P393 Treatment patterns of patients with perianal fistulizing Crohn’s disease from a US administrative claims database

Abstract Background Perianal fistula (PAF), a complication of Crohn’s disease (CD), is indicative of high disease severity and poor prognosis. We estimated the cumulative prevalence and treatment patterns of PAF CD in the USA. Methods In this retrospective study of IBM® MarketScan® Commercial and Medicare databases (conducted 1 October 2015 to 30 September 2018), patients (pts) were 18 to 89 years of age with at least two diagnoses of CD at least 30 days apart, and had continuous health plan enrolment for at least 12 months pre- and post-index date (first PAF diagnosis or procedure [PAF pts]). Non-PAF CD pts were assigned the same index date as matched PAF pts based on birth year, sex, presence/lack of CD diagnosis before index date, CD disease location and follow-up duration. Descriptive analysis was used for all variables. Treatment patterns and costs related to opioid use were compared among PAF pts. We also assessed four PAF pt cohorts with PAF-related surgery treated with one (cohort 1) or more than one (cohort 2) opioid within 7 days of index date or one (cohort 3) or more than one (cohort 4) opioid more than 7 days after index date. Results Cumulative prevalence of PAF CD (n = 81 862) was 7.7% (0.01% of the US population) over 3 years. The economic impact and treatment patterns were assessed in PAF (n = 1218; mean age 42 years; 52.4% men; 56.5% preferred provider organization [PPO] health plan) and matched non-PAF CD pts (n = 4095; mean age 43 years; 50.9% men; 57.6% PPO health plan). During follow-up, 65.8% of PAF and 42.3% of non-PAF pts were treated with at least one biologic agent. In the 30 days post-index, 31.9% of PAF pts were treated with biologics, with this percentage increasing over time; steroid use also remained high (Figure 1). Opioid treatment was associated with higher mean per patient per year (PPPY) total gastrointestinal (GI)-related costs for PAF pts (p < 0.0001). Mean PPPY total GI-related costs for pts with PAF-related surgery and opioid treatment were $50 605, $53 984, $82 973 and $92 375 for cohorts 1, 2, 3 and 4, respectively (Figure 2). Generalized linear model-adjusted mean PPPY PAF-related surgeries were 7.2 versus 0 for PAF pts and non-PAF pts (p < 0.0001), respectively. In the 30 days post-index date, 22.5% of PAF pts had minor surgeries and 20.0% had definitive surgeries. Conclusion Based on treatment guidelines as well as the study population’s use of inflammatory bowel disease medications and opioids, and higher rates of PAF-related surgeries, a need for better disease state management of patients with PAF CD is warranted. Sponsor: Takeda Pharmaceuticals USA, Inc.

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P340 Real-world treatment patterns and recurrence rates of rectovaginal fistulas in patients with Crohn’s disease: A retrospective cohort database analysis

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.464 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S364-S365

Author(s):

C Karki ◽

D Latremouille-Viau ◽

I Gilaberte ◽

G Hantsbarger ◽

H Romdhani ◽

...

Keyword(s):

