Bone Targeting Agent Treatment Patterns Among Patients with Multiple Myeloma Treated at Oncology Clinics Across the United States: Observations from Real-World Data

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2364-2364
Author(s):  
Christopher Kim ◽  
Rohini K. Hernandez ◽  
Paul C Cheng ◽  
Jeremy Smith ◽  
Lori Cyprien ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Real World ◽  
The United States ◽  
Treatment Patterns ◽  
First Year ◽  
Real World Data ◽  
Employment Equity ◽  
The Us ◽  
Equity Ownership

Abstract Introduction: Multiple myeloma (MM) is a hematologic malignancy with 30,330 estimated new cases in the US in 2016. The International Myeloma Working Group recommended that intravenous (IV) bisphosphonates be initiated in all patients with active MM administered at 3 to 4-week intervals. However, there are limited data to date on the real-world use of bone target agents (BTA; zoledronic acid and pamidronate disodium) in MM. The primary goal of this study is to describe current real-world BTA treatment patterns. Methods: A database of electronic medical records from >1 million patients treated at approximately 220 cancer centers across the United States, OSCER (Oncology Services Comprehensive Electronic Records, generated by Flatiron Health), was used to identify individuals 18 years or older diagnosed with MM (ICD-9 203.00; ICD-10 C90.00) with at least 1 clinic visit within 1 month of diagnosis date between January 1, 2009 and March 31, 2016. Timing of BTA administrations, frequency, schedule, and changes/discontinuation were calculated, renal function, and BTA treatment relative to anti-MM therapy regimens was also determined. Results: During the study period, 11,099 patients were diagnosed with MM; most were male (55%), white (59%), and 65 and older at diagnosis (66%). Through the end of the follow-up period (median follow-up: 687 days), 64% of patients received ≥1 administration of a BTA (% consistent across study period) and zoledronic acid was the predominant BTA (93% of patients received ≥1 administration). The mean time from MM diagnosis until first BTA was 105.7 days (median: 29, IQR: 11-78). In more recent years, the time to BTA initiation decreased. Initial BTA treatment occurred in first year after MM diagnosis in 58.7% of patients. By calendar year of diagnosis, the percentage of patients that ever received BTA treatment had decreased over time (2009-2010: 72.3%; 2011-2012: 68.0%; 2013-2014: 63.6%). Most BTA administrations were dosed on a Q4W schedule (77%), particularly in the first year of MM diagnosis (84%). A total of 2,350 patients (33.2%) either discontinued or changed BTA dosing scheduling through the end of follow-up. Approximately 54% of patients that received a first line anti-MM therapy received BTA concomitantly; in second line, concomitant BTA was 59%, and in third line, 55%. Conclusions: Real-world data from oncology practices across the US indicate that approximately two-thirds of MM patients received BTA treatment, and the treatment rate did not increase in more recent years. Additionally, few patients continued BTA beyond 2 years. Among BTA treated patients, BTA initiation occurred at approximately 3.5 months after diagnosis, and the majority of administrations followed a Q4W schedule with zoledronic acid. Further work will explore reasons for non-treatment and treatment discontinuation with particular attention given to potential contraindications such as renal impairment, and the added burden of IV therapy in MM. Disclosures Kim: Amgen Inc.: Employment, Equity Ownership. Hernandez:Amgen: Employment, Equity Ownership. Cheng:Amgen: Employment, Equity Ownership. Smith:Amgen: Consultancy. Cyprien:Amgen: Consultancy. Liede:Amgen: Employment, Equity Ownership.

scholarly journals Epidemiology of PNH and Real-World Treatment Patterns Following an Incident PNH Diagnosis in the US

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3407-3407 ◽  
Author(s):  
Jessica J Jalbert ◽  
Umesh Chaudhari ◽  
Haixin Zhang ◽  
Jonathan Weyne ◽  
Jamile M. Shammo
Keyword(s):  
Incidence Rate ◽  
Real World ◽  
Treatment Duration ◽  
Research Funding ◽  
The United States ◽  
Treatment Patterns ◽  
Employment Equity ◽  
Equity Ownership ◽  
Procedure Codes ◽  
Rbc Transfusion

