Real‐world experience and analyses of the performance of ixekizumab as first‐line biologic agent versus second‐line (or higher) biologic agent in the treatment of chronic plaque psoriasis

2021 ◽  
Author(s):  
Peter Kin Cho Goon ◽  
Hai‐Yee Lim ◽  
Liz Summerfield ◽  
Cedric Charles Banfield ◽  
Holger Sudhoff ◽  
...  
Keyword(s):  
Real World ◽  
Plaque Psoriasis ◽  
Biologic Agent ◽  
Second Line ◽  
First Line ◽  
Chronic Plaque Psoriasis

scholarly journals Real-world systemic therapy treatment patterns for squamous cell carcinoma of the head and neck in Canada

2019 ◽  
Vol 26 (2) ◽  
Author(s):  
K. Byrne ◽  
P. Hallworth ◽  
A. Abbas Tahami Monfared ◽  
A. Moshyk ◽  
J. W. Shaw
Keyword(s):  
Squamous Cell Carcinoma ◽  
Clinical Practice ◽  
Drug Treatment ◽  
Real World ◽  
Treatment Patterns ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Line Drug ◽  
First Line Treatment

Background In the present study, we examined real-world treatment patterns for squamous cell carcinoma of the head and neck (scchn) in Canada, which are largely unknown.Methods Oncologists across Canada provided data for disease history, characteristics, and treatment patterns during May–July 2016 for 6–8 consecutive patients receiving first-line or second-line drug treatment for scchn (including locally advanced and recurrent or metastatic disease).Results Information from 16 physicians for 109 patients receiving drug treatment for scchn was provided; 1 patient was excluded from the treatment-pattern analysis. Median age in the cohort was 63 years [interquartile range (iqr): 57–68 years], and 24% were current smokers, with a mean exposure of 26.2 ± 12.7 pack–years. The most common tumour site was the oropharynx (48%). Most patients (84%) received platinum-based regimens as first-line treatment (44% received cisplatin monotherapy). Use of cetuximab-based regimens as first-line treatment was limited (17%). Of 53 patients receiving second-line treatment, 87% received a first-line platinum-based regimen. Median time between first-line treatment with a platinum-based regimen and initiation of second-line treatment was 55 days (iqr: 20–146 days). The most common second-line regimen was cetuximab monotherapy (43%); platinum-based regimens were markedly infrequent (13%).Conclusions Our analysis provides real-world insight into scchn clinical practice patterns in Canada, which could inform reimbursement decision-making. High use of platinum-based regimens in first-line drug treatment was generally reflective of treatment guidelines; cetuximab use in the second-line was higher than anticipated. Additional real-world studies are needed to understand the effect of novel therapies such as immuno-oncology agents on clinical practice and outcomes, particularly for recurrent or metastatic scchn.

Value of Survival Gains In Chronic Myelogenous Leukemia

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4736-4736
Author(s):  
Wesley Yin ◽  
John R Penrod ◽  
Ross Maclean ◽  
Jeffrey Humphrey ◽  
Erkut Bahceci ◽  
...  
Keyword(s):  
Health Economics ◽  
Real World ◽  
Social Value ◽  
Myelogenous Leukemia ◽  
Second Line ◽  
First Line ◽  
Community Based ◽  
First Line Therapy ◽  
Line Therapy ◽  
Precision Health

