Comparing the Clinical and Economic Outcomes Associated with Adjuvanted versus High-Dose Trivalent Influenza Vaccine among Adults Aged ≥ 65 Years in the US during the 2019–20 Influenza Season—A Retrospective Cohort Analysis

The burden of influenza is disproportionally higher among older adults. We evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent (aIIV3) compared to high-dose trivalent influenza vaccine (HD-IIV3e) against influenza and cardio-respiratory disease (CRD)-related hospitalizations/ER visits among adults ≥65 years during the 2019–2020 influenza season. Economic outcomes were also compared. A retrospective cohort analysis was conducted using prescription, professional fee claims, and hospital data. Inverse probability of treatment weighting (IPTW) was used to adjust for confounding. IPTW-adjusted Poisson regression was used to evaluate the adjusted rVE of aIIV3 versus HD-IIV3e. All-cause and influenza-related healthcare resource utilization (HCRU) and costs were examined post-IPTW. Recycled predictions from generalized linear models were used to estimate adjusted costs. Adjusted analysis showed that aIIV3 (n = 798,987) was similarly effective compared to HD-IIV3e (n = 1,655,979) in preventing influenza-related hospitalizations/ER visits (rVE 3.1%; 95% CI: −2.8%; 8.6%), hospitalizations due to any cause (−0.7%; 95% CI: −1.6%; 0.3%), and any CRD-related hospitalization/ER visit (0.9%; 95% CI: 0.01%; 1.7%). Adjusted HCRU and annualized costs were also statistically insignificant between the two cohorts. The adjusted clinical and economic outcomes evaluated in this study were comparable between aIIV3 and HD-IIV3e during the 2019–2020 influenza season.

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6. MF59 ASSURANCE 2: A Real-world Study to Estimate the Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to Egg-based Trivalent High-dose Among U.S. Older Adults During 2018–19 Influenza Season

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa417.005 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S3-S3

Author(s):

Stephen I Pelton ◽

Maarten Postma ◽

Victoria Divino ◽

Drishti Shah ◽

Joaquin F Mould-Quevedo ◽

...

Keyword(s):

Older Adults ◽

Influenza Vaccine ◽

Poisson Regression ◽

Influenza Season ◽

Cohort Analysis ◽

Vaccine Effectiveness ◽

High Dose ◽

Office Visits ◽

Research Support ◽

Trivalent Influenza Vaccine

Abstract Background In the 2018–19 influenza season, influenza resulted in almost 280,000 hospitalizations and over 25,000 deaths in U.S. adults > 65 years. This study aimed to evaluate the relative vaccine effectiveness (rVE) of adjuvant trivalent influenza vaccine (aTIV) compared to high-dose trivalent influenza vaccine (TIV-HD), against influenza-related hospitalizations/emergency room (ER) visits, office visits and hospitalization/ER visit for cardio-respiratory disease (CRD) among older adults for the 2018–19 flu season. Methods A retrospective cohort analysis of older adults (> 65 years) was conducted using professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, region, Charlson Comorbidity Index (CCI), comorbidities, indicators of frail health status, and pre-index hospitalization rates. Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE against influenza-related hospitalizations/ER visits and office visits and any hospitalization/ER visit for CRD (based on diagnoses codes). An unrelated outcome, urinary tract infection (UTI) hospitalization, was assessed. Results During 2018–19 flu season, following IPTW analyses, 561,315 recipients of aTIV and 1,672,779 of TIV-HD were identified. After IPTW adjustment and Poisson regression, aTIV was more effective in reducing influenza-related office visits compared to TIV-HD (6.6%; 95% CI: 2.8%-10.3%). aTIV was statistically comparable to TIV-HD (2.0%; 95% CI: -3.7%-7.3%) for prevention of influenza-related hospitalizations/ER visits but more effective than TIV-HD (2.6%; 95% CI: 2.0%-3.2%) in reducing hospitalizations/ER visits for CRD. No treatment effect was identified for control condition (UTI hospitalization). Conclusion In adjusted analyses, aTIV reduced influenza-related office visits and CRD hospitalizations/ER visits compared to TIV-HD. aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits. Disclosures Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Maarten Postma, Dr., IQVIA (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant) Girishanthy Krishnarajah, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder)

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25. Relative Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to Egg-Based Trivalent High-Dose Influenza Vaccine among U.S. Older Adults during 2019-20 Influenza Season

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.227 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S136-S136

Author(s):

myron J levin ◽

Victoria Divino ◽

Stephen I Pelton ◽

Maarten Postma ◽

Drishti Shah ◽

...

