scholarly journals Real-world Effectiveness of Advanced Therapies Among Patients With Moderate to Severe Ulcerative Colitis in the United States

2019 ◽  
Vol 26 (6) ◽  
pp. 941-948
Author(s):  
Millie D Long ◽  
Timothy W Smith ◽  
Marco Dibonaventura ◽  
David Gruben ◽  
Danielle Bargo ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Real World ◽  
Claims Data ◽  
Biologic Therapy ◽  
Patient Characteristics ◽  
The United States ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
Induce Response ◽  
Analysis Of Claims Data

Abstract Background Ulcerative colitis (UC) treatment aims to induce response and maintain steroid-free remission. For patients with moderate to severe UC and/or nonresponse to conventional treatment, advanced therapies (immunosuppressants and biologics) are available. We assessed real-world effectiveness of advanced UC therapies. Methods This retrospective analysis of claims data included adult patients with UC initiating immunosuppressant or biologic therapy, with 12 months’ continuous enrollment pre- and postinitiation. Patients had no prescription for biologic therapy (and/or immunosuppressant if initiating immunosuppressant) in the previous 12 months. Proportion of patients remaining steroid-free (excluding 14-week tapering period), hospitalizations, and costs in the 12 months postinitiation were assessed. Results In total, 3562 patients were included in the analysis. Most patients (83.0%) used steroids in the 12 months before initiating advanced therapy. Overall, 47.8% remained steroid-free after 12 months (excluding tapering). After adjusting for patient characteristics, remaining steroid-free was significantly more likely with infliximab (43.9%) than with adalimumab (39.4%; P < 0.05); golimumab (38.2%) and vedolizumab (41.4%) were not significantly different vs adalimumab. Overall, 12.2% of patients had a UC-related hospitalization within 12 months of initiation, with a mean (SD) total length of stay of 8.2 (8.9) days and no significant differences between biologic therapies. Mean, unadjusted, UC-related costs in the 12 months postinitiation were $42,579 and were similar between therapies. Conclusions Patients with UC initiating advanced therapy frequently continued using steroids for at least a year. Some patients experienced extended UC-related hospitalizations, with high UC-related costs overall. This suggests an ongoing challenge in managing patients with moderate to severe UC.

scholarly journals P377 Inadequate response with advanced therapies in real-world patients with Ulcerative Colitis – Results of a German claims database study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S392-S392
Author(s):  
B Bokemeyer ◽  
N Picker ◽  
T Wilke ◽  
L Rosin ◽  
H Patel
Keyword(s):  
Ulcerative Colitis ◽  
Median Time ◽  
Real World ◽  
Index Date ◽  
Sickness Fund ◽  
Inadequate Response ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
Significant Difference

Abstract Background Therapeutic management of Ulcerative Colitis (UC) is challenging, and clinicians are often obliged to attempt a variety of therapies in sequence until an adequate clinical response is achieved. However, real-world data regarding response rates in UC treatment are rare, particularly for later lines of therapy. Thus, this study aimed to investigate the incidence of inadequate response to advanced therapies in patients with UC. Methods This retrospective study was based on claims data from a regional German sickness fund covering the period from 01/2014-06/2019. Patients were included if they had at least two outpatient diagnoses in two different quarters or one inpatient diagnosis of UC (ICD-10: K51) and started a newly introduced advanced therapy (adalimumab, golimumab, infliximab, tofacitinib, vedolizumab) in 01/2015-06/2019. Patients were followed from treatment initiation (index date) until the end of the study period or loss to follow-up (median = 23.4 months). Proxies of inadequate response included: discontinuation (a supply gap of >60 days), switch, escalation (as dose increase exceeding 1.5 times the recommended maintenance dose), augmentation with 5-ASA, corticosteroid (CS) dependency (two CS prescriptions were observed starting more than 14 weeks after the index date), UC-related hospitalization, or UC-related surgery. CS dependency and treatment escalation were only assessed in the maintenance phase. Inadequate response in the analyzed sample was evaluated by means of Kaplan-Meier survival analysis. Results Among 574 UC patients (median age: 39 years; female: 53.5%), in whom an advanced therapy was initiated, 458 (79.8%) received an anti-TNF therapy, 113 (19.7%) vedolizumab and 3 (0.5%) tofacitinib. According to the available baseline period, 72 (12.4%) patients were identified as biologic-experienced. Most patients received CS (86.4%) and/or 5-aminosalicylic acids (81.7%) in the 12-month pre-index period. The median time to inadequate response to the initiated advanced therapy was 4.8 months (IQR: 2.6-11.9; Figure 1) with an inadequate response over 12 months in 75% (Figure 2). There was no significant difference in median time to inadequate response between biologic-naïve and biologic-experienced patients (4.9 vs. 4.7 months; p-value = 0.285). During the observable follow-up period, 172 (61%) patients switched from their index agent to another advanced therapy. Conclusion From the real-world settings in Germany, we found an inadequate response in UC-patients starting an advanced therapy in 75% of patients over 12 months. There is a need for more effective therapies among these patients.

