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1.
Eur J Neurol ; 28(10): 3369-3374, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1604034

ABSTRACT

BACKGROUND AND PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic challenges neurologists in counseling multiple sclerosis (MS) patients with respect to their risk for and by severe acute respiratory syndrome coronavirus 2 and in guiding disease-modifying treatment (DMT). The objective was to determine the frequency and distribution of currently known risk factors for COVID-19 mortality in an MS population. METHODS: Multiple sclerosis patients with at least one complete case report between January 1, 2015 and December 31, 2019 from the Innsbruck MS database were cross-sectionally included. Frequencies of currently estimated COVID-19 mortality risk factors were analyzed, and the cumulative risk was calculated by a recently developed score. For every risk group, the proportions of patients under DMT and immunosuppressive treatment were determined. RESULTS: Of 1931 MS patients, 63.4% had low risk of COVID-19 mortality, 26% had mild risk, 8.8% had a moderate risk, whereas a combined 0.9% had high or very high risk of COVID-19 mortality. Of the patients at high or very high risk, only one patient received DMT and none had an immunosuppressive therapy. CONCLUSIONS: In a population-based MS cohort, the proportion of patients at high risk of COVID-19 mortality is below 1%. Importantly, the vast majority of these MS patients did not receive any DMT.


Subject(s)
COVID-19 , Multiple Sclerosis , Humans , Immunosuppressive Agents/therapeutic use , Multiple Sclerosis/drug therapy , Multiple Sclerosis/epidemiology , Pandemics , SARS-CoV-2
2.
Neurol Neuroimmunol Neuroinflamm ; 9(1)2022 01.
Article in English | MEDLINE | ID: covidwho-1596607

ABSTRACT

BACKGROUND AND OBJECTIVES: To investigate whether children receiving immunosuppressive therapies for neuroimmunologic disorders had (1) increased susceptibility to SARS-CoV2 infection or to develop more severe forms of COVID-19; (2) increased relapses or autoimmune complications if infected; and (3) changes in health care delivery during the pandemic. METHODS: Patients with and without immunosuppressive treatment were recruited to participate in a retrospective survey evaluating the period from March 14, 2020, to March 30, 2021. Demographics, clinical features, type of immunosuppressive treatment, suspected or confirmed COVID-19 in the patients or cohabitants, and changes in care delivery were recorded. RESULTS: One hundred fifty-three children were included: 84 (55%) female, median age 13 years (interquartile range [8-16] years), 79 (52%) on immunosuppressive treatment. COVID-19 was suspected or confirmed in 17 (11%) (all mild), with a frequency similar in patients with and without immunosuppressive treatment (11/79 [14%] vs 6/74 [8%], p = 0.3085). The frequency of neurologic relapses was similar in patients with (18%) and without (21%) COVID-19. Factors associated with COVID-19 included having cohabitants with COVID-19 (p < 0.001) and lower blood levels of vitamin D (p = 0.039). Return to face-to-face schooling or mask type did not influence the risk of infection, although 43(28%) children had contact with a classmate with COVID-19. Clinic visits changed from face to face to remote for 120 (79%) patients; 110 (92%) were satisfied with the change. DISCUSSION: In this cohort of children with neuroimmunologic disorders, the frequency of COVID-19 was low and not affected by immunosuppressive therapies. The main risk factors for developing COVID-19 were having cohabitants with COVID-19 and low vitamin D levels.


Subject(s)
COVID-19/complications , COVID-19/immunology , Immunocompromised Host , Immunosuppressive Agents/adverse effects , Nervous System Diseases/complications , Nervous System Diseases/immunology , SARS-CoV-2/immunology , Adolescent , COVID-19/prevention & control , COVID-19/virology , Child , Delivery of Health Care/organization & administration , Delivery of Health Care/statistics & numerical data , Female , Humans , Immunosuppressive Agents/therapeutic use , Male , Masks/statistics & numerical data , Masks/virology , Nervous System Diseases/virology , Pandemics , Recurrence , Retrospective Studies , Vitamin D/blood
4.
J Med Virol ; 93(12): 6760-6764, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1544331

