Real-world treatment patterns and sequencing for metastatic renal cell carcinoma (mRCC): Results from the Flatiron database.

286 Background: RCC accounts for ~80%‒90% of all kidney cancers worldwide. The mRCC treatment landscape is rapidly changing with the approval of new therapies; data describing real-world (RW) treatment patterns and sequencing are limited. This study investigates the characteristics, treatment patterns, and sequencing for mRCC patients in the RW (December 2015‒May 2020) and post-dual immuno-oncology therapy (IO-IO) approval in the United States (April 2018‒May 2020). Methods: Adults diagnosed with mRCC between December 2015 and May 2020 were selected from the Flatiron electronic medical record database for this retrospective study. The study cohort was required to have ≥ 1 month of medical data from the initial mRCC diagnosis date (index date). We used descriptive statistics to analyze baseline patient characteristics, treatment patterns, and sequencing. Results: Of 3,524 patients with mRCC (overall cohort, December 2015–May 2020), most were male (68.5%) and had clear cell histology (68.2%). The median age at metastatic diagnosis was 68 years (range, 23–85) and the median follow-up from index date was 328 days. Based on IMDC risk score, 75.8% of patients were categorized as intermediate/poor risk and 23.2% as favorable risk (1% missing). Systemic therapy for RCC was initiated in 79.1% (N = 2788) of patients. The most common treatments for first-line (1L) therapy were tyrosine kinase inhibitor (TKI) monotherapy (mono; 56.4%), IO-IO (19.1%), IO-TKI (9.5%), IO mono (6.9%), and others (8.1%). Second-line (2L) therapy was received by 1303 patients; treatment sequences are presented in the table below. Among patients who received IO-based therapy in the 1L (N = 990), 11% were retreated with IO on any subsequent line. When stratified by clear cell and non-clear cell histology, similar treatment patterns and sequences were observed. Among patients who initiated 1L treatment post-April 2018 (N = 1395), the most common treatments for 1L therapy were IO-IO (36.9%) and TKI mono (32.7%). Among patients who received 2L treatment after initiating 1L post-April 2018 (N = 486), TKI mono followed by IO mono, and IO-IO followed by TKI mono were the most prescribed sequences (Table). Conclusions: Following approval of IO-based therapies for 1L, RW treatment patterns for mRCC are evolving; IO-IO has become the most common 1L therapy received by all patients initiating treatment for mRCC. [Table: see text]

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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 ◽

10.1182/blood-2018-99-118848 ◽

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.

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Real-World Bruton Tyrosine Kinase Inhibitor Treatment Patterns, Compliance, Costs, and Hospitalizations in Patients with Mantle Cell Lymphoma in the United States

Blood ◽

10.1182/blood-2021-148053 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 3046-3046

Author(s):

Bijal D. Shah ◽

Keri Yang ◽

Sizhu Liu ◽

Jai Sivanantham ◽

Yasser Ali ◽

...

Keyword(s):