Crohn’S Disease ◽

Health Plan ◽

Real World ◽

Index Date ◽

Baseline Period ◽

Treatment Patterns ◽

Database Analysis ◽

Adult Females ◽

Rectovaginal Fistulas

Abstract Background Rectovaginal fistulas (RVF) are a difficult to treat perianal complication of Crohn’s disease (CD) with a significant impact on quality of life. Management of RVF includes both medical and surgical interventions. Few studies have assessed real-world treatment patterns for CD-related RVF. This retrospective US cohort database analysis aimed to assess the rate of, and time to RVF episodes of care in CD, and describe treatment patterns. Methods IBM Truven Health MarketScan® databases (Commercial and Medicare supplemental administrative claims [01/01/01 to 31/12/19]) were used. Adult females with a diagnosis code for CD, ≥1 medical claim with a RVF-specific diagnosis/procedure ICD-9/10 code on or after the date of first observed CD diagnosis, and ≥180 and ≥720 days of continuous health plan enrolment before and after index (date of first RVF-related code after first CD diagnosis date), respectively, were included. Treatment patterns were assessed during the 6 months pre-index (baseline period) and any time post-index. The first RVF episode of care (episode) started on the date of the first RVF-related code after CD diagnosis. RVF-related codes ≤90 days apart were considered as the same episode. Time to subsequent episodes was assessed by Kaplan–Meier (KM) analysis. Only descriptive statistics were reported for the proportion of patients with episodes and subsequent treatment patterns. Results Of 274 096 adult females diagnosed with CD during a continuous eligibility period, 2540 (0.9%) had a RVF-specific code. Overall, 963 patients met the inclusion criteria (median age: 46.0 years). The median follow-up (time between the index date and end of continuous health plan enrolment or data availability) was 48.5 months. During the follow-up period, 963 (100%), 430 (44.7%) and 217 (22.5%) patients had at least one, two or three episodes, respectively. KM analysis showed the probability of having a subsequent episode within 1, 2 and 5 years of their first or second episode (Figure). During the baseline period, 775 (80.5%) and 287 (29.8%) patients received non-biologic or biologic therapies, respectively, and 929 (96.5%) and 494 (51.3%) at any time post-index. At any time post-index, 587 (61.0%) patients had ≥1 RVF-related surgery. Conclusion This study showed patients with CD-related RVF required recurrent episodes of medical and surgical care in a US real-world setting. In addition, post-index, an important proportion of patients were observed with biologics use (>50%) and nearly two-thirds of patients had RVF-related surgery. Patients with CD-related RVF had varied treatment patterns and more studies are needed to inform the standard of care for patients with RVF. Sponsor: Takeda Pharmaceuticals, Inc.

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Real-World Analysis of Ruxolitinib Treatment Patterns and Outcomes Among Patients with Myelofibrosis

Blood ◽

10.1182/blood-2019-124651 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 4750-4750 ◽

Cited By ~ 1

Author(s):

Tanya Burton ◽

Kejal Parikh ◽

Manish Patel ◽

Kevin Sundquist ◽

Lincy S. Lal ◽

...

Keyword(s):

