Ge, Y., Wu, T., Zhao, K., Chen, Y., Wu, B., Zhu, F., Zhu, B., & Cui, L. (2020). Co-infection with respiratory pathogens among COVID-2019 cases. Virus research, 285, 198005. https://doi.org/10.1016/j.virusres.2020.198005 DISCLOSURES: No relevant relationships by Albert Chang No relevant relationships by Eric Chang No relevant relationships by KOMAL KAUR No relevant relationships by Katiria Pintor Jime ez

11.
Chest ; 162(4):A65-A66, 2022.
Article in English | EMBASE | ID: covidwho-2060535

ABSTRACT

SESSION TITLE: Management of COVID-19-Induced Complications SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/19/2022 12:45 pm - 1:45 pm INTRODUCTION: Anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-AV) is an autoimmune mediated inflammation of small and medium sized vessel walls. The occurrence of this autoimmune vasculitis is typically associated with underlying infection, medications, and genetic predisposition.(1) The objective of this case report is to describe a rare presentation of ANCA-AV in the setting of COVID-19 infection. CASE PRESENTATION: A 67-year-old male presented to the hospital with a three-week history of cough productive of brown sputum, epistaxis, fatigue, decreased appetite, and unintentional weight loss. During the previous week, he experienced worsening dyspnea and bilateral lower extremity swelling. On physical examination, he was hypoxic requiring 4L of supplemental oxygen to maintain saturations greater than 90%. Diffuse and bilateral wheezes were heard on auscultation of his lungs. A tender petechial rash was dispersed over his limbs, trunk, oropharynx, and nasopharynx. A basic metabolic panel revealed a mild, acute renal impairment. Urinalysis showed new onset proteinuria and hemoglobinuria. Nasopharyngeal swab was positive for SARS-COV-2. Contrast-enhanced computed tomography of the chest revealed diffuse, bilateral ground glass opacities and interstitial changes. Therapy with piperacillin-tazobactam was started for presumed superimposed bacterial community acquired pneumonia in the setting of COVID-19 infection. On day three of hospitalization, the petechial rash progressed to hemorrhagic blisters. His oral petechiae were now ulcerated. A punch biopsy of the affected skin showed leukocytoclastic vasculitis. Anti-Proteinase 3 (PR3) antibodies were positive. Subsequent renal biopsy showed pauci-immune focal necrotizing crescentic glomerulonephritis consistent with ANCA-AV. Therapy with intravenous pulse dose corticosteroids led to improvement in his rash and body aches, and he was discharged home on oral steroids ten days after admission. DISCUSSION: This report describes a rare case of ANCA-AV in the setting of recent COVID-19 infection. Differentiation of ANCA-AV, bacterial and COVID-19 pneumonia can be challenging on chest imaging alone.(1) New onset renal impairment, hematuria, proteinuria and the presence of the petechial rash were suspicious for co-existing ANCA-AV in this patient. COVID-19- associated cytokine storm and formation of neutrophil extracellular traps (NETs) is postulated to be the underlying cause.(1-3) NETs present myeloperoxidase (MPO) and PR3 antigens to the immune system. Formation of auto-antibodies to MPO and PR3 lead to the development of ANCA-AV. The findings of NETs on kidney biopsy specimens in patients with ANCA-AV supports this hypothesis.(1,2) CONCLUSIONS: To avoid the misdiagnosis of COVID-19-induced vasculitis, a low threshold to investigate co-existing vasculitis in patients with COVID-19 and associated clinical findings is highly recommended. Reference #1: Izci Duran T, Turkmen E, Dilek M, Sayarlioglu H, Arik N. ANCA-associated vasculitis after COVID-19. Rheumatol Int. 2021;41(8):1523-1529. Reference #2: Uppal NN, Kello N, Shah HH, et al. De Novo ANCA-Associated Vasculitis With Glomerulonephritis in COVID-19. Kidney Int Rep. 2020;5(11):2079-2083. Reference #3: Cobilinschi C, Cobilinschi C, Constantinescu A, Draniceanu I, Ionescu R. New-Onset ANCA-Associated Vasculitis in a Patient with SARS-COV2. Balkan Med J. 2021;38(5):318-320. DISCLOSURES: No relevant relationships by Andrei Hastings No relevant relationships by Jason Lane No relevant relationships by Tanya Marshall No relevant relationships by Palak Rath No relevant relationships by Sterling Shriber No relevant relationships by inderprit Singh No relevant relationships by Samuel Wiles