Real World ◽

Research Funding ◽

Index Date ◽

Kinase Inhibitor ◽

Cell Lymphoma ◽

The United States ◽

Treatment Patterns ◽

Sociodemographic Characteristics ◽

Mantle Cell ◽

Bruton Tyrosine Kinase

Abstract Introduction: Mantle cell lymphoma (MCL) is a rare, aggressive, and incurable B-cell malignancy. MCL patients may initially respond well to frontline treatments; however, most will relapse or become refractory (r/r) to treatment. While there are real-world data available on the use of ibrutinib, the first Bruton tyrosine kinase inhibitor (BTKi) approved in 2013 for the treatment of r/r MCL, there is limited data on the more recently approved BTKis, acalabrutinib (approved in 2017) and zanubrutinib (approved in late 2019), primarily due to disease rarity and time lag of claims dataset. This study aimed to examine (1) clinical and sociodemographic characteristics of patients receiving BTKi, (2) treatment patterns and compliance by each BTKi, and (3) costs and hospitalizations associated with each BTKi use in the real-world setting in the United States. Methods: A retrospective observational study was conducted using the patient longitudinal data between July 2017 and May 2021 from the Symphony Health's IDV® (Integrated Dataverse), a de-identified, open-source claims database. IDV captures and aggregates data from different data vendors and assigns a unique patient identifier to each claim through a proprietary patient matching process. Patients were considered to be active in the open-source database and eligible for the study if they have ≥ 1 MCL diagnosis and ≥ 1 BTKi prescription claim for two consecutive semesters (1 semester = 6 months) pre- and post- index date. The index date was defined as the use of one of the BTKis of interest: ibrutinib, acalabrutinib, or zanubrutinib. The BTKi groups were not mutually exclusive to capture the potential switching between groups. Descriptive analysis was conducted to examine patient sociodemographic characteristics, comorbidities, concomitant medications, treatment patterns, costs, and hospitalizations in overall BTKi users, and by each BTKi. Treatment patterns were evaluated by frequency and duration of each BTKi use. Days of supplies and medication possession ratio were used to calculate persistency and compliance rates. Results: Among 30,199 patients with MCL identified from the database, 3,821 MCL patients were on BTKi therapy, and the final study population consisted of 1,653 active patients with MCL and BTKi treatment. Patients in the zanubrutinib group were older (n=67, median age=78, 67.2% male) than those in either the acalabrutinib group (n=485, median age=74, 74.9% male) and ibrutinib group (n=1,242, median age=70, 73.8% male). Among zanubrutinib users, 22% were switched from ibrutinib and 7% switched from acalabrutinib, while 21% of acalabrutinib users were switched from ibrutinib. Over half of the ibrutinib use was in the frontline setting (68.4%) while the use of acalabrutinib and zanubrutinib was more in the r/r setting (68.9% and 80.6%, respectively). The most common comorbidities at BTKi treatment initiation were hypertension (41.1%), followed by dyslipidemia (28.6%), diabetes (17.5%), cardiac arrhythmia (15.6%), and gastroesophageal reflux disease (14.5%). However, 28.5% of acalabrutinib users were concurrently on proton pump inhibitors even though such concomitant use should be avoided. The compliance rate was higher in zanubrutinib group (65%) than acalabrutinib (62%) and ibrutinib (59%) groups. Overall, the average length of stay (LOS) is 5.9 days among MCL patients who used BTKi and had at least 1 hospitalization. Patients in the zanubrutinib group had a shorter LOS (4.0 days) than those in the ibrutinib (5.9 days) and acalabrutinib (5.8 days) groups (Figure 1A). On average, the total submitted inpatient charge per stay is lower for patients in the zanubrutinib group ($51,051) than patients in the ibrutinib ($79,482) and acalabrutinib ($74,546) groups (Figure 1B). Conclusions: This study provides the first real-world evidence on patients with MCL treated with all currently available BTKis, zanubrutinib, ibrutinib and acalabrutinib. BTKis are largely being used in second-line plus settings. Future studies are needed to understand the long-term outcomes of BTKi treatment as data matures. Figure 1 Figure 1. Disclosures Shah: Novartis: Consultancy, Other: Expenses; Pfizer: Consultancy, Other: Expenses; Amgen: Consultancy; Precision Biosciences: Consultancy; Kite, a Gilead Company: Consultancy, Honoraria, Other: Expenses, Research Funding; Servier Genetics: Other; Jazz Pharmaceuticals: Research Funding; Incyte: Research Funding; BeiGene: Consultancy, Honoraria; Acrotech/Spectrum: Honoraria; Pharmacyclics/Janssen: Honoraria, Other: Expenses; Bristol-Myers Squibb/Celgene: Consultancy, Other: Expenses; Adaptive Biotechnologies: Consultancy. Yang: BeiGene, Ltd.: Current Employment. Liu: BeiGene, Ltd.: Current Employment. Sivanantham: PRA Symphony Health Solutions: Consultancy; BeiGene, Ltd.: Consultancy. Ali: BeiGene, Ltd.: Current Employment. Casten: PRA Symphony Health Solutions: Consultancy; BeiGene, Ltd.: Consultancy. Satya: PRA Symphony Health Solutions: Consultancy; BeiGene, Ltd.: Consultancy. Tang: BeiGene, Ltd.: Current Employment.

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Real-world evidence of cancer immunotherapy (CIT) combination treatment in first-line (1L) extensive-stage small cell lung cancer (ES-SCLC).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.8561 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 8561-8561

Author(s):

Eric S. Nadler ◽

Anupama Vasudevan ◽

Kalatu Davies ◽

Yunfei Wang ◽

Ann Johnson ◽

...

