scholarly journals AB0196 SURVIVAL ANALYSIS OF TIME TO FIRST ADVERSE DRUG REACTION AND DRUG SURVIVAL IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH ADALIMUMAB AND ETANERCEPT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1122.1-1122
Author(s):  
M. Nguyen ◽  
K. Velthuis ◽  
J. Scholl ◽  
J. Jansen ◽  
L. Kosse ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Treatment ◽  
Median Survival ◽  
Exact Test ◽  
Drug Survival ◽  
Time Treatment ◽  
Kaplan Meier ◽  
Ada 95 ◽  
Continuous Use ◽  
First Time

Background:Treatment of rheumatoid arthritis (RA) with biologic disease-modifying antirheumatic drugs (bDMARDs) has been common practice in the last two decades. However, differences in patients experiencing adverse drug reactions (ADRs) between individual bDMARDs, such as adalimumab (ADA) and etanercept (ETN), during first time treatment has not been studied yet in real-world settings.Objectives:To compare proportions of RA patients experiencing ADRs as well as survival to first ADR and drug survival during treatment with ADA and ETN.Methods:Retrospective single centre cohort study including adult patients with RA, treated with either ADA or ETN between 1 January 2003 and 30 April 2020. The proportions of patients experiencing an ADR were compared by assessing the percentage of patients, treated with either ADA or ETN, experiencing at least one ADR during their first time treatment. Survival to first ADR and drug survival were assessed by calculating time between start of treatment and first ADR and start of treatment and discontinuation of treatment respectively. Stop and restart of treatment within 90 days was considered as continuous use. Differences in proportions were statistically tested using Fisher’s Exact Test. Differences in drug survival between ADA and ETN were tested by Kaplan-Meier analysis and Log Rank tests.Results:A total of 422 patients were included in this study (ADA 259, ETN 163). For 93 patients (21.2%) an ADR was registered during first time treatment. The proportion of patients experiencing at least one ADR during their first time treatment was 22.7% for ADA and 20.2% for ETN (p=0.628). Survival time to first ADR did not differ significantly between ADA and ETN (median survival ADA 10.34 years (95% CI [7.62-13.06], median survival ETN not reached, p=0.109, figure 1A). Median drug survival was 1.75 years for ADA (95 CI [1.38-2.11]) and 2.68 years for ETN (95% CI [1.73-3.64]). Drug survival differed significantly (p<0.001, figure 1B).Figure 1.Kaplan-Meier survival curves for adalimumab and etanercept with (a) survival to first ADR and (b) drug survival.Conclusion:Neither the proportion of patients experiencing ADRs nor survival to first ADR during first time treatment with ADA and ETN differed significantly. Drug survival of first time drug treatment of ADA was significantly lower compared to drug survival of first time drug treatment of ETN.Disclosure of Interests:My Nguyen: None declared, Kimberly Velthuis: None declared, Joep Scholl: None declared, Jurriaan Jansen: None declared, Leanne Kosse: None declared, Peter ten Klooster: None declared, Naomi Jessurun: None declared, Harald Vonkeman Consultant of: BMS, Celgene, Celltrion, Galapagos, Gilead, Janssen-Cilag, Lilly, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: Abbvie

scholarly journals POS0648 SURVIVAL ANALYSIS OF TIME TO FIRST ADVERSE DRUG REACTION AND DRUG SURVIVAL IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH METHOTREXATE AND HYDROXYCHLOROQUINE MONOTHERAPIES OR COMBINATION THERAPY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 562-563
Author(s):  
K. Velthuis ◽  
M. Nguyen ◽  
J. Scholl ◽  
J. Jansen ◽  
J. Van Lint ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Survival Analysis ◽  
Drug Use ◽  
Combination Therapy ◽  
Drug Discontinuation ◽  
Exact Test ◽  
Drug Survival ◽  
Kaplan Meier ◽  
First Time ◽  
Start Dates