ABSTRACT

The coronavirus disease 2019 (COVID-19) has affected more than a hundred million individuals and caused more than three million deaths worldwide. Specific risk groups were defined for increased risk of mortality and morbidity in COVID-19, and renal transplant recipients are at a significantly increased risk regarding outcomes due to their immunosuppressed conditions. This study evaluated the general characteristics of kidney transplant recipients with COVID-19 infection. Among 1257 transplant cases, 56 had COVID-19 infection, and 23 (41%) were hospitalized during the 9-month study period. Among all COVID-19 cases, 58% were male with a mean age of 45.5 (±13.2, 19-71) years, and the most frequent comorbidities were hypertension (70.9%) and diabetes (23.6%). Hospitalized patients were older (p = 0.03) and had higher rates of hypertension (p = 0.008), diabetes (p = 0.002), and ischemic heart disease (p = 0.03). Therapeutic management included antimetabolite withdrawal and prednisolone increase in 71%, calcineurin inhibitor withdrawal in 8% and decrease in 58%, hydroxychloroquine in 17%, tocilizumab in 3%, and antivirals in 67% of patients. Acute kidney injury and respiratory failure developed in 34% and 85%, respectively. The mortality rate was 23%. These results emphasized that the COVID-19 infection in renal transplant recipients significantly increases the risk of morbidity and mortality. Therefore, these patients should be intervened earlier and monitored closely to prevent poor outcomes.


Subject(s)
COVID-19/physiopathology , Immunocompromised Host/drug effects , Immunosuppressive Agents/therapeutic use , Kidney Transplantation/adverse effects , Acute Kidney Injury/drug therapy , Adult , Aged , Comorbidity , Female , Humans , Hydroxychloroquine/therapeutic use , Kidney/drug effects , Male , Middle Aged , Retrospective Studies , Transplant Recipients , Young Adult
5.
Drug Discov Ther ; 15(5): 278-280, 2021 Nov 21.
Article in English | MEDLINE | ID: covidwho-1542929

ABSTRACT

To help stop the coronavirus disease 2019 (COVID-19) pandemic, vaccines are currently the most critical tool. However, the COVID-19 mRNA vaccines frequently cause systemic side effects shortly after the injection, such as fever, headache and generalized fatigue. In our survey, after receiving the second dose of the COVID-19 vaccine, 80% developed fever, 62% headache and 69% generalized fatigue. Among people who required antipyretics, the average durations of fever and headache were significantly shorter in those who took non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, loxoprofen and ibuprofen, than those who took acetaminophen. In our patch-clamp studies, NSAIDs effectively suppressed the delayed rectifier K+-channel (Kv1.3) currents in T-lymphocytes and thus exerted immunosuppressive effects. Because of this pharmacological property, the use of NSAIDs should be more effective in reducing the vaccine-induced systemic side effects that are caused primarily by the enhanced cellular immunity.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , COVID-19 Vaccines/adverse effects , Immunosuppressive Agents/therapeutic use , Acetaminophen/therapeutic use , Adolescent , Aspirin/therapeutic use , Fatigue/drug therapy , Fatigue/etiology , Fever/drug therapy , Fever/etiology , Headache/drug therapy , Headache/etiology , Humans , Ibuprofen/therapeutic use , Patch-Clamp Techniques , Phenylpropionates/therapeutic use , Young Adult
6.
Blood Coagul Fibrinolysis ; 32(7): 427-433, 2021 Oct 01.
Article in English | MEDLINE | ID: covidwho-1526210

ABSTRACT

Immune thrombocytopenia is a haematological, autoimmune disorder characterized by elevated platelet demolition due to the presence of antiplatelet autoantibodies derived from B cells and to an irregular, deficient process of platelets production in bone marrow. In this review, after a brief presentation of 'old' strategies used nowadays yet, we focused on new drugs used in the treatment of immune thrombocytopenia and their mechanism of action and posology, basing on the last scientific literature. The observation that CoViD-19 can be associated with immune thrombocytopenia is also put in evidence. Particular attention will be dedicated on the concept that the ideal treatment should represent a solution not only for the failure of normal processes of production and survival of platelets, but also it should improve quality of life of patients, with minimum adverse events. Anyway, despite enormous advances of the last years, further investigations are necessary in order to define scrupulously long-term efficacy of new molecules proposed.