Keyword(s):

Brain Metastases ◽

Real World ◽

Performance Status ◽

Descriptive Analysis ◽

Patient Characteristics ◽

Treatment Patterns ◽

Combination Regimen ◽

Duration Of Treatment ◽

The Real

8561 Background: Atezolizumab plus chemotherapy was the first CIT combination regimen approved for 1L treatment of ES-SCLC in 2019. This study investigated patient characteristics and treatment patterns for patients with ES-SCLC receiving this regimen in the real-world community oncology setting. Methods: This was a retrospective study including adult patients diagnosed with ES-SCLC between 01-Oct-2018 (after IMpower 133 publication in NEJM Sep-2018) and 31-Dec-2019, with follow-up through 31-March-2020 using The US Oncology Network electronic health records data. Descriptive analyses of patient characteristics and treatment patterns were conducted, with Kaplan-Meier (K-M) methods used to assess time to treatment discontinuation (TTD) and time to next treatment/death (TTNT). Results: Of the 408 patients included in this study, 267 (71.4%) received atezo+carboplatin+etoposide (Atezo+Chemo), 80 (21.4%) received carboplatin+etoposide (Chemo only) and the rest received other regimens. The Atezo+Chemo patients in the real-world cohort compared with the IMpower 133 trial (n = 201) were older (median age 68 vs. 64 years) and included fewer males (45% vs. 64%), fewer white race (73% vs. 81%), more patients with brain metastases at baseline (23% vs. 9%), and more patients with worse ECOG (2/3) performance-status score (24% vs. 0%). The median follow-up, TTD, and TTNT in months (mo) for the real-world cohort are presented in the table alongside the best comparable measures reported for the trial. Conclusions: Most patients in this real-world ES-SCLC cohort received the Atezo+Chemo regimen in the 1L setting. While the follow-up was much shorter and patients had worse baseline characteristics (age, brain metastases, ECOG) in the real-world setting compared to the IMpower 133 trial, the real-world median TTD in this descriptive analysis was found to be in line with the median duration of treatment in the trial. Further research with longer follow-up comparing the real-world effectiveness of the CIT and chemo regimens is needed.[Table: see text]

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Real-World Treatment Patterns Among a Contemporary Cohort of Commercially Insured Mantle Cell Lymphoma Patients in the United States

Blood ◽

10.1182/blood-2018-99-112532 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 4845-4845

Author(s):

Lindsey E. Roeker ◽

Shaum Kabadi ◽

Chakkarin Burudpakdee ◽

Aimee Near ◽

Keiko Wada ◽

...

Keyword(s):

Clinical Practice ◽

Real World ◽

Research Funding ◽

Index Date ◽

Treatment Patterns ◽

Treatment Regimens ◽

Oral Medications ◽

Mantle Cell ◽

Insured Patients

Abstract Introduction Mantle cell lymphoma (MCL) is a rare, aggressive non-Hodgkin lymphoma associated with a poor prognosis. The approval of ibrutinib in November 2013 has changed the treatment paradigm for patients with relapsed or refractory MCL. There remains a lack of information on the current treatment patterns used in clinical practice in a contemporary cohort of commercially insured patients. We aimed to identify the treatment patterns for MCL overall and by line of therapy (LOT) and to describe patient demographics and clinical characteristics in a large cohort of commercially insured MCL patients. Methods A retrospective cohort study was conducted with the IQVIA Real-World Data Adjudicated Claims-US database. Adult patients (≥18 years old) with ≥1 claim for a NCCN-recommended MCL treatment between November 1, 2013 and December 31, 2017 were identified. Index date was the first treatment claim. Patients were also required to have ≥1 diagnosis of MCL during the study period (November 1, 2012 to January 31, 2018), ≥12 months of continuous enrollment prior to index date (pre-index period) and ≥30 days after index date (follow-up period). Patients were excluded if they were ≥65 years at index and not enrolled in Medicare Risk or Medicare Cost, enrolled in a clinical trial during the study period, had evidence of MCL treatment in the pre-index period (except for patients indexed on ibrutinib as it is indicated for MCL patients with ≥1 prior treatment), or had evidence of stem cell transplant (SCT) before index date. The most commonly observed MCL treatment regimens were identified, and demographic and clinical characteristics of patients and treatment durations by regimen were described. Treatment regimen was defined as the combination of all agents observed in the 35-day period after the first MCL treatment claim; treatment duration was defined as the start of treatment until a gap of ≥90 days between end date and next date of treatment or treatment modification. Treatment end date occurred 90 days after the end of the supply for oral medications or 30 days after the last administration for non-oral medications. Results There were 1,785 patients treated with the most commonly observed MCL treatment regimens. The most common regimens, irrespective of LOT, were rituximab monotherapy (including maintenance therapy; n=773, 43.3%), R-CHOP (n=723, 40.5%), B-R (n=436, 24.4%), and ibrutinib monotherapy (n=199, 11.1%). Overall, patients had a median (IQR) age of 57 (52-62) years, and 59.4% were male. Most patients were commercially or self- insured (57.5% and 33.6%, respectively). Patients had a median Charlson Comorbidity Index (CCI) of 0 (IQR 0-1; mean [SD] 0.9 [1.4]), with the most common CCI components being diabetes (15.7%), chronic pulmonary disease (12.8%), and congestive heart failure (9.5%). During the follow-up period (median [IQR] 22.5 [10.5-35.3] months), in addition to the MCL regimen(s), patients received radiation therapy (17.4%), SCT (10.0%), and/or immunotherapy (0.2%). The use of targeted therapies (i.e. lenalidomide, bortezomib) other than ibrutinib was infrequent. When considering treatment lines, R-CHOP was the most commonly observed first regimen, followed by rituximab, B-R, and ibrutinib; for the second and third observed regimens, rituximab was the most common, followed by ibrutinib (Figure 1). The median (IQR) duration for the first observed regimen was 8.1 (3.9-18.0) months for ibrutinib, 5.0 (3.3-5.6) months for B-R, 4.0 (2.5-4.4) months for R-CHOP, and 1.9 (1.7-4.4) months for rituximab; ibrutinib also had the longest duration in the second and third line (median [IQR] 5.5 [2.4-13.5] months and 8.3 [3.9-12.4] months, respectively). Conclusion This is the largest study of MCL patients describing treatment patterns in current clinical practice among commercially insured patients. MCL patients were most commonly treated with chemoimmunotherapy for all treatment lines while ibrutinib was the second most common LOT2 and LOT3 regimen. As the treatment landscape and clinical practice continues to change with the use of novel agents, future studies are warranted to further study toxicities and outcomes in the real-world setting. Disclosures Kabadi: AstraZeneca: Employment. Burudpakdee:IQVIA received funds from AstraZeneca to conduct the analysis, interpret data, and coauthor the publication.: Consultancy. Near:IQVIA received funds from AstraZeneca to conduct the analysis, interpret data, and coauthor the publication.: Consultancy. Wada:IQVIA received funds from AstraZeneca to conduct the analysis, interpret data, and coauthor the publication.: Consultancy. Mato:TG Therapeutics: Research Funding; Sunesis: Honoraria, Research Funding; Acerta: Research Funding; Janssen: Consultancy, Honoraria; AstraZeneca: Consultancy; Pharmacyclics: Consultancy, Honoraria, Research Funding; Regeneron: Research Funding; Celgene: Consultancy; Prime Oncology: Speakers Bureau; Abbvie: Consultancy.