Abstract Abstract 4736 Background: Tyrosine Kinase Inhibitors (TKI) are the first line therapies for patients with chronic myelogenous leukemia (CML). The value of survival gains to patients associated with TKI treatment—in aggregate or relative to the cost of treatment—is unknown. Methods: Multivariate Cox proportional hazard models are used to construct real-world, community-based estimates of survival improvements in CML associated with the introduction of first-line TKI therapy, controlling for characteristics of patients which may independently affect survival. We then employ an economic framework following Becker, Philipson and Soares (2005) to calculate social value of infra-marginal improvements in survival gains due to treatment with TKIs. Finally, the value of community-based improvements in CML survival from treatment by newer TKIs used in second line is estimated by combining community-based survival data for first-line TKIs, along with clinical data on health improvements for CML patients receiving a TKI in second line. Results: Introduction of first-line TKIs in 2001 is associated with a real-world decrease in the all-cause mortality hazard rate of 0.183 (p < 0.01) for CML patients. A decrease of this magnitude is associated with an increase in life expectancy from 60 to 110 months for treated CML patients with median survival length in 2001. We estimate that patients place an annual value of $110,000 on first-line treatment with TKIs. This implies that for all patients in present and future CML cohorts, the present social value of first-line TKI therapy is $88bn. The present value of costs is estimated to be $8bn, suggesting that more than 90% of social value of TKIs in first line therapy is retained by patients. In second-line CML therapy, use of newer TKI agents is estimated to have created $47bn in social value, of which roughly 88% is retained by patients. This estimated value of the newer TKIs does not incorporate possible benefits in first-line therapy. Conclusions: In total, the TKI class in first and second-line theray has created over $135bn in social value. Approximately 90% of this value is retained by patients; approximately 10% is recouped by manufacturers. These estimates suggest that at current price levels, the vast majority of value created by new therapies in CML is appropriated by patients. In addition, since our estimates of survival community-based improvements are somewhat smaller than those contained in clinical trial estimates, this suggests the potential value of addressing real-world obstacles to efficacy, such as poor adherence. Disclosures: Yin: Precision Health Economics: Consultancy. Penrod:Bristol-Myers Squibb: Employment. Maclean:Bristol-Myers Squibb: Employment. Humphrey:Bristol-Myers Squibb: Employment. Bahceci:Bristol-Myers Squibb: Employment. Lakdawalla:Bristol-Myers Squibb: Consultancy; Precision Health Economics: Equity Ownership.

Real world outcomes in advanced urothelial cancer and the role of neutrophil to lymphocyte ratio.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16020-e16020
Author(s):  
Steven Yip ◽  
Jeenan Kaiser ◽  
Haocheng Li ◽  
Scott A. North ◽  
Daniel Yick Chin Heng ◽  
...  
Keyword(s):  
Real World ◽  
Cox Regression ◽  
Response Rates ◽  
Neutrophil To Lymphocyte Ratio ◽  
Second Line ◽  
First Line ◽  
Cox Regression Analysis ◽  
Lymphocyte Ratio ◽  
Line Setting

e16020 Background: Advanced urothelial carcinoma (UC) patients have a poor prognosis. In the first and second line UC treatment setting, we investigated real world outcomes and evaluated the prognostic role of the neutrophil to lymphocyte ratio (NLR). Methods: A retrospective analysis was performed on advanced UC patients treated with systemic therapy. Overall response rates (ORR), time to treatment failure (TTF) and overall survival (OS) were calculated. Cox regression analysis was performed to examine the association between baseline NLR (low NLR<3 vs high NLR≥3) and TTF and OS. Results: We evaluated 233 advanced UC patients. In the first line setting, the ORR was 25%. Median TTF and OS were 6.9 mo and 9 mo, respectively. Low baseline NLR was significantly associated with improved 8.3 mo median TTF, versus 5.8 mo for high NLR patients (p=0.05). Low NLR was significantly correlated with a longer median OS of 13.1 mo, in comparison to 8.2 mo in patients with high NLR (p=0.007). In the second line, an ORR of 22%, a median TTF of 4.1 mo and a median OS of 8 mo were observed. Low NLR in the second line was significantly associated with improved median TTF at 7.9 mo, versus 3.6 mo for patients with high NLR (p=0.03). Second line low NLR was also significantly associated with a longer median OS of 12.2 mo, in comparison to 6.8 mo in patients with high NLR (p=0.003). Conclusions: In this real world analysis of advanced UC patients, first line outcomes were lower than expected, while response rates in the second line compared favorably to the literature, suggesting a highly selected patient population actually receives second line treatment. A low baseline NLR in the first and second line is associated with improved TTF and OS and warrants further prospective evaluation. [Table: see text]

Activity of second line axitinib in metastatic renal cell carcinoma (mRCC) patients treated with sunitinib: Results from SAX Italian real world trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16054-e16054
Author(s):  
Sabrina Rossetti ◽  
Francesco Jacopo Romano ◽  
Carmine D'Aniello ◽  
Carla Cavaliere ◽  
Salvatore Pisconti ◽  
...  
Keyword(s):  
Real World ◽  
Medical Records ◽  
Kinase Inhibitor ◽  
Univariate Analysis ◽  
P Value ◽  
World Population ◽  
Second Line ◽  
First Line ◽  
Primary Endpoints ◽  
Significant Difference

