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1. Duration of frontline therapy and impact on clinical outcomes in newly diagnosed multiple myeloma patients not receiving frontline stem cell transplant.

Author

Ailawadhi, Sikander, Ogbonnaya, Augustina, Murty, Sharanya, Cherepanov, Dasha, Schroader, Bridgette, Romanus, Dorothy, Farrelly, Eileen, and Chari, Ajai

Subjects
chemotherapy, clinical management, multiple myeloma, target therapy, Adult, Humans, Aged, Multiple Myeloma, Retrospective Studies, Stem Cell Transplantation, Progression-Free Survival, Disease Progression, Antineoplastic Combined Chemotherapy Protocols, Bortezomib
Abstract

BACKGROUND: Extended first-line therapy (1LT) has improved clinical outcomes in newly diagnosed multiple myeloma (NDMM). This retrospective study of NDMM patients evaluated the relationship between dose-attenuation of 1LT and duration of therapy (DOT) and DOT on outcomes. METHODS: Adults with NDMM not undergoing stem cell transplant (SCT) from January 1, 2012 toMarch 31, 2018 from the Integrated Oncology Network were included; 300 were randomly selected for chart review. 1LT DOT, time to next treatment (TTNT), progression-free survival (PFS), and overall survival (OS) were estimated using Kaplan-Meier analysis. Marginal structural models evaluated relationships between DOT and TTNT, PFS, and OS at 2 years accounting for confounders and survival bias from the time-dependent nature of DOT. RESULTS: Of 300 chart-reviewed patients, 93 were excluded for incomplete data or meeting exclusion criteria. Among 207 NDMM patients, median age was 74 years; 146 (70.5%) did not receive dose-attenuation during 1LT. Patients with short DOT were older, frailer, with a higher comorbidity burden, and a significantly lower proportion had an Eastern Cooperative Oncology Group PS = 0. As DOT increased, more patients underwent dose-attenuation (p

Published
2023

2. Real-world treatment utilization and economic implications of lupus nephritis disease activity in the United States.

Author

DallEra, Maria, Eaddy, Michael, Ogbonnaya, Augustina, Farrelly, Eileen, Turowski, Eric, Birardi, Vanessa, Solomons, Neil, Randhawa, Simrat, Mina-Osorio, Paola, and Kalunian, Kenneth

Subjects
Humans, Female, United States, Middle Aged, Male, Lupus Nephritis, Retrospective Studies, Mycophenolic Acid, Glucocorticoids, Lupus Erythematosus, Systemic, Health Care Costs, Kidney Failure, Chronic, Pharmaceutical Preparations
Abstract

BACKGROUND: Lupus nephritis (LN) is a common and severe complication of systemic lupus erythematosus (SLE), with approximately 40% of patients with SLE developing LN. Even with treatment, 10%-30% of patients will progress to end-stage renal disease (ESRD). Although many studies have assessed the clinical value of low disease activity in LN, the economic implications are less defined. OBJECTIVE: To evaluate treatment utilization and health care costs associated with active disease, low disease activity, and ESRD in patients with LN. METHODS: A retrospective analysis of Optum pharmacy and medical claims data from 2015 to 2019 was performed and included patients with a diagnosis of SLE (International Classification of Diseases, Ninth Revision or Tenth Revision codes 710.0 or M32, respectively) and additional prespecified criteria for LN. Total health care payer costs for medical and pharmacy services and treatment utilization for commonly prescribed medications were determined for periods of low disease activity, active disease, or ESRD. RESULTS: A total of 21,251 patients (mean age 60.3 years; 87% female; 55% White patients and 18% Black patients) with a mean follow-up period of 30.6 months were included; the majority of patients had active disease (67.3%), followed by low disease activity (51.3%), and ESRD (10.5%). Glucocorticoids were used 2 times more often and mycophenolate mofetil was used 4 times more often in patients with active disease vs low disease activity. Glucocorticoids, mycophenolate mofetil, and tacrolimus were more commonly used in patients with ESRD vs those with low disease activity. Mean medical costs were $4,777 per month in active disease and $18,084 per month in ESRD vs $2,523 per month in low disease activity. CONCLUSIONS: Treatment burden and costs are high for patients with active disease and ESRD in LN. Treatments that allow patients to achieve and maintain low disease activity may help improve patient outcomes and reduce medication use and overall health care costs. DISCLOSURES: Maria DallEra and Kenneth Kalunian are consultants of Aurinia Pharmaceuticals. Eric Turowski, Vanessa Birardi, Neil Solomons, Simrat Randhawa, and Paola Mina-Osorio are employees and stockholders of Aurinia Pharmaceuticals. Michael Eaddy is a former employee of Xcenda, LLC. Augustina Ogbonnaya and Eileen Farrelly are employees of Xcenda, LLC, which was contracted by Aurinia Pharmaceuticals to assist in the conduct of this study and the writing of this manuscript. Aurinia Pharmaceuticals provided funding for this study and the preparation of the manuscript. Aurinia Pharmaceuticals had a role in writing the report and decision to submit for publication.