Background:Methotrexate (MTX) and hydroxychloroquine (HCQ) are first line treatments of rheumatoid arthritis (RA). Adverse drug reactions (ADRs) during treatment with these drugs are common. Survival analysis on time to first ADR and on first time drug use duration have not yet been performed for these drugs in real-world settings.Objectives:To compare proportions of patients with ADRs during first time use of either MTX monotherapy, HCQ monotherapy or MTX+HCQ combination therapy and to compare survival to first ADR and drug survival between these drugs.Methods:Retrospective single centre cohort study including adult RA patients treated with either MTX monotherapy, HCQ monotherapy or MTX+HCQ combination therapy. First time users between 1 January 2003 and 30 April 2020 were followed until discontinuation of their first time drug use. The proportion of patients with ADRs was defined as the percentage of patients experiencing an ADR during their first time drug use. Survival to first ADR and drug survival of first time drug use were also assessed. MTX+HCQ use was considered combination therapy when the start dates of these drugs differed less than 14 days. For both monotherapies, end of first time drug use was defined as drug discontinuation for more than 90 days. For MTX+HCQ combination therapy, end of first time drug use was defined as discontinuation of either MTX, HCQ or both for more than 90 days. Differences in the proportion of patients experiencing an ADR during first time drug use of MTX, HCQ or a combination of both was statistically tested using Fisher’s Exact Test. Survival to first ADR and drug survival were studied by Kaplan-Meier analysis and statistically tested by performing Log Rank tests.Results:In total, 794 patients were included (MTX 363, HCQ 77, MTX+HCQ 354). For 156 patients (19.6%) at least one ADR was registered during first time drug use (MTX 59 [16.3%], HCQ 9 [11.7%], MTX+HCQ 88 [24.9%]). Proportions of ADRs differed significantly between MTX monotherapy and MTX+HCQ combination therapy (p=0.005) and between HCQ monotherapy and MTX+HCQ combination therapy (p=0.011). Survival to first ADR also differed significantly for both monotherapies compared to MTX+HCQ combination therapy (medians not reached, p<0.001 and p<0.008, respectively (figure 1A)). Drug survival differed significantly between MTX and HCQ monotherapy and between MTX monotherapy and MTX+HCQ combination therapy (median survival MTX 3.32 years (95% CI [2.81-3.83]; HCQ 1.39 years (95% CI [1.03-1.75]); MTX+HCQ 1.23 years (95% CI [1.11-1.34]), both p<0.001 (figure 1B)).Figure 1.Kaplan-Meier curves of MTX and HCQ monotherapies and MTX+HCQ combination therapy, with (a) survival to first ADR and (b) drug survival.Conclusion:Patients using MTX+HCQ combination therapy are more likely to experience an ADR during the first time drug use compared to MTX and HCQ monotherapies. MTX+HCQ combination therapy also leads to experiencing an ADR sooner compared to both monotherapies. Drug survival of patients treated with HCQ monotherapy as well as MTX+HCQ combination therapy is shorter compared to MTX monotherapy.Disclosure of Interests:Kimberly Velthuis: None declared, My Nguyen: None declared, Joep Scholl: None declared, Jurriaan Jansen: None declared, Jette van Lint: None declared, Peter ten Klooster: None declared, Harald Vonkeman Consultant of: BMS, Celgene, Celltrion, Galapagos, Gilead, Janssen-Cilag, Lilly, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: Abbvie, Naomi Jessurun: None declared

Reasons for Discontinuation and Adverse Effects of TNFα Inhibitors in a Cohort of Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

2016 ◽  
Vol 51 (5) ◽  
pp. 388-393 ◽  
Author(s):  
María Henar García-Lagunar ◽  
María Rocío Gutiérrez-Cívicos ◽  
María Sergia García-Simón ◽  
Pablo Conesa-Zamora ◽  
Enrique Jimenez-Santos ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Ankylosing Spondylitis ◽  
Adverse Effects ◽  
Dosage Regimen ◽  
Survival Rates ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Tnfα Inhibitors ◽  
Treatment Objective ◽  
Factor Α