Subject(s)
Purpura, Thrombocytopenic, Idiopathic/drug therapy , Aminopyridines/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19/complications , COVID-19/immunology , Histocompatibility Antigens Class I , Humans , Immunosuppressive Agents/therapeutic use , Morpholines/therapeutic use , Protein Kinase Inhibitors/therapeutic use , Purpura, Thrombocytopenic, Idiopathic/etiology , Purpura, Thrombocytopenic, Idiopathic/immunology , Pyrimidines/therapeutic use , Receptors, Fc/antagonists & inhibitors , Receptors, Thrombopoietin/agonists , SARS-CoV-2/immunology , Syk Kinase/antagonists & inhibitors , Thiazoles/therapeutic use , Thiophenes/therapeutic use
9.
Inflamm Bowel Dis ; 27(Supplement_2): S25-S32, 2021 Nov 15.
Article in English | MEDLINE | ID: covidwho-1522203

ABSTRACT

BACKGROUND: Patients with Crohn's disease (CD) undergo frequent endoscopic procedures, with visualization of the gastrointestinal mucosa central to treatment decision-making. Subsequently, a noninvasive alternative to optical colonoscopy (OC) would be welcomed. One such technology is capsule endoscopy, including the PillCam COLON 2 (PCC2), though research validating its use in ileocolonic CD is limited. This study aims to compare PCC2 with ileocolonoscopy (OC) in assessing mucosal CD through use of a standardized scoring system. METHODS: At an Australian tertiary hospital, same-day PCC2 and ileocolonoscopy results of 47 CD patients, with known nonstricturing disease, were prospectively collected and analyzed for correlation and agreement. Deidentified recordings were reported by a single expert gastroenterologist. Mucosal disease was quantified using the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD results of paired endoscopic modalities were compared in total per bowel segment and per SES-CD variable. RESULTS: Of 47 PCC2 recordings, 68% were complete, fully assessing terminal ileum to rectum, and OC was complete in 89%. Correlation (r) between total SES-CD scores was strongest in the terminal ileum (r = 0.77, P < .001), with the SES-CD variable of "ulcer detection" showing the strongest agreement. The PCC2 (vs OC) identified additional ulcers in the terminal ileum; ascending, transverse, and descending colon; and rectum; scores were 5 (1), 5 (3), 1 (1), 2 (1), and 2 (2), respectively. CONCLUSIONS: The PCC2 shows promise in assessing ileocolonic mucosa, especially in proximal bowel segments, with greater reach of visualization in the small bowel. Given the resource and safety considerations raised by the Coronavirus disease 2019 pandemic, capsule endoscopy has particular significance.This article aims to contribute to the limited body of research surrounding the validity of capsule endoscopy technology in assessing ileocolonic mucosa in Crohn's Disease patients. In doing so, an alternative option for patients enduring frequent endoscopies is given potential.


Subject(s)
Capsule Endoscopy/methods , Colon/diagnostic imaging , Colonoscopy/methods , Crohn Disease/diagnostic imaging , Intestinal Mucosa/diagnostic imaging , Ulcer/diagnostic imaging , Wound Healing , Australia , COVID-19 , Capsule Endoscopes , Colon/drug effects , Humans , Immunosuppressive Agents/therapeutic use , Intestinal Mucosa/drug effects , SARS-CoV-2 , Severity of Illness Index , Treatment Outcome , Ulcer/drug therapy , Wound Healing/drug effects , Wound Healing/physiology
10.
Reumatol Clin (Engl Ed) ; 17(9): 491-493, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1510266

ABSTRACT

SARS-COV-2 infection has spread worldwide since it originated in December 2019, in Wuhan, China. The pandemic has largely demonstrated the resilience of the world's health systems and is the greatest health emergency since World War II. There is no single therapeutic approach to the treatment of COVID-19 and the associated immune disorder. The lack of randomised clinical trials (RCTs) has led different countries to tackle the disease based on case series, or from results of observational studies with off-label drugs. We as rheumatologists in general, and specifically rheumatology fellows, have been on the front line of the pandemic, modifying our activities and altering our training itinerary. We have attended patients, we have learned about the management of the disease and from our previous experience with drugs for arthritis and giant cell arteritis, we have used these drugs to treat COVID-19.