12.
Arch Argent Pediatr ; 120(5): 310-316, 2022 10.
Article in English, Spanish | MEDLINE | ID: covidwho-2056103

ABSTRACT

INTRODUCTION: Renal involvement among pediatric patients with coronavirus disease 2019 (COVID-19) ranges between 1.2% and 44%. Given the limited information available locally, the primary objective of this study was to estimate the prevalence of renal involvement in our setting. POPULATION AND METHODS: Cross-sectional study conducted in 13 Argentine sites between March and December 2020. Patients aged 1 month to 18 years hospitalized due to COVID-19 and with at least one measurement of serum creatinine and/or a urinalysis were included. Those with a known kidney disease were excluded. Renal involvement was defined as the presence of acute kidney injury (AKI), proteinuria, hematuria, leukocyturia and/or arterial hypertension (HTN). RESULTS: Among 528 eligible medical records, 423 patients were included (55.0% were males; median age: 5.3 years). The clinical presentation was asymptomatic in 31%; mild, in 39.7%; moderate, in 23.9%; severe, in 1.2%; critical, in 0.7%; and 3.5% had multisystem inflammatory syndrome in children (MIS-C). Two patients (0.47%) died. The prevalence of renal involvement was 10.8% (95% confidence interval: 8.2-14.2); it was described as leukocyturia (16.9%), proteinuria (16.0%), hematuria (13.2%), HTN (3.7%), and AKI (2.3%). No patient required dialysis. Renal involvement was associated with severe forms of disease (p < 0.0001). CONCLUSIONS: The prevalence of renal involvement among pediatric patients hospitalized due to COVID-19 in 13 Argentine sites was 10.8%; severe forms of disease prevailed.


Introducción. El compromiso renal (CR) en niños internados con enfermedad por coronavirus 2019 (COVID-19, por su sigla en inglés) varía entre el 1,2 % y el 44 %. Dado que existe limitada información local, el objetivo primario de este estudio fue estimar la prevalencia de CR en nuestro medio. Población y métodos. Estudio transversal realizado en 13 centros de Argentina entre marzo y diciembre de 2020. Se incluyeron pacientes internados con COVID-19, de 1 mes a 18 años y que tuvieran al menos una determinación de creatinina sérica y/o de orina completa. Se excluyeron aquellos con enfermedad renal conocida. Se consideró CR la presencia de lesión renal aguda (LRA), proteinuria, hematuria, leucocituria y/o hipertensión arterial (HTA). Resultados. De 528 historias clínicas elegibles, se incluyeron las de 423 pacientes (el 55,0 % de sexo masculino, mediana de edad 5,3 años). El cuadro clínico fue asintomático en el 31 %, leve en el 39,7 %, moderado en el 23,9 %, grave en el 1,2 %, crítico en el 0,7 %, y el 3,5 % presentó síndrome inflamatorio multisistémico pediátrico (SIMP). Dos pacientes (0,47 %) fallecieron. La prevalencia de CR fue del 10,8 % (intervalo de confianza 95% 8,2-14,2), expresada por leucocituria (16,9 %), proteinuria (16,0 %), hematuria (13,2 %), HTA (3,7 %) y LRA (2,3 %). Ninguno requirió diálisis. Presentar CR se asoció (p <0,0001) con formas graves de enfermedad. Conclusión. La prevalencia de CR en pacientes pediátricos internados con COVID-19 en 13 centros de nuestro país fue del 10,8 % y predominó en las formas clínicas graves.