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Treatment patterns and characteristics of acute promyelocytic leukemia (APL) patients receiving arsenic trioxide (ATO) therapy in a real-world setting.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e18522 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e18522-e18522

Author(s):

Boxiong Tang ◽

Susan Gabriel ◽

Jifang Zhou ◽

Ashutosh K. Pathak ◽

Debra Irwin ◽

...

Keyword(s):

Real World ◽

Index Date ◽

Claims Data ◽

Treatment Patterns ◽

Chronic Obstructive ◽

Administrative Claims ◽

First Line ◽

Real World Data ◽

World Data

e18522 Background: Clinical trials have shown that low-risk APL patients had significantly better outcomes when receiving first-line all-trans retinoic acid (ATRA) + ATO compared with standard ATRA + chemotherapy. Few published studies have used real-world data to describe patients using ATO and their current treatment patterns. This study used United States (US) administrative claims data to describe treatment patterns and characteristics of patients receiving first-line ATO. Methods: This retrospective, observational cohort study used claims data from the MarketScan databases. As there is no ICD-9-CM diagnosis code for APL, ATO treatment was used as a surrogate for the diagnosis of APL since ATO is typically used only in APL patients. Patients were selected if they had ≥1 claims for ATO between January 1, 2000, and June 30, 2015. Date of first use was designated the index date. To identify first-line ATO initiation, patients with ATRA or other APL-indicated chemotherapy claims any time before the index date were excluded. Variable baseline and follow-up periods consisting of ≥3 months of pre-index and ≥30 days of post-index continuous enrollment in medical and pharmacy benefit were used. Results: In total, 331 patients were identified with a subset (n = 265) having ≥2 claims for ATO. The analysis focused on these 265 patients, 54% of whom were male. Mean age was 60.6 years; 45% were covered by Medicare. The most common comorbid conditions measured were diabetes (6%), chronic obstructive pulmonary disease (5%), and congestive heart failure (4%). The most commonly selected APL treatments administered during follow-up were ATRA (17%) and daunorubicin (9%) with the use of idarubicin, cytarabine, and mitoxantrone at less than 3%. Maintenance therapy with methotrexate or 6-mercaptopurine was observed in 7% and 6% of patients, respectively. Conclusions: This is one of the first studies to examine patient characteristics and treatment patterns for first-line ATO using real-world data. Further research is needed to evaluate outcomes for patients receiving ATO as first-line therapy and to re-evaluate treatment guidelines in light of these outcomes.