Published
2023

3. Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US.

Author

Davies, Faith, Rifkin, Robert, Costello, Caitlin, Morgan, Gareth, Usmani, Saad, Abonour, Rafat, Palumbo, Antonio, Romanus, Dorothy, Hajek, Roman, Terpos, Evangelos, Cherepanov, Dasha, Stull, Dawn, Huang, Hui, Leleu, Xavier, Berdeja, Jesus, Lee, Hans, Weisel, Katja, Thompson, Michael, Boccadoro, Mario, Zonder, Jeffrey, Cook, Gordon, Puig, Noemi, Vela-Ojeda, Jorge, Farrelly, Eileen, Raju, Aditya, Blazer, Marlo, and Chari, Ajai

Subjects
Bortezomib, Carfilzomib, Daratumumab, Ixazomib, Lenalidomide, Pomalidomide, Proteasome inhibitor triplet therapy, Real-world, Relapsed refractory multiple myeloma, Aged, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Boron Compounds, Bortezomib, Female, Glycine, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Recurrence, Local, Oligopeptides, Retrospective Studies, Treatment Outcome
Abstract

Multiple available combinations of proteasome inhibitors, immunomodulators (IMIDs), and monoclonal antibodies are shifting the relapsed/refractory multiple myeloma (RRMM) treatment landscape. Lack of head-to-head trials of triplet regimens highlights the need for real-world (RW) evidence. We conducted an RW comparative effectiveness analysis of bortezomib (V), carfilzomib (K), ixazomib (I), and daratumumab (D) combined with either lenalidomide or pomalidomide plus dexamethasone (Rd or Pd) in RRMM. A retrospective cohort of patients initiating triplet regimens in line of therapy (LOT) ≥ 2 on/after 1/1/2014 was followed between 1/2007 and 3/2018 in Optums deidentified US electronic health records database. Time to next treatment (TTNT) was estimated using Kaplan-Meier methods; regimens were compared using covariate-adjusted Cox proportional hazard models. Seven hundred forty-one patients (820 patient LOTs) with an Rd backbone (VRd, n = 349; KRd, n = 218; DRd, n = 99; IRd, n = 154) and 348 patients (392 patient LOTs) with a Pd backbone (VPd, n = 52; KPd, n = 146; DPd, n = 149; IPd, n = 45) in LOTs ≥2 were identified. More patients ≥75 years received IRd (39.6%), IPd (37.8%), and VRd (36.7%) than other triplets. More patients receiving VRd/VPd were in LOT2 vs other triplets. Unadjusted median TTNT in LOT ≥ 2: VRd, 13.9; KRd, 8.7; IRd, 11.4; DRd, not estimable (NE); and VPd, 12.0; KPd, 6.7; IPd, 9.5 months; DPd, NE. In covariate-adjusted analysis, only KRd vs DRd was associated with a significantly higher risk of next LOT initiation/death (HR 1.72; P = 0.0142); no Pd triplet was significantly different vs DPd in LOT ≥ 2. Our data highlight important efficacy/effectiveness gaps between results observed in phase 3 clinical trials and those realized in the RW.

Published
2021

7. Disease Burden and Health-Related Quality of Life (HRQoL) of Chronic Obstructive Pulmonary Disease (COPD) in the US – Evidence from the Medical Expenditure Panel Survey (MEPS) from 2016-2019

Author

Roberts,Melissa H, Mannino,David, Mapel,Douglas W, Lunacsek,Orsolya, Amin,Shahla, Farrelly,Eileen, Feigler,Norbert, Pollack,Michael, Roberts,Melissa H, Mannino,David, Mapel,Douglas W, Lunacsek,Orsolya, Amin,Shahla, Farrelly,Eileen, Feigler,Norbert, and Pollack,Michael