Subject(s)
Acute Kidney Injury , COVID-19 , Hypertension , Acute Kidney Injury/epidemiology , Acute Kidney Injury/etiology , COVID-19/complications , COVID-19/epidemiology , Child , Child, Preschool , Creatinine , Cross-Sectional Studies , Female , Hematuria/epidemiology , Hematuria/etiology , Humans , Hypertension/epidemiology , Male , Prevalence , Proteinuria/epidemiology , Retrospective Studies , SARS-CoV-2 , Systemic Inflammatory Response Syndrome
13.
Kidney International Reports ; 7(9):S471, 2022.
Article in English | EMBASE | ID: covidwho-2041699

ABSTRACT

Introduction: Vaccination is a known trigger for the development of de-novo or flare of glomerular diseases. Here we present a case series of fourteen patients with COVID vaccine- associated glomerular diseases (CVAGD). Methods: Patients with new onset proteinuria, hematuria or renal failure after SARS- CoV2 vaccine were included in the study. Demographic and clinical details were collected and laboratory investigations including serum creatinine, albumin, urine microscopy and urine spot protein creatinine ratio were done. Renal biopsy specimens were subjected to light microscopy and immunofluorescence examination. Results: We cared for 14 patients with CVAGD. Of them, eight patients were males. The mean age was 25.7 years. Three patients had relapse of their previous disease while eleven patients had no previously detected renal diseases. Eleven patients had received COVISHIELD and three had received COVAXIN. All patients presented after the first vaccine dose. At presentation, seven patients had nephrotic syndrome, two patients had rapidly progressive renal failure and five patients had nephritic syndrome. The mean duration of symptom onset after vaccination was 18 days. Renal biopsy revealed IgA nephropathy in 3 patients, endocapillary proliferative glomerulonephritis in 2 patients, minimal change disease in 5 patients, pauci- immune glomerulonephritis (ANCA associated vasculitis) in one patient, lupus nephritis ISN/RPS class 3 in one and focal segmental glomerulosclerosis in two patients. There was no history of COVID infection in any of our patients. Three patients had renal failure at presentation but none required renal replacement therapy. The patients with MCD and FSGS were treated with steroids, patients with ANCA vasculitis and lupus nephritis were managed with the appropriate Cyclophosphamide and steroid regimens while the others were managed conservatively with anti-proteinuric medications. On follow up, five patients (One IgAN, three MCD, one endocapillary proliferative GN) achieved complete remission of proteinuria and resolution of renal failure, while the remaining eight patients achieved partial remission. One patient with MCD had a relapse of proteinuria 3 weeks after achieving partial remission, he responded well to steroid therapy. All 14 patients remain on close follow up. Conclusions: Although causality cannot be definitively established, there is a definite temporal association between the presentation of glomerular diseases and COVID vaccination, in the absence of other inciting factors. Hence, new-onset or relapse of glomerular diseases presenting post vaccination, although rare, should be observed as a possible adverse event. Intriguing questions such as how to proceed with the vaccination schedule in patients with CVAGD and would changing the vaccine type reduce the risk of relapse remain unanswered. No conflict of interest

