Patterns of hedgehog inhibitor (HHI) treatment interruptions and re-initiations among patients with basal cell carcinoma (BCC) in real-world clinical practice.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19349-e19349
Author(s):  
Jessica J. Jalbert ◽  
Chieh-I Chen ◽  
Ning Wu ◽  
Matthew G. Fury ◽  
Emily S Ruiz ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Treatment Duration ◽  
Index Date ◽  
Sensitivity Analyses ◽  
Kaplan Meier ◽  
Treatment Interruptions ◽  
Observational Cohort ◽  
Practice Methods

e19349 Background: HHIs are oral targeted therapies approved for the treatment of advanced BCC but treatment-related adverse events may result in treatment interruptions or discontinuation. The objective of this study was to describe HHI treatment patterns among patients with BCC in real-world clinical practice. Methods: We conducted an observational cohort study using MarketScan Commercial/Medicare databases (01/01/2013–09/30/2018). We identified new users of HHIs (index date = date of the first dispensation), ≥18 years of age who were continuously enrolled for ≥6 months prior to the index date (i.e. baseline) with ≥1 baseline BCC diagnosis. Treatment interruptions (TI) were defined as a lack of dispensation following the exhaustion of days’ supply and allotted grace period (GP). Re-initiation (RI) was defined as ≥1 HHI dispensation after TI. The Kaplan–Meier method was used to estimate risk and time to TI and, among patients with a TI, incidence of RI. HHIs are generally dispensed in 30-days’ supply and indicated as long as a patient derives a clinical benefit; however, since TIs are commonly employed during HHI therapy, sensitivity analyses were conducted using GPs of 14, 30, 60, 90, and 120 days. Results: We identified 469 patients with a BCC diagnosis initiating HHIs. The mean (SD) age was 67.6 (15.8) years, 64.2% were men, 51.2% were covered by commercial insurance, and 99.2% initiated vismodegib. Using a GP of 14, 30, 60, 90, and 120 days, the risk of TI was 79.2%, 68.8%, 60.0%, 55.4%, and 51.4% at 6 months and 94.8%, 91.3%, 88.2%, 83.2%, and 80.2% at 1 year, respectively. Median HHI treatment duration ranged from 94 days (95% CI: 90–109) using a GP of 14 days to 173 days (95% CI: 156–194) using a GP of 120 days. At 6 months following TI, incidence of RI was 35.8%, 19.8%, 11.3%, 6.9%, and 4.9% using a GP of 14, 30, 60, 90, and 120 days, respectively. The incidence of HHI RI at 1-year following TI ranged from 40.8% using a 14-day GP to 13.4% using a 120-day GP. Conclusions: Median HHI treatment duration was approximately 6 months, even after allowing for a 120-day GP. Median treatment duration was considerably shorter than what has been reported in clinical trials. Our results suggest that long-term HHI therapy may be difficult in a real-world setting.

scholarly journals Prostatic urethral lift (UroLift): a real-world analysis of outcomes using hospital episodes statistics

BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Toby Page ◽  
Rajan Veeratterapillay ◽  
Kim Keltie ◽  
Julie Burn ◽  
Andrew Sims
Keyword(s):  
Real World ◽  
Hazard Analysis ◽  
Attendance Rate ◽  
Day Case ◽  
Patient Demographics ◽  
Kaplan Meier ◽  
Accident And Emergency ◽  
Case Surgery ◽  
Observational Cohort ◽  
Rate Requirement

Abstract Background To determine real-world outcomes of prostatic urethral lift (UroLift) procedures conducted in hospitals across England. Methods A retrospective observational cohort was identified from Hospital Episode Statistics data including men undergoing UroLift in hospitals in England between 2017 and 2020. Procedure uptake, patient demographics, inpatient complications, 30-day accident and emergency re-attendance rate, requirement for further treatment and catheterization were captured. Kaplan–Meier and hazard analysis were used to analyse time to re-treatment. Results 2942 index UroLift procedures from 80 hospital trusts were analysed; 85.3% conducted as day-case surgery (admitted to hospital for a planned surgical procedure and returning home on the same day). In-hospital complication rate was 3.4%. 93% of men were catheter-free at 30 days. The acute accident and emergency attendance rate within 30 days was 12.0%. Results of Kaplan Meier analysis for subsequent re-treatment (including additional UroLift and endoscopic intervention) at 1 and 2 years were 5.2% [95% CI 4.2 to 6.1] and 11.9% [10.1 to 13.6] respectively. Conclusions This real-world analysis of UroLift shows that it can be delivered safely in a day-case setting with minimal morbidity. However, hospital resource usage for catheterization and emergency hospital attendance in the first 30 days was substantial, and 12% required re-treatment at 2 years.

scholarly journals Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice

Allergy ◽  
2017 ◽  
Vol 72 (6) ◽  
pp. 994-998 ◽  
Author(s):  
A. Zanichelli ◽  
M. Maurer ◽  
W. Aberer ◽  
T. Caballero ◽  
H. J. Longhurst ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World

scholarly journals How I manage ibrutinib intolerance and complications in patients with chronic lymphocytic leukemia