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Real-World Treatment Patterns and Outcomes Among Patients with Hairy Cell Leukemia

Blood ◽

10.1182/blood.v126.23.2125.2125 ◽

2015 ◽

Vol 126 (23) ◽

pp. 2125-2125

Author(s):

Sudeep Karve ◽

Victoria Divino ◽

Andrew Gaughan ◽

Mitch DeKoven ◽

Guozhi Gao ◽

...

Keyword(s):

Health Plan ◽

Real World ◽

Index Date ◽

Treatment Patterns ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

First Line Therapy ◽

Line Therapy

Abstract Background and Objective : Hairy cell leukemia (HCL) is a rare condition and accounts for ~2% of all leukemia cases in the US. NCCN guidelines recommend first-line agents including pentostatin and cladribine among patients with HCL. However, a paucity of data exists with regard to real-world treatment patterns among patients with HCL. Current study evaluates treatment patterns and associated clinical outcomes among patients with HCL using a large US administrative claims database. Methods : This retrospective observational study was conducted using the IMS Health PharMetrics Plus Health Plan Claims Database (2006-2014), which includes over 150 million unique health plan members across the US and is nationally representative of the commercially-insured US population. Data includes date stamped medical and pharmacy records along with information on health plan enrollment. Individuals with at least 2 medical claims with a diagnosis for HCL (identified using ICD-9-CM cod: 202.4x) were selected and the first observed claim defined the "index date." Patients <18 years of age at index date or with other malignancies during 6 months (the "pre-index period") prior to index date were excluded. Patients were required at least 90 days of continuous enrollment (the variable "follow-up period") in the health plan post index date with exception of patients who died within 3 months of diagnosis. Patients were followed until death (recorded on inpatient discharge disposition), end of enrollment or end of database, whichever occurred earlier. Study measures including patient demographic and baseline clinical characteristics, line of therapy (LOT), treatment patterns, relapse (receipt of same or new regimen in subsequent LOT following a gap of 365 days) and refractory disease (receipt of same or new regimen where the gap of two adjacent LOTs was <365 days) and post-treatment complications were assessed during the follow-up period. All analyses were descriptive in nature. Results : The study cohort included 749 patients after applying the selection criteria (mean follow-up from diagnosis 32 months). At diagnosis, the mean age (standard deviation) of the study cohort was 56 (10) years and majority of patients were male (77%). Mean baseline comorbidity burden (assessed using Charlson Comorbidity Index score) was 0.8 (1.1) with hypertension (24%) and aplastic anemia (22%) being the two most common co-morbidities. Only 38% (n=282) of patients received first-line chemotherapy post diagnosis. Majority initiated first-line cladribine (76%) as a single agent, while 9% had evidence of single agent pentostatin. Mean time to initiation of first-line therapy from diagnosis was 132 (294) days and average time on first-line therapy was 34 (104) days. Among patients with first-line therapy 14% received second-line therapy and rituximab (53%) and cladribine (21%) were frequently observed second-line agents. Post first-line therapy, mean time to initiation of second-line therapy was 303 (406) days. Among second-line initiators, 76% had refractory disease and 24% had relapsed following first-line. Neutropenia and fever were frequently reported complications while on chemotherapy. Conclusion : The real-world chemotherapy utilization patterns observed in this study are consistent with the NCCN guidelines with cladribine and pentostatin being the agents of choice for first-line therapy. Following diagnosis, more than one-third of patients initiated chemotherapy and only a small proportion of these received second-line chemotherapy suggesting durable response with first-line therapy. Limited follow-up post first-line therapy may have impacted the proportion of patients initiating second-line therapy as well as categorization of refractory and relapse disease. Disclosures Karve: AstraZeneca: Employment. Divino:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gaughan:AstraZeneca: Employment. DeKoven:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gao:MedImmune: Employment. Lanasa:MedImmune: Employment.

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1422. Real-World Study of the Effects of Inappropriate or Suboptimal Treatment on the Burden of Illness Among Patients with Uncomplicated Urinary Tract Infection and High-Risk Comorbid Conditions in the United States

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1614 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S794-S795

Author(s):

Madison T Preib ◽

Alen Marijam ◽

Fanny S Mitrani-Gold ◽

Daniel C Gibbons ◽

Xiaoxi Sun ◽

...