14.
Annals of Oncology ; 33:S958, 2022.
Article in English | EMBASE | ID: covidwho-2041540

ABSTRACT

Background: Surufatinib (a small-molecule inhibitor of VEGFR1-3, FGFR1, and CSF-1R) has exhibited encouraging antitumor activity for the treatment of advanced neuroendocrine tumors (including NEN and NEC) in multiple registration studies. Here, we report the preliminary results of advanced neuroendocrine tumors of an ongoing, multicenter, real-world study of surufatinib + MDT (ChiCTR2100049999). Challenges in tumor clinical trials management in the face of the COVID-19 resurgence period in Shanghai. Methods: In this multicenter, single-arm real-world study, adults (18-80) with advanced neuroendocrine tumors (including NEN and NEC) were eligible and received surufatinib (300mg orally, QD) with MDT(multidisciplinary collaborative diagnosis and treatment). The primary endpoint was progression-free survival (PFS) per RECIST 1.1. We minimized the interruptions caused by the pandemic using telemedicine platforms for all patients. This included online consultations, follow-up drug distributions, and health management services. Results: Twenty-three pts were enrolled, with 20 NEN and 3 NEC. At the data cutoff date (April 10, 2022), 15 pts had at least one post-baseline tumor assessment;of them, the confirmed ORR (95%CI) was 20% (4.3-48.1), and DCR (95%CI) was 93.33% (68.1-99.8). Median PFS (mPFS) (95%CI): 10.640 mo (3.796-17.484);median OS: not reached and median duration of follow up was 6.870 mo (6.797-6.943). A pNET patient (NO. 010007) was interrupted by asymptomatic COVID-19 infection 9 mo after enrollment. There are no interruptions caused by COVID-19 for other patients. An NEC patient treated with single agent had a 5.85 mo PFS, evaluated as NE, in whom target lesion resected after baseline. In overall pts (n=23), most commonly (≥3 pts) with hemorrhage, anemia, hypertension, proteinuria, and abdominal pain. Three pts had TRAEs that led to treatment discontinuation. Conclusions: Surufatinib + MDT exhibited promising efficacy and manageable toxicity in pts with advanced neuroendocrine tumors. Now and in the future, it is necessary to design regulatory changes in telehealth adoption for clinical trial design in the pandemic era. Clinical trial identification: ChiCTR2100049999. Legal entity responsible for the study: The authors. Funding: Hutchison MediPharma Limited. Disclosure: All authors have declared no conflicts of interest.

15.
Pediatr Nephrol ; 2022 Sep 22.
Article in English | MEDLINE | ID: covidwho-2035067

ABSTRACT

BACKGROUND: Children with underlying kidney diseases display a mild course of SARS-CoV-2 infection, but they only accounted for a minority of cases until the spread of the Omicron variant. Nonetheless, idiopathic nephrotic syndrome (INS) has been advocated as a predictor of worse outcome. METHODS: We investigated the spread, severity, and risk of relapse related to SARS-CoV-2 infection among children with INS. The incidence and characteristics of SARS-CoV-2 infections, immunosuppression, and vaccination status were retrospectively collected from the beginning of the pandemic to May 31, 2022. RESULTS: We enrolled 176 patients (73 females, median age 10.22 years); 28 had a steroid-resistant disease, and 108 (61.4%) were on immunosuppressive therapy. Sixty-one (34.7%) patients reported a SARS-CoV-2 infection, with incidence peaking between December 2021 and January 2022. No hospitalization or deaths were reported, and symptoms were absent or mild. The rate of SARS-CoV-2 infection was similar in children with and without immunosuppression (33.8% vs 35.2%; p = 0.85). None of the 38 immunosuppressed patients discontinued the therapy, but they had a longer time to negativization (13.31 vs. 10.04 days; p = 0.03). Proteinuria was detected in 7 patients, but only one had a relapse requiring steroid therapy, with prompt remission and a mild course. CONCLUSIONS: After the spread of the Omicron variant, the rate of SARS-CoV-2 infection in children with INS was much higher than previously reported. In this large cohort, symptoms were mild, even in immunosuppressed patients and those with proteinuria. During the infection, transient proteinuria was common with a low rate of relapses. A higher resolution version of the Graphical abstract is available as Supplementary information.