Blood ◽  
2019 ◽  
Vol 133 (12) ◽  
pp. 1298-1307 ◽  
Author(s):  
Deborah M. Stephens ◽  
John C. Byrd
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Chronic Lymphocytic Leukemia ◽  
Adverse Events ◽  
Real World ◽  
Lymphocytic Leukemia ◽  
Targeted Therapeutics ◽  
Therapeutic Approaches ◽  
Therapeutic Alternatives

Abstract Chronic lymphocytic leukemia (CLL) therapy has changed dramatically with the introduction of several targeted therapeutics. Ibrutinib was the first approved for use in 2014 and now is used for initial and salvage therapy of CLL patients. With its widespread use in clinical practice, ibrutinib’s common and uncommon adverse events reported less frequently in earlier clinical trials have been experienced more frequently in real-world practice. In particular, atrial fibrillation, bleeding, infections, and arthralgias have been reported. The management of ibrutinib’s adverse events often cannot be generalized but must be individualized to the patient and their long-term risk of additional complications. When ibrutinib was initially developed, there were limited therapeutic alternatives for CLL, which often resulted in treating through the adverse events. At the present time, there are several effective alternative agents available, so transition to an alternative CLL directed therapy may be considered. Given the continued expansion of ibrutinib across many therapeutic areas, investigation of the pathogenesis of adverse events with this agent and also clinical trials examining therapeutic approaches for complications arising during therapy are needed. Herein, we provide strategies we use in real-world CLL clinical practice to address common adverse events associated with ibrutinib.

Treatment duration and utilization patterns in metastatic castration-resistant prostate cancer patients receiving enzalutamide or abiraterone acetate.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 229-229
Author(s):  
Vahan Kassabian ◽  
Scott Flanders ◽  
Samuel Wilson ◽  
Bruce A. Brown ◽  
Yan Song ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Treatment Duration ◽  
Index Date ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Kaplan Meier ◽  
Utilization Patterns ◽  
The Difference ◽  
Hormonal Therapies

229 Background: Enzalutamide (ENZA) and abiraterone acetate (ABI) are approved hormonal therapies for men with metastatic castration-resistant prostate cancer (mCRPC). This study assessed real-world treatment duration and utilization patterns in patients receiving ENZA or ABI. Methods: Adult mCRPC patients initiating ENZA or ABI before or after cytotoxic chemotherapy were identified from the Truven MarketScan® claims database (2012–2015). The index date was the first initiation of ENZA or ABI; continuous insurance enrollment for ≥6 months prior to and ≥3 months after the index date was required. Treatment discontinuation was defined as a prescription gap of ≥45 days. Median treatment duration was estimated using Kaplan–Meier method. Treatment switching was defined as starting a new mCRPC-related therapy within 30 days before to 45 days after the discontinuation date. Analyses were separately conducted for chemo-naïve and chemo-experienced patients. Results: The study included 3230 chemo-naive (ENZA 920; ABI 2310) and 692 chemo-experienced patients (ENZA 262; ABI 430). Among chemo-naive patients, ENZA cohort was older (mean age 74.5 vs 73.5; p = 0.013), with a higher proportion of comorbidities vs ABI cohort. Treatment duration was longer for ENZA cohort than ABI cohort (log-rank p = 0.008; median = ENZA 10.7 vs ABI 8.8 months). Within 1 year of initiation, 55.7% of ENZA and 60.8% of ABI cohort discontinued treatment and 22.5% and 34.7%, respectively, switched to other mCRPC therapies. Results were consistent among subgroups with specific comorbidities. Treatment duration was shorter among chemo-experienced patients than chemo-naïve; the difference between ENZA vs ABI among chemo-experienced patients was not statistically significant (log-rank p = 0.255; median = ENZA 7.5 vs ABI 7.1 months). Conclusions: Despite a more complex profile at baseline, chemo-naive mCRPC patients in the ENZA cohort had a longer treatment duration and lower proportion of switching to other prostate-cancer-directed therapies vs the ABI cohort. The difference of treatment duration between the two cohorts was not statistically significant for chemo-experienced patients.