Keyword(s):

Older Adults ◽

Influenza Vaccine ◽

Poisson Regression ◽

Influenza Season ◽

Cohort Analysis ◽

Relative Effectiveness ◽

Geographic Region ◽

Negative Control ◽

High Dose ◽

Trivalent Influenza Vaccine

Abstract Background According to the Centers for Disease Control and Prevention (CDC), during the 2019-20 U.S. influenza season, influenza resulted in almost 180,000 hospitalizations and over 13,000 deaths in adults ≥ 65 years. The current study evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) compared to high-dose trivalent influenza vaccine (TIV-HD), against influenza-related hospitalizations/emergency room (ER) visits, all-cause hospitalizations and hospitalizations/ER visits for cardio-respiratory disease (CRD) among adults ≥65 years for the 2019-20 influenza season. Methods A retrospective cohort analysis of older adults (≥ 65 years) was conducted using IQVIA’s professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, geographic region, Charlson Comorbidity Index (CCI), comorbidities, indicators of frail health status, and pre-index hospitalization rates. To avoid any influenza outcome misclassification with COVID-19 infection, the study period ended March 7, 2020. Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE against influenza-related hospitalizations/ER visits, all-cause hospitalizations and any hospitalization/ER visit for CRD. An unrelated negative control outcome, urinary tract infection (UTI) hospitalization was included. Results During the 2019-20 influenza season, following IPTW, 798,987 recipients of aTIV and 1,655,979 recipients of TIV-HD were identified. After IPTW adjustment and Poisson regression, aTIV was statistically comparable to TIV-HD for prevention of influenza-related hospitalizations/ER visits (3.1%; 95% CI: -2.8%-8.6%) and all-cause hospitalizations (-0.7%; 95% CI: -1.6%-0.3%). Similar comparable outcomes were found for reduction of any hospitalization/ER visit for CRD (0.9%; 95% CI: 0.0%-1.7%). No treatment effect was identified for the negative control outcome. Conclusion aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits, all-cause hospitalizations and hospitalizations/ER visits for CRD. Disclosures myron J. levin, MD, GSK group of companies (Employee, Research Grant or Support) Victoria Divino, PhD, Seqirus (Consultant) Stephen I. Pelton, MD, Seqirus (Consultant) Maarten Postma, Dr., Seqirus (Consultant) Drishti Shah, PhD, Seqirus (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus (Employee) Mitchell DeKoven, PhD, Seqirus (Consultant)

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Evaluating the Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to High-Dose Trivalent and Other Egg-Based Influenza Vaccines among Older Adults in the US during the 2017–2018 Influenza Season

Vaccines ◽

10.3390/vaccines8030446 ◽

2020 ◽

Vol 8 (3) ◽

pp. 446

Author(s):

Stephen I. Pelton ◽

Victoria Divino ◽

Drishti Shah ◽

Joaquin Mould-Quevedo ◽

Mitch DeKoven ◽

...

Keyword(s):