Background: The introduction of anti–tumor necrosis factor α (anti-TNFα) drugs has improved the clinical outcomes in rheumatoid arthritis (RA) and ankylosing spondylitis (AS). However, these drugs may cause adverse effects that motivate a change in or discontinuation of the treatment. Objective: To evaluate the causes of discontinuation or changes in the dosage regimen in a cohort of patients with RA and AS treated with infliximab, adalimumab, etanercept, and golimumab under clinical practice conditions. Methods: This was a retrospective observational study that included patients with RA or AS treated with anti-TNFα drugs between 2008 and 2013. Changes in the dosage regimen, reasons for treatment discontinuation, and adverse effects were recorded and analyzed. Time to discontinuation was estimated using Kaplan-Meier survival analysis. Results: A total of 123 patients with RA and 93 patients with AS were treated with anti-TNFα therapy. During the study, 55.3% of RA patients and 41.7% of AS patients had stopped the treatment. The most frequent changes were modifications in the dosing, and the most frequent adverse effects were reactions after the infusion or injection (53.8% and 66.7% in RA and AS, respectively). Drug survival of etanercept in RA (67.9%) is greater than for adalimumab and infliximab, whereas drug survival of infliximab in AS (70.0%) is greater than for etanercept and adalimumab at 5 years, although there were no significant differences ( P = 0.098 in RA and 0.194 in AS). Conclusions: The main cause of discontinuation of anti-TNFα is therapeutic failure in both diseases. Etanercept and infliximab have the best survival rates in RA and AS, respectively.

Tolerance, survival and adherence to treatment with methotrexate in patients with rheumatoid arthritis

2019 ◽  
pp. 13-17
Author(s):  
J.M. Sevillano Gutierrez ◽  
D. Capelusnik ◽  
E.E. Schneeberger ◽  
G. Citera
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Descriptive Statistics ◽  
P Value ◽  
Multiple Logistic Regression ◽  
Adherence To Treatment ◽  
Exact Test ◽  
Cumulative Survival ◽  
Kaplan Meier ◽  
Chi2 Test

Background: Methotrexate (MTX) is the most frequently used medication in patients with Rheumatoid Arthritis (RA). However, several authors have questioned its success due to the presence of adverse events and the lack of adherence. Objectives: to determine cumulative survival of MTX, frequency and type of adverse events and causes of discontinuation in patients with RA. Methods: consecutive patients 18 years and older with a diagnosis of RA (ACR/EULAR 2010 criteria), who had begun treatment with MTX during their disease were included. Sociodemographic, clinical and therapeutic data were collected. Date of initiation and suspension of MTX, route of administration, concomitant treatments, consumption of coffee and tobacco, presence of adverse events (AE) were all consigned. Adherence was evaluated using the Compliance Questionnaire Rheumatology questionnaire 5-item summary version (CQR5). Statistical analysis: descriptive statistics. Chi2 test or Fisher’s exact test; Survival of treatment by Kaplan-Meier and log Rank. Multiple logistic regression. A p value <0.05 was considered significant.

scholarly journals Anti-Rheumatic Effect of Antisense Oligonucleotide Cytos-11 Targeting TNF-α Expression

2021 ◽  
Vol 22 (3) ◽  
pp. 1022
Author(s):  
Tatyana P. Makalish ◽  
Ilya O. Golovkin ◽  
Volodymyr V. Oberemok ◽  
Kateryna V. Laikova ◽  
Zenure Z. Temirova ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Gene Expression ◽  
Rat Model ◽  
Peripheral Blood ◽  
Antisense Oligonucleotide ◽  
Joint Inflammation ◽  
Blood Concentrations ◽  
Tnf Α ◽  
Effective Drugs ◽  
First Time

The urgency of the search for inexpensive and effective drugs with localized action for the treatment of rheumatoid arthritis continues unabated. In this study, for the first time we investigated the Cytos-11 antisense oligonucleotide suppression of TNF-α gene expression in a rat model of rheumatoid arthritis induced by complete Freund’s adjuvant. Cytos-11 has been shown to effectively reduce peripheral blood concentrations of TNF-α, reduce joint inflammation, and reduce pannus development. The results achieved following treatment with the antisense oligonucleotide Cytos-11 were similar to those of adalimumab (Humira®); they also compared favorably with those results, which provides evidence of the promise of drugs based on antisense technologies in the treatment of this disease.

