Belatacept Use after Kidney Transplantation and Its Effects on Risk of Infection and COVID-19 Vaccine Response

Introduction: Belatacept is a common immunosuppressive therapy used after kidney transplantation (KT) to avoid calcineurin-inhibitor (CNI) use and its related toxicities. It is unclear whether its use exposes KT recipients (KTx) to a greater risk of infection or a poorer response to vaccines. Areas covered: We reviewed PubMed and the Cochrane database. We then summarized the mechanisms and impacts of belatacept use on the risk of infection, particularly opportunistic, in two settings, i.e., de novo KTx and conversion from CNIs. We also focused on COVID-19 infection risk and response to SARS-Cov-2 vaccination in patients whose maintenance immunosuppression relies on belatacept. Expert opinion: When belatacept is used de novo, or after drug conversion the safety profile regarding the risk of infection remains good. However, there is an increased risk of opportunistic infections, mainly CMV disease and Pneumocystis pneumonia, particularly in those with a low eGFR, in older people, in those receiving steroid-based therapy, or those that have an early conversion from CNI to belatacept (i.e., <six months post-transplantation). Thus, we recommend, if possible, delaying conversion from CNI to belatacept until at least six months post-transplantation. Optimal timing seems to be eight months post-transplantation. In addition, KTx receiving belatacept respond poorly to SARS-CoV-2 vaccination.

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Risk of infection associated with targeted therapies for solid organ and hematological malignancies

Therapeutic Advances in Infectious Disease ◽

10.1177/2049936121989548 ◽

2021 ◽

Vol 8 ◽

pp. 204993612198954

Author(s):

Isabel Ruiz-Camps ◽

Juan Aguilar-Company

Keyword(s):

Hematological Malignancies ◽

Opportunistic Infections ◽

Respiratory Infections ◽

Fungal Infections ◽

Checkpoint Inhibitors ◽

Janus Kinase ◽

Prolonged Treatment ◽

Solid Organ ◽

Risk Of Infection ◽

Increased Risk

Higher risks of infection are associated with some targeted drugs used to treat solid organ and hematological malignancies, and an individual patient’s risk of infection is strongly influenced by underlying diseases and concomitant or prior treatments. This review focuses on risk levels and specific suggestions for management, analyzing groups of agents associated with a significant effect on the risk of infection. Due to limited clinical experience and ongoing advances in these therapies, recommendations may be revised in the near future. Bruton tyrosine kinase (BTK) inhibitors are associated with a higher rate of infections, including invasive fungal infection, especially in the first months of treatment and in patients with advanced, pretreated disease. Phosphatidylinositol 3-kinase (PI3K) inhibitors are associated with an increased risk of Pneumocystis pneumonia and cytomegalovirus (CMV) reactivation. Venetoclax is associated with cytopenias, respiratory infections, and fever and neutropenia. Janus kinase (JAK) inhibitors may predispose patients to opportunistic and fungal infections; need for prophylaxis should be assessed on an individual basis. Mammalian target of rapamycin (mTOR) inhibitors have been linked to a higher risk of general and opportunistic infections. Breakpoint cluster region-Abelson (BCR-ABL) inhibitors are associated with neutropenia, especially over the first months of treatment. Anti-CD20 agents may cause defects in the adaptative immune response, hypogammaglobulinemia, neutropenia, and hepatitis B reactivation. Alemtuzumab is associated with profound and long-lasting immunosuppression; screening is recommended for latent infections and prevention strategies against CMV, herpesvirus, and Pneumocystis infections. Checkpoint inhibitors (CIs) may cause immune-related adverse events for which prolonged treatment with corticosteroids is needed: prophylaxis against Pneumocystis is recommended.