Influenza Vaccine ◽

Influenza Season ◽

Cohort Analysis ◽

Vaccine Effectiveness ◽

The Other ◽

Influenza Vaccines ◽

High Dose ◽

Office Visits ◽

Trivalent Influenza Vaccine ◽

Respiratory Events

The influenza-related disease burden is highest among the elderly. We evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) compared to other egg-based influenza vaccines (high-dose trivalent (TIV-HD), quadrivalent (QIVe-SD), and standard-dose trivalent (TIVe-SD)) against influenza-related and cardio-respiratory events among subjects aged ≥65 years for the 2017–2018 influenza season. This retrospective cohort analysis used prescription claims, professional fee claims, and hospital charge master data. Influenza-related hospitalizations/ER visits and office visits and cardio-respiratory events were assessed post-vaccination. Inverse probability of treatment weighting (IPTW) and Poisson regression were used to evaluate the adjusted rVE of aTIV compared to other vaccines. In an economic analysis, annualized follow-up costs were compared between aTIV and TIV-HD. The study was composed of 234,313 aTIV, 1,269,855 TIV-HD, 212,287 QIVe-SD, and 106,491 TIVe-SD recipients. aTIV was more effective in reducing influenza-related office visits and other respiratory-related hospitalizations/ER visits compared to the other vaccines. For influenza-related hospitalizations/ER visits, aTIV was associated with a significantly higher rVE compared to QIVe-SD and TIVe-SD and was comparable to TIV-HD. aTIV was also associated with a significantly higher rVE compared to TIVe-SD against hospitalizations/ER visits related to pneumonia and asthma/COPD/bronchial events. aTIV and TIV-HD were associated with comparable annualized all-cause and influenza-related costs. Adjusted analyses demonstrated a significant benefit of aTIV against influenza- and respiratory-related events compared to the other egg-based vaccines.

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Dose-Intensive (R-HCVAD) and High Dose Therapy (ASCT) Frontline Strategies More Than Double PFS Over Standard Therapy in MCL Patients

Blood ◽

10.1182/blood.v120.21.3658.3658 ◽

2012 ◽

Vol 120 (21) ◽

pp. 3658-3658

Author(s):

Anthony R Mato ◽

Ewelina A Protomastro ◽

Tania Zielonka ◽

Tatyana Feldman ◽

Scott D Rowley ◽

...

Keyword(s):

Board Of Directors ◽

Retrospective Cohort ◽

Cohort Analysis ◽

High Dose ◽

Single Center ◽

Front Line ◽

Advisory Committees ◽

Retrospective Cohort Analysis ◽

Lr Test ◽

Line Setting

Abstract Abstract 3658 Background: While current front-line treatment options for the management of MCL are still debated, a growing consensus in the lymphoma community suggest that MCL pts show superior outcomes with either consolidative ASCT or dose-intensive treatment approaches over CHOP-like regimens and that cytarabine containing regimens achieve earlier and deeper (hence more durable) responses. On the other hand, such dose-intensive strategies can be difficult to administer to the elderly (a relevant issue with a median age at diagnosis of mid 60's) or in pts with comorbidities. Few studies have looked at the comparative effectiveness of initial therapies in MCL in the community setting. Methods: Utilizing KM and Cox regression analyses, we performed a single-center, retrospective cohort analysis to describe the survival experience of 139 MCL pts (med follow up 50 months) treated in the front-line setting with R-CHOP (n=35), R-HCVAD (n=63) or induction-chemotherapy followed by HDT-ASCT (n=41). The primary endpoints of this retrospective cohort analysis were overall (OS) and progression free survival (PFS). The proportional hazards assumption was met for this analysis. Results: The JTCC MCL outcomes database contains 214 total patient entries (newly dx + relapsed MCL) from 1993–2012 of which 139 pts met inclusion/exclusion criteria with complete outcomes data available. The R-CHOP, R-HCVAD and HDT-ASCT groups were comparable in terms of known prognostic factors including age (median 60), ECOG PS (median 1), MIPI score (median score 4, 30% int risk, 29% high risk) and Ki-67 (median 30% and range 5–95%). The median PFS was superior for pts treated with either R-HCVAD (53 months) or ASCT (63 months) (p=<.001, LR test, Figure) compared to R-CHOP (24 months). No significant difference (HR 1.15, p=.7, 95%CI .5–2.5) in PFS could be detected between pts age < 65 vs. those age >= 65 (n=25) treated with either R-HCVAD (med PFS 46 months) or HDT-ASCT (med PFS 54 months). Median OS favored pts treated with R-HCVAD or HDT-ASCT (103 months and 108 months respectively) over R-CHOP (67 months) but did not meet statistical significance (p=.16, LR test). Conclusions: These data represent the largest published single center experience of MCL patients treated in the front-line setting. Our results confirm a recent NCCN report showing benefit of dose-intensive/high dose strategies in MCL over conventional therapy with more than doubling median PFS over R-CHOP. Of notice when compared to recently updated STiL trial (Rummel ASCO 2012, abst #3) our results are c/w with a median PFS of 22 months after R-CHOP but appear superior to med PFS (35 months) seen with bendamustine-rituximab in MCL even in a subset of elderly pts >= age 65. Our results support the use of dose-intensive strategies in a fit geriatric patient population. Finally the excellent PFS seen in that setting represents a promising platform for integrating novel agents in combination and/or maintenance in future strategies to prevent recurrence and continue to improve MLC pts outcome. Disclosures: Mato: Genentech: Speakers Bureau; Seattle Genetics: Speakers Bureau; Millennium: Speakers Bureau; Celgene: Speakers Bureau. Feldman:Allos: Speakers Bureau; celgene: Speakers Bureau; Seattle Genetics: Speakers Bureau; Merck: Speakers Bureau. Goy:Milennium: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; J & J: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees.