Health Plan ◽

Research Funding ◽

Index Date ◽

Myeloproliferative Neoplasm ◽

Treatment Patterns ◽

Systemic Steroid ◽

Administrative Claims ◽

Employment Equity ◽

Oncology Research ◽

Equity Ownership

Background: Myelofibrosis (MF) is a myeloproliferative neoplasm characterized by bone marrow fibrosis, splenomegaly, cytopenias, and poor survival. Ruxolitinib (RUX) is the only approved treatment for Intermediate or High-risk MF. In a previous study, we have shown almost 1 in 3 patients initiating RUX had dose modifications during the first 3 months of treatment (Burton T et al. HemaSphere 2019). The objective of this study was to assess RUX treatment patterns among patients with MF. Methods: This retrospective analysis used administrative claims data from a large US health plan to identify adults (aged ≥ 18 years) with ≥ 1 claim for RUX and ≥ 2 non-diagnostic medical claims for primary (International Classification of Diseases [ICD] 9th or 10th Revision [9/10]: 238.76, D47.4) or secondary MF (ICD-9/10: 289.83, D75.81) from January 1, 2012 to June 30, 2018. The first RUX claim on or after the first MF claim defined the index date. Included patients were continuously enrolled in a commercial or Medicare Advantage health plan for 3 months before the index date (pre-index period) and 6 months on or after the index date (post-index period). Clinical characteristics, MF-related treatments, health care resource utilization (HCRU), and costs were assessed during the pre- and post-index periods. Costs were adjusted to 2018 US dollars using the medical component of the Consumer Price Index. Cohorts were created based on the maximum (max) RUX daily dose observed during the 6-month post-index period: suboptimal max < 30 mg/day (SUB); and optimal max ≥ 30 mg/day (OPT). All variables were analyzed descriptively. Results: Among 495 eligible patients, mean (SD) age was 69.4 (10.3) years; 54.1% were male; and 25% had a primary MF diagnosis code. Median initial RUX dose was 30 mg/day and patients continued with this dose for a mean (SD) of 70.0 (45.8) days. RUX dose was modified for 19.4% of patients during the 6-month post-index period, and the distribution of max RUX daily doses was: < 15 mg (13.7%), 15-29 mg (24.9%), 30-40 mg (55.8%), and > 40 mg (5.7%). Two groups based on max RUX dosing were further analyzed: 191 (38.6%) in the SUB cohort (< 30 mg), and 304 (61.4%) in the OPT cohort (≥ 30 mg). Patients in the SUB cohort were older than patients in the OPT cohort (SUB: mean 70.8 [SD 10.1] years; OPT: mean 68.5 [SD 10.3] years; P = 0.013), but the mean Charlson Comorbidity Index scores did not differ (SUB: mean 1.6 [SD 1.8]; OPT: mean 1.5 [SD 1.8]; P = 0.601). Rates of anemia were higher at baseline for the SUB cohort than the OPT cohort (SUB: 64.9%; OPT: 53%; P = 0.009). During the 6-month post-index period, compared with patients in the OPT cohort, patients in the SUB cohort had a higher proportion of thrombocytopenia (SUB: 31.4%; OPT: 22.7%; P = 0.03). Nearly half (45.5%) the sample used a supportive agent such as an androgen, systemic steroid, or erythropoiesis-stimulating agent during the post-index period (SUB: 48.2%; OPT: 43.8%; P = 0.34). With respect to HCRU and costs, the SUB cohort had a higher proportion of emergency department (ED) visits than the OPT cohort during baseline (SUB: 31.4%; OPT: 23.4%; P = 0.048); and baseline total mean (SD) all-cause costs were USD 18,079 (21,876) overall, USD 18,908 (24,411) for the SUB cohort, and USD 17,559 (20,145) for the OPT cohort (P = 0.523). During the 6-month follow-up period, 31.1% of patients had ≥ 1 ED visit (SUB: 35.1%; OPT: 28.6%; P = 0.131), 22.8% had ≥ 1 inpatient (IP) hospitalization (SUB: 24.6%; OPT: 21.7%; P = 0.455), and total mean (SD) all-cause costs were USD 94,498 (97,391) overall (SUB: USD 93,289 [115,418]; OPT: USD 95,258 [84,315]; P = 0.839). Conclusion: In this study, patients with MF treated with RUX experienced significant disease burden and high costs, regardless of dose. Both anemia and thrombocytopenia were observed along with nearly half of patients using a supportive agent. Given the large proportion of patients with a dose adjustment, suboptimal dosing, and an IP hospitalization, there continues to be a need for additional therapeutic options for patients with MF. Disclosures Parikh: Celgene Corporation: Employment, Equity Ownership. Patel:Celgene Corporation: Employment, Equity Ownership. Sundquist:Optum: Employment, Equity Ownership. Lal:Optum: Employment. Copher:Celgene Corporation: Employment. Gerds:Roche: Research Funding; Incyte: Consultancy, Research Funding; Sierra Oncology: Research Funding; CTI Biopharma: Consultancy, Research Funding; Imago Biosciences: Research Funding; Celgene Corporation: Consultancy, Research Funding; Pfizer: 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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P618 Treatment outcomes of patients with Crohn’s disease and complex perianal fistula in five European countries: the PREFACE retrospective study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.739 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S560-S560

Author(s):

M Ferrante ◽

L Siproudhis ◽

G Poggioli ◽

M Reinshagen ◽

S Milicevic ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Treatment Outcomes ◽