17.
Annals of the Rheumatic Diseases ; 81:975-976, 2022.
Article in English | EMBASE | ID: covidwho-2009177

ABSTRACT

Background: It is well established that severe forms of SARS-CoV2 infection can induce a massive cytokine storm, which may disrupt the immune system stability and conceivably stimulate the development of reactive manifestations through a molecular mimicry process. Likewise, anti-COVID-19 vaccines, which have so far proved an excellent tolerability and safety profile, are able boost the immune response via different biologic technologies and adjuvant combinations possibly facilitating, in predisposed subjects, the onset of infammatory or even autoimmune manifestations. Objectives: We report a case series of suspected rheumatic adverse events following immunization (AEFI) associated with anti-COVID-19 vaccine. We focused our attention on the prognosis of these patients by analysing their available follow-up data. Methods: We included patients evaluated at frst-aid rheumatologic consultancy and at rheumatologic outpatient and inpatient clinic at Padua University Hospital between May and September 2021 presenting with new-onset rheumatic manifestation or a fare of an underlying rheumatic disease within 30 days after receiving an anti-COVID-19 vaccine dose. Inclusion and exclusion criteria were in accordance with the World Health Organization guidelines for AEFI surveillance. All patients were re-evaluated in January 2022: telemedicine or face-to-face visit. Response to therapy was classifed as complete, good or absent according to the clinician's judgment based on clinical examination, patient's reporting and analysis of laboratory data. Results: We identifed 30 cases of suspected rheumatic AEFI reported in Table 1. Comprehensively the most common manifestations were infammatory arthritis (40.0%), rheumatic polymyalgia (26.7%) and adult-onset Still disease (13.3%). Among patients with an underlying rheumatic disease we recorded an AOSD fare, a rheumatoid arthritis fare with involvement of hands proximal inter-phalangeal joints, one case of wrist arthritis in a patient with psoriatic arthritis, one of aortitis in a patient with large vessels vasculitis, one case of polyarthritis in undifferentiated connective tissue disease and a nephritis fare in a patient with systemic lupus erythematosus. Treatment for the suspected AEFI was based on systemic glucocorticoids (GC) alone (63.3%), systemic GC plus IL-1R antagonists (13.3%), non-steroidal autoinfammatory drugs (13.3%), intra-articular GC (6.6%), colchicine (3.3%) and non-steroidal anti-infammatory drugs (13.3%). At last follow-up contact (7.8±1.5 months) 26 patients (89.6%) were classified as complete responders. Eleven of them (42.3%) withdrew therapy without experiencing recurrence of disease manifestation. One patient with lupus nephritis had a proteinuric flare after the first BNT162b dose;he showed an initial good response to increased glucocorticoid therapy but had a new 24h proteinuria increase at second follow-up visit three months later requiring implementation of immunosuppressive therapy. Another patient with AOSD was in remission at last FU visit in December 2021 but required hospitalization in January 2022 for disease relapse due to a suspected gastrointestinal infection. Finally, one patient hospitalized for a seronegative polyarthritis after the first BNT162b dose achieved complete remission at last available contact (one month after hospital discharge) but was then lost in follow-up. Conclusion: After a mean follow-up of 7.8±1.5 months nearly all of patients showed a complete/good response to standard therapy and about half of them withdrew the treatment without losing the remission status.

