NHL and rituximab biosimilar: How have prescribing behaviours changed in EU5 in 15 months?

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19054-e19054
Author(s):  
Alessandra Franceschetti
Keyword(s):  
Real World ◽  
Chart Review ◽  
Descriptive Statistics ◽  
Medical Chart Review ◽  
Anti Cancer ◽  
Proven Efficacy ◽  
Treatment Data ◽  
Prescribing Behaviour ◽  
Diagnosis Date ◽  
Over Time

e19054 Background: 15 months after EMA approval of the first rituximab biosimilar to treat NHL – and 12 months on from our presentation on its initial impact at the Biosimilars Special Clinical Symposium of ASCO 2018 – this study tracks the real world impact of official endorsement on prescribing behaviour and biosimilar adoption for NHL. Methods: The Ipsos Global Oncology Monitor – an online multi-country, multi-centre medical chart review of NHL patients, where 138 geographically representative physicians provided de-identified data on 3,239 patients treated with anti-cancer drugs in France (565), Germany (379), Italy (622), Spain (684) and UK (989) from July 2017 to Sept 2018. Physicians provided diagnosis date, current and historic treatment and reasons for prescribing treatment. Data on patients treated with and without a rituximab biosimilar were compared using descriptive statistics. Results: While prescribing of the rituximab molecule was stable over the study period, prescribing of rituximab biosimilars significantly increased – from 7% to 35% (p < 0.01), most notably in Germany and UK. By Q3 2018, for those patients treated with a rituximab-including regimen (N = 483), prescribing of any EMA-approved rituximab biosimilar was 72% in Germany and 63% in UK; France, Italy and Spain reported 47%, 32% and 30%, respectively. Physicians were significantly more likely to state “Well tolerated” and “Proven efficacy” as reasons for prescribing rituximab biosimilars in Q3 2018 vs Q3 2017 (p < 0.01). Prescribing of branded rituximab in the SC formulation significantly increased, from 21% to 33% (p < 0.01). Rituxan prescribing may be partially driven by availability of the SC mode of administration (MoA) not available for biosimilars. Conclusions: Over time, prescribing of rituximab biosimilars has significantly increased in the EU5, mainly in Germany and UK. Growth is less evident in Italy and Spain, perhaps as Southern physicians are historically more averse to ‘generic’ versions. Physicians’ ongoing experience of mAb biosimilars has resulted in higher associations with “Well tolerated” and “Proven efficacy”. The rise in prescribing Rituxan with the SC MoA has likely contained an even higher prescribing of rituximab biosimilars.

Real-world utilization of the novel AR-targeted therapies in mCRPC management: An electronic medical records retrospective study.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 176-176
Author(s):  
A. Oliver Sartor ◽  
Jyotsna Mehta ◽  
Eileen Fonseca ◽  
Catherine Balderston McGuiness ◽  
Allison Petrilla ◽  
...  
Keyword(s):  
Real World ◽  
Targeted Therapies ◽  
Data Entry ◽  
Cancer Staging ◽  
The Novel ◽  
Community Oncology ◽  
Anti Cancer ◽  
Treatment Data ◽  
Primary Neoplasms ◽  
One Year

176 Background: New androgen receptor (AR) targeted therapies, including abiraterone (AA) and enzalutamide (EZ), have recently been approved for mCRPC management. This study examined use of AA in community oncology practices to understand real world practice patterns. Methods: Deidentified EMRs were retrospectively analyzed for cancer staging, tumor histology, metastatic coding, lab results and drug orders from 78 practices (300+ locations; 37 states; >500,000 cancer patients) to identify mCRPC patients initiating AA between May 2011-Jan 2013, provided there was one year of baseline data prior to starting AA and 3 mos of data after initiating AA. Patients were excluded if participating in clinical trials, diagnosed with other primary neoplasms, or from practices inconsistently reporting data. Key outcomes were changes in systemic anti-cancer therapy, discontinuation of AA, and death during the first 3 mos after AA initiation. Results: Of 3,930 mCRPC patients observed with an oncology visit during study period, 356 met criteria for analysis (mean age at AA initiation 73.3 yrs); 37% of patients (n=131) received prior docetaxel (D) and 16% of patients (n=56) received prior cabazitaxel (C) before starting AA. Of these 356 patients, 153 (43%) experienced a change of therapy or death in the 3 mos post-starting AA. Of the total patients, 19% (n=66) discontinued AA, while 17% (n=62) changed systemic therapy. Of those changing therapy, 5 patients started EZ, 20 CBZ, 24 D. A total of 11% of the total patients (n=39) died within 3 mos of starting AA. Conclusions: Real-world treatment data suggests more than 57% of patients were alive and continuing AA while 43% discontinued AA/changed treatments, or died within 3 mos of starting AA. EMR data provide important insights into real world practice; limitations include inconsistency in data entry and difficulty in aligning prescription start dates with actual dispensed medication. [Table: see text]

scholarly journals Real World Performance Evaluation of Transcatheter Aortic Valve Implantation