Index Date ◽

Perianal Fistula ◽

European Countries ◽

Standards Of Care ◽

Patient Level ◽

Remission Rates

Abstract Background Presence of fistulas in Crohn’s disease (CD) is an indicator of poor prognosis; 20% of CD patients suffer from perianal fistula. There are few studies specifically designed to assess treatment outcomes in complex perianal fistula (CPF) in CD. This retrospective chart review study describes the outcomes of patients with CPF in CD in five European countries after medical and/or surgical treatment. Methods Adult patients with CD receiving treatment for a new episode of CPF during the eligibility period (September 2011 to September 2014), in Belgium, France, Germany, Italy and Spain, were included. Index date was defined as date of any medical or surgical CPF treatment initiation. Data was collected from CD diagnosis to at least 3 years after index date (except for deceased or lost to follow-up patients) to describe patient characteristics and treatments used for all CPF episodes since CD diagnosis. Effectiveness outcomes were measured as remission rates based on Fistula Drainage Assessment (FDA) recorded in medical charts for fistula reported at index date (index fistula). Remission rates are expressed as percentage rates on patient level after 6- and 12-months follow-up period. For calculation of treatment outcomes, the most recent FDA prior to the respective timepoint was used. Results A total of 372 patients (51% male) with a mean (SD) age of 38 (13) were included by 31 sites. Median time since CD diagnosis was 7 years, and median length of follow-up was 6 years. A total of 498 CPFs were presented at index date and during FU period. Out of the 498 CPFs, 94% were treated with at least one surgical intervention (most frequent: 61% long-term seton placement, 51% surgical drainage) and 82% with at least one medical treatment (most frequent: 40% anti-TNFs, 33% antibiotics, 16% immunosuppressants). After 6 months the remission rate at patient level for index fistula was 28% and after 12 months 35%. Conclusion Current standards of care achieved remission in one third of patients with CPF in CD over a period of one year. Improved therapeutic strategies and new treatment options are required to improve outcomes in this manifestation of CD.

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P472 Payer addressable burden of Crohn’s disease in patients treated with ustekinumab and vedolizumab in the United States

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.595 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S461-S462

Author(s):

T Ghosh ◽

I Smith ◽

J Fehr ◽

J Davidson ◽

T Fan ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Health Plan ◽

Unit Cost ◽

The United States ◽

Cost Of Care ◽

Medical Utilization ◽

Administrative Claims ◽

Cost Burden ◽

Claims Analysis

Abstract Background Vedolizumab (VDZ) and ustekinumab (UST) are treatments for moderate-to-severe Crohn’s disease (CD). The payer addressable burden (PAB) is the total allowed cost of care of a national health plan based on an actuarial analysis of all members total cost burden, for a given disease, regardless of any other underlying conditions. We used an actuarial retrospective claims analysis of direct and indirect costs associated with payer allowed resource utilizations to understand the US payer cost burden of the biologic-treated CD population. Methods Mean annual allowed cost per member with CD in the commercial health plan population was examined from a health plan actuarial and financial perspective. Data were obtained from medical and prescription claims of commercial and Medicare health plan members from Optum’s proprietary de-identified Normative Health Information database. Administrative claims data for all commercial members with pharmacy and medical coverage were used to determine medical utilization and medication unit cost patterns for CD treatment for 2017–2019. PAB analysis includes resource utilizations and associated costs among CD patients (pts) whose last biologic agent received in a year was UST subcutaneous (SC) or VDZ intravenous (IV). Costs captured were the total paid by plan and pts for medical or pharmacy claims. ICD-10 diagnosis codes were used to identify prescriptions to be included based on CD diagnosis. Members with diagnostic codes for concomitant ulcerative colitis (UC) were included only if they had more claims for CD than UC. Allowed claims costs, the sum of all medical and pharmacy costs, were categorized as CD-specific PAB and all-cause PAB. Cost per member per month was estimated by dividing total costs by total member enrolled months. Results In this retrospective claims analysis, more members with CD were treated with VDZ IV than UST SC in 2017 and 2018. Total and CD-related costs were lower with VDZ IV than with UST SC in overall members with CD and biologic-naïve members with CD (Figure 1). Both CD-related and all-cause PAB were markedly lower for VDZ IV than UST SC (Figure 2). Conclusion PAB can help payers identify opportunities for cost-saving. For patients with CD, the payer cost burden was lower with VDZ IV than with UST SC. This analysis provides a cross-sectional view of financial burden for US payers in managing members with CD. The analysis did not include longitudinal follow-up of pts for cost difference or adjustment of confounders in biologic-treated pts. The results capture the real-world burden of all forms of clinical practice and resource utilization in treating pts with CD enrolled in a commercial national plan.