Introduction: Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired, life-threatening blood disease. While PNH is known to be a rare disease, the incidence and prevalence of the condition has been described only in a few small studies. In addition, while the International PNH registry is a rich source of data on real-world PNH patients globally, it is not possible to estimate the incidence and prevalence of PNH directly from the registry. As complement inhibitors are becoming the standard of care for PNH treatment, we also sought to explore how patients are managed following an incident PNH diagnosis. The objective of this study was to estimate the incidence and prevalence of PNH and to describe real-world treatment patterns among patients newly diagnosed with PNH in the United States (US). Methods: We conducted a retrospective cohort study using Truven US MarketScan Commercial/Medicare data (1 Jan 2015 to 30 June 2018), an employer-sponsored insurance claims database including annually approximately 30 million insured patients and their dependents' complete longitudinal records of inpatient services, outpatient services, and prescription drug claims covered under a variety of fee-for-service and capitated health plans. While these data are considered nationally representative of Americans with employer-provided health insurance, data come mainly from large employers. To estimate prevalence, we identified patients with ≥ 1 PNH diagnosis (ICD10: D59.5) among persons continually enrolled in the databases in 2017. To estimate incidence, we required ≥1-year of baseline enrolment and no PNH diagnosis or eculizumab exposure, identified using national drug codes [NDC] or procedure codes for drug administration, during the baseline period. Person-time accrued post-baseline until PNH diagnosis, end of study period, or disenrollment. We stratified incidence and prevalence estimates by age and sex and described patients with incident PNH in terms of demographics, comorbidities, and past-year healthcare resource utilization. Using Kaplan-Meier estimators, we estimated incidence of eculizumab initiation, timing of initiation, treatment duration, and risk of discontinuation/treatment holiday (>42 days between eculizumab exposures [i.e. 14-day exposure period + 28-day grace period between infusions], the equivalent of missing 2 infusions assuming a bi-weekly infusion schedule for eculizumab) following the incident PNH diagnosis. While accounting for censoring, we also investigated patterns of red blood cell (RBC) transfusions, identified using procedure codes, in terms of incidence and timing of first transfusion following an incident PNH diagnosis. Results: The prevalence of PNH varied little between 2016 and 2017, from 12 to 13 per 1,000,000. The incidence rate over the study period was 5.7 per 1,000,000 person-years, representing 257 incident PNH cases. The incidence rate of PNH increased with age and was similar across sex. At diagnosis, mean age was 50.0 years (standard deviation [SD]: 18.6), 3.1% (8/257) were less than 18 years, 52.1% were women, 19.5% had a past-year diagnosis of aplastic anemia, 8.2% had a past-year diagnosis of myelodysplastic syndrome, 14.0% had a past-year RBC transfusion, and 31.5% had been hospitalized in the past-year. Over a mean follow-up time of 385.6 days (SD: 253.2), 10.3% (95% confidence interval [CI]: 6.3-14.1%) of patients initiated eculizumab on average 60.5 days (SD: 55.9) from PNH diagnosis. At 1 year, about one third of patients discontinued eculizumab or had taken a treatment holiday; average treatment duration was 328.2 days (SD:245.4). Cumulative incidence of RBC transfusions at 6 months and 1 year was 14.6% (10.1-18.9%) and 17.4% (12.2-22.3%), respectively. On average, the first RBC transfusion occurred within 63.6 days (SD: 114.4) of an incident PNH diagnosis. Conclusions: In routine clinical practice, only a minority of patients recently diagnosed with PNH are initiated on eculizumab. Among PNH patients treated with eculizumab, less than 70% remain on treatment after 1 year. Findings must be interpreted in the context of limitations including lack of information on clone size, symptom burden, measures of disease activity, or bone marrow failure state which may affect treatment course. Future studies should explore factors affecting eculizumab initiation and persistence on treatment. Disclosures Jalbert: Regeneron Pharmaceuticals, Inc.: Employment, Equity Ownership. Chaudhari:Regeneron Pharmaceuticals, Inc.: Employment, Equity Ownership. Zhang:Regeneron Pharmaceuticals, Inc.: Employment, Equity Ownership. Weyne:Regeneron Pharmaceuticals, Inc.: Employment, Equity Ownership. Shammo:Incyte: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Alexion: Consultancy, Honoraria, Research Funding, Speakers Bureau; Onconova: Research Funding; Apellis: Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Speakers Bureau; Astex Pharma: Research Funding; Novartis: Consultancy, Honoraria; Otsuka: Consultancy, Honoraria; CTI Pharma: Research Funding.

scholarly journals 1358. A Real-World Study of the Burden of Illness and Treatment Patterns Among Patients with Uncomplicated Urogenital Gonorrhea in the United States

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S765-S766
Author(s):  
Madison T Preib ◽  
Fanny S Mitrani-Gold ◽  
Ziyu Lan ◽  
Xiaoxi Sun ◽  
Ashish V Joshi
Keyword(s):  
Real World ◽  
Healthcare Costs ◽  
Linear Models ◽  
Burden Of Illness ◽  
Unmet Need ◽  
The United States ◽  
Prescribing Practices ◽  
Real World Data ◽  
The Us

Abstract Background Gonorrhea (GC) is a major public health threat in the US. The Centers for Disease Control and Prevention (CDC) estimated direct healthcare costs of &271 million in 2018. CDC 2015 guidelines (applicable up to December 18, 2020) recommended cephalosporin plus azithromycin for GC. We used real-world data to assess patterns of inappropriate or suboptimal (IA/SO) or appropriate and optimal (AP&OP) antibiotic (AB) prescription (by CDC 2015 guidelines), and related healthcare costs, in US patients with uncomplicated urogenital GC (uUGG) diagnosed from July 1, 2013–June 30, 2018. Methods A retrospective cohort study of IBM MarketScan data (commercial/Medicare claims) in patients ≥ 12 years old with uUGG. Eligible patients had an AB prescription ±5 days of uUGG diagnosis (index date) and continuous health-plan enrollment with ≥ 6 months’ baseline/≥ 12 months’ follow-up data. Patients with complicated urogenital GC were excluded. Patients were stratified by AB prescription (IA/SO or AP&OP; defined in Table 1) during the first uUGG episode (ie, within 30 days of index). Generalized linear models were used for multivariate analysis. Table 1. Definitions of appropriateness of AB prescriptions Results Of 2847 patients with uUGG (58.5% male), 77.1% had an IA/SO prescription (mostly due to IA AB class [~82.0%] and duration [24.0%]), while only 22.9% had an AP&OP prescription; uUGG episodes were more frequent with IA/SO (n=2386) than AP&OP (n=714) prescriptions during follow-up. Patients with IA/SO prescriptions had higher GC-related total adjusted costs per patient (PP) per index episode (&196) vs those with AP&OP prescriptions (&124, p < 0.0001; Figure). Patients with IA/SO prescriptions also had higher GCrelated total adjusted costs PP during follow-up (&220) vs those with AP&OP prescriptions (&148, p < 0.0001), mostly driven by higher outpatient ambulatory and emergency room (ER) adjusted costs with IA/SO (&148 and &71, respectively) vs AP&OP prescriptions (&129 and &12, respectively, p ≤ 0.0152; Figure). ER visits PP at index and during follow-up were higher with IA/SO vs AP&OP prescriptions (p < 0.0001; Table 2). Figure. GC-related costs per patient with uUGG, stratified by appropriateness of AB prescription* Table 2. GC-related HRU per patient with uUGG, stratified by AB prescription Conclusion Most patients with uUGG were not prescribed treatments in accordance with CDC 2015 guidelines. High IA/SO AB prescriptions and associated healthcare costs suggest an unmet need for improved prescribing practices for uUGG in the US. Disclosures Madison T. Preib, MPH, STATinMED Research (Employee, Former employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Ziyu Lan, MSc, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Xiaoxi Sun, MA, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