scholarly journals Drug survival in rheumatoid arthritis

Rheumatology ◽  
2006 ◽  
Vol 45 (9) ◽  
pp. 1178-1178 ◽  
Author(s):  
D. Mulherin ◽  
M. Wong
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Survival

scholarly journals Secreted KIAA1199 promotes the progression of rheumatoid arthritis by mediating hyaluronic acid degradation in an ANXA1-dependent manner

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Wei Zhang ◽  
Guoyu Yin ◽  
Heping Zhao ◽  
Hanzhi Ling ◽  
Zhen Xie ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Hyaluronic Acid ◽  
Dependent Manner ◽  
Collagen Induced Arthritis ◽  
Intracellular Degradation ◽  
Main Pathway ◽  
First Time

AbstractIn inflamed joints, enhanced hyaluronic acid (HA) degradation is closely related to the pathogenesis of rheumatoid arthritis (RA). KIAA1199 has been identified as a hyaladherin that mediates the intracellular degradation of HA, but its extracellular function remains unclear. In this study, we found that the serum and synovial levels of secreted KIAA1199 (sKIAA1199) and low-molecular-weight HA (LMW-HA, MW < 100 kDa) in RA patients were significantly increased, and the positive correlation between them was shown for the first time. Of note, treatment with anti-KIAA1199 mAb effectively alleviated the severity of arthritis and reduced serum LMW-HA levels and cytokine secretion in collagen-induced arthritis (CIA) mice. In vitro, sKIAA1199 was shown to mediate exogenous HA degradation by attaching to the cell membrane of RA fibroblast-like synoviosytes (RA FLS). Furthermore, the HA-degrading activity of sKIAA1199 depended largely on its adhesion to the membrane, which was achieved by its G8 domain binding to ANXA1. In vivo, kiaa1199-KO mice exhibited greater resistance to collagen-induced arthritis. Interestingly, this resistance could be partially reversed by intra-articular injection of vectors encoding full-length KIAA1199 instead of G8-deleted KIAA119 mutant, which further confirmed the indispensable role of G8 domain in KIAA1199 involvement in RA pathological processes. Mechanically, the activation of NF-κB by interleukin-6 (IL-6) through PI3K/Akt signaling is suggested to be the main pathway to induce KIAA1199 expression in RA FLS. In conclusion, our study supported the contribution of sKIAA1199 to RA pathogenesis, providing a new therapeutic target for RA by blocking sKIAA1199-mediated HA degradation.

scholarly journals OP0211 TIME TO DISCONTINUATION OF TOFACITINIB AND TNF INHIBITORS IN RHEUMATOID ARTHRITIS PATIENTS WITH AND WITHOUT METHOTREXATE: DATA FROM A RHEUMATOID ARTHRITIS COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 131.2-132
Author(s):  
M. Movahedi ◽  
A. Cesta ◽  
X. LI ◽  
E. Keystone ◽  
C. Bombardier
Keyword(s):  
Rheumatoid Arthritis ◽  
Propensity Score ◽  
Best Practice ◽  
Practice Research ◽  
Research Support ◽  
Real World Data ◽  
Kaplan Meier ◽  
Rheumatoid Arthritis Cohort ◽  
Research Initiative ◽  
Significant Difference