Real World Effectiveness of Advanced Therapies Among Patients With Moderate-to-Severe Ulcerative Colitis in the United States

2018 ◽  
Vol 113 (Supplement) ◽  
pp. S354
Author(s):  
Timothy W. Smith ◽  
Marco DiBonaventura ◽  
David Gruben ◽  
Danielle Bargo ◽  
Leonardo Salese ◽  
...  
Keyword(s):  
United States ◽  
Ulcerative Colitis ◽  
Real World ◽  
The United States ◽  
Severe Ulcerative Colitis ◽  
Advanced Therapies

IDENTIFYING INADEQUATE RESPONSE AMONG ULCERATIVE COLITIS PATIENTS ON AN ADVANCED THERAPY IN A REAL-WORLD ADMINISTRATIVE CLAIMS DATABASE

2021 ◽  
Vol 160 (3) ◽  
pp. S26-S27
Author(s):  
April Naegeli ◽  
Theresa Hunter ◽  
Michael Grabner ◽  
Keith Isenberg ◽  
Mingyang Shan ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Real World ◽  
Administrative Claims ◽  
Inadequate Response ◽  
Claims Database ◽  
Advanced Therapy

scholarly journals A multidisciplinary pulmonary embolism response team (PERT)—experience from a national multicenter consortium

2019 ◽  
Vol 9 (3) ◽  
pp. 204589401882456 ◽  
Author(s):  
Jacob Schultz ◽  
Nicholas Giordano ◽  
Hui Zheng ◽  
Blair A. Parry ◽  
Geoffrey D. Barnes ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Patient Characteristics ◽  
Risk Groups ◽  
The United States ◽  
Categorical Variables ◽  
P Value ◽  
Continuous Variables ◽  
Exact Test ◽  
Advanced Therapy ◽  
Chi Squared

Background We provide the first multicenter analysis of patients cared for by eight Pulmonary Embolism Response Teams (PERTs) in the United States (US); describing the frequency of team activation, patient characteristics, pulmonary embolism (PE) severity, treatments delivered, and outcomes. Methods We enrolled patients from the National PERT Consortium™ multicenter registry with a PERT activation between 18 October 2016 and 17 October 2017. Data are presented combined and by PERT institution. Differences between institutions were analyzed using chi-squared test or Fisher's exact test for categorical variables, and ANOVA or Kruskal-Wallis test for continuous variables, with a two-sided P value < 0.05 considered statistically significant. Results There were 475 unique PERT activations across the Consortium, with acute PE confirmed in 416 (88%). The number of activations at each institution ranged from 3 to 13 activations/month/1000 beds with the majority originating from the emergency department (281/475; 59.3%). The largest percentage of patients were at intermediate–low (141/416, 34%) and intermediate–high (146/416, 35%) risk of early mortality, while fewer were at high-risk (51/416, 12%) and low-risk (78/416, 19%). The distribution of risk groups varied significantly between institutions ( P = 0.002). Anticoagulation alone was the most common therapy, delivered to 289/416 (70%) patients with confirmed PE. The proportion of patients receiving any advanced therapy varied between institutions ( P = 0.0003), ranging from 16% to 46%. The 30-day mortality was 16% (53/338), ranging from 9% to 44%. Conclusions The frequency of team activation, PE severity, treatments delivered, and 30-day mortality varies between US PERTs. Further research should investigate the sources of this variability.

Real-world prescribing patterns in acute myeloid leukemia in the United States.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18524-e18524 ◽  
Author(s):  
Bruno C. Medeiros ◽  
Bhavik J. Pandya ◽  
Anna Hadfield ◽  
Samuel Wilson ◽  
Cynthia Mueller ◽  
...  
Keyword(s):  
United States ◽  
Acute Myeloid Leukemia ◽  
Real World ◽  
High Intensity ◽  
Myeloid Leukemia ◽  
Patient Characteristics ◽  
The United States ◽  
First Line ◽  
Low Intensity ◽  
Acute Myeloid