Abstract 307: Real-world Clinical Characteristics and Recurrence Burden of Patients Diagnosed With Recurrent Pericarditis in The United States

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
David Lin ◽  
Christine Majeski ◽  
Maral DerSarkissian ◽  
Matt Magestro ◽  
Cristi Cavanaugh ◽  
...  
Keyword(s):  
Real World ◽  
The United States ◽  
Recurrent Pericarditis ◽  
Real World Data ◽  
Acute Pericarditis ◽  
The Us ◽  
History Of ◽  
Artery Disease ◽  
First Recurrence

Introduction: Real-world data describing acute pericarditis (AP) etiology in the US are limited. Data on the characteristics of recurrent pericarditis (RP) patients (pts) are also sparse. To fill this gap, our study assesses longitudinal data from a nationwide privately-insured population. Methods: OptumHealth Reporting and Insights employer claims data (1/2007-3/2017) were used. AP pts were identified and categorized as idiopathic or non-idiopathic etiology based on presence or absence of attributable conditions. Among idiopathic AP pts, a subgroup of RP pts was identified. Recurrence was defined as ≥2 AP events separated by >4 weeks. First recurrence date marked the index date. Pts aged ≥18 years with ≥12 months of continuous enrollment pre-index (baseline) were included. Results: Of 17,168 AP pts, 4,175 (24.3%) had non-idiopathic and 12,993 (75.7%) had idiopathic etiology (Table 1). Application of inclusion criteria left 8,822 idiopathic AP pts, of whom 1,604 (18.2%) had ≥1 recurrence during a mean observation period of 29 months. On average, idiopathic RP pts were aged 50.7 years, 51.6% female, and 42.3% had baseline history of hypertension, 23.8% of coronary artery disease, 11.7% of hypercholesterolemia, and 7.3% of myocardial infarction. Mean (±SD) time from initial AP diagnosis to first recurrence was 8.7 (±12.1) months and mean (±SD) number of recurrences was 1.7 (±1.3) per pt. In idiopathic RP pts with ≥4 years of follow-up after the initial AP diagnosis (N=512), 35.9% had ≥2, 18.2% had ≥3, and 9.8% had ≥4 recurrences within 4 years. Conclusions: The etiologic distribution and proportion of pts with RP are consistent with previous reports. About 36% of RP pts experience ≥2 recurrences after AP diagnosis over 4 years. RP represents a significant clinical burden for affected pts.

scholarly journals Treatment Patterns and Outcomes of Relapsed/Refractory Peripheral T-Cell Lymphoma (RR-PTCL) Patients Treated in the Community Oncology Setting

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1656-1656
Author(s):  
Chadi Nabhan ◽  
Jalyna Laney ◽  
Joseph Feliciano ◽  
Choo Hyung Lee ◽  
Andrew J Klink
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Novel Therapies ◽  
Employment Equity ◽  
The Real ◽  
Community Oncology ◽  
The Us ◽  
Equity Ownership

Abstract Introduction: The majority of PTCL cases are pathologically heterogeneous, aggressive and chemorefractory; nearly 70% of patients who undergo induction chemotherapy develop RR disease. Data on how RR-PTCL patients are managed outside of clinical trials and academic settings have not been adequately studied. Understanding how PTCL patients are treated in the real world allows better design of future clinical trials and refined development of novel therapies. This study aimed to describe contemporary treatment patterns, clinical characteristics, and overall survival (OS) among RR-PTCL patients treated in the US community oncology setting. Methods: We conducted a retrospective, observational cohort study of RR-PTCL patients treated between 1/1/2010-12/31/2016. Data were collected from patient medical records abstracted from 30 community oncologists across all geographic areas in the US (38% South, 22% West, 7% Midwest, 26% Northeast, and 7% unknown). Patient characteristics, treatment patterns, adverse events (AEs), physician-reported response to first- and second-line (1L, 2L) treatments, and date of death were collected. Descriptive statistics were calculated to summarize patient characteristics and study outcomes. Median (95% confidence interval [CI]) OS from RR disease was calculated by the Kaplan-Meier method. Results: We analyzed 200 RR PTCL patients (71% received CHOP, 20% received CHOEP, and 9% received another regimen as 1L systemic therapy). The majority (58%) were PTCL not otherwise specified (NOS), 61% were males, and median age was 62 years (range: 20-90) (Table). Overall response rate (ORR) to 1L treatment was 80% (CR, 54%; PR, 26%), and ORR to 2L treatment was 55% (CR, 31%, PR, 24%). Among all PTCL patients and among those with PTCL NOS, the OS (95% CI) from RR disease was 13.0 months (95% 7.0-not estimable) and 9.0 months (95% 6.0-not estimable), respectively (Figure). Median time to RR disease from 1L initiation was 12.9 months. Median durations of 1L and 2L treatments were 4.4 months and 3.7 months, respectively. Among those who continued to 2L therapy, 27% received brentuximab vedotin (2% in combination), 19% received ICE (carboplatin/cisplatin, ifosfamide, etoposide), 13% received romidepsin (2% in combination with pralatrexate), 10% received pralatrexate monotherapy, 7% received GEMOX (gemcitabine, oxaliplatin), and the rest (22%) received other 2L regimens or an unknown regimen (2%). After 1L initiation, only 14/200 (7%) received hematopoietic stem cell transplant (HSCT) and 28/151 (19%) after 2L. AEs resulting in a dose reduction, discontinuation, or hospitalization during 1L treatment and occurring among ≥10% included anemia (39%), thrombocytopenia (27%), neutropenia (23%), mouth sores (16%), diarrhea (15%), neuropathy (14%), febrile neutropenia (13%), and vomiting (10%). Conclusions: While response to 1L treatment in this cohort was high (80%), all developed RR disease (or died), for whom the prognosis remains poor. Very few patients underwent HSCT in any line of therapy. Our data demonstrate the unmet medical need for RR-PTCL patients and the need for novel therapies in the 1L setting. It also underscores the need to better understand factors leading to treatment selection and optimal treatment sequencing in the real world. Disclosures Nabhan: Cardinal Health: Employment, Equity Ownership. Laney:Cardinal Health: Employment, Equity Ownership. Feliciano:Seattle Genetics: Employment, Equity Ownership. Lee:Cardinal Health: Employment. Klink:Cardinal Health: Employment, Equity Ownership.