Keyword(s):

Urinary Tract ◽

High Risk ◽

Real World ◽

Index Date ◽

The United States ◽

Uncomplicated Urinary Tract Infection ◽

Comorbid Conditions ◽

Tract Infections ◽

High Risk Cohort

Abstract Background Urinary tract infections (UTIs) are associated with significant morbidity and economic burden. Nitrofurantoin (NFT) and fosfomycin are among the first-line treatments for uncomplicated UTI (uUTI) recommended by Infectious Diseases Society of America (IDSA) 2011 guidance. We used real-world data (RWD) to assess patterns of appropriate and optimal (AP&OP) and inappropriate or suboptimal (IA/SO) antibiotic (AB) prescribing (RX), and related healthcare resource use (HRU) and costs, in US uUTI patients with high-risk comorbid conditions. Methods This was a retrospective cohort study of RWD (IBM MarketScan, commercial/Medicare Supplemental claims January 1, 2014–December 31, 2017) in females ≥ 12 years of age with uUTI, who had an oral AB prescription ± 5 days of uUTI diagnosis (index date) and continuous health-plan enrollment ≥ 1 year pre-/post-index date. Patients were stratified into high-risk cohorts (Table 1) and by AB RX (AP&OP and IA/SO) during first uUTI episode (within 28 days of index). AP&OP RX followed IDSA guidance, IA RX did not; SO RX was considered a proxy for treatment failure (e.g., AB switch or a second UTI diagnosis [acute care setting] in index episode). Sample size was balanced via random match selection, AP&OP:IA/SO ratio 1:5 (age and region). uUTIrelated HRU and costs were compared between cohorts (at index episode and 1-year follow-up) via multivariable analysis. Table 1. High-risk cohorts identified in the study Results IA/SO AB RX was highest in the elderly cohort (94.3%, likely influenced by renal impairment/no NFT RX in this group) and > 90% in other cohorts; AP&OP AB RX was highest in the postmenopausal cohort (9.0%). IA/SO AB RX in all cohorts was associated with significantly higher uUTI-related HRU (outpatient visits and pharmacy claims) per index episode/during follow-up versus AP&OP AB RX (p ≤ 0.0237, Table 2). IA/SO AB RX in all cohorts was associated with significantly higher adjusted total costs per index episode/during follow-up versus AP&OP AB RX (p < 0.05; Table 3). Table 2. uUTI-related HRU* per patient according to high-risk cohort and stratified by AB RX Table 3. uUTI-related costs* per patient according to high-risk cohort and stratified by AB RX Conclusion Over 90% of females in each high-risk cohort identified had IA/SO AB RX (outside IDSA 2011 guidance for uUTI treatment), leading to high HRU and cost burden. This suggests an unmet need for uUTI symptom relief, new treatments, training, and improved RX practices in the US and, furthermore, a need for additional research in this area. Disclosures Madison T. Preib, MPH, STATinMED Research (Employee, Former employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Alen Marijam, MSc, GlaxoSmithKline plc. (Employee, Shareholder) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Daniel C. Gibbons, PhD, GlaxoSmithKline plc. (Employee, Shareholder) Xiaoxi Sun, MA, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Christopher Adams, MPH, 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)

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Real-world mapping of allergy immunotherapy in the United States: The argument for improving adherence

Allergy and Asthma Proceedings ◽

10.2500/aap.2021.42.200114 ◽

2021 ◽

Vol 42 (1) ◽

pp. 55-64 ◽

Cited By ~ 1

Author(s):

Brian Stone ◽

Karen Rance ◽

Douglas Waddell ◽

Mark Aagren ◽

Eva Hammerby ◽

...

Keyword(s):

United States ◽

Real World ◽

Index Date ◽

Patient Characteristics ◽

The United States ◽

Care Utilization ◽

Upper Respiratory Tract ◽

Allergy Immunotherapy ◽

Related Service ◽

Tract Infections

Background: There is a dearth of real-world evidence studies focused on allergy immunotherapy (AIT) use among patients with allergic rhinitis (AR). Objective: This study examined claims data of AR patients residing in the United States to assess patient characteristics and health outcomes. Methods: AR patients were identified in the IBM MarketScan database between January 1, 2014, and March 31, 2017. Patients receiving AIT were identified with relevant billing codes (earliest AIT claim for vaccine as the index date); patients without AIT were identified with claims that contained a diagnosis code for AR (earliest AR claim as the index date). All the patients were required to have continuous enrollment 12 months prior to and following their index date. AIT patients reaching 25+ injection claims were analyzed as a separate maintenance cohort. Patients were assessed for demographic characteristics, comorbid conditions, and health care utilization. Results: A total of 2,334,530 AR patients were included; 103,207 had at least one AIT claim, with 45,279 (43.9%) of these patients reaching maintenance. Patients who reached AIT maintenance presented higher rates of baseline comorbidities than both the full AIT cohort and the patients with no AIT claims, including asthma (34.6% versus 30.1% versus 7.5%) and upper respiratory tract infections (63.1% versus 60.3% versus 34.2%). From baseline to follow-up, maintenance AIT patients demonstrated reductions in all AR-related comorbidities assessed, along with reductions in all-cause and AR-related service utilization. Conclusion: Patients initiating AIT presented the greatest need for therapeutic intervention, as evidenced by higher allergy-related comorbidities; those who reached maintenance demonstrated improved outcomes following the initiation of therapy. Continued efforts to increase patient awareness and adherence to AIT are needed.