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P1667ANALYSIS OF RISK FACTORS FOR CMV DISEASE IN KIDNEY TRANSPLANT PATIENTS - SINGLE CENTER STUDY

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa142.p1667 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Vladimir Hanzal ◽

Janka Slatinska ◽

Petra Hruba ◽

Ondrej Viklicky

Keyword(s):

Risk Factors ◽

Kidney Transplantation ◽

Multivariable Analysis ◽

Graft Function ◽

Kidney Graft ◽

Cmv Infection ◽

Post Transplantation ◽

Increased Risk ◽

Cmv Disease ◽

Cmv Prophylaxis

Abstract Background and Aims Cytomegalovirus (CMV) disease and infection negatively influence outcome of kidney transplantation. The aim of this retrospective study was to analyze risk factors for CMV disease and its influence on kidney graft function and survival. Method 1050 patients underwent kidney transplantation from January 2014 to December 2018 and received calcineurin inhibitor, mycophenolate mofetil and steroid-based immunosuppression. Recipients with PRA>20% received rATG while others had received basiliximab as induction. 825 out of 1050 patients (78.6%) received CMV prophylaxis (D+/R-, n=173; R+, n=652). Patients were followed up to 71 months /median 38 months/. Results CMV tissue invasive disease occurred in 49 out of 1050 patients (4.7%), while CMV infection in 87 patients (8.3%). CMV disease, but not CMV infection, had significant negative influence on graft survival at 5 years post transplantation (p=0.0029). Patients with CMV disease had significantly worse graft function at 4 years post transplantation (p<0.0001). CMV disease occurred in 31 out of 173 patients (17.9%) in D+/R- group vs. 18 out of 652 patients (2.8%) in R+ group. Incidence of CMV infection was 30/173 patients (17.3%) in D+/R- group vs. 57/652 patients (8.7%) with induction therapy. Shortening of CMV prophylaxis was found in 82 patients (9.9%). Leukopenia (≤ 2.0 x 109/L) was observed in 97 (11.7%) patients from those who received CMV prophylaxis, Its shortening significantly increased risk for both CMV infection (20,7% vs. 7.2%, p<0,0001) and CMV disease (8,5% vs. 4,2%, p=0,04). Among most significant risk factors for CMV disease in univariable analysis were CMV mismatch (OR 11, 95% CI: 5,9-20,4; p<0,0001), delayed graft function (OR 2,8, 95% CI: 1,6-5,1; p<0,0001, cadaveric donor (OR 6, 95% CI: 1,5-25,1; p=0,00013) and shortening of CMV prophylaxis (OR 2.1, 95% CI: 0,91-4,86; p=0,08). Multivariable analysis revealed as independent significant predictors of CMV disease DGF (OR 2,29, 95% CI: 1,2-4,3; p=0,01) and CMV mismatch (OR 10,8, 95% CI: 5,7-20,6; p<0.0001) in a model adjusted for type of donor, prophylaxis shortening and leukopenia. Conclusion CMV mismatch is the main independent predictor of CMV disease after kidney transplantation in multivariable analysis.

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Occurrence of Serious Infection in Patients with Rheumatoid Arthritis Treated with Biologics and Denosumab Observed in a Clinical Setting

The Journal of Rheumatology ◽

10.3899/jrheum.161270 ◽

2017 ◽

Vol 45 (2) ◽

pp. 170-176 ◽

Cited By ~ 10

Author(s):

Arthur N. Lau ◽

Matthew Wong-Pack ◽

Rod Rodjanapiches ◽

George Ioannidis ◽

Sally Wade ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Opportunistic Infection ◽

Opportunistic Infections ◽

Biologic Agent ◽

Risk Of Infection ◽

Group 4 ◽

Concurrent Use ◽

Serious Infection ◽

Increased Risk ◽

Group 3

Objective.Previous studies combining biologic disease-modifying antirheumatic drugs (bDMARD) to treat rheumatoid arthritis (RA) have shown an increased risk of infection. However, the risk of infection with concurrent use of denosumab, a biologic agent for the treatment of osteoporosis, and a bDMARD remains unclear. Here, we evaluated the incidence of serious and opportunistic infections in patients treated concurrently with denosumab and a bDMARD and patients treated with a bDMARD alone.Methods.A chart review of patients with RA from 2 Canadian rheumatology practices between July 1, 2010, and July 31, 2014, identified 2 groups of patients: those taking denosumab and a bDMARD concurrently (concurrent group) and those taking only a bDMARD (biologic-alone group). Patients were followed from the time of initiation of denosumab, or a matched index date for the biologic-alone group, to the end of the study or loss to followup. Instances of serious or opportunistic infections were recorded.Results.A total of 308 patients (n = 102 for the concurrent group and n = 206 for the biologic-alone group) were evaluated. Within the concurrent group, 3 serious infection events occurred. Within the biologic-alone group, 4 serious infection events and 1 opportunistic infection event occurred. In both groups, all patients with serious or opportunistic infection recovered, and there were no instances of death during the study period.Conclusion.This study demonstrated a low occurrence of serious and opportunistic infections in patients with RA taking bDMARD, including patients with concurrent denosumab use.