scholarly journals Treatment Patterns and Outcomes of 159 Ibrutinib-Treated MCL Patients in the United States: A Retrospective Electronic Medical Record Database and Chart Review Study

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4163-4163
Author(s):  
Jeff Sharman ◽  
Shaum Kabadi ◽  
Jamyia Clark ◽  
E Susan Amirian ◽  
David J. Andorsky
Keyword(s):  
Real World ◽  
Research Funding ◽  
Chart Review ◽  
Kinase Inhibitor ◽  
Stage Iv ◽  
The United States ◽  
Treatment Patterns ◽  
Discontinuation Rate ◽  
Real World Data

Abstract Introduction Ibrutinib, a Bruton's tyrosine kinase inhibitor, was approved in the U.S. for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in November of 2013. However, real-world data on ibrutinib use for the treatment of MCL is limited. The purpose of this study was to examine ibrutinib use, dosages, and reasons for treatment discontinuation among MCL patients treated in a community oncology practice setting. Methods The study population consisted of adult (≥18 year old) MCL patients treated with ibrutinib between November 1, 2013 and October 31, 2016, who were not enrolled in a clinical trial and had at least 2 visits to a US Oncology Network (USON) clinic. Patients with other primary cancers were excluded. Patient data were sourced from the USON's electronic health records system, iKnowMed (iKM)™. The structured iKM database provided information on demographics and clinical and treatment characteristics. Manual chart review was used to confirm ibrutinib treatment patterns. Duration of ibrutinib therapy (DOT), overall survival (OS), and progression-free survival (PFS) from systemic treatment initiation were estimated using Kaplan-Meier methods. Events were defined as death in the OS analysis, and progression or death in the PFS analysis. Patients were censored if their treatment was ongoing for DOT. Censors for OS and PFS were patients lost to follow up or those who did not experience a failure event within the study period. Results 159 eligible MCL patients were identified through iKM. The majority of patients were Caucasian (n=141, 88.7%), male (n=121, 76.1%), and diagnosed with Stage IV disease (n=117, 73.6%). Median follow-up for the population was 16.1 months. Approximately 7.5% (n=12) of patients received ibrutinib as first-line therapy (1L), compared to 54.1% (n=86) in 2L and 38.4% (n=61) in 3L or beyond. Median ibrutinib dose at initiation was 560mg (range: 140-700). During ibrutinib treatment, 16.4% (n=26) of patients experienced a dose reduction. Dose holds occurred in 30.2% (n=48), 66.7% (n=32) due toxicities. The overall discontinuation rate was 83.6% The primary reason for discontinuation was disease progression (n=46, 34.6%) followed by toxicities (n=34, 25.6%). Median DOT was higher for patients initiating treatment in 3L+ (14.9: 95% CI 8.8-17.1) compared to other lines. Median PFS was 19.6 (95% CI: 16.5-24.3) for the overall population and median OS was 25.8 months (95% CI: 19.9-not reached). Conclusions Our real-world findings on survival are consistent with those from clinical trials on ibrutinib in relapsed/refractory MCL, although our observed discontinuation rate (~84%) was higher than that of the trial (~58%), which had a similar median follow-up time (16.1 months vs. 15.3 months, respectively). Our findings provide additional data on MCL treatment patterns and patient outcomes in clinical practice. Disclosures Sharman: Acerta: Consultancy, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Research Funding. Kabadi:AstraZeneca: Employment. Clark:McKesson Specialty Health: Employment, Equity Ownership. Amirian:McKesson Specialty Health: Employment. Andorsky:Celgene: Research Funding; CTI BioPharma: Consultancy, Research Funding; AstraZeneca: Consultancy; Genentech: Consultancy.

scholarly journals Treatment Patterns Among Newly Diagnosed Multiple Myeloma Patients in the United States Veteran Population (2010-2015)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5952-5952
Author(s):  
Kejal Parikh ◽  
Shivani Pandya ◽  
Safiya Abouzaid ◽  
Onur Baser ◽  
Lin Xie ◽  
...  
Keyword(s):  
Research Funding ◽  
Cox Regression ◽  
Treatment Patterns ◽  
Novel Therapies ◽  
Newly Diagnosed ◽  
Employment Equity ◽  
Chemotherapy Agent ◽  
The Us ◽  
Equity Ownership