e16054 Background: Axitinib, a selective tyrosine kinase inhibitor (TKI), is currently approved for the treatment of mRCC after failure of prior treatment with sunitinib or cytokine, according to AXIS trial results. The best sequence hasn’t been established: both axitinib and everolimus (a mTOR inhibitor) are viable therapeutic options, although recently immunotherapy agents entered this setting. This Italian multi-institutional retrospective analysis evaluated outcomes of Axitinib in exclusive sequence after sunitinib in second line treatment of mRCC Methods: Medical records of 148 patients treated with Axitinib from 21 Italian Oncology Centers were retrospectively assessed: PFS, OS, ORR DCR, and safety profile of axitinib were primary endpoints. Results: Median PFS and OS were 7.14 and 15.5 months, respectively. Overall, axitinib at standard schedule of 5 mg bid, was well tolerated, with no grade 4 toxicity event. Most common adverse events were hypertension (26% of the cases), fatigue (50 %), hypothyroidism (18%). At univariate analysis, when patients were stratified by Heng score, mPFS was 5.8, 7.0 and 9.0 months according to poor, intermediate and favourable risk group, respectively. When stratified by median duration of prior sunitinib therapy (≥ 13,1 mo vs < 13,1 mo), there was a statistically significant difference in PFS with 8.8 vs 6.3 months, respectively. Disease control rate (DCR) to previous sunitinib treatment was associated to longer PFS with axitinib ( 8.0 months vs4.0 months). The sequence sunitinib-axitinib was well tolerated, with a mOS of 41 months. At multivariate analysis, prognostic factors for progression were gender (p-value = 0,006), DCR to axitinib (p < 0,0001) and to previous sunitinib (p = 0,041); DCR to axitinib (p = < 0,0001), nephrectomy (p = 0,002) and Heng score (p = 0,025) independently affected overall survival. Conclusions: The preliminary SAX results in the real world population are consistent with available literature. The study confirms that Axitinib is effective and safe in routine clinical practice, and its efficacy seems to be greater in patients who most benefited from first-line sunitinib.

scholarly journals Efficacy and Safety of Bevacizumab in Combination with Chemotherapy for Colorectal Cancer – A Real World Study in China

2020 ◽  
Author(s):  
Tao Shen ◽  
Xian-Shuo Cheng ◽  
Wei-Xun Chunyu ◽  
Hong-Tao Zhang ◽  
Cui-Feng Xia ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Real World ◽  
Large Scale ◽  
Progression Free Survival ◽  
Secondary Outcome ◽  
Second Line ◽  
Efficacy And Safety ◽  
First Line ◽  
Demographic Subgroups

Abstract Background Large scale randomized trials have demonstrated that bevacizumab in addition to chemotherapy as first-line or second-line treatment has significant survival benefits. We aim to explore the clinical impact of bevacizumab in combination with chemotherapy in first-line or second-line in patients with colorectal cancer (CRC). Methods The medical records of patients with CRC who received bevacizumab at first or second-line of treatment were collected retrospectively. The primary outcome of the study was to evaluate the efficacy of bevacizumab in combination with chemotherapy by survival endpoints i.e. overall survival (OS) and progression-free survival (PFS) and the secondary outcome was to evaluate its safety by incidence of adverse events (AE). Results Fifty-one patients with CRC had met the selection criteria for treatment with bevacizumab to either cetuximab or FOLFOX or both. The median age was 54 years. During follow-up, ten patients had exhibited progression after treatment while 5 patients died. The median OS and PFS of the overall population were not reached. The Cox proportional regression analysis revealed no significant prognostic factors of OS and PFS for treatment with bevacizumab in various demographic subgroups. The 1-year PFS rates of all 51 patients was 76%. The 1-year and 3-year OS rates for all 51 patients were 95% and 88%, respectively. Toxicities were usually mild in nature, with nausea, vomiting, hand and foot syndrome, neutropenia, asthenia and palpitation being the commonly reported adverse events. Conclusion In this real-world setting, the efficacy and safety of bevacizumab in combination with chemotherapy is limited and further research is warranted as to whether bevacizumab with chemotherapy is an optimal treatment as first-line or second-line therapy in Chinese CRC patients.

scholarly journals First- and Second-Line Palliative Systemic Treatment Outcomes in a Real-World Metastatic Pancreatic Cancer Cohort

2021 ◽  
pp. 1-8
Author(s):  
Esther N. Pijnappel ◽  
Willemieke P.M. Dijksterhuis ◽  
Lydia G. van der Geest ◽  
Judith de Vos-Geelen ◽  
Jan Willem B. de Groot ◽  
...  
Keyword(s):  
Real World ◽  
Systemic Treatment ◽  
Population Based ◽  
Ductal Adenocarcinoma ◽  
Rank Test ◽  
Time To Failure ◽  
Second Line ◽  
First Line ◽  
Kaplan Meier ◽  
Netherlands Cancer Registry