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Immunosuppression as a Risk Factor for De Novo Angiotensin II Type Receptor Antibodies Development after Kidney Transplantation

Journal of Clinical Medicine ◽

10.3390/jcm10225390 ◽

2021 ◽

Vol 10 (22) ◽

pp. 5390

Author(s):

Bogdan Marian Sorohan ◽

Ioanel Sinescu ◽

Dorina Tacu ◽

Cristina Bucșa ◽

Corina Țincu ◽

...

Keyword(s):

Risk Factors ◽

Kidney Transplantation ◽

Angiotensin Ii ◽

De Novo ◽

Multivariate Logistic Regression Analysis ◽

Study Cohort ◽

Type I ◽

Factors Associated ◽

Maintenance Immunosuppression ◽

Receptor Antibodies

(1) Background: Angiotensin II type I receptor antibodies (AT1R-Ab) represent a topic of interest in kidney transplantation (KT). Data regarding the risk factors associated with de novo AT1R-Ab development are lacking. Our goal was to identify the incidence of de novo AT1R-Ab at 1 year after KT and to evaluate the risk factors associated with their formation. (2) Methods: We conducted a prospective cohort study on 56 adult patients, transplanted between 2018 and 2019. Recipient, donor, transplant, treatment, and complications data were assessed. A threshold of >10 U/mL was used for AT1R-Ab detection. (3) Results: De novo AT1R-Ab were observed in 12 out of 56 KT recipients (21.4%). The median value AT1R-Ab in the study cohort was 8.5 U/mL (inter quartile range: 6.8–10.4) and 15.6 U/mL (10.8–19.8) in the positive group. By multivariate logistic regression analysis, induction immunosuppression with anti-thymocyte globulin (OR = 7.20, 95% CI: 1.30–39.65, p = 0.02), maintenance immunosuppression with immediate-release tacrolimus (OR = 6.20, 95% CI: 1.16–41.51, p = 0.03), and mean tacrolimus trough level (OR = 2.36, 95% CI: 1.14–4.85, p = 0.01) were independent risk factors for de novo AT1R-Ab at 1 year after KT. (4) Conclusions: De novo AT1R-Ab development at 1 year after KT is significantly influenced by the type of induction and maintenance immunosuppression.

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De Novo Cancer Incidence after Kidney Transplantation in South Korea from 2002 to 2017

Journal of Clinical Medicine ◽

10.3390/jcm10163530 ◽

2021 ◽

Vol 10 (16) ◽

pp. 3530

Author(s):

Boyeon Kim ◽

Minjin Kang ◽

Yoonjung Kim ◽

Hyung Soon Lee ◽

Banseok Kim ◽

...

Keyword(s):

Kidney Transplantation ◽

South Korea ◽

Cancer Incidence ◽

Proportional Hazards ◽

De Novo ◽

Cancer Development ◽

National Database ◽

Monitoring Methods ◽

Increased Risk ◽

Risk Of Cancer

Advances in patient care and immunosuppressive drugs have improved graft survival, resulting in an increase in kidney transplantation (KT); however, persistent immunosuppression is thought to cause late occurrence of cancer. This population-based study consisted of a total of 14,842 patients whose data from the years 2002 to 2017 were collected from the National Health Information Database in South Korea. Malignancies occurred in 7.6% of the total KT patients. Prostate and thyroid cancers were the most common in males and females, respectively. From the age-adjusted incidence analysis, Kaposi’s sarcoma showed the highest standardized incidence ratio in both male and female patients. According to the linear regression model, cancer incidence in KT recipients under immunosuppressive conditions increased by approximately 0.1% each month. Patients’ age over 39 and the use of prednisolone as an initial steroid regimen were associated with increased risk of cancer development after KT. Our regression and proportional hazards models will help clinicians to predict the approximate cancer incidence risk when monitoring KT recipients. Based on the largest available national database, screening or monitoring methods for cancer detection and prevention can be established for KT patients by considering the factors involved in cancer development.