e18524 Background: The effective treatment of patients with acute myeloid leukemia (AML) remains a challenge in clinical practice. This analysis describes the patient characteristics and real-world use of AML treatments in the United States for patients on high- and low-intensity treatment. Methods: Data from the Adelphi AML Disease-Specific Programme, a real-world, cross-sectional survey conducted between February–May 2015, were analysed. A total of 61 hematologist/hem-oncologists, across academic, non-academic and office-based practice locations, provided data on 457 AML patients. Patient characteristics were derived from physician-completed patient record forms where each physician was asked to provide treatment details, including the treatment intensity, for each line of therapy. Results: A total of 91% (n = 415) of patients included in this analysis were previously untreated for AML. Patients had a mean age of 60 years and been diagnosed with AML for a median of 5.0 months. At first-line induction therapy, over half (53%; n = 241) of the patients were initiated on a high-intensity treatment, the most common regimen being cytarabine plus anthracycline (61%; n = 147). The remaining 47% (n = 216) of patients received a low-intensity induction therapy such as low dose cytarabine monotherapy (28%, n = 61), azacitidine monotherapy (25%, n = 54), or decitabine monotherapy (21%, n = 45). Over half (55%, n = 62) of patients suited to high intensity treatment went on to receive cytarabine monotherapy during the consolidation phase of their first-line treatment. Conclusions: According to treating physicians, the large majority of patients receive traditional, well-established therapies at first-line induction for AML. Whilst cytarabine combinations dominate the high-intensity treatment setting, the hypomethylating agents, azacitidine and decitabine, are frequently used for those more suited to low-intensity treatment.

Comparison of real-world outcomes of adalimumab and infliximab for patients with ulcerative colitis in the United States

2016 ◽  
Vol 32 (7) ◽  
pp. 1233-1241 ◽  
Author(s):  
William J. Sandborn ◽  
Atsushi Sakuraba ◽  
Anthony Wang ◽  
Dendy Macaulay ◽  
William Reichmann ◽  
...  
Keyword(s):  
United States ◽  
Ulcerative Colitis ◽  
Real World ◽  
The United States

Sa1258 Comparison of Real-World Outcomes of Adalimumab (ADA) and Infliximab (IFX) for Patients With Ulcerative Colitis (UC) in the United States

2015 ◽  
Vol 148 (4) ◽  
pp. S-272 ◽  
Author(s):  
William Sandborn ◽  
Atsushi Sakuraba ◽  
A Burak Ozbay ◽  
Rachael A. Sorg ◽  
William Reichmann ◽  
...  
Keyword(s):  
United States ◽  
Ulcerative Colitis ◽  
Real World ◽  
The United States

scholarly journals P464 Steroid dependency in patients with Ulcerative Colitis treated with advanced therapies in a German real-world-setting

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S455-S456
Author(s):  
B Bokemeyer ◽  
N Picker ◽  
T Wilke ◽  
L Rosin ◽  
H Patel
Keyword(s):  
Ulcerative Colitis ◽  
Baseline Period ◽  
Therapy Discontinuation ◽  
Steroid Dependency ◽  
Kaplan Meier ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
Increased Risk ◽  
Claims Data Analysis

Abstract Background An important treatment goal in Ulcerative Colitis (UC) is a long-lasting corticosteroid (CS)-free remission. Avoidance of steroid dependency in these patients is essential as chronic CS use is known to be associated with an increased risk for multiple severe adverse events. This study aimed to identify CS dependency in patients with moderate to severe UC treated with advanced therapies. Methods This German claims data analysis includes adult patients with ≥2 outpatient diagnoses and/or one inpatient diagnosis for UC (ICD-10: K51) in whom an advanced therapy (anti-TNF agent, vedolizumab or tofacitinib) was initiated between 01/01/2015–30/06/2019. CS dependency was indicated by ≥2 prescriptions of systemic CS and/or oral budesonide within a median follow-up of 23.4 months. Prior CS use was evaluated by outpatient prescriptions observed in a 12-months baseline period. Costs were assessed until the end of the study period or loss to follow-up considering all-cause expenses for inpatient and outpatient visits, and approximated indirect cost related to sick-leave days. Exceeding the recommended dose in maintenance therapy by more than 150% was rated as an escalation of therapy. Time to the therapy discontinuation, escalation or first UC-related hospitalization from start of index therapy were estimated using Kaplan-Meier analysis. Results Of 574 included UC patients with a new advanced therapy, 252 (43.9%) received ≥2 prescriptions of CS while on treatment with advanced agents in the observation period up to 24 months. Altogether, 496 patients (86.4%) had prior experience with CS in the 12-months baseline-period. Among patients with ≥2 CS prescriptions, 47.0% had switched their index therapy to another advanced agent after 24 months (31.2% without CS dependency). Median time to therapy discontinuation was 17.3 months in CS-dependent patients; and 19.3 months in those without CS dependency (p = 0.639). There were no differences between naïve or advanced therapy experienced patients, but with clearly more discontinuations in patients with previously more than 1 advanced therapy (p&lt;0.001). CS-dependent patients were more likely to require dose escalation/UC-related hospitalization within the first two years after treatment start (26.7% vs. 16.1%; p = 0.018/ 44.1% vs. 26.6%; p = 0.048; Figure 1). Total cost per patient-year was significantly higher in patients with than without CS dependency (40,884 € vs. 37,449 €; p &lt; 0.001). Conclusion Most UC patients starting new advanced therapies were previously treated with CS, and more than two-fifths continue to be CS dependent even after starting such a therapy. More effective therapies are needed to achieve CS-free remission.

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