2021 ◽  
Vol 10 (9) ◽  
pp. 1890
Author(s):  
Gabriele Pesarini ◽  
Gabriele Venturi ◽  
Domenico Tavella ◽  
Leonardo Gottin ◽  
Mattia Lunardi ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Real World ◽  
Baseline Risk ◽  
Risk Scores ◽  
World Population ◽  
Control Analysis ◽  
Transcatheter Aortic Valve ◽  
Procedural Control ◽  
Risk Patients ◽  
Over Time

Background: The aim of this research is to describe the performance over time of transcatheter aortic valve implantations (TAVIs) in a high-volume center with a contemporary, real-world population. Methods: Patients referred for TAVIs at the University Hospital of Verona were prospectively enrolled. By cumulative sum failures analysis (CUSUM), procedural-control curves for standardized combined endpoints—as defined by the Valve Academic Research Consortium-2 (VARC-2)—were calculated and analyzed over time. Acceptable and unacceptable limits were derived from recent studies on TAVI in intermediate and low-risk patients to fit the higher required standards for current indications. Results: A total of 910 patients were included. Baseline risk scores significantly reduced over time. Complete procedural control was obtained after approximately 125 and 190 cases for device success and early safety standardized combined endpoints, respectively. High risk patients (STS ≥ 8) had poorer outcomes, especially in terms of VARC-2 clinical efficacy, and required a higher case load to maintain in-control and proficient procedures. Clinically relevant single endpoints were all influenced by operator’s experience as well. Conclusions: Quality-control analysis for contemporary TAVI interventions based on standardized endpoints suggests the need for relevant operator’s experience to achieve and maintain optimal clinical results, especially in higher-risk subjects.

scholarly journals POS0619 MODELLING OF DISEASE ACTIVITY IN PATIENTS WITH INFLAMMATORY ARTHROPATHIES TREATED WITH ETANERCEPT ORIGINATOR OR BIOSIMILAR AS FIRST-LINE BIOLOGIC IN AN AUSTRALIAN REAL-WORLD DATASET

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 547.1-547
Author(s):  
C. Deakin ◽  
G. Littlejohn ◽  
H. Griffiths ◽  
T. Smith ◽  
C. Osullivan ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Data ◽  
Real World ◽  
Rank Test ◽  
P Value ◽  
Continuous Variables ◽  
Linear Quadratic ◽  
First Line ◽  
Modest Improvement ◽  
Over Time