Abstract Background: Despite a relatively higher incidence in the veteran population, there are few real-world claims-based analyses to describe Multiple Myeloma (MM) treatment patterns among this patient population (Landgren O, Blood, 2006). This study aimed to assess treatment patterns among newly diagnosed MM (ndMM) patients using the US Veteran Health Administration (VHA) data. Methods: This retrospective study identified adult patients with ≥2 claims for MM (ICD-9-CM code: 203.0x) 30 days apart and ≥1 treatment during identification period (1OCT2011-31MAR2015) from the VHA dataset. The initial course of therapy (COT1) date was the index date and included all treatments prescribed within 60 days of this date. Patients were required to have continuous enrollment for 12 months pre- and ≥6 months post-index date unless patients died within 6 months (follow up period), ≥1 full cycle of therapy with a valid COT1 regimen, no evidence of prior MM diagnosis or treatment (including autologous stem cell transplant (ASCT)), and no evidence of ASCT in the follow up period. A subsequent COT (COT2) was defined as the earliest occurrence of: the addition of a new drug or switch in regimen after the first 60 days, restart of a previous regimen after >180-day gap, or a dose increase from maintenance to relapse therapy. Dexamethasone/prednisone[d] which were assumed to be included regardless of whether or not they were observed during the study period did not impact the ongoing COT. Treatment patterns during the follow-up period were initially examined among patients treated with novel (lenalidomide [R] and/or bortezomib [V] with or without chemotherapy agents) and non-novel therapies (≥1 chemotherapy agent, steroid monotherapy) and then compared among those initiating Rd and Vd. Time to next treatment (TTNT) was defined as the duration from initiation of COT1 plus any gaps before COT2. Kaplan Meier and Cox regression analyses were performed to evaluate TTNT and assess the impact of various predictors on TTNT among patients initiating Rd and Vd. Results: Of 1,183 patients that met the inclusion criteria, 55.4% (n=655) were treated with novel therapies and 44.6% (n=528) with non-novel therapies. Among patients treated with novel therapy, the majority initiated Rd (47.8%; n=313) as COT1 followed by Vd (31.2%; n=204), Vd with cyclophosphamide (11.5%; n=75), RVd (6.6%; n=43), Vd with a chemotherapy agent (2.4%; n=16) and Rd with a chemotherapy agent (0.6%; n=4).Rd initiators were significantly older (75.1 vs 70.6 years, p=0.0002) and a higher percentage was white (69.7% vs 47.0%; p<0.0001) than Vd treated patients. While the Charlson Comorbidities Index score did not differ between the two groups (3.6 vs 4.0, p=0.0583), a significantly higher percentage of patients treated with Vd had some comorbidities including hepatitis and renal disease. Among patients with laboratory tests, patients treated initially with Vd had lower hemoglobin (10.8 vs 11.4 g/dl, p=0.0012) and higher serum creatinine (2.3 vs 1.4 mg/dl, p<0.0001) during the pre-index period. The overall average treatment duration in COT1 was significantly longer among patients treated with Rd vs Vd (10.9 vs 7.0 months, p<0.0001). Among patients who were still on active COT1, the mean duration in COT1 was longer among patients treated with Rd than Vd (18.7 vs 13.3 months, p=0.0061). A significantly higher percentage of patients treated with Vd progressed to COT2 (52.5%, vs 26.2% p<0.0001) as compared to Rd. Among patients who progressed to COT2, those treated with Vd had a shorter TTNT compared to Rd (Mean: 9.3 vs 12.8 months, p=0.0049). After adjusting for baseline demographic and clinical factors using Cox regression, TTNT remained significantly shorter for Vd vs those treated with Rd (HR: 2.67, 95% CI: 1.9-3.7, p <0.0001). Conclusion: Slightly over half of MM patients in the US Veteran population were treated with a regimen containing novel therapies; Rd and Vd were the most commonly observed among these. Patients treated initially with Vd had a significantly shorter TTNT compared to those treated with Rd. The difference remained significant after controlling for baseline characteristics including markers for higher disease severity among patients on Vd. Disclosures Parikh: Celgene Corporation: Employment, Equity Ownership, Research Funding. Pandya:Celgene: Research Funding. Abouzaid:Celgene Corporation: Employment, Equity Ownership, Research Funding. Baser:Celgene: Research Funding. Xie:Celgene: Research Funding. Patel:Celgene: Consultancy.

An Adjusted Treatment Comparison of Bortezomib/Cyclophosphamide /Dexamethasone and Bortezomib/Thalidomide/Dexamethasone from Real-World Data in Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant-Eligible

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2142-2142
Author(s):  
Maneesha Mehra ◽  
Sarah Cote ◽  
Tobias Kampfenkel ◽  
Sandhya Nair
Keyword(s):  
United States ◽  
Multiple Myeloma ◽  
Real World ◽  
The United States ◽  
Induction Treatment ◽  
Newly Diagnosed ◽  
Real World Data ◽  
Employment Equity ◽  
Equity Ownership ◽  
Baseline Characteristics