Subject(s)
Antiviral Agents/therapeutic use , Biological Factors/therapeutic use , COVID-19/drug therapy , Immunosuppressive Agents/therapeutic use , Physician's Role , Rheumatologists , Autoimmune Diseases/complications , Autoimmune Diseases/drug therapy , Autoimmune Diseases/immunology , COVID-19/complications , COVID-19/epidemiology , COVID-19/immunology , Drug Therapy, Combination , Education, Medical, Graduate , Fellowships and Scholarships , Global Health , Humans , Immunocompromised Host , Opportunistic Infections/complications , Opportunistic Infections/drug therapy , Opportunistic Infections/immunology , Patient Care Team/organization & administration , Practice Patterns, Physicians' , Rheumatic Diseases/complications , Rheumatic Diseases/drug therapy , Rheumatic Diseases/immunology , Rheumatologists/education , Rheumatologists/organization & administration , Rheumatology/education , Rheumatology/methods , Rheumatology/organization & administration , Spain/epidemiology
12.
Ann Transplant ; 26: e933001, 2021 Oct 26.
Article in English | MEDLINE | ID: covidwho-1485494

ABSTRACT

BACKGROUND There are many safety concerns regarding the use of antithymocyte globulin (ATG) in kidney transplant recipients (KTRs) during the ongoing COVID-19 pandemic. Hereby, we present our recent experience with ATG administration both as induction therapy and as an anti-rejection treatment. MATERIAL AND METHODS We retrospectively analyzed all patients transplanted during the first 12 months of the COVID-19 pandemic who were treated with thymoglobulin. The ATG dosing, lymphocyte number and percentage in blood smear, adverse effects (thrombocytopenia and infectious complications), and kidney graft function up to 12 months and patients' outcomes were analyzed and compared to KTRs who received basiliximab induction. RESULTS During pandemic, a total of 31 patients were treated with ATG and 59 received basiliximab. The median cumulative ATG doses were 275 (175-325) mg in the induction subgroup and 263 (200-275) mg in the anti-rejection treatment subgroup. Mild thrombocytopenia was noted in 7 (22.6%) and 13 (29.5%) patients, respectively. There were more infectious complications among patients treated with ATG as compared with the basiliximab subgroup (32.3 vs 10.2%, P<0.01), but there were similar incidence rates of thrombocytopenia. Kidney graft function up to 12 months after transplant was comparable (1.1 [1.0-1.9] vs 1.1 [1.0-1.4] mg/dl, respectively). CONCLUSIONS 1. ATG use in the induction protocol or as the anti-rejection treatment during the COVID-19 pandemic appears to be safe and the risk of adverse events is acceptable. 2. During the COVID-19 pandemic the necessary use of ATG should not be postponed, especially in KTRs with increased immunologic risk.


Subject(s)
Antilymphocyte Serum , COVID-19 , Immunosuppressive Agents , Kidney Transplantation , Antilymphocyte Serum/adverse effects , Antilymphocyte Serum/therapeutic use , Basiliximab/therapeutic use , Graft Rejection/epidemiology , Graft Rejection/prevention & control , Graft Survival , Humans , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/therapeutic use , Kidney , Pandemics , Retrospective Studies
13.
J Infect Dev Ctries ; 15(9): 1257-1262, 2021 09 30.
Article in English | MEDLINE | ID: covidwho-1478145

ABSTRACT

Severe COVID-19 infection management for a recipient of kidney transplant has debatable prognosis and treatment. We described the case of a COVID-19 infected 70 year old female, previously had renal transplantation in 2017. The patient took immunosuppressive agents as routine drugs for transplant recipient status and received lopinavir/ritonavir, hydroxychloroquine, and dexamethasone daily at the hospitalization. Specific question arises about renal transplant recipients being infected by COVID-19 - whether the infection will get worse compared to those without immunosuppresive agent. In this case, author decided to stop the immunosuppressive agent followed administration of combination lopinavir/ritonavir, hydroxychloroquine, and dexamethasone that gives a good clinical impact change to patient's condition after once getting worsened and mechanically ventilated. Nevertheless, the assessment of risk and benefit in continuing immunosuppressive drugs is concurrently essential due to the prevention of transplant rejection.