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P3674Patient characteristics and treatment patterns in the multicentre, retrospective chart review of first-time Opsumit (macitentan) users in the United States (OrPHeUS)

European Heart Journal ◽

10.1093/eurheartj/ehz745.0529 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

V McLaughlin ◽

R Channick ◽

K Chin ◽

P Leary ◽

C Miller ◽

...

Keyword(s):

Chart Review ◽

Retrospective Chart Review ◽

Patient Characteristics ◽

Exposure Period ◽

The United States ◽

Treatment Patterns ◽

Functional Class ◽

Kaplan Meier ◽

Real World Evidence

Abstract Introduction The OPsumit® Historical USers cohort (OrPHeUS) is a multicentre, US, retrospective medical chart review conducted to supplement the OPsumit® USers (OPUS) Registry to fulfil the FDA request to characterise the safety of macitentan in clinical practice. Purpose To describe patient characteristics, treatment patterns, hepatic safety and survival in patients with pulmonary hypertension (PH) newly treated with macitentan. Methods OrPHeUS (NCT03197688) aimed to include 2200 new users of macitentan, between October 2013 and March 2017, who were not enrolled in OPUS. Here we present patients with follow-up data, including characteristics and treatment patterns at macitentan initiation, hepatic adverse events (HAEs) identified using preferred terms in chart entries and pharmacovigilance reporting, hospitalisations and survival. Results OrPHeUS included 2982 patients newly treated with macitentan and with follow-up data; the reason for macitentan prescription was pulmonary arterial hypertension (PAH) in 2362 (79.3%) patients, other PH aetiologies in 612 (20.6%) patients and 8 patients with other/unknown reasons. At macitentan initiation, the median (Q1, Q3) age of the patients was 62 (51, 72) years and 73.9% were female. WHO functional class (FC) was documented in 654 (21.9%) patients, 35.6% of patients were in FC I/II and 64.4% in FC III/IV; median (Q1, Q3) 6-minute walk distance, documented in 411 (13.8%) patients, was 293 (200, 383) metres. At macitentan initiation, 41.5% (n=1239) of patients were not receiving PAH therapy, 46.3% (n=1382) were already receiving one PAH therapy and 11.9% (n=356) were already receiving two PAH therapies. The median (Q1, Q3) exposure to macitentan was 14.9 (5.6, 27.1) months; 57% and 43% of patients had exposures of >12 and >18 months. During the exposure period, 933 (31.3%) patients discontinued treatment, including 474 (15.9%) patients who discontinued due to an adverse event (AE), 6 (0.2%) due to a HAE, 449 (15.1%) for reasons other than an AE/HAE, and 4 (0.1%) for unknown reasons. There were 275 (9.2%) patients who experienced ≥1 HAE (incidence rate [IR]: 0.07 [95% CI, 0.06, 0.08] per 1 person-year); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN) were experienced by 113 (3.8%) patients (IR: 0.028 [95% CI, 0.023, 0.033] per 1 person-year); ALT/AST ≥x3 ULN and bilirubin ≥2x ULN was experienced by 33 (1.1%) patients (IR: 0.008 [95% CI, 0.006, 0.011] per 1 person-year). There were 1148 (38.5%) patients who experienced at least one hospitalisation (IR: 0.36 [95% CI, 0.34, 0.39] per 1 person-year). The 12-month Kaplan-Meier survival estimate was 92% (95% CI, 91, 93). Conclusion OrPHeUS provides additional real-world evidence in patients newly treated with macitentan, confirming the hepatic safety profile of macitentan. Acknowledgement/Funding Actelion Pharmaceuticals Ltd

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Real World Evidence in Relapsed/Refractory Classical Hodgkin Lymphoma Patients Who Are Ineligible for Stem Cell Transplant in the United States (US)

Blood ◽

10.1182/blood-2018-99-113682 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 2268-2268