Introduction: For patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem-cell transplantation (ASCT), two standard of care (SoC) induction regimens are bortezomib/cyclophosphamide/dexamethasone (VCd) and bortezomib/thalidomide/dexamethasone (VTd), each followed by ASCT. While VCd and VTd are both treatment options according to international guidelines, treatment selection varies by country. Additionally, while some clinical studies have evaluated the efficacy and safety of these therapies, direct comparisons have been limited to response endpoints post-induction and post-transplant (Moreau P, et al. Blood. 2016;127[21]2569-2574; Cavo M, et al. Blood. 2014;124[21]197; Cavo M, et al. Leukemia. 2015;29[12]2429-31). Herein we describe real-world treatment patterns in the United States for patients with NDMM who are transplant-eligible, and report results from a matched adjusted comparison to evaluate real-world long-term efficacy (overall survival, OS) for VCd +ASCT versus VTd +ASCT. Methods: Data for the VCd and VTd real-world evidence (RWE) cohorts were identified from 3 US data sources collectively covering the period January 2000 to March 2017: the OPTUM™ Commercial Claims database, the OPTUM™ Integrated (CLAIMS+EMR) database, and the Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked database. RWE data were from patients with an index MM diagnosis on or after 1 January 2007, medical prescription coverage in place at diagnosis, no prior malignancies in the 1-year period prior to index diagnosis, a 1-year look-back period prior to index diagnosis, received ≥1 line of therapy, and received stem cell transplantation with induction as frontline treatment. The Kaplan-Meier method and Cox proportional hazard model compared outcomes with and without adjustments for baseline characteristics (age, sex, renal impairment, and anemia) and induction treatment duration; comparisons were also conducted with inverse probability of treatment weighting (IPTW). Results: Analysis of RWE from the United States demonstrated that bortezomib (V)-based regimens were the most common induction treatment (together accounting for approximately 75% of therapies), with bortezomib/lenalidomide/dexamethasone (VRd) being the most common (31%). Use of VCd (13%) and VTd (5%) was limited. Comparisons were conducted for VCd (n = 135) and VTd (n = 51). Baseline characteristics were generally similar between groups, except for fewer male patients in the VCd group than the VTd group (57% vs 65%), and lower rates of renal impairment in the VCd group than the VTd group (29% vs 43%; Table 1). The naïve and adjusted comparisons of OS for VCd versus VTd therapy showed these treatments were not statistically different (adjusted hazard ratio, 1.180 [95%: 0.468-2.972]; P = 0.7260; Figure 1). The IPTW method generated similar results. Conclusions: Real-world data from the United States show that V-based induction regimens are the most commonly used for treatment of patients with NDMM who are transplant-eligible. Results from the naïve, adjusted, and IPTW comparisons all showed that OS was not significantly different for VCd + ASCT versus VTd + ASCT. Survival data for VTd from RWE are generally consistent with VTd data reported in the recent phase 3 CASSIOPEIA study, although OS data from CASSIOPEIA remain immature (Moreau P, et al. Lancet. 2019;394[10192]:29-38). Disclosures Cote: Janssen: Employment, Equity Ownership. Kampfenkel:Janssen: Employment, Equity Ownership. Nair:Janssen: Employment, Equity Ownership.

scholarly journals Utilization Patterns of Bone-Targeting Agents Among Patients with Multiple Myeloma: Analysis of Real-World Data

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4501-4501 ◽  
Author(s):  
Yi Qian ◽  
Debajyoti Bhowmik ◽  
Nandita Kachru ◽  
Rohini K. Hernandez ◽  
Paul Cheng ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Zoledronic Acid ◽  
Real World ◽  
The United States ◽  
Treatment Patterns ◽  
Prescribing Patterns ◽  
Bone Targeting ◽  
Real World Setting ◽  
Increased Risk

Abstract Background: At diagnosis, 80% of patients with multiple myeloma (MM) are reported to have osteolytic lesions.MM is characterized by substantial bone destruction, resulting in increased risk of skeletal-related events (SREs), defined as pathological fracture, spinal cord compression, radiation or surgery to bone. SREs are associated with debilitating bone pain, significant morbidity, and increased mortality. SREs also have substantial economic consequences on patients and healthcare systems. Bone-targeting agents (BTAs) approved for the prevention of SREs in MM include intravenous bisphosphonates (IV BPs) zoledronic acid (ZA) and pamidronate (PA). ZA and PA may be used monthly for up to two years and longer for patients who continue to have active or relapsed disease. Given the increased risk of atypical femoral fracture and osteonecrosis of the jaw (ONJ) with cumulative dosing, and medical contraindications (e.g., renal function deterioration), there may be clinician preference to reduce or limit IV BPs. Limited information is available regarding compliance to BTAs in real-world setting in the US. The objective of this study is to examine BTA treatment patterns, including compliance and time to non-persistence among MM patients. Methods: This retrospective cohort study was conducted using the Oncology Services Comprehensive Oncology Records (OSCER) electronic medical records database, including over 750,000 patients from >200 hematology/oncology practices across the United States. The following selection criteria were used: (1) MM diagnosis (ICD-9CM: 203.0x) between 1st January 2012 and 31st December 2014; (2) ≥18 years of age at MM diagnosis; and (3) initiation of BTA therapy between 1-Jan-2012 and 31-Dec-2014. Patients with solid tumors were excluded. Compliance with BTA therapy was defined as ≥12 administrations in each year of follow-up. Non-persistence was operationalized as either a gap in therapy of ≥90 days or ≥90 days between last administration and last date of follow-up (i.e., discontinuation), or switch from initial BTA. Kaplan-Meier method was used for analysis of time to non-persistence. Results: Out of 9,617 patients diagnosed with MM, a total of 3,394 (35.3%) patients treated with ZA therapy and 341 (3.6%) treated with PA met inclusion criteria. Majority of the patients were male (ZA: 54.1%, PA: 53.1%), white (ZA: 72.2%, PA: 64.2%), and ≥65 years (ZA: 64.5%, PA: 67.7%). Average time to initiation of therapy from MM diagnosis was 3 months for both ZA and PA. Most of the patients initiated therapy within 3 months (ZA: 76.1%, PA: 75.1%) or 6 months (ZA: 86.3%, PA: 85.6%) of MM diagnosis. Overall the compliance rate was low and declined during follow-up (Table 1). The median time to non-persistence was 16.2 (15.4-17.4) months for ZA and 13.8 (11.5-15.4) months for PA (Fig. 1). Persistence rates declined over the follow-up years, ranging from 86% at 6 months to 34% at 24 months for ZA, and from 77% at 6 months to 30% at 24 months for PA (Fig. 1). Table 1. Compliance with BTA therapy over follow-up years Patients with Minimum 12 Months of Follow-up (N=2,211) Patients with Minimum 24 Months of Follow-up (N=899) Pamidronate Zoledronic Acid Pamidronate Zoledronic Acid N 191 2,020 95 804 Current Users 191 2,020 64 641 Mean Administrations (Standard Deviation) 7.6 (4) 8.3 (3.8) 7.0 (3.7) 7.3 (3.9) Switch (n, %) 28 (14.7) 39 (1.9) 3 (3.2) 9 (1.1) ≥12 Administrations/Year (n, %) 44 (23) 553 (27.4) 10 (15.6) 127 (19.8) Conclusions: The treatment landscape in MM has evolved in recent years with clinical trial data supporting improved survival for patients. In this dynamic landscape, it is increasingly important to understand prescribing patterns and patient compliance with BTAs. This analysis indicates there may be limited compliance to BTA therapy in the real-world setting. Potential reasons for non-compliance may include concerns of medical contraindications, patient burden associated with IV administration, or clinician preference. With emerging therapies being evaluated in MM, BTA treatment patterns warrant investigation in future studies. Figure 1. Figure 1. Disclosures Qian: Amgen Inc.: Employment. Bhowmik:Amgen Inc.: Employment. Kachru:Amgen Inc.: Employment. Hernandez:Amgen Inc.: Employment. Cheng:Amgen Inc.: Employment. Liede:Amgen Inc.: Employment.