Subject(s)
COVID-19/drug therapy , Dexamethasone/therapeutic use , Hydroxychloroquine/therapeutic use , Lopinavir/therapeutic use , Ritonavir/therapeutic use , Aged , Drug Combinations , Female , Humans , Immunosuppressive Agents/therapeutic use , Kidney Transplantation , Transplant Recipients
14.
Biomed Res Int ; 2021: 9318725, 2021.
Article in English | MEDLINE | ID: covidwho-1476889

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic poses a special risk for both immunosuppressed patients, especially transplant recipients. Although the knowledge about this infection is growing, many uncertainties remain, particularly regarding the kidney. Kidney transplant recipients (KDRs) should be considered immunocompromised hosts since a potential risk for infection, comorbidity, and immunosuppression exposure exists. Additionally, the management of immunosuppressive agents in KDRs remains challenging. Potential drug interactions with immunosuppressive treatment escalated the risk of unwanted side effects. In this review, we aimed to attain an augmented awareness and improved management immunosuppressant for COVID-19 KDRs.


Subject(s)
COVID-19/immunology , Immunosuppressive Agents/therapeutic use , Kidney Transplantation , Humans , Immunocompromised Host , Immunosuppressive Agents/immunology , Immunosuppressive Agents/pharmacokinetics , Kidney Transplantation/adverse effects , Kidney Transplantation/mortality , SARS-CoV-2/drug effects
15.
Front Immunol ; 12: 708848, 2021.
Article in English | MEDLINE | ID: covidwho-1468339

ABSTRACT

Impressive efforts have been made by researchers worldwide in the development of target vaccines against the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and in improving the management of immunomodulating agents. Currently, different vaccine formulations, such as viral vector, mRNA, and protein-based, almost all directed toward the spike protein that includes the domain for receptor binding, have been approved. Although data are not conclusive, patients affected by autoimmune rheumatic diseases (ARDs) seem to have a slightly higher disease prevalence, risk of hospitalization, and death from coronavirus disease-2019 (COVID-19) than the general population. Therefore, ARD patients, under immunosuppressive agents, have been included among the priority target groups for vaccine administration. However, specific cautions are needed to optimize vaccine safety and effectiveness in these patients, such as modification in some of the ongoing immunosuppressive therapies and the preferential use of mRNA other than vector-based vaccines. Immunomodulating agents can be a therapeutic opportunity for the management of COVID-19 patients; however, their clinical impact depends on how they are handled. To place in therapy immunomodulating agents in the correct window of opportunity throughout the identification of surrogate markers of disease progression and host immune response is mandatory to optimize patient's outcome.


Subject(s)
Autoimmunity/immunology , COVID-19 Vaccines/immunology , COVID-19/prevention & control , Immunocompromised Host/immunology , Rheumatic Diseases/immunology , Spike Glycoprotein, Coronavirus/immunology , Humans , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/therapeutic use , Rheumatic Diseases/drug therapy , SARS-CoV-2/immunology , Vaccination
16.
Front Immunol ; 12: 753558, 2021.
Article in English | MEDLINE | ID: covidwho-1463476

ABSTRACT

To date there is limited data on the immune profile and outcomes of solid organ transplant recipients who encounter COVID-19 infection early post-transplant. Here we present a unique case where the kidney recipient's transplant surgery coincided with a positive SARS-CoV-2 test and the patient subsequently developed symptomatic COVID-19 perioperatively. We performed comprehensive immunological monitoring of cellular, proteomic, and serological changes during the first 4 critical months post-infection. We showed that continuation of basiliximab induction and maintenance of triple immunosuppression did not significantly impair the host's ability to mount a robust immune response against symptomatic COVID-19 infection diagnosed within the first week post-transplant.