Background: Metastatic pancreatic ductal adenocarcinoma (PDAC) is characterized by a poor survival rate, which can be improved by systemic treatment. Consensus on the most optimal first- and second-line palliative systemic treatment is lacking. The aim of this study was to describe the use of first- and second-line systemic treatment, overall survival (OS), and time to failure (TTF) of first- and second-line treatment in metastatic PDAC in a real-world setting. Patients and Methods: Patients with synchronous metastatic PDAC diagnosed between 2015 and 2018 who received systemic treatment were selected from the nationwide Netherlands Cancer Registry. OS and TTF were evaluated using Kaplan-Meier curves with log-rank test and multivariable Cox proportional hazard analyses. Results: The majority of 1,586 included patients received FOLFIRINOX (65%), followed by gemcitabine (18%), and gemcitabine + nab-paclitaxel (13%) in the first line. Median OS for first-line FOLFIRINOX, gemcitabine + nab-paclitaxel, and gemcitabine monotherapy was 6.6, 4.7, and 2.9 months, respectively. Compared to FOLFIRINOX, gemcitabine + nab-paclitaxel showed significantly inferior OS after adjustment for confounders (hazard ratio [HR], 1.20; 95% CI, 1.02–1.41), and gemcitabine monotherapy was independently associated with a shorter OS and TTF (HR, 1.98; 95% CI, 1.71–2.30 and HR, 2.31; 95% CI, 1.88–2.83, respectively). Of the 121 patients who received second-line systemic treatment, 33% received gemcitabine + nab-paclitaxel, followed by gemcitabine (31%) and FOLFIRINOX (10%). Conclusions: Based on population-based data in patients with metastatic PDAC, treatment predominantly consists of FOLFIRINOX in the first line and gemcitabine with or without nab-paclitaxel in the second line. FOLFIRINOX in the first line shows superior OS compared with gemcitabine with or without nab-paclitaxel.

The AWARE Study: Methodology and Baseline Characteristics

2009 ◽  
Vol 13 (6_suppl) ◽  
pp. S113-S121 ◽  
Author(s):  
Robert Bissonnette ◽  
Gordon Searles ◽  
Ian Landells ◽  
Neil H. Shear ◽  
Kim Papp ◽  
...  
Keyword(s):  
Disease Control ◽  
Real World ◽  
Plaque Psoriasis ◽  
Best Practice ◽  
Treatment Plan ◽  
Demographic Data ◽  
Clinical Practices ◽  
Chronic Plaque Psoriasis ◽  
Real World Evidence ◽  
Patient Demographic Data

Background: Alefacept was the first biologic therapy approved by Health Canada for the treatment of moderate to severe chronic plaque psoriasis and is used either alone or as part of combination therapy. Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational phase IV Canadian study of psoriasis patients treated with alefacept. This study's main goals were to develop a shared, real-time, national clinical database to support best practice and optimize the care of patients receiving alefacept and to gain an understanding of how alefacept is used in Canadian clinical practice. Baseline patient demographic data are described herein. Methods: Patients with chronic plaque psoriasis were enrolled from 37 clinics across Canada. Subjects received at least one course of alefacept treatment followed by a period of at least 12 weeks off treatment and were prospectively followed for at least 60 weeks. Baseline assessments included patient demographics, relevant medical history, psoriasis and treatment history, reasons for initiating alefacept, enrolling physician's initial alefacept treatment plan and strategy, percent body surface area (BSA) involvement with psoriasis, and physician's baseline assessment of disease control. Subsequent assessments at each follow-up visit included the patient's response and the physician's assessment. Results: A total of 426 adult patients with predominantly chronic plaque psoriasis, with or without other types of psoriasis, were enrolled into the AWARE registry. Patients generally had moderate to severe psoriasis, with more than half (55.8%) having little or no disease control at baseline as assessed by their clinician, and 77% had > 10% BSA involvement with psoriasis. All patients in the AWARE patient population were receiving one or more treatments for psoriasis prior to or at the time of enrolment, and the majority continued to receive concomitant treatments at the time of study enrolment. Conclusion: The AWARE registry enrolled a broad group of real-world patients with chronic plaque psoriasis treated with alefacept in clinical practices across Canada.