scholarly journals Treatment Patterns and Outcomes of Patients with Relapsed or Refractory Follicular Lymphoma Treated with Idelalisib in a Community Oncology Setting

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2810-2810
Author(s):  
David Andorsky ◽  
Rebecca J Chan ◽  
Jamyia Clark ◽  
Bianca Ruzicka ◽  
Nicholas James Robert ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Follicular Lymphoma ◽  
Real World ◽  
Research Funding ◽  
Treatment Patterns ◽  
Employment Equity ◽  
Real World Setting ◽  
Equity Ownership ◽  
Systemic Therapies

Introduction: Idelalisib (IDELA, Zydelig®) is the first-in-class PI3Kδ inhibitor and is approved in the U.S. as an oral monotherapy for relapsed / refractory follicular lymphoma (R/R FL) after at least two prior lines of systemic therapy. IDELA's regulatory approval was based on a phase 2, open-label clinical trial in 125 patients with R/R indolent non-Hodgkin's lymphoma (Gopal et al., NEJM, 2014) and outcomes in the FL subgroup were published by Salles et al. (Haematologica, 2017). The current study evaluates the characteristics and treatment patterns of patients treated with IDELA for R/R FL in a real-world setting. Methods: Adult patients diagnosed with R/R FL (grades 1, 2, and 3a) and treated with IDELA within the US Oncology Network (USON) between 7/1/2014 to 6/30/2018 were analyzed retrospectively. Patient data were obtained from USON's structured electronic health records' system, iKnowMed (iKM)TM. Manual chart review (ChR) was used to determine physician response and to confirm IDELA treatment patterns. Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan-Meier methods. Descriptive statistics were generated for outcomes of interest, including duration of therapy (DoT), median follow-up, and adverse event (AE) frequency. Results: A total of 124 patients with FL and prescribed IDELA were identified in iKM TM. After Chr confirming the diagnosis of follicular lymphoma diagnosis and initiation of IDELA, 88 patients were retained for analysis. Median age of patients was 68.9 years, with 52.3% female and the majority white and non-Hispanic (90.9% and 93.2%, respectively, Table 1). The most common regimens immediately prior to IDELA initiation were bendamustine + rituximab (22.7%), rituximab (17%), and rituximab maintenance (11.4%). Eighty-six (97.7%) patients had co-morbidities categorized as vascular (50%), endocrine (33%), respiratory (13.6%), or cardiac (12.5%). Thirteen (14.8%), 21 (23.9%), and 54 (61.4%) patients initiated IDELA in second line (2L), 3L, and >4L, respectively. Baseline lab values at IDELA initiation were similar regardless of line of therapy (LOT). mDOT was 5.5 mos. for the entire population and was similar across all LOTs (4.1 mos., 6.1 mos., and 5.5 mos. in 2L, 3L, and >4L, respectively). AEs were noted in 45.5% with the most common being gastrointestinal (31.8%) and dermatologic (10.2%). Respiratory and infectious AEs were noted in 2.3% and 1.1%, respectively, although Pneumocystis jirovecii pneumonia (PJP) prophylaxis was rarely prescribed (2.3%). Toxicity as a reason for IDELA discontinuation varied in frequency across LOT and was more common in 2L compared to 3L and >4L (91.7% compared to 43.8% and 46.9%, respectively). With a median follow-up of 18.6 months for the population, the mPFS was 11.4 mos. [95%CI: 8.5,17.0] and mOS was 32.5 mos. [95% CI: 25.3,NR]. Stratified by LOT, median follow-up time, mOS, and mPFS were greater in 2L (30.8 mos., NR [95% CI: 27.37,NR], and 29.0 mos. [95% CI: 8.6,NR], respectively) than in 3L or >4L (3L: 17.9 mos., 29.4 mos. [95%CI: 18.6,NR], and 17.5 mos. [95% CI: 6.1,NR]; >4L: 16.5 mos., 25.3 mos. [95%CI: 13.5.,NR], and 8.6 mos. [95% CI: 6.1,12.6], respectively, Figures 1 and 2). Conclusion: Findings from this analysis suggest that R/R FL patients treated with IDELA in a real-world setting experience a similar mDOT and mPFS as those treated in the clinical trial setting (Salles et al., Haematologica, 2017). Patients treated in 2L demonstrated longer PFS and OS compared to later lines, but also experienced increased IDELA discontinuation due to toxicity, perhaps reflecting a lower incidence of progressive disease in earlier treatment lines, or a more immunocompetent population leading to higher rates of autoimmune AEs. Use of PJP prophylaxis in IDELA-treated patients was uncommon, an observation suggesting an opportunity for provider education. Our findings enhance available data on relapsed FL patient outcomes in real-world clinical practice and support the use of IDELA in patients with R/R FL after at least 2 systemic therapies. Disclosures Andorsky: Gilead: Research Funding; Genetech: Research Funding; CTI: Research Funding; AstraZeneca: Consultancy; Celgene: Research Funding. Chan:Gilead Sciences, Inc.: Employment, Equity Ownership. Clark:McKesson: Consultancy, Employment, Equity Ownership. Ruzicka:Gilead Sciences, Inc.: Employment. Robert:McKesson: Employment. Awan:Pharmacyclics: Consultancy, Research Funding; AstraZeneca: Consultancy, Speakers Bureau; Abbvie: Consultancy, Speakers Bureau; Janssen: Consultancy; Genentech: Consultancy; Sunesis: Consultancy; Gilead: Consultancy. OffLabel Disclosure: Idelalisib is a PI3 kinase inhibitor indicated for the treatment of patients with relapsed follicular B-cell lymphoma who have received at least two prior systemic therapies. Some patients in this observational study used Idelalisib after one prior systemic treatment.