Subject(s)
Basiliximab/therapeutic use , COVID-19/immunology , Glomerulonephritis, IGA/therapy , Graft Rejection/immunology , Immunosuppressive Agents/therapeutic use , Kidney Transplantation , SARS-CoV-2/physiology , Adult , Humans , Immune Tolerance , Immunity , Male , Perioperative Period , Transcriptome
17.
Neurol Neuroimmunol Neuroinflamm ; 8(6)2021 11.
Article in English | MEDLINE | ID: covidwho-1456026

ABSTRACT

BACKGROUND AND OBJECTIVES: To describe the clinical features and disease outcomes of coronavirus disease 2019 (COVID-19) in patients with neuromyelitis optica spectrum disorder (NMOSD). METHODS: The Neuroimmunology Brazilian Study Group has set up the report of severe acute respiratory syndrome (SARS-CoV2) cases in patients with NMOSD (pwNMOSD) using a designed web-based case report form. All neuroimmunology outpatient centers and individual neurologists were invited to register their patients across the country. Data collected between March 19 and July 25, 2020, were uploaded at the REDONE.br platform. Inclusion criteria were as follows: (1) NMOSD diagnosis according to the 2015 International Panel Criteria and (2) confirmed SARS-CoV2 infection (reverse transcription-polymerase chain reaction or serology) or clinical suspicion of COVID-19, diagnosed according to Center for Disease Control / Council of State and Territorial Epidemiologists (CDC/CSTE) case definition. Demographic and NMOSD-related clinical data, comorbidities, disease-modifying therapy (DMT), COVID-19 clinical features, and severity were described. RESULTS: Among the 2,061 pwNMOSD followed up by Brazilian neurologists involved on the registry of COVID-19 in pwNMOSD at the REDONE.br platform, 34 patients (29 women) aged 37 years (range 8-77), with disease onset at 31 years (range 4-69) and disease duration of 6 years (range 0.2-20.5), developed COVID-19 (18 confirmed and 16 probable cases). Most patients exhibited mild disease, being treated at home (77%); 4 patients required admission at intensive care units (severe cases); and 1 patient died. Five of 34 (15%) presented neurologic manifestations (relapse or pseudoexacerbation) during or after SARS-CoV2 infection. DISCUSSION: Most NMOSD patients with COVID-19 presented mild disease forms. However, pwNMOSD had much higher odds of hospitalization and intensive care unit admission comparing with the general Brazilian population. The frequency of death was not clearly different. NMOSD disability, DMT type, and comorbidities were not associated with COVID-19 outcome. SARS-CoV2 infection was demonstrated as a risk factor for NMOSD relapses. Collaborative studies using shared NMOSD data are needed to suitably define factors related to COVID-19 severity and neurologic manifestations.


Subject(s)
COVID-19/physiopathology , Hospitalization/statistics & numerical data , Neuromyelitis Optica/physiopathology , Adolescent , Adult , Aged , Brazil/epidemiology , COVID-19/epidemiology , COVID-19/therapy , Child , Disease Progression , Female , Humans , Immunosuppressive Agents/therapeutic use , Intensive Care Units/statistics & numerical data , Male , Middle Aged , Neuromyelitis Optica/drug therapy , Neuromyelitis Optica/epidemiology , Recurrence , SARS-CoV-2 , Severity of Illness Index , Young Adult
18.
J Hepatol ; 75(2): 435-438, 2021 08.
Article in English | MEDLINE | ID: covidwho-1454287