18.
Annals of the Rheumatic Diseases ; 81:440, 2022.
Article in English | EMBASE | ID: covidwho-2009122

ABSTRACT

Background: Patients with systemic lupus erythematosus (SLE) are at increased risk of severe COVID-19 due to the underlying disease, comorbidities and use of immuno-suppressants (IS). An alternative option would be to adopt telemedicine (TM) to maintain medical care while minimizing exposure. Despite being widely adopted during the pandemic, the evidence supporting the use of TM in rheumatology has been limited. Objectives: We primarily aimed to evaluate the effectiveness to maintain disease activity control using TM delivered care compared to conventional in-person follow-up in patients with lupus nephritis (LN). The secondary objectives were to compare the patient reported outcomes, safety and cost-of-illness from the patient's perspective between the 2 modes of health care delivery. Methods: This was a 1-year, single-center, RCT conducted at a regional hospital in Hong Kong. From May 2020, consecutive adult patients with a SLE according to the 2019 EULAR/ACR classifcation criteria followed up at the LN clinic were invited to participate in the study. Participants were randomized 1:1 to either TM (TM group) or standard FU (SF group). Patients randomized to receive TM FU were scheduled for a video consultation via a commerical software ZOOM. Patients in the SF group received standard in-person outpatient care. SLE disease activity at each consultation was assessed by SLEDAI-2k and physician global assessment (PGA). Results: A total of 144 patients with LN were randomized and 3 patients self-withdrew from the study. The mean age was 44.5±11.4 years and the median time from diagnosis to randomization was 168 months (range: 1-528). Most of the patients had class III, IV or V LN (87.2%) and were on prednisolone (89.4%, median dose 5mg daily). Many of them (68.1%) were on IS. While 66.0% of the patients were in lupus low disease activity state (LLDAS), none had disease remission. There were no baseline differences, including demographics, SLEDAI-2k (TM: 3.8±2.3, SF: 3.2±2.2, p=0.13, PGA (TM: 6.2±6.5, SF: 4.6±5.9, p=0.13) and SLE damage index (TM: 1.1±1.3, SF: 0.8±1.1, p=0.10), between the 2 groups. At one year, 80.0% and 80.2% of the patients in the TM group and SF group were in LLDAS or remission respectively. SLE disease activity indices including SLEDAI-2k, PGA, proteinuria amount and serum anti-ds-DNA level remained similar between the 2 groups. Within the study period, 28 (40%) patients in the TM group and 21 (29.6%) patients in the SF group had disease fare (p=0.20). There were no differences in the SF-36, lupusQoL and HADS scores between the 2 groups at the end of the study. The overall patient satisfaction score was higher in the TM group with a signifcantly shorter waiting time before seeing doctors. At the end of the study, 67.9% of the overall participants agreed to (versus 15.0% who did not agree to) use TM as a mode of future FU. The mean indirect costs of illness (HKD26,681 vs HKD12,016, p=0.20) and the out-of-pocket costs for health care services were similar between the 2 groups (TM: HKD13,547 vs SF: HKD12,297, p=0.83) in one year. The total number of FU was similar (TM: 6.0±2.0, SF: 5.7±1.7, p=0.40). However, signifcantly more patients in the TM group (29/70, 41.4% vs 4/71, 5.6%;p<0.01) requested change mode of FU. The proportion of patients requiring hospitalization during the study period was also higher in the TM group (TM: 23/70, 32.9% vs 11/71, 15.5%;p=0.02). After adjusting for age and pred-nisolone dosage, not being in LLDAS at baseline was the predictor of hospitalization (OR 3.4, 95%CI 1.20-9.65). None of the participants was tested positive for COVID-19. Conclusion: TM FU resulted in similar 1-year disease activity control and better satisfaction in patients with LN compared to standard care. However, a signifcant proportion of patients cared by TM required in-person visits or were hospitalized. The results of the study suggest that TM delivered care could help minimizing exposure to COVID-19, but it needs to be complemented by physical visits, particularly in those with unstable d sease.

19.
Annals of the Rheumatic Diseases ; 81:325, 2022.
Article in English | EMBASE | ID: covidwho-2009097

ABSTRACT

Background: Voclosporin (VCS), a novel calcineurin inhibitor, was approved in the US in January 2021 for the treatment of adult patients with active lupus nephritis (LN) in combination with background immunosuppressive therapy. The Phase 3 AURORA 1 study showed that the addition of VCS to mycophenolate mofetil (MMF) and low-dose steroids in patients with LN signifcantly increased rates of complete renal response at 52 weeks. Objectives: Here we report the results of the completed continuation study, AURORA 2, which assessed the long-term safety and tolerability of VCS compared to placebo in patients with LN receiving treatment for an additional 24 months following completion of the AURORA 1 study Methods: Key inclusion criteria for the parent AURORA 1 study included a diagnosis of biopsy-proven active LN (Class III, I V, or V ± III/IV), proteinuria ≥1.5 mg/mg (≥2 mg/mg for Class V) and estimated glomerular fltration rate (eGFR) >45 mL/min/1.73 m2. Patients who completed AURORA 1 and who elected and were eligible to enter AURORA 2 continued on the same blinded therapy as at the end of AURORA 1 (either VCS or placebo twice daily in combination with MMF and low-dose steroids). Safety and tolerability were monitored, and eGFR, serum creatinine (SCr), and urine protein creatinine ratio (UPCR) were also assessed. Results: In total, 116 and 100 patients in the VCS and control arms enrolled in AURORA 2, with 92 (79.3%) and 73 (73.0%) patients in each respective arm receiving treatment to the end of AURORA 2. There were no unexpected safety signals in the VCS arm compared to control, with similar rates of serious adverse events reported in both arms (VCS [18.1%] vs. control [23.0%];Table 1). Eight patients in each arm experienced serious adverse events of infection;serious coronavirus infections were observed in 2 patients in the voclosporin arm and 5 patients in the control arm. There were 4 and 2 adverse events by preferred term of renal impairment reported in the VCS and control arms, respectively, none of which were considered serious, and no reports of acute kidney injury by preferred term in either arm. There were no deaths in the VCS arm during AURORA 2;four deaths were reported in the control arm (pulmonary embolism [n=1], coronavirus infection [n=3]). Mean eGFR and SCr levels remained stable through the end of AURORA 2. The difference between the VCS and control arms in LS mean change from baseline in eGFR was 2.7 mL/min/1.73 m2 at 4 weeks following study drug discontinuation (Figure 1). The mean reductions in UPCR observed in patients treated with VCS in AURORA 1 were maintained in AURORA 2 with no increase in UPCR noted at the follow-up visit 4 weeks after study drug discontinuation. Conclusion: Voclosporin was well-tolerated over 3 years of treatment with no unexpected safety signals detected. Further, eGFR remained stable throughout the study period, and the signifcant and meaningful reductions in proteinuria achieved in AURORA 1 were maintained. These data provide evidence of a longterm treatment beneft of VCS in patients with LN. Includes adverse events starting on or after the frst dose of study drug in AURORA 2 up to 30 days after the last dose and all events of death reported during study follow-up. Adverse events were aggregated by System Organ Class and Preferred Term and coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 20.0. AE, adverse event.