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Cancer and mTOR inhibitors in kidney transplantation recipients

PeerJ ◽

10.7717/peerj.5864 ◽

2018 ◽

Vol 6 ◽

pp. e5864

Author(s):

Chih-Chin Kao ◽

Jia-Sin Liu ◽

Yu-Kang Chang ◽

Ming-Huang Lin ◽

Yen-Chung Lin ◽

...

Keyword(s):

Kidney Transplantation ◽

De Novo ◽

Mtor Inhibitors ◽

Cancer Development ◽

Cumulative Exposure ◽

National Database ◽

Risk Of Death ◽

Increased Risk ◽

De Novo Cancer ◽

Risk Of Cancer

Background Previous studies show that mTOR inhibitors decrease the risk of cancer development after kidney transplantation. However, the effect of cumulative doses of mTOR inhibitors on cancer after kidney transplantation is not well known. Methods In the current study, patients were registered into a national database in Taiwan. Between year 2000 and 2013, 4,563 patients received kidney transplantation. They were divided into two groups, according to mTOR inhibitors usage. The cumulative dose of mTOR inhibitors was recorded. Patients were followed-up until de novo cancer development, death, or the end of 2014. Results Patients were divided into two groups: mTOR inhibitors users (study group, n = 828) and mTOR inhibitors non-users (control group, n = 3,735). The median follow-up duration was 7.8 years. The risk of de novo cancer (hazards ratio (HR) 0.80, 95% CI [0.60–1.09], p = 0.16) and risk of death (HR 1.14, 95% CI [0.82–1.60], p = 0.43) was not different between mTOR inhibitor user and non-user groups. Neither high- nor low-dose exposure to mTOR inhibitors was associated with increased risk of cancer or mortality. Analysis of cancer subtypes showed no influence by mTOR inhibitors. In addition, the cause of mortality was not significantly different between the two groups. Discussion We could not find the association of mTOR inhibitors use and risk of de novo cancer development or mortality in patients with kidney transplantation in Chinese patients. Cumulative exposure to mTOR inhibitors did not change the results.

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Opportunistic Infections and Efficacy Following Conversion to Belatacept-Based Therapy after Kidney Transplantation: A French Multicenter Cohort

Journal of Clinical Medicine ◽

10.3390/jcm9113479 ◽

2020 ◽

Vol 9 (11) ◽

pp. 3479 ◽

Cited By ~ 1

Author(s):

Dominique Bertrand ◽

Florian Terrec ◽

Isabelle Etienne ◽

Nathalie Chavarot ◽

Rebecca Sberro ◽

...

Keyword(s):

Opportunistic Infections ◽

Real Life ◽

Calcineurin Inhibitors ◽

Pneumocystis Pneumonia ◽

Post Transplantation ◽

Infectious Risk ◽

Real Life Setting ◽

Cmv Disease ◽

Cmv Dnaemia

Conversion from calcineurin-inhibitors (CNIs) to belatacept can help kidney-transplant (KT) recipients avoid CNI-related nephrotoxicity. The risk of associated opportunistic infections (OPIs) is ill-defined. We conducted a multicentric cohort study across 15 French KT-centers in a real-life setting. Between 07-2010 and 07-2019, 453 KT recipients were converted from CNI- to belatacept-based therapy at 19 [0.13–431] months post-transplantation. Most patients, i.e., 332 (79.3%), were converted after 6-months post-transplantation. Follow-up time after conversion was 20.1 +/− 13 months. OPIs developed in 42(9.3%) patients after 14 +/− 12 months post-conversion. Eight patients (19%) had two OPI episodes during follow-up. Incidences of CMV DNAemia and CMV disease were significantly higher in patients converted before 6-months post-KT compared to those converted later (i.e., 31.6% vs. 11.5%; p < 0.001; and 11.6% vs. 2.4%, p < 0.001, respectively). Cumulative incidence of OPIs was 6.5 OPIs/100 person–years. Incidence of CMV disease was 2.8/100 person–years, of pneumocystis pneumonia 1.6/100 person–years, and of aspergillosis 0.2/100 person–years. Multivariate analyses showed that estimated glomerular filtration (eGFR) < 25 mL/min/1.73 m2 at conversion was independently associated with OPIs (HR = 4.7 (2.2 − 10.3), p < 0.001). The incidence of EBV DNAemia was 17.3 events /100 person–years. At 1-year post-conversion, mean eGFR had significantly increased from 32.0 +/− 18 mL/min/1.73 m2 to 42.2 +/− 18 mL/min/1.73 m2 (p < 0.0001). Conversion to belatacept is an effective strategy with a low infectious risk.