Abstract

Melissa H Roberts,1 David M Mannino,2,3 Douglas W Mapel,4 Orsolya Lunacsek,5 Shahla Amin,5 Eileen Farrelly,5 Norbert Feigler,6 Michael F Pollack6 1College of Pharmacy, University of New Mexico, Albuquerque, NM, USA; 2College of Medicine, University of Kentucky, Lexington, KY, USA; 3COPD Foundation, Miami, FL, USA; 4Northern Arizona Pulmonary Associates, Flagstaff, AZ, USA; 5Global Consulting, Cencora, Conshohocken, PA, USA; 6BioPharmaceuticals, US Medical, AstraZeneca, Wilmington, DE, USACorrespondence: Michael F Pollack, BioPharmaceuticals, Global Medical Evidence, AstraZeneca, Wilmington, DE, USA, Email michael.pollack1@astrazeneca.comPurpose: Chronic obstructive pulmonary disease (COPD) is a progressive disease associated with reduced life expectancy, increased morbidity, mortality, and cost. This study characterized the US COPD burden, including socioeconomic and health-related quality of life (HRQoL) outcomes.Study Design and Methods: In this retrospective, cross-sectional study using nationally representative estimates from Medical Expenditures Survey (MEPS) data (2016– 2019), adults (≥ 18 years) living with and without COPD were identified. Adults living without COPD (control cohort) and with COPD were matched 5:1 on age, sex, geographic region, and entry year. Demographics, clinical characteristics, socioeconomic, and generic HRQoL measures were examined to include a race-stratified analysis of people living with COPD.Results: A total of 4,135 people living with COPD were identified; the matched dataset represented a weighted non-institutionalized population of 11.3 million with and 54.2 million people without COPD. Among people living with COPD, 66.3% had ≥ 1 COPD-related condition; 62.7% had ≥ 1 cardiovascular condition, compared to 33.5% and 50.5% without COPD. More people living with COPD were unemployed (56.2% vs 45.3%), unable to work due to illness/disability (30.1% vs 12.1%), had problems paying bills (16.1% vs 8.8%), reported poorer perceive

Published
2024

28. Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US

Author

Davies, Faith Rifkin, Robert Costello, Caitlin Morgan, Gareth Usmani, Saad Abonour, Rafat Palumbo, Antonio and Romanus, Dorothy Hajek, Roman Terpos, Evangelos Cherepanov, Dasha Stull, Dawn Marie Huang, Hui Leleu, Xavier and Berdeja, Jesus Lee, Hans C. Weisel, Katja Thompson, Michael and Boccadoro, Mario Zonder, Jeffrey Cook, Gordon Puig, Noemi Vela-Ojeda, Jorge Farrelly, Eileen Raju, Aditya and Blazer, Marlo Chari, Ajai

Abstract

Multiple available combinations of proteasome inhibitors, immunomodulators (IMIDs), and monoclonal antibodies are shifting the relapsed/refractory multiple myeloma (RRMM) treatment landscape. Lack of head-to-head trials of triplet regimens highlights the need for real-world (RW) evidence. We conducted an RW comparative effectiveness analysis of bortezomib (V), carfilzomib (K), ixazomib (I), and daratumumab (D) combined with either lenalidomide or pomalidomide plus dexamethasone (Rd or Pd) in RRMM. A retrospective cohort of patients initiating triplet regimens in line of therapy (LOT) >= 2 on/after 1/1/2014 was followed between 1/2007 and 3/2018 in Optum’s deidentified US electronic health records database. Time to next treatment (TTNT) was estimated using Kaplan-Meier methods; regimens were compared using covariate-adjusted Cox proportional hazard models. Seven hundred forty-one patients (820 patient LOTs) with an Rd backbone (VRd, n = 349; KRd, n = 218; DRd, n = 99; IRd, n = 154) and 348 patients (392 patient LOTs) with a Pd backbone (VPd, n = 52; KPd, n = 146; DPd, n = 149; IPd, n = 45) in LOTs >= 2 were identified. More patients >= 75 years received IRd (39.6%), IPd (37.8%), and VRd (36.7%) than other triplets. More patients receiving VRd/VPd were in LOT2 vs other triplets. Unadjusted median TTNT in LOT >= 2: VRd, 13.9; KRd, 8.7; IRd, 11.4; DRd, not estimable (NE); and VPd, 12.0; KPd, 6.7; IPd, 9.5 months; DPd, NE. In covariate-adjusted analysis, only KRd vs DRd was associated with a significantly higher risk of next LOT initiation/death (HR 1.72; P = 0.0142); no Pd triplet was significantly different vs DPd in LOT >= 2. Our data highlight important efficacy/effectiveness gaps between results observed in phase 3 clinical trials and those realized in the RW.

Published
2021

33. Real-World Treatment Patterns and Outcomes of Proteasome Inhibitor (PI: Bortezomib [V], Carfilzomib [K], or Ixazomib [I])-Lenalidomide/Dexamethasone (Rd)-Triplets By Prior Lenalidomide-Exposure in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Engaged in Routine Care in the United States (US)

Author

Sanchez, Larysa, primary, Cherepanov, Dasha, additional, Romanus, Dorothy, additional, Raju, Aditya, additional, Blazer, Marlo, additional, Farrelly, Eileen, additional, Stull, Dawn Marie, additional, and Ailawadhi, Sikander, additional

Published
2020
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34. Real-world outcomes and factors impacting treatment choice in relapsed and/or refractory multiple myeloma (RRMM): a comparison of VRd, KRd, and IRd