Characteristics Of Patients Included In The Myelofibrosis Real-World Practice-Based Network Research (ENRiCH) Data Platform

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1580-1580
Author(s):  
Gregory Hess ◽  
Eileen Fonseca ◽  
Andrew Lee ◽  
Hongwei Wang ◽  
Ravinder Dhawan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Real World ◽  
Clinical Characteristics ◽  
Unmet Needs ◽  
Clinical Trial Design ◽  
The United States ◽  
Real World Data ◽  
Employment Equity ◽  
Network Research ◽  
Equity Ownership

Abstract Introduction The prevalence of myelofibrosis (MF) is 3.6 to 5.6 cases per 100,000 in the United States. Overall median survival is 3 years and 1.3 years for patients with intermediate-2 and high-risk disease, respectively. The MF PracticE-Based Network ResearCH (ENRiCH) platform is an adaptive, dynamic, data hub designed to accumulate real-world data to identify MF patients, understand their treatment patterns and unmet needs, inform clinical trial design, and conduct research using clinically relevant outcomes. A descriptive analysis of the demographic and clinical characteristics of MF patients from the ENRiCH platform is reported in this study. Methods The ENRiCH platform was developed from patient-level data representing approximately 1 billion US private practitioner medical claims, >1.6 billion pharmacy claims, and electronic medical records from >500,000 cancer patients treated in community oncology practices at 344 locations in 37 states and encompassing approximately 550 treating providers. ENRiCH includes patients with a diagnosis of MF, polycythemia vera (PV), or essential thrombocytopenia (ET), and/or a ruxolitinib prescription between November 1, 2010 and October 31, 2012; patients who received ruxolitinib in a clinical trial were excluded. Results As of March 2013, 6362 MF and 299 ruxolitinib patients were identified. Mean (SD) age was 67.0 (12.6) years for MF patients and 65.8 (15.0) years for the ruxolitinib subgroup, with 45% females. Hematologic comorbidities included myeloid disorders (80% MF; 70% ruxolitinib) and lymphoid disorders (10% MF; 5% ruxolitinib). The most common myeloid disorders were primary MF (47% MF; 29% ruxolitinib), myelodysplastic syndrome (35% MF; 26% ruxolitinib), ET (25% MF; 17% ruxolitinib), and PV (25% MF; 17% ruxolitinib). Common comorbidities of interest that were observed included infectious diseases (35% MF; 35% ruxolitinib), thrombocytopenia (33% MF; 23% ruxolitinib), pulmonary hypertension (7% MF; 7% ruxolitinib), and vitamin D deficiency (7% MF; 8% ruxolitinib). The mean (SD) Charlson comorbidity index (CCI) was 4.36 (2.4) for MF patients and 4.28 (2.4) for the ruxolitinib subgroup. Clinical characteristics and laboratory results among patients with diagnostic or clinical data from the index date forward are shown in the table. The 5 most common concomitant medication groups for ruxolitinib patients were loop diuretics (11%), gout agents (10%), hydrocodone combinations (9%), opioid agonists (9%), and proton pump inhibitors (9%). The top 5 most common medications taken within 180 days prior to new ruxolitinib starts were hydrocodone combinations (21%), antineoplastics (19%), gout agents (18%), glucocorticosteroids (15%), and fluoroquinolones (14%). The predominant [MF (ruxolitinib)] payer types observed were Medicare [48% (37%)], Medicaid [4% (1%)], and commercial insurance [37% (21%)]. Conclusions The observed demographic and clinical characteristics of MF patients are similar to prior MF epidemiological studies (Mehta J et al. Leuk Lymphoma. 2013;Early Online: 1-6), suggesting that the sample of MF ENRiCH patients is reflective of the broader US MF population and will allow for broad-based quantification of unmet needs and treatment outcomes. The addition of more MF patients and longer follow-up data will further enhance the value of this large US real-world MF patient data hub including those on current MF therapies. This study was sponsored by Sanofi. Disclosures: Fonseca: IMS Health - a company that received funds from Sanofi to conduct the study: Employment. Lee:Sanofi: Employment. Wang:Sanofi: Employment, Equity Ownership. Dhawan:Sanofi: Employment. Thompson:Sanofi: Employment. Iqbal:Sanofi: Employment, Equity Ownership. Redmond:IMS Health: Consultancy, Employment.

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