scholarly journals POS0223 PATTERNS OF JANUS KINASE INHIBITOR CYCLING FOR THE MANAGEMENT OF RHEUMATOID ARTHRITIS IN REAL-WORLD CLINICAL PRACTICE: AN ANALYSIS OF THE OPAL DATASET

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 330-331
Author(s):  
S. Ciciriello ◽  
T. Smith ◽  
C. Osullivan ◽  
K. Tymms ◽  
P. Youssef ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Medical Record ◽  
Clinical Data ◽  
Real World ◽  
Visual Analytics ◽  
Clinical Care ◽  
Janus Kinase ◽  
Second Line ◽  
First Line ◽  
Third Line

Background:There are currently eleven biologic and targeted synthetic (b/ts)DMARDs acting via five different modes of action available for the treatment of RA in Australia. The cost of b/tsDMARDs is subsidized by government for patients that have active RA despite six months of combination csDMARD therapy. Once a patient is eligible, the clinician can prescribe the b/tsDMARD they deem to be the most clinically appropriate for the patient. In Oct 2015 the first JAK inhibitor (JAKi) became available in Australia (tofacitinib, TOF), baricitinib (BARI) became available in Sept 2018, and upadacitinib (UPA) in May 2020. Each of these oral tsDMARDs possess different selectivity profiles towards different members of the JAK family (JAK1–3 and Tyk2).Objectives:The aim of this analysis was to determine the patterns of JAKi cycling in real-world practice in Australia.Methods:Deidentified clinical data were sourced from the OPAL dataset, which is collected in a custom-built electronic medical record during the routine consultation1. Data from patients >18 years with RA who commenced a b/tsDMARD between Jan-2007 and Dec-2020 were included in the analysis. A visual analytics software program was used to display data on medication initiation and cessation dates, and reasons for stopping tsDMARDs, which is recorded in the medical record at the time of the decision.Results:At Dec 2020, 28% of the 52,190 patients with RA in the OPAL dataset were prescribed b/tsDMARDs. Of these patients, 3,850 (26.3%) were currently prescribed a JAKi with 51.4% receiving TOF, 29.2% BARI and 19.4% UPA. In 2020, JAKi initiations accounted for 48.8% of all initiations and 30.7% of 1st line initiations; an increase of 6.1% and 3.5% from 2019, respectively. The percentage of patients switching from a first line JAKi to a second line JAKi rather than an agent with another mode of action increased from 33.1% in 2019 to 42.6% in 2020. This is despite 26.2% in 2019 and 45.8% in 2020 of the patients switching to another JAKi citing lack of efficacy as the reason for JAKi discontinuation. In the period between May 2020, when a third JAKi (UPA) become available, and Dec 2020, the majority of patients switching from first line TOF or BARI to another JAKI switched to UPA (69.4% and 83.9%, respectively), whilst 30.6% of first line TOF patients switched to BARI (30.6%), and 16.1% of first line BARI patients switched to TOF in second line. The majority of patients switching from second line TOF or BARI to a third line JAKi switched to UPA (73% and 96%, respectively), with 27% of second line TOF patients switching to BARI and a very low number moving from second line BARI to TOF (4%). JAKi choice after a third line TOF or BARI was almost exclusively UPA (86.2% and 95.5%, respectively).Conclusion:There has been significant and sustained uptake of JAKi for the management of RA in Australia and JAKi cycling is increasingly common in routine clinical care. Clinical outcomes and persistence following JAKi cycling requires further investigation.References:[1]Littlejohn GO, Tymms KE, Smith T, Griffiths HT. Using big data from real-world Australian rheumatology encounters to enhance clinical care and research. Clin Exp Rheumatol. Sep-Oct 2020;38(5):874-880.Figure 1.Patterns of JAKi cycling for the management of rheumatoid arthritis in first, second and third line switching.Acknowledgements:The authors acknowledge the members of OPAL Rheumatology Ltd and their patients for providing clinical data for this study, and Software4Specialists Pty Ltd for providing the Audit4 platformDisclosure of Interests:Sabina Ciciriello: None declared, Tegan Smith: None declared, Catherine OSullivan: None declared, Kathleen Tymms: None declared, Peter Youssef: None declared, David Mathers: None declared, Claire Deakin: None declared, Hedley Griffiths Consultant of: AbbVie, Gilead, Novartis and Lilly., Geoff Littlejohn Speakers bureau: Over the last 5 years Geoffrey Littlejohn has received educational grants and consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, Novartis, Pfizer, Janssen, Sandoz, Sanofi and Seqirus.

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