Background:The availability of biosimilars as non-proprietary versions of established biologic disease-modifying anti-rheumatic drugs (bDMARDs) is enabling greater access for patients with rheumatic diseases to effective medications at a lower cost. Since April 2017 both the originator and a biosimilar for etanercept (trade names Enbrel and Brenzys, respectively) have been available for use in Australia.Objectives:[1]To model effectiveness of etanercept originator or biosimilar in reducing Disease Activity Score 28-joint count C reactive protein (DAS28CRP) in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) treated with either drug as first-line bDMARD[2]To describe persistence on etanercept originator or biosimilar as first-line bDMARD in patients with RA, PsA or ASMethods:Clinical data were obtained from the Optimising Patient outcomes in Australian rheumatoLogy (OPAL) dataset, derived from electronic medical records. Eligible patients with RA, PsA or AS who initiated etanercept originator (n=856) or biosimilar (n=477) as first-line bDMARD between 1 April 2017 and 31 December 2020 were identified. Propensity score matching was performed to select patients on originator (n=230) or biosimilar (n=136) with similar characteristics in terms of diagnosis, disease duration, joint count, age, sex and concomitant medications. Data on clinical outcomes were recorded at 3 months after baseline, and then at 6-monthly intervals. Outcomes data that were missing at a recorded visit were imputed.Effectiveness of the originator, relative to the biosimilar, for reducing DAS28CRP over time was modelled in the matched population using linear mixed models with both random intercepts and slopes to allow for individual heterogeneity, and weighting of individuals by inverse probability of treatment weights to ensure comparability between treatment groups. Time was modelled as a combination of linear, quadratic and cubic continuous variables.Persistence on the originator or biosimilar was analysed using survival analysis (log-rank test).Results:Reduction in DAS28CRP was associated with both time and etanercept originator treatment (Table 1). The conditional R-squared for the model was 0.31. The average predicted DAS28CRP at baseline, 3 months, 6 months, 9 months and 12 months were 4.0 and 4.4, 3.1 and 3.4, 2.6 and 2.8, 2.3 and 2.6, and 2.2 and 2.4 for the originator and biosimilar, respectively, indicating a clinically meaningful effect of time for patients on either drug and an additional modest improvement for patients on the originator.Median time to 50% of patients stopping treatment was 25.5 months for the originator and 24.1 months for the biosimilar (p=0.53). An adverse event was the reason for discontinuing treatment in 33 patients (14.5%) on the originator and 18 patients (12.9%) on the biosimilar.Conclusion:Analysis using a large national real-world dataset showed treatment with either the etanercept originator or the biosimilar was associated with a reduction in DAS28CRP over time, with the originator being associated with a further modest reduction in DAS28CRP that was not clinically significant. Persistence on treatment was not different between the two drugs.Table 1.Respondent characteristics.Fixed EffectEstimate95% Confidence Intervalp-valueTime (linear)0.900.89, 0.911.5e-63Time (quadratic)1.011.00, 1.011.3e-33Time (cubic)1.001.00, 1.007.1e-23Originator0.910.86, 0.960.0013Acknowledgements: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 platform.Supported in part by a research grant from Investigator-Initiated Studies Program of Merck & Co Inc, Kenilworth, NJ, USA. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck & Co Inc, Kenilworth, NJ, USA.Disclosure of Interests:Claire Deakin: None declared, Geoff Littlejohn Consultant of: 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., Hedley Griffiths Consultant of: AbbVie, Gilead, Novartis and Lilly., Tegan Smith: None declared, Catherine OSullivan: None declared, Paul Bird Speakers bureau: Eli Lilly, abbvie, pfizer, BMS, UCB, Gilead, Novartis

scholarly journals Leveraging Real-World Data for the Selection of Relevant Eligibility Criteria for the Implementation of Electronic Recruitment Support in Clinical Trials

2021 ◽  
Vol 12 (01) ◽  
pp. 017-026
Author(s):  
Georg Melzer ◽  
Tim Maiwald ◽  
Hans-Ulrich Prokosch ◽  
Thomas Ganslandt
Keyword(s):  
Data Warehouse ◽  
Real World ◽  
Chart Review ◽  
Patient Recruitment ◽  
Real World Data ◽  
Eligibility Criteria ◽  
Health Records ◽  
World Data ◽  
Paper Chart ◽  
Data Elements

Abstract Background Even though clinical trials are indispensable for medical research, they are frequently impaired by delayed or incomplete patient recruitment, resulting in cost overruns or aborted studies. Study protocols based on real-world data with precisely expressed eligibility criteria and realistic cohort estimations are crucial for successful study execution. The increasing availability of routine clinical data in electronic health records (EHRs) provides the opportunity to also support patient recruitment during the prescreening phase. While solutions for electronic recruitment support have been published, to our knowledge, no method for the prioritization of eligibility criteria in this context has been explored. Methods In the context of the Electronic Health Records for Clinical Research (EHR4CR) project, we examined the eligibility criteria of the KATHERINE trial. Criteria were extracted from the study protocol, deduplicated, and decomposed. A paper chart review and data warehouse query were executed to retrieve clinical data for the resulting set of simplified criteria separately from both sources. Criteria were scored according to disease specificity, data availability, and discriminatory power based on their content and the clinical dataset. Results The study protocol contained 35 eligibility criteria, which after simplification yielded 70 atomic criteria. For a cohort of 106 patients with breast cancer and neoadjuvant treatment, 47.9% of data elements were captured through paper chart review, with the data warehouse query yielding 26.9% of data elements. Score application resulted in a prioritized subset of 17 criteria, which yielded a sensitivity of 1.00 and specificity 0.57 on EHR data (paper charts, 1.00 and 0.80) compared with actual recruitment in the trial. Conclusion It is possible to prioritize clinical trial eligibility criteria based on real-world data to optimize prescreening of patients on a selected subset of relevant and available criteria and reduce implementation efforts for recruitment support. The performance could be further improved by increasing EHR data coverage.

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