Background:Tofacitinib (TOFA) is an oral, small molecule drug used for rheumatoid arthritis (RA) treatment and is prescribed alone or with methotrexate (MTX). Tofa can be used as an alternative to biologic disease modifying antirheumatic drugs (bDMARDs) including tumor necrosis factor inhibitors (TNFi).Objectives:We aimed to evaluate the discontinuation rate of this drug, with and without concurrent MTX in comparison with TNFi, in patients with RA in the Ontario Best Practices Research Initiative (OBRI).Methods:RA patients enrolled in the OBRI initiating their TOFA or TNFi (adalimumab, certolizumab, etancercept, golimumab, and infliximab) within 30 days prior to or any time after enrolment between 1stJune 2014 (TOFA approval date in Canada) and 31stDec 2018 were included. Time to discontinuation (due to any reason) were assessed using Kaplan-Meier survival (adjusted for propensity score using inverse probability of treatment weight) to compare patients with and without MTX use at initiation of TOFA or TNFi.Results:A total of 565 patients initiated TOFA (n=208) or TNFi (n=357). Of those, 106 (51%) and 222 (62%) were treated with MTX in the TOFA and TNFi group, respectively and mean (SD) disease duration were 13.1 (9.4) and 9.5 (9.4) years. In the TOFA group, 86% were female and mean (SD) age at treatment initation was 60.4 (10.6) years. In the TNFi group 82% were female and mean age (SD) at treatment initation was 57.0 (12.6) years. The TOFA group was more likely to have prior biologic use (61.5%) compared with the TNFi group (31%). At treatment initiation, the mean (SD) clinical disease activcity index was 24.8 (12.1) in the TOFA group and 21.8 (12.0) in the TNFi group.Over a mean of 17.3 month follow-up, discontinuation was reported in 75 (36%) and 103 (29%) of all TOFA and TNFi patients, respectively. After adjusting for propensity score, patients treated with TNFi and MTX remained on treatment longer than those treated without MTX (Logrank p=0.002) while there was no significant difference in TOFA discontinuation in patients with and without MTX (Logrank p=0.31).Conclusion:In this real world data study, we found that TOFA retention is similar in patients with and without MTX, while patients treated with TNFi and MTX remained on treatment longer than those treated without MTX. Merging data with other RA registries in Canada is proposed to increase study power and to provide more robust results.Disclosure of Interests:Mohammad Movahedi Consultant of: Allergan, Angela Cesta: None declared, Xiuying Li: None declared, Edward Keystone Grant/research support from: AbbVie; Amgen; Gilead Sciences, Inc; Lilly Pharmaceuticals; Merck; Pfizer Pharmaceuticals; PuraPharm; Sanofi, Consultant of: AbbVie; Amgen; AstraZeneca Pharma; Bristol-Myers Squibb Company; Celltrion; F. Hoffman-La Roche Ltd.; Genentech, Inc; Gilead Sciences, Inc.; Janssen, Inc; Lilly Pharmaceuticals; Merck; Myriad Autoimmune; Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis., Speakers bureau: AbbVie; Amgen; Bristol-Myers Squibb; Celltrion; F. Hoffman-La Roche Ltd, Janssen, Inc; Merck; Pfizer Pharmaceuticals; Sanofi-Genzyme; UCB, Claire Bombardier Grant/research support from: Dr Bombardier reports sources of funding for Ontario Best Practice Research Initiative Research grants from Abbvie, Janssen, Amgen, Medexus, Merck, Pfizer, and Novartis outside of the submitted work. Consulting Agreements: Abbvie, Covance, Janssen, Merck, Pfizer, Sanofi and Novartis outside of the submitted work. Advisory Board Membership: Hospira, Sandoz, Merck, Pfizer and Novartis outside of the submitted work.

scholarly journals AB0243 CONSIDERING THE COMBINATION OF TWO BIOLOGICS IN CASE OF FAILURE OF THE MONOTHERAPY IN JUVENILE ONSET RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1147.1-1147
Author(s):  
A. Haddouche ◽  
K. Ait Bellabas ◽  
W. F. Hamrani ◽  
S. Sahraoui ◽  
R. Fatma ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Alternative Therapy ◽  
Biologic Therapies ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Juvenile Onset ◽  
Multiple Treatment ◽  
Tnf Blocker ◽  
Different Types ◽  
First Time

