Victoria Socha

DocwireNews

Patients with end-stage renal disease 
(ESRD) are at increased risk of morbidity and mortality associated with 
influenza compared with individuals in the general population. Patients with 
ESRD have an impaired innate and adaptive immune system, including defects in 
complement activation and B- and T-cell function, adding to the increased risks 
for complications from influenza, mortality, and increased healthcare costs. 
The recommendation from the Centers for Disease Control and Prevention (CDC) strongly 
recommend annual influenza vaccinations for patients with ESRD.At present, there are several types 
of influenza vaccines in the United States, including the standard-dose vaccine 
(SDV) and the high-dose vaccine (HDV). Standard practice in dialysis clinics is 
administration of the trivalent, and more recently quadrivalent, inactivated 
seasonal SDVs. In 2009, a trivalent HDV was licensed by the US FDA for use 
among adults &ge;65 years of age; the HDV contains the same three strains as the 
SDV, but has more antigen than standard vaccines (60 vs 15 mg per strain). Over time, use of the 
HDV among patients receiving maintenance dialysis has increased.A small observational study conducted 
among the dialysis population demonstrated that the HDV was more effective in 
preventing all-cause hospitalization during the 2016 to 2017 influenza season. 
However, the results were limited by the small sample size, adjustment for a 
small set of confounders, and the lack of outcomes related to influenza. Anne 
M. Butler, PhD, and colleagues recently conducted a cohort study to examine 
the effectiveness of standard-dose versus high dose influenza vaccine among 
patients on dialysis. Results were reported in the American Journal of 
Kidney Diseases [2020;75(1):72-83].Patients with chronic kidney disease 
receiving in-center maintenance dialysis during 2009 to 2015 were identified 
using data from the US Renal Data System. The researchers constructed yearly 
cohorts for five individual influenza seasons: 2010 to 2011, 2011 to 2012, 2012 
to 2013, 2013 to 2014, and 2014 to 2015. Eligible patients were &ge;18 years of 
age with ESRD who had initiated hemodialysis at least 9 months prior to the 
index date. Additional inclusion criteria were receipt of continuous 
hemodialysis for 3 months immediately prior to vaccination and Medicare as a 
primary insurance payer.There were three primary clinical 
outcomes of interest: (1) all-cause mortality; (2) the first occurrence of 
hospitalization for influenza or pneumonia; and (3) the first occurrence of 
influenza-like illness (ILI).Patients were eligible for inclusion 
in multiple yearly cohorts. The unit of analysis was the influenza 
patient-season. Propensity score weighting of Kaplan-Meier functions were used 
to estimate risk differences and risk ratios. A wide range of covariates were 
identified during the 6-month baseline period, including demographic 
characteristics (age, sex, race, dual-eligible for Medicaid, region, and year), 
clinical characteristics (cause of ESRD and duration of dialysis), dialysis 
facility characteristics (affiliation, type, profit status, and size), and 
comorbid conditions and procedures. Other covariates included preventive health 
services (other vaccinations and health screenings), health care utilization, 
and frailty. Timing of administration of the influenza vaccine was categorized 
as August or September versus October through the start of the influenza 
season.Following application of inclusion 
and exclusion criteria, the researchers identified 255,281 eligible adults who 
contributed 507,552 unique influenza patient-seasons. The primary analysis 
included 225,215 adults &ge;65 years of age; of those, 97.4% (n=219,439) of eligible 
vaccinations were SDV, and the remaining 2.6% (n=5776) received HDV. All HDV 
were trivalent; 76.7% of SDV were trivalent&nbsp; 
and 23.3% were quadrivalent.Mean age was slightly older among 
those who received the HDV compared with those who received SDV (75.8 years vs 
74.6 years). HDV administration was less common among patients who were black 
or other race, were dual-eligible for Medicaid, were on dialysis for &gt;3 
years, or resided outside of the Midwest. The prevalence of comorbid conditions 
was higher in recipients of HDV; frailty indicators were similar between those 
who received SDV and those who received HDV. Recipients of HDV were more likely 
to receive preventive healthcare such as diabetic eye examinations, lipid 
testing, and cancer screenings.After accounting for the competing 
risk of death for nonmortality outcomes, for each outcome of interest the 
weighted risks for HDV and SDV were similar. In the weighted analyses, there 
were similar associations between vaccine dose and risk for mortality (risk 
difference, &ndash;0.08%; 95% confidence interval [CI], &ndash;0.85% to 0.80%), 
hospitalization due to influenza or pneumonia (risk difference, 0.15%; 95% CI, 
&ndash;0.69% to 0.93%), and ILI (risk difference, 0.00%; 95% CI, &ndash;1.50% to 1.08%).Risks for mortality, hospitalization 
for influenza or pneumonia, and ILI within subgroups defined by influenza 
season, age group, dialysis vintage, month of influenza vaccination, and 
vaccine valence were generally similar between HDV and SDV recipients 
throughout the influenza season, with a few exceptions. In the 2010 to 2011 
season, there was a higher risk for hospitalization among patients who received 
the HDV compared with patients who received the SDV (risk difference, 2.85%; 
95% CI, 0.59% to 5.86%). There were no differences in risk in any of the other 
four seasons. For both hospitalization and ILI 
outcomes, the risk among HDV versus SDV recipients &ge;65 years of age was higher; 
the risk was lower among HDV versus SDV recipients 75 to 84 years of age. There 
was no difference in risk among those &lt;65 years of age or &ge;85 years of age.There were some limitations to the 
findings cited by the authors, including the observational design of the study 
that did not involve randomization of the exposure, only accounting for 
baseline characteristics measured prior to vaccination, the requirement of 
survival until 9 months following initiation of dialysis, and basing the study 
primarily on administrative billing claims data.In summary, the researchers said, 
&ldquo;Our large comparative study failed to demonstrate that HDV has superior 
effectiveness compared to SDV for preventing all-cause mortality and 
influenza-related outcomes among patients receiving maintenance hemodialysis. Given 
the findings of our population-level study, along with the substantially higher 
cost and side-effect profile of HDV compared to SDV, it appears that HDV should 
not conclusively be considered the standard of care at the present time for 
influenza immunization of patients treated by maintenance hemodialysis. The 
findings of our population-level study should not be interpreted to discourage 
influenza vaccination in the dialysis population. Rather, dialysis patients 
should continue to receive annual influenza immunization per CDC guidelines. In 
addition, future studies of alternative strategies (eg, booster doses) and alternative 
vaccine production technologies (eg, adjuvanted or cell-based vaccines) are 
warranted because there remains a need for improved influenza prevention 
efforts in this population.&rdquo;Takeaway Points<ol class="wp-block-list">
<li>Researchers conducted a cohort study 
to compare the effectiveness of standard-dose influenza vaccine (SDV) with 
high-dose influenza vaccine (HDV) in patients on maintenance hemodialysis.</li>
<li>Outcomes of interest were all-cause 
mortality, hospitalization for influenza or pneumonia, and influenza-like 
illness during the influenza season.</li>
<li>The findings suggested that the HDV 
does not provide additional protection beyond that of the SDV for adults on maintenance 
hemodialysis.</li>
</ol>

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