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P285 A retrospective observational study on the effectiveness and safety of vedolizumab with or without budesonide induction therapy among patients with moderate-to-severe Crohn’s disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.410 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S317-S319

Author(s):

R Weisshof ◽

S Vavricka ◽

L Pouillon ◽

F Braegger ◽

M Roset ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Induction Therapy ◽

Clinical Remission ◽

Index Date ◽

Severe Disease ◽

Added Value ◽

Induction Treatment ◽

Patient Reported

Abstract Background The α4β7 integrin monoclonal antibody vedolizumab (VDZ) has been shown to be efficacious for patients with moderate-to-severe Crohn’s disease (CD). This study aimed to analyse the added value of budesonide in combination with VDZ as an induction treatment for this indication. Methods A multicentre, retrospective chart review study was conducted in Belgium, Israel, and Switzerland. Adult patients with moderately to severely active CD (defined as an abdominal pain [AP] score of ≥2 and/or a mean daily loose stool frequency [LSF] score of ≥4 for the previous 7 days) who initiated induction therapy with either VDZ monotherapy (mono) or a combination therapy (combo) of VDZ with budesonide (index date) between 1 January 2015 and 31 January 2019 were included. Patients who received VDZ by IV infusion at weeks 0, 2, 6, 10 (only some patients received VDZ during week 10), and 8 weeks thereafter were assessed for time to patient-reported outcome (PRO) clinical remission (Kaplan-Meier curves), defined as an average daily composite score of AP ≤1 and LSF ≤31 within 14 weeks. Regression models were used to assess differences and associations. Results Overall, 123 patients were included (mono, n=73; combo, n=50). Patients initiating combo presented with more severe disease at index date than patients initiating mono. PRO clinical remission rates were estimated at 71.4% (50/70) in the mono and 68.0% (34/50) in the combo groups, with a similar median time to PRO remission of 91 days (95% CI: 70–98) and 95 days (95% CI: 70–98), respectively (Figure 1). Figure 2 shows the mean % change in AP and LSF from baseline to week 14, which was comparable for mono and combo. The variables associated with mean % change were moderate and severe AP scores for AP and being a current smoker for LSF. One patient in each group discontinued VDZ before week 14 (due to lack of effectiveness [mono] and adverse event [AE; combo]); 68.0% of patients in the combo group discontinued budesonide by the end of the follow up period. The reasons for discontinuation were routine treatment regimen (8 weeks 9 mg/day+subsequent tapering-off) in 85.3% of the patients, lack of effectiveness in 5.9% and AEs in 2.9% (5.8% other reasons). Safety event rates were similar among the groups for overall AEs (mono, 23.3%; combo, 26.0%), with the majority designated as mild to moderate in severity, and 83.3% resolved within the follow-up period. Conclusion Comparable effectiveness and safety outcomes were observed with mono and combo therapy in patients with CD; however, disease state among patients receiving combo was more refractory/severe at baseline. Further evidence is needed to corroborate these findings. Reference

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P801 Treatment patterns of complex perianal fistula in Crohn’s disease in five European countries: the PREFACE study, a retrospective chart review

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.929 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S628-S628

Author(s):