Background:The management of rheumatoid arthritis refractory to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) is currently well codified and includes different types of biologics and even targeted sDMARDs. A rotation of biologic therapies is recommended in order to better control the disease.Methods:We report the case of a 20-year-old patient followed in our hospital for the management of a deforming and erosive seropositive rheumatoid arthritis (FR +, ACPA +) with a juvenile onset at the age of 8 years. The diagnosis of an immunopositive polyarticular form of JIA was retained in 2010 (9 years old); the patient was treated with methotrexate (MTX) at a dose of 10 mg per week and methylprednisolone at doses varying between 4 and 10 mg per day. Following the failure of MTX, etanercept was introduced for 6 months without success, followed by tocilizumab in 2012 at a dose of 8mg/kg/month for a year, without good response. In 2014, a course of rituximab (RTX) at a dose of 2 shots of 500mg, 2 weeks apart was prescribed followed 9 months later by etanercept at a dose of 50 mg a week for 3 years then by adalimumab (40mg/ week) because of the multiple treatment failures.In 2018, the repetition of RTX at a dose of 1g, renewed 15 days later, improved the patient for only 3 months. Then, a combination of two biologics, namely RTX (2 x 1g, 15 days apart) and adalimumab 1 month later (40mg / week) was received by the patient with a good response at 3 months. The latter was maintained for 7 months even after stopping the adalimumab following confinement for COVID-19. In September 2020, flares occurred and the adalimumab (ADA) has been delivered but without success during 3 months, stopped later for a benign form of COVID-19 (15 months after RTX). In January 2021, the association RTX + ADA was given again and we hope that it will be as effective as the first prescription.Results:The clinical and biological severity of our patient’s rheumatoid arthritis led us to give a combination of two biological treatments. Indeed, we do not have other therapeutic classes to deliver to her, that encouraged us to rotate between all the available biological therapies in our country. The combination of a CD20 inhibitor (RTX) with a TNF blocker (ADA) was safe and made possible, for the first time, the achievement of clinical and biological remission during 7 months, even after stopping the TNF blocker. Greenwald et al. reported the safety of the combination of RTX + TNF inhibitors in a randomized clinical trial in 51 patients. Its efficacy, a secondary goal of the study, was suggested at 24 weeks by the percentage of ACR 20 and ACR 50 responses that was greater than in the RTX placebo group.Conclusion:The combination of RTX with a TNF blocker can be a real alternative therapy in rheumatoid arthritis with failure to a biological monotherapy.Disclosure of Interests:None declared

Heart Transplantation for Pediatric and Congenital Cardiac Disease: A Comparison of Two Eras over 23 Years and 188 Transplants at a Single Institution

2021 ◽  
Vol 12 (1) ◽  
pp. 17-26
Author(s):  
Genevieve C. Tuite ◽  
James A. Quintessenza ◽  
Alfred Asante-Korang ◽  
Sharon R. Ghazarian ◽  
Bethany L. Wisotzkey ◽  
...  
Keyword(s):  
Heart Transplantation ◽  
Multivariable Analysis ◽  
Immunosuppressive Agent ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Congenital Cardiac Disease ◽  
Cox Proportional Hazard Models ◽  
One Year ◽  
Patterns Of Practice ◽  
First Time

Background: To assess changes in patterns of practice and outcomes over time, we reviewed all patients who underwent heart transplantation (HTx) at our institution and compared two consecutive eras with significantly different immunosuppressive protocols (cohort 1 [80 HTx, June 1995-June 2006]; cohort 2 [108 HTx, July 2006-September 2018]). Methods: Retrospective study of 180 patients undergoing 188 HTx (June 1995-September 2018; 176 first time HTx, 10 second HTx, and 2 third HTx). In 2006, we commenced pre-HTx desensitization for highly sensitized patients and started using tacrolimus as our primary postoperative immunosuppressive agent. The primary outcome was mortality. Survival was modeled by the Kaplan-Meier method. Univariable and multivariable Cox proportional hazard models were created to identify prognostic factors for survival. Results: Our 188 HTx included 18 neonates, 85 infants, 83 children, and 2 adults (>18 years). Median age was 260.0 days (range: 5 days-23.8 years). Median weight was 7.5 kg (range: 2.2-113 kg). Patients in cohort 1 were less likely to have been immunosensitized preoperatively (12.5% vs 28.7%, P = .017). Nevertheless, Kaplan-Meier analysis suggested superior survival in cohort 2 ( P = .0045). Patients in cohort 2 were more likely to be alive one year, five years, and ten years after HTx. Multivariable analysis identified the earlier era (hazard ratio [HR] [95% confidence interval] for recent era = 0.32 [0.14-0.73]), transplantation after prior Norwood operation (HR = 4.44 [1.46-13.46]), and number of prior cardiac operations (HR = 1.33 [1.03-1.71]) as risk factors for mortality. Conclusions: Our analysis of 23 years of pediatric and congenital HTx reveals superior survival in the most recent 12-year era, despite the higher proportion of patients with elevated panel reactive antibody in the most recent era. This improvement was temporally associated with changes in our immunosuppressive strategy.

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