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Cardiovascular calcifications in kidney transplant recipients

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfab053 ◽

2021 ◽

Author(s):

Manuel Alfredo Podestà ◽

David Cucchiari ◽

Paola Ciceri ◽

Piergiorgio Messa ◽

José-Vicente Torregrosa ◽

...

Keyword(s):

Kidney Transplantation ◽

Kidney Transplant ◽

De Novo ◽

Immunosuppressive Drugs ◽

Current Evidence ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Increased Risk ◽

Cardiovascular Calcifications

AbstractVascular and valvular calcifications are highly prevalent in kidney transplant recipients (KTRs) and are associated with an increased risk of cardiovascular events, which represent the leading cause of long-term mortality in these patients. However, cardiovascular calcification has been traditionally considered as a condition mostly associated with advanced chronic kidney disease stages and dialysis, and comparatively fewer studies have assessed its impact after kidney transplantation. Despite partial or complete resolution of uraemia-associated metabolic derangements, KTRs are still exposed to several pro-calcifying stimuli that favour the progression of pre-existing vascular calcifications or their de novo development. Traditional risk factors, bone mineral disorders, inflammation, immunosuppressive drugs and deficiency of calcification inhibitors may all play a role, and strategies to correct or minimize their effects are urgently needed. The aim of this work is to provide an overview of established and putative mediators involved in the pathogenesis of cardiovascular calcification in kidney transplantation, and to describe the clinical and radiological features of these forms. We also discuss current evidence on preventive strategies to delay the progression of cardiovascular calcifications in KTRs, as well as novel therapeutic candidates to potentially prevent their long-term deleterious effects.

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Timing of antiretroviral therapy for HIV-infected patients with moderate-to-severe Pneumocystis pneumonia: study protocol for a multi-center prospective randomized controlled trial

10.21203/rs.3.rs-19306/v1 ◽

2020 ◽

Author(s):

Yuanyuan Qin ◽

Yanqiu Lu ◽

Yihong Zhou ◽

Vijay Harypursat ◽

Feng Sun ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Antiretroviral Therapy ◽

Opportunistic Infections ◽

Controlled Trial ◽

Pneumocystis Pneumonia ◽

Optimal Timing ◽

Randomized Controlled ◽

Art Initiation ◽

Prospective Randomized Controlled Trial ◽

Registration Number

Abstract Background: Pneumocystis pneumonia (PCP) is a common AIDS-related opportunistic infection. Recent reports estimate that more than 400,000 HIV patients develop PCP each year globally. However, the timing of antiretroviral therapy (ART) initiation for HIV infected patients with PCP is still controversial, and the benefits and risks of early initiation of ART are not completely clear. We thus designed this study in order to determine the optimal timing for ART initiation for HIV-positive patients with moderate to severe PCP.Methods: This study will be an open-labelled, multi-center, prospective, randomized controlled trial. A total of 200 subjects will be randomized to an early ART initiation group (≤14 days after PCP diagnosis), and a deferred ART initiation group (>14 days after PCP diagnosis) at a 1:1 ratio. All subjects will be followed up for 48 weeks after starting ART. The primary outcome is incidence of disease progression (including new opportunistic infections and all-cause mortality) at week 48. The secondary endpoints are the changes in CD4 counts from baseline at week 12, week 24 and week 48, the degree of virological suppression (HIV-RNA<50 copies/mL) at week 24 and week 48, the rate of development of PCP-associated immune reconstitution inflammatory syndrome (IRIS), and adverse events(AEs) at each visit.Discussion: We hope that the results of this study will reveal the optimal timing for initiation of ART in HIV-infected patients with moderate to severe PCP.Trial registration: This trial was registered as one of the twelve trials under the name of a general project at chictr.org.cn on February 1, 2019, and the registration number of the general project is ChiCTR1900021195.