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29. Impact of Enhanced Influenza Vaccines on Direct Healthcare Costs for the U.S. Elderly: A Comprehensive Real-World Evaluation of Adjuvanted Trivalent Influenza Vaccine Compared to Trivalent High-Dose Influenza Vaccine for the 2018–19 Influenza Season

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.074 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S38-S39

Author(s):

Maarten Postma ◽

Stephen I Pelton ◽

Victoria Divino ◽

Joaquin F Mould-Quevedo ◽

Drishti Shah ◽

...

Keyword(s):

Influenza Vaccine ◽

Healthcare Costs ◽

Influenza Season ◽

Elderly Subjects ◽

High Dose ◽

Office Visits ◽

Research Support ◽

Physician Office ◽

Trivalent Influenza Vaccine ◽

The U.S

Abstract Background Influenza generates a substantial economic burden ($3.2B in the U.S. annually) due to direct medical costs such as physician office visits or hospitalizations, especially among the elderly. Recent published literature for the 2018–19 influenza season has demonstrated similar clinical effectiveness between adjuvanted trivalent influenza vaccine (aTIV) and trivalent high dose influenza vaccine (TIV-HD). This research aimed to assess the annualized mean all-cause and influenza-related healthcare costs among subjects 65+ years vaccinated with aTIV or TIV-HD during the 2018–19 influenza season. Methods A retrospective cohort analysis was conducted using professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, region, Charlson Comorbidity Index, comorbidities, indicators of frail health status, and pre-index hospitalization rates. Treatment selection bias was adjusted through 1:1 propensity score matching (PSM). Economic outcomes included annualized mean all-cause costs and influenza-related costs, which comprised influenza-related hospitalizations, emergency room (ER) visits, and physician office visits costs. Mean costs were compared using paired t-test. Adjusted analyses were conducted using generalized estimating equation (GEE) models, with two-part models for influenza-related costs. With the GEEs, adjustment for outliers (99th percentile) were addressed and predicted healthcare costs were obtained through bootstrapping (500 replications). Results During the 2018–19 influenza season, the PSM sample comprised 561,243 recipients of aTIV and 561,243 recipients of TIV-HD. Following GEE adjustment, predicted mean annualized all-cause and influenza-related costs per patient were statistically similar between aTIV and TIV-HD (US$9,676 vs. US$9,625 and US$23.75 vs. US$21.79, respectively). Both aTIV and TIV-HD were comparable in terms of predicted mean annualized costs for influenza-related hospitalizations (US$20.28 vs. US$18.13) and influenza-related office visits (US$1.29 vs. US$1.34). Conclusion In adjusted analyses, total all-cause and influenza-related healthcare costs were comparable among elderly subjects vaccinated with either aTIV or TIV-HD. Disclosures Maarten Postma, Dr., IQVIA (Consultant) Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant) Girishanthy Krishnarajah, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder)

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