M Ferrante ◽

L Siproudhis ◽

G Poggioli ◽

M Reinshagen ◽

S Milicevic ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Index Date ◽

Chart Review ◽

Surgical Intervention ◽

Perianal Fistula ◽

Treatment Patterns ◽

Surgical Drainage ◽

Limited Information ◽

Seton Placement

Abstract Background Presence of fistulas in Crohn’s disease (CD) is an indicator of poor prognosis; 22.1% of CD patients suffer from fistulising disease1 with high variability in complex perianal fistula (CPF) prevalence2. There is limited information available about the management of CPF in a real-world setting. This study describes the treatment patterns of patients with CPF in CD in Europe. Methods Retrospective medical chart review of consecutive patients with CD receiving treatment for a new episode of CPF during the period (September 2011 to September 2014), in Belgium, France, Germany, Italy and Spain. Index date was defined as the date of treatment initiation for a new episode of CPF during the eligibility period. Data was collected from CD diagnosis to at least 3 years after index date (except for deceased or lost to follow-up patients) to describe patient characteristics and treatments used for all CPFs episodes since CD diagnosis. Results A total of 386 patients (51% female) were included with a mean (SD) age of 38 (13) and 10 (9) years since CD diagnosis. At CD diagnosis, 28% of patients had ileal, 29% colonic and 39% ileocolonic involvement; 24% of study patients had anal or perianal fistula. Prior to index date, 42% of patients had at least one surgery, being partial resection of small bowel the most common one. ASA-5, anti-TNFs and immunosuppressants were used for CD or complications in 47%, 48% and 42% of patients. Patients presented 584 CPFs during the study period. More than half of these CPFs were trans-sphincteric (60%). Out of the 584 CPFs, 92% were treated with at least one surgical intervention (most frequent: 56% long-term seton placement, 46% surgical drainage), and 86.6% with at least one medical treatment. Medical treatments most frequently used for CPFs or CD and complications (overlapping a CPF episode) were anti-TNFs (49%), antibiotics (44%) and immunosuppressants (26%). Conclusion Almost one fourth of the patients with CPF already had anal or perianal fistulas at CD diagnosis. Based on ECCO guidelines it was expected that almost all CPFs in CD patients should be treated with anti-TNF with or without surgical intervention. However, the use of anti-TNF during CPF episodes was lower than expected. Surgical drainage and seton placement were performed in a majority of patients in at least 3 years following treatment intensification, with a low rate of other types of surgery. Almost two third of CPFs were trans-sphincteric and if inadequately treated, sphincter function may be compromised.

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P805 Patients with Crohn’s disease treated with ustekinumab vs. vedolizumab in real-world settings

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.933 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S630-S630

Author(s):

M Chiorean ◽

J Jiang ◽

N Candela ◽

G Chen ◽

H Romdhani ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Real World ◽

Healthcare Costs ◽

Index Date ◽

Drug Costs ◽

Healthcare Outcomes ◽

Coding System ◽

Cost Differences

Abstract Background Ustekinumab (UST) and vedolizumab (VDZ) are approved biologic therapies for moderate to severe Crohn’s disease (CD). Comparative data on real-world patient characteristics and healthcare costs for these drugs are scarce. Methods We examined healthcare costs associated with UST (healthcare common procedure coding system [HCPCS]: J3357, J3358, C9261, C9487, Q9989) and VDZ (HCPCS: C9026, J3380) in a retrospective cohort study of Truven commercial claims data (2009–2018) for adults with CD (international classification of diseases-9/10 codes: 555/K50). Eligible patients (18–89 years old) initiated UST or VDZ (index drug) on/after Sept 26, 2016, had CD as the latest relevant autoimmune disease on or before index drug initiation (index) date, ≥6 months of data available both before and after the index date, completed induction, and initiated maintenance therapy. Entropy balancing was used to address confounding factors (baseline characteristics). Primary outcome was healthcare costs assessed from a US payer perspective from index date to treatment discontinuation or end of follow-up (time on treatment). Cost were reported in 2018 US$ per patient per month and compared between treatment groups overall, and for biologic-naïve and -experienced (≥1 pre-index biologic therapy for CD) subgroups, using mean cost differences (MCD) obtained from weighted two-part models. Results The 599 (117 biologic-naive) UST- and 589 (172 biologic-naive) VDZ-treated patients who met eligibility criteria were similar in sex (54% and 57% female), mean age (41 ± 14 and 44 ± 14 years), time since diagnosis (42 ± 33 and 46 ± 35 months) and Charlson comorbidity index (0.4 ± 1.0 and 0.6 ± 1.1). Disease location, follow-up duration, and prior therapies and surgeries were also comparable. Characteristics were similar in biologic-naïve and -experienced patients. Mean weighted time on treatment was 11.4 and 12.1 months in UST- and VDZ-treated patients. Mean weighted total healthcare costs per patient per month was higher with UST vs. VDZ (MCD=$5051) driven by total index drug costs (MCD=$4946; Table). Cost differences were consistent in biologic-naïve and -experienced patients (total cost MCD=$4466 and $4836, both p < 0.01). Conclusion Characteristics of UST- and VDZ-treated patients in real-world settings were comparable. In this population of patients receiving maintenance treatment for CD, index drug costs make UST treatment substantially more costly than VDZ. Further comparison of healthcare outcomes in patients treated with UST vs. VDZ is warranted.