Author(s):

Joseph Feliciano ◽

Nate Way ◽

Gerald Engley ◽

Nilanjan Ghosh

Keyword(s):

Real World ◽

Systemic Therapy ◽

Research Funding ◽

Patient Characteristics ◽

The United States ◽

Treatment Patterns ◽

Cell Transplant ◽

Real World Evidence ◽

The Us ◽

Line Of Therapy

Abstract Introduction: Treatment of relapsed or refractory classical Hodgkin lymphoma (R/R cHL) in patients considered ineligible for stem cell transplant (SCT) in the United States (US) has evolved since 2011. It is important to understand the current treatment landscape and the outcomes associated with current standards of care as new treatment options have been introduced. This analysis provides recent real-world evidence on patient characteristics, treatment patterns, and outcomes in R/R cHL patients in the US who are initially considered ineligible for SCT and are treated with or without brentuximab vedotin (BV). Methods: Hematologists and oncologists (N=205) from the US retrospectively identified patients diagnosed with R/R cHL who received at least two lines of therapy and received their most recent line of therapy between January 2014 and May 2018. The physicians were responsible for abstracting data and completing response forms for variables of interest. The current analysis focused on patients who were considered ineligible for SCT by their physician: descriptive statistics on patient demographics/clinical characteristics, treatment patterns, and outcomes by line of therapy; bivariate analyses (chi-square) comparing treatment modalities by line of therapy. Results: Physicians retrospectively identified 297 patients that they considered ineligible for SCT. Mean (SD) age at initial cHL diagnosis was 53.0 (18.5), most patients were male (69.4%) and Caucasian (61.3%). The most common cHL subtype at diagnosis was nodular sclerosis HL (40.4%), and patients had either Stage I/II (45.8%) or Stage III/IV (54.2%) cHL at initial diagnosis. Median follow-up time for the cohort included here was 15.96 months from initiation of 1L treatment. The majority of the cohort (N = 297) received systemic therapy alone (84.5%) compared to those who received systemic therapy in combination with radiation therapy (RT) (15.5%) in 1L. 1L systemic regimens included regimens that contained ABVD alone or ABVD in combination with other regimens (69.4%). Of those who used ABVD alone or in combination with another regimen (N = 206), 24.8% used a PET adapted approach and deescalated to AVD (N = 51) and 11% escalated to be BEACOPP (N = 18). Other systemic regimens included AVD (10.1%), BEACOPP (7.4%) and ICE (5.7 %). The majority of patients achieved a complete response (CR) or partial remission (PR) after 1L therapy (41.4%, 38% respectively) while 34.1% (N = 61) failed to achieve remission or progressed while on therapy. The most common systemic regimens in 2L (N = 293) were BV monotherapy or in combination with bendamustine (34.6%), salvage regimens [including ICE, DHAP, ESHAP or gemcitabine based combinations] (33%), re-challenge with a previous 1L regimen (19.5%), and PD-1 inhibitors (10.8%). Very few patients received systemic therapy in combination with RT (6.7%) in 2L.The most common systemic regimens used in 3L (N = 21) for the selected cohort of patients not eligible for SCT were BV monotherapy (28.6%) and PD-1 inhibitors (33.3%). Median (range) number of cycles in 2L and 3L was four (1-18) and two (1-14), respectively. Treatment outcomes were variable for patients in 2L and 3L. In 2L, 27.6% achieved a CR, 25.6% achieved a PR, while 24.2% and 15.8% were refractory or progressed on treatment. There were no CRs reported in 3L (N = 21). 26 patients died in 2L and 3L combined. Conclusion/Summary: Given the rapid evolution of therapies used to treat R/R cHL, these findings fill a crucial data gap in real-world evidence on patient characteristics, treatment patterns, and outcomes of patients deemed SCT ineligible in the US. Disclosures Feliciano: Seattle Genetics: Employment. Way:Kantar Health: Employment; Seattle Genetics: Research Funding. Engley:Seattle Genetics: Employment. Ghosh:Juno: Consultancy, Research Funding; SGN: Consultancy, Research Funding, Speakers Bureau; PCYC: Consultancy, Research Funding, Speakers Bureau; Celgene: Consultancy; Spectrum: Consultancy; Gilead: Consultancy, Speakers Bureau; Pharmacyclics, an Abbvie Company: Consultancy, Research Funding, Speakers Bureau; Genentech: Research Funding; F. Hoffman-La Roche Ltd: Research Funding; Abbvie: Consultancy, Speakers Bureau; Forty seven Inc: Research Funding; TG Therapeutics: Honoraria, Research Funding.

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