Author

Chari, Ajai, primary, Richardson, Paul G., additional, Romanus, Dorothy, additional, Dimopoulos, Meletios A., additional, Sonneveld, Pieter, additional, Terpos, Evangelos, additional, Hajek, Roman, additional, Raju, Aditya, additional, Palumbo, Antonio, additional, Cain, Lauren E., additional, Blazer, Marlo, additional, Huang, Hui, additional, Farrelly, Eileen, additional, and Ailawadhi, Sikander, additional

Published
2020
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35. Comparative Effectiveness of Triplets Containing Bortezomib (V), Carfilzomib (K), or Ixazomib (I) Combined with a Lenalidomide and Dexamethasone Backbone (Rd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) in Routine Care in the United States (US)

Author

Chari, Ajai, primary, Romanus, Dorothy, additional, Raju, Aditya, additional, Cain, Lauren, additional, Blazer, Marlo, additional, Farrelly, Eileen, additional, Stull, Dawn Marie, additional, and Ailawadhi, Sikander, additional

Published
2019
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37. Clinical and economic outcomes associated with the use of fluticasone propionate 250 mcg and salmeterol 50 mcg combination versus tiotropium bromide 18 mcg as initial maintenance treatment for chronic obstructive pulmonary disease in managed care

Author

Bell, Christopher F., Coutinho, Anna D., Farrelly, Eileen, Tasneem Lokhandwala, and Landsman-Blumberg, Pamela

Abstract

Aims: To examine the clinical and economic outcomes associated with the use of long-acting bronchodilators for initial maintenance treatment of chronic obstructive pulmonary disease (COPD) by analyzing health insurance claims data in the US. Methods: A retrospective, observational, matched cohort study used health insurance claims data (January 2008 to June 2013) to assess COPD-related outcomes for subjects aged ≥40 years. Subjects were assigned to a study cohort according to the first observed prescription fill for a long-acting bronchodilator (fluticasone propionate 250 mcg/salmeterol 50 mcg [FSC] or tiotropium bromide 18 mcg [TIO]). The analysis period for each subject comprised a 1-year pre-index date and 1-year post-index date. Primary outcome measure was total COPD-related costs per-patient per-year (PPPY) during the follow-up period. Secondary outcome measures included COPD-related exacerbations and the components of COPD-related costs. Results: Overall, 24,040 subjects were identified; the analysis sample consisted of 19,090 subjects (9,545 per cohort) with no significant differences between cohorts. Mean COPD-related total costs PPPY were numerically lower among the FSC cohort; however, the difference was not statistically significant ($2,224 [±4,108] vs $2,352 [±3,721], p = .057). There was no difference between cohorts for COPD-related medical costs (p = .894). COPD-related pharmacy costs were significantly, yet modestly, lower in the FSC cohort compared with the TIO cohort ($1,160 [±1,106] vs 1,275 [±1,110], p Limitations: While propensity scoring achieved balance in baseline characteristics, some residual confounding unobserved in the database may be present. Conclusions: Few clinical and economic differences between subjects initiating maintenance therapy with FSC or TIO were observed.

Published
2018
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41. Randomized Clinical Trial (RCT) Representativeness and Outcomes Among Relapsed/Refractory Multiple Myeloma (RRMM) Patients Treated in the Real World (RW): Comparison of ASPIRE, TOURMALINE MM1, POLLUX, AND ELOQUENT-2 RCTS

Author

Chari, Ajai, primary, Romanus, Dorothy, additional, Farrelly, Eileen, additional, Huang, Hui, additional, Blazer, Marlo, additional, Raju, Aditya, additional, Noga, Stephen, additional, Skacel, Tomas, additional, and Richardson, Paul, additional

Published
2018
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45. Overall survival (OS) in patients (pts) with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP): A real-world retrospective study.

Author

Hennenfent, Kristin L., primary, Girvan, Allicia C., additional, Chaudhry, Aafia, additional, Abada, Paolo, additional, Sheffield, Kristin, additional, Herren, Catherine K, additional, Raju, Aditya, additional, Farrelly, Eileen, additional, Bowman, Lee, additional, and Landsman-Blumberg, Pamela, additional

Published
2017
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50. Newly Diagnosed Multiple Myeloma (NDMM): Effect of Age, Renal Insufficiency (RI), & Cardiovascular (CV) Disease (dz) on Overall Survival (OS) & Treatment (tx) Patterns Among Stem Cell Transplant (SCT)-Ineligible Patients (pts) in the United States (US)

Author

Romanus, Dorothy, primary, Raju, Aditya, additional, Seal, Brian, additional, Farrelly, Eileen, additional, Skacel, Tomas, additional, Blazer, Marlo, additional, and Parameswaran, Hari, additional

Published
2017
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