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Understanding disease progression and treatment patterns in metastatic breast, colorectal, and lung cancer: Implications for evaluating value and quality of care.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.7_suppl.24 ◽

2016 ◽

Vol 34 (7_suppl) ◽

pp. 24-24

Author(s):

Nicole M. Engel-Nitz ◽

Stacey DaCosta Byfield ◽

Timothy Bancroft ◽

Amy J Anderson ◽

Carolina M. Reyes ◽

...

Keyword(s):

Quality Of Care ◽

Disease Progression ◽

Health Plan ◽

Cancer Care ◽

Index Date ◽

Metastatic Breast ◽

Treatment Patterns ◽

Colorectal Cancers

24 Background: Impact of strategies for evaluating value and quality of cancer care may vary for patients with metastatic tumors, particularly for strategies considering lines of treatment therapy as distinct events. To aid in evaluating the value and quality of care in patients’ overall trajectory of disease, this study examined disease progression, mortality, hospice, and treatment patterns in patients (pts) with metastatic breast (mBC), lung (mLC), and colorectal cancers (mCRC). Methods: Included were commercially insured and Medicare Advantage adults from a large US health plan administrative claims database (2007-2014); pts had ≥ 2 claims for BC, CRC, or LC, and ≥ 2 claims for metastases. Index date was defined as the first post-metastatic systemic anti-cancer therapy (TX). Health plan enrollment for 6 mo pre- and post-index date was required; pts with < 6 mo of follow-up due to death were included. Pts with other primary cancers were excluded. A line of therapy (LOT) algorithm was developed and outcomes assessed over a variable follow-up. Progressive disease (PD) was defined as: start of a new LOT, where 1) previous LOT duration > 60 days, and 2) ≥ 1 imaging/lab test occurred between previous LOT and new LOT; receipt of hospice care; or death. Results: Among 7070 mBC, 4767 mCRC and 6994 mLC patients, 73%, 72%, and 84% respectively progressed during the study period (incidence rates: 7, 7, and 13 per 10-pt-years). Mean (median) time in months to PD was 9.5 (6.5) for mBC, 9.0 (7.0) for mCRC and 6.3 (5.0) for mLC. For all cancers, median number of LOT over 1 year was 2, with means of 1.8 (mBC), 1.7 (mCRC), and 1.7 (mLC). Compared to patients without PD, patients with PD had shorter LOT1. Mortality was highest among mLC patients (50%) compared to mCRC (27%) and mBC (22%), with rates per 100-pt-years of 50, 16, and 11 respectively. Hospice rates varied by tumor type. Conclusions: The high level of progression and use of multiple lines of therapy in the metastatic setting suggests a need to delay progression with effective treatments for breast, lung, and colorectal cancers. The value and quality of cancer care should be evaluated across the entire span of patients’ disease.

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