20.
Annals of the Rheumatic Diseases ; 81:1858, 2022.
Article in English | EMBASE | ID: covidwho-2008876

ABSTRACT

Background: Numerous immune-mediated diseases fare or new disease onset after SARS-CoV2-vaccination have been reported. There were case reports showed the immune-mediated disease fare post vaccination but study on new disease occurs post Covid-19 vaccination is still lacking. Objectives: To describe two SLE cases that diagnosed post Covid-19 vaccination. Methods: Case report Results: 14 years old girl, post Covid-19 vaccination 1st dose 3 weeks ago presented with 2 day history of giddiness, breathlessness, vomiting and diarrhea prior to admission. She also complained of frothy urine for the past 1 week associated with lower limbs swelling and facial puffiness. Clinical examination noted she had sparse hair, oral ulcers and discoid lupus at the ear concha. She also noted to have periorbital puffiness with pedal edema. Lung auscultation noted bi-basal crepitations. Blood investigation noted ANA positive (1:640, speckled) with low complement 3 (0.1g/L). Her full blood count showed leucopenia (3100 UL) with low lymphocyte count of 810UL. UFEME noted protein of 3 + and red blood cell of 2+ with normal renal profile. Her serum albumin was 22g/L. Chest x ray showed clear lung field with no cardiomegaly. Her 24-hour urine protein showed proteinuria of 2.345g/dl and her renal biopsy showed mesangial proliferative lupus nephritis class iI. She was given intravenous methyl-prednisolone 500mg OD for 3 days and discharged with tapering dose of prednisolone, hydroxychloroquine, calcium supplements, perindopril and frusemide. Another case was a 17 year-old female, post covid-19 vaccination 10 weeks, presented with 3 weeks history of bilateral lower limbs weakness with difficulty in getting up from chair. She also had fever on and off with cough for 1 week. There was no alopecia, oral ulcer, facial rash or photosensitivity. No joints pain. Clinical examination noted presence of proximal myopathy with stable vital signs. Other systemic examinations were unremarkable. Blood investigation noted ANA positive (1: 640, homogenous and speckled) with low complements level (C3 0.19g/L and C4 0.049 g/L).Her creatine kinase was 2367U/L and EMG showed evidence of irritable myopathic process which is consistent with inflammatory myositis. Her TFT was normal. Myositis panel showed anti-Ku and anti-Ro 52 were positive. She was treated as SLE with myositis and intravenous methylprednisolone was given. She discharge well with tapering dose of prednisolone and azathioprine. Her creatine kinase showed improvement with immunosuppression therapy and she was advised on intensive physiotherapy. Conclusion: The onset of these two SLE cases were occurred within the 2 month of post covid-19 vaccination. Whether Covid-19 vaccination direct contribute to the occurrence of SLE remained inconclusive. More studies are required to show its correlation between onset of SLE and Covid-19 vaccination.

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