ABSTRACT

BACKGROUND & AIMS: Two SARS-CoV-2 mRNA vaccines were approved to prevent COVID-19 infection, with reported vaccine efficacy of 95%. Liver transplant (LT) recipients are at risk of lower vaccine immunogenicity and were not included in the registration trials. We assessed vaccine immunogenicity and safety in this special population. METHODS: LT recipients followed at the Tel-Aviv Sourasky Medical Center and healthy volunteers were tested for SARS-CoV-2 IgG antibodies directed against the Spike-protein (S) and Nucleocapsid-protein (N) 10-20 days after receiving the second Pfizer-BioNTech BNT162b2 SARS-CoV-2 vaccine dose. Information regarding vaccine side effects and clinical data was collected from patients and medical records. RESULTS: Eighty LT recipients were enrolled. Mean age was 60 years and 30% were female. Twenty-five healthy volunteer controls were younger (mean age 52.7 years, p = 0.013) and mostly female (68%, p = 0.002). All participants were negative for IgG N-protein serology, indicating immunity did not result from prior COVID-19 infection. All controls were positive for IgG S-protein serology. Immunogenicity among LT recipients was significantly lower with positive serology in only 47.5% (p <0.001). Antibody titer was also significantly lower in this group (mean 95.41 AU/ml vs. 200.5 AU/ml in controls, p <0.001). Predictors for negative response among LT recipients were older age, lower estimated glomerular filtration rate, and treatment with high dose steroids and mycophenolate mofetil. No serious adverse events were reported in either group. CONCLUSION: LT recipients developed substantially lower immunological response to the Pfizer-BioNTech SARS-CoV-2 mRNA-based vaccine. Factors influencing serological antibody responses include age, renal function and immunosuppressive medications. The findings require re-evaluation of vaccine regimens in this population. LAY SUMMARY: The Pfizer-BioNTech BNT162b2 SARS-CoV-2 vaccine elicited substantially inferior immunity in liver transplant recipients. Less than half of the patients developed sufficient levels of antibodies against the virus, and in those who were positive, average antibody levels were 2x less compared to healthy controls. Factors predicting non-response were older age, renal function and immunosuppressive medications.


Subject(s)
Antibodies, Viral/blood , COVID-19 Vaccines , COVID-19 , Immunogenicity, Vaccine/immunology , Immunoglobulin G/blood , Immunosuppressive Agents/therapeutic use , Liver Transplantation/methods , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , Female , Humans , Israel/epidemiology , Kidney Function Tests , Male , Middle Aged , Risk Factors , SARS-CoV-2/immunology , Serologic Tests/methods , Serologic Tests/statistics & numerical data , Vaccination/adverse effects , Vaccination/methods
19.
Eur Rev Med Pharmacol Sci ; 25(18): 5865-5870, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1451045

ABSTRACT

OBJECTIVE: Dupilumab (Dupixent®) is a monoclonal antibody that inhibits IL-4 and IL-13 signaling used for the treatment of allergic diseases. Whilst biologic therapy is traditionally regarded as immunosuppressive and capable to increase the infectious risk, Dupilumab does not display these characteristics and may be even protective in certain cases. We investigated the link between Dupilumab therapy and SARS-CoV-2 infection. MATERIALS AND METHODS: We carried out a comprehensive data mining and disproportionality analysis of the WHO global pharmacovigilance database. One asymptomatic COVID-19 case, 106 cases of symptomatic COVID-19, and 2 cases of severe COVID-19 pneumonia were found. RESULTS: Dupilumab treated patients were at higher risk of COVID-19 (with an IC0.25 of 3.05), even though infections were less severe (IC0.25 of -1.71). The risk of developing COVID-19 was significant both among males and females (with an IC0.25 of 0.24 and 0.58, respectively). The risk of developing COVID-19 was significant in the age-group of 45-64 years (with an IC0.25 of 0.17). CONCLUSIONS: Dupilumab use seems to reduce COVID-19 related severity. Further studies are needed to better understand the immunological mechanisms and clinical implications of these findings. Remarkably, the heterogenous nature of the reports and the database structure did not allow to establish a cause-effect link, but only an epidemiologically decreased risk in the patients subset treated with dupilumab.


Subject(s)
Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal, Humanized/therapeutic use , Big Data , COVID-19/epidemiology , COVID-19/immunology , Adolescent , Adult , Aged , COVID-19/drug therapy , Databases, Factual , Female , Humans , Immunosuppressive Agents/therapeutic use , Male , Middle Aged , Risk Factors , SARS-CoV-2/drug effects , SARS-CoV-2/immunology , Severity of Illness Index , World Health Organization , Young Adult
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