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

Blood ◽  
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.

scholarly journals P431 Teduglutide use and nutritional outcomes in short bowel syndrome with intestinal failure: a real-world claims database analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S433-S434
Author(s):  
D Micic ◽  
J Jiang ◽  
L Chen ◽  
T Fan ◽  
F Mu ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Clinical Trials ◽  
Short Bowel Syndrome ◽  
Real World ◽  
Index Date ◽  
Intestinal Failure ◽  
Sensitivity Analyses ◽  
Future Research ◽  
Short Bowel

Abstract Background Teduglutide (TED) is a glucagon-like peptide 2 analogue approved for the treatment of patients with short bowel syndrome (SBS) requiring parenteral support (PS). SBS is a rare condition resulting from a reduced absorptive surface area of the small intestine, most commonly due to inflammatory bowel disease (IBD). Patients with SBS with intestinal failure (SBS-IF) remain dependent on PS to maintain adequate calorie, fluid, electrolyte and micronutrient stability. In phase 3 clinical trials, TED reduced PS requirements in patients with SBS-IF. This study aimed to assess PS use and discontinuation rates among patients with SBS on TED using real-world data. Methods This retrospective cohort study of adults with SBS-IF (≥18 years) with ≥1 TED pharmacy claim(s) used the US-based administrative healthcare claims IBM MarketScan database (2009–2019). The first TED claim was defined as the index date. Patients required ≥6 months of continuous enrolment prior to index date (baseline period) and no history of malignancy. Primary analysis was conducted during the follow-up period (index date to earliest of continuous enrolment end or 2 years post-index). A sensitivity analysis was also conducted among the cohort during the TED utilization period (index date to the earliest of continuous enrolment end or TED discontinuation). Patients required PS use during both baseline and follow-up/TED utilization periods (primary and sensitivity analyses). PS discontinuation was defined as a PS utilization gap of ≥30 days. A generalized estimating equation linear regression model evaluated if PS use (days/week) changed significantly from baseline to selected time points post-index. Results Of 110 identified patients with SBS-IF, mean age was 53.4 (SD 13.2) years and 77 (70%) were women. Included were 51 (46%) patients with Crohn’s disease and 20 (18%) with ulcerative colitis. The main comorbidities were renal disease (23%) and liver disease (15%). PS frequency was 4.6 (2.5), 3.3 (2.9), 2.9 (3.0) and 3.6 (3.0) days/week at baseline and months 6 (p<0.0001), 12 (p<0.0001), and 24 (p=0.0267), respectively. PS discontinuation increased over time to 34.4%, 46.7% and 65.2% at 3, 6, and 12 months, respectively. The sensitivity analysis demonstrated similar rates of PS use and discontinuation. Conclusion In this real-world study of adults with SBS-IF, including >50% with IBD, TED was associated with PS reductions comparable to those achieved in clinical trials and higher PS discontinuation rates even when using a conservative analysis approach. Future research will be required to determine individual predictive factors of PS discontinuation.

Paclitaxel exposure and long-term mortality of patients treated with the Zilver PTX drug-eluting stent

Vascular ◽  
2020 ◽  
pp. 170853812096437
Author(s):  
Jordan R Stern ◽  
Kenneth Tran ◽  
Venita Chandra ◽  
E John Harris ◽  
Jason T Lee
Keyword(s):  
Real World ◽  
Drug Eluting Stent ◽  
Secondary Patency ◽  
Kaplan Meier ◽  
Drug Eluting ◽  
Lifetime Exposure ◽  
Zilver Ptx ◽  
Long Term Mortality

Objectives Paclitaxel-eluting stents have demonstrated improved patency over balloon angioplasty and bare metal stenting for endovascular interventions in the femoral-popliteal segment. Recently, concerns have arisen regarding the safety of paclitaxel use and its association with mortality. This study aims to examine real-world, long-term mortality, and patency of patients treated with the Zilver PTX drug-eluting stent. Methods Patients treated with the PTX stent after FDA approval between 2013 and 2015 were identified from an institutional database. Demographic, procedural, and device information was collected and initial- and lifetime-exposure dose of paclitaxel was calculated. The primary outcome was all-cause mortality and its association with paclitaxel exposure. Long-term patency was also evaluated. Results Seventy-nine procedures involving PTX placement were performed on 64 individual patients during the study period, with 15 (23.4%) having bilateral procedures. Average age was 70 years, and 71.9% were male. Forty-five patients (70.3%) were claudicants, and 19 (29.7%) had chronic, limb-threatening ischemia. An average of 2.3 PTX stents, totaling 203 mm in length, were placed per procedure. Paclitaxel exposure was 1.87 mg/procedure initially (range 0.38–4.03 mg), and average lifetime exposure was 4.65 mg/patient (range 0.38–27.91 mg). Average follow-up was 59.6 months. Kaplan–Meier estimated survival was 96.9%, 81.2% and 71.7% at one , three, and five years. On multivariate analysis, no specific factors were associated with overall morality including initial paclitaxel dose (HR 0.99, 95% CI 0.99–1.00) and lifetime paclitaxel exposure (HR 0.98, 95% CI 0.89–1.08). Kaplan–Meier primary patency was 76.2%, 60.1%, and 29.3% at one, two, and five years, respectively. Secondary patency was 92.2%, 85.4%, and 75.2% at the same intervals. Conclusions At a mean follow-up of five years, exposure to higher doses of paclitaxel from Zilver PTX does not appear to be associated with increased mortality compared to lower doses in real-world patients. Long-term patency rates confirm the efficacy of Zilver PTX, and further investigation may be warranted before abandoning paclitaxel use altogether.

Sign in / Sign up

Export Citation Format

Share Document