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MO959KIDNEY TRANSPLANT TRANSITION FROM PEDIATRIC TO ADULT FACILITY CARE: DIFFICULTIES AND RISK FACTORS

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfab110.0038 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

Francesca Tinti ◽

Luca Salomone ◽

Michele Ferrannini ◽

Annalisa Noce ◽

Sandro Mazzaferro ◽

...

Keyword(s):

Kidney Transplantation ◽

Medical Care ◽

De Novo ◽

Transition Process ◽

Adherence Rate ◽

Post Transplant ◽

Transplant Centre ◽

Increased Risk ◽

Transplant Complications

Abstract Background and Aims Kidney transplantation (KTx) in pediatric ages is successful, leading to optimal patients and graft survival with indication, in adolescent age, to transition toward an adult transplant facility. To date, the transition process of adolescents and young adults with KTx is not well defined. Transfer to a different medical facility marks a vulnerable phase in the adolescents’ lives with an increased risk for non-adherence and allograft failure. Some studies report unexpected loss rates in kidney grafts as high as 24%–42% within 3 years after transfer. In addition, some studies show that the age ranging from 18 to 26 years is the age in which graft losses are most concentrated, an age that coincides with the transition. Several makers have been shown to influence non-adherence rate in kidney transplanted patients during transition: a bad doctor-patient relationship, the absence of specialized centers capable to face these particular needs and care requests, the lack of psychological support, and a low availability of specialized nurses. Moreover, many patients are lost to follow-up as the result of breakdowns in the transition and transfer to adult medical care. Method In this study we enrolled patients transited from the pediatric transplant Centre to the adult transplant nephrological facility between 2017 and 2020. Data of KTx, baseline renal disease, post-transplant medications and post-transplant complications were recorded. Follow-up of renal function were performed and analyzed during the transition process and forward during the adult follow-up. Results Data of 19 patients (pts) were analysed. Six were male (31.6%) and 13 female (68.4%). The cause of renal dysfunction was malformations in 10 patients (52.6%), glomerulonephritis (GN) in 5 pts (26.3%) and genetic syndromes in 4 pts (21.1%). They received the kidney transplantation at a median age of 12 years [IQR 10-18]. Median age at transition resulted 31 years [interquartile range (IQR) 30-33]. Seven pts (36.8%) had a history of post-transplant lymphoproliferative disease (PTLD). All patients were receiving steroids, 11 pts (57.9%) cyclosporine A and 8 pts (42.2%) tacrolimus; only 9 pts (47.4%) were receiving mycophenolate or azathioprine. The median follow-up at the adult Transplant Centre was 1 year [IQR 1-2]. After transition, five patients experienced complications: 2 pts developed PTLD de novo, 2 pts had a recurrence of native GN after reduction of immunosuppression for PTLD and pregnancies (one pt underwent re-tx), 1 pt experienced an acute cellular rejection after transition to another Centre and is developing ESRD. The median eGFR slightly decreased from baseline at transition to the last follow-up (80 ml/min/1.73 m2 at baseline [55-112]; 74 ml/min/1.73m2 at last follow-up [35-98]) but this was not significant (p=0.127). Conclusion Our results confirm that the transition from pediatric to adult transplant Centre is not a simple process. Several factors linked to the patient and to the kidney have to be considered in the development of post-transplant complications: the age of transplantation with long term immunosuppression; infections typical of pediatric ages that may develop in adulthood, such as EBV, that force to modulate immunosuppression exposing the patient to increased risk of rejection or recurrence of native disease; the exposure to different immunological stimuli and physiological events such as pregnancies in female patients. These patients may develop complications linked to non-adherence and low compliance to immunosuppressive medications, but also complications typical of adult age, like arterial hypertension, obesity, diabetes, and dyslipidemias. Therefore, defining effective practices for recipient transition and transfer from pediatric to adult medical care are essential to optimize the KTx patients follow-up and outcome.

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