Dataset Information

One-year results after transitioning from etanercept originator to biosimilar in a setting promoting shared decision-making in rheumatology.

ABSTRACT: Objective:The aim was to study the effect of non-mandatory transitioning from etanercept originator to etanercept biosimilar on retention rates in a setting promoting shared decision-making. Methods:In 2016, all patients treated with etanercept originator and stable disease at the Rheumatology department in Bernhoven were offered transitioning to etanercept biosimilar by an opt-in approach. A historical cohort of patients treated with etanercept originator in 2015 was identified as the control group. Etanercept discontinuation was compared between the cohorts using Cox regression. To study the nocebo effect, reasons for discontinuation were categorized into objective reasons (e.g. laboratory abnormalities, increase in swollen joint count, allergic reaction) and subjective health complaints (symptoms perceptible only to the patient, e.g. tiredness, arthralgia). An adjusted Kaplan-Meier curve for retention of the etanercept biosimilar was made, censoring subjective health complaints as the reason for discontinuation. Results:Seventy of the 79 patients eligible for transitioning agreed to transition (89%). The 1-year crude retention rate of etanercept in the transition cohort was 73% (95% CI: 0.62, 0.83), compared with a retention rate of 89% (95% CI: 0.81, 0.95) in the historical cohort (P?=?0.013). This resulted in a higher risk of treatment discontinuation in the transition cohort (adjusted hazard ratio?=?2.73; 95% CI: 1.23, 6.05, P?=?0.01). After adjusting for the nocebo effect, the cohorts had comparable retention rates (86 vs 89%, P?=?0.51). Conclusion:Non-mandatory transition from etanercept originator to its biosimilar using an opt-in approach in a setting promoting shared decision-making resulted in a higher discontinuation of etanercept compared with the historical cohort. This could be attributed largely to the nocebo effect.

SUBMITTER: Muskens WD

PROVIDER: S-EPMC7519774 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

One-year results after transitioning from etanercept originator to biosimilar in a setting promoting shared decision-making in rheumatology.

Müskens Wieland D WD Rongen-van Dartel Sanne A A SAA Teerenstra Steven S Adang Eddy M M EMM van Riel Piet L C M PLCM

Rheumatology advances in practice 20200806 2

<h4>Objective</h4>The aim was to study the effect of non-mandatory transitioning from etanercept originator to etanercept biosimilar on retention rates in a setting promoting shared decision-making.<h4>Methods</h4>In 2016, all patients treated with etanercept originator and stable disease at the Rheumatology department in Bernhoven were offered transitioning to etanercept biosimilar by an opt-in approach. A historical cohort of patients treated with etanercept originator in 2015 was identified a ...[more]

PMID: 33005860

Similar Datasets

Project description:BackgroundPatients in clinical practice are transitioned from originator etanercept (OR-ETA) to biosimilar etanercept (BS-ETA), but some subsequently retransition. Insights into the incidence of and reasons for retransitioning and the characteristics of these patients could help clinicians successfully introduce biosimilars.ObjectiveOur objective was to assess the incidence of and reasons for retransitioning from BS-ETA to OR-ETA in patients with a rheumatic disease (RD) and to explore the determinants thereof.MethodsThis cohort study included all patients with RD who had transitioned from OR-ETA to BS-ETA in a large hospital in the Netherlands in 2016. The incidence of retransitioning to OR-ETA and the 1-year persistence with BS-ETA were assessed using the Kaplan-Meier estimator. Reasons for retransitioning were classified as related to (1) efficacy, (2) adverse events, (3) the administration device, and (4) other. Determinants for retransitioning, including baseline and treatment characteristics, were assessed in a nested case-control study using conditional logistic regression.ResultsWe included 342 patients (median age 57.8 years; 53.5% females). At 1 year after transitioning, 9.4% of patients had retransitioned to OR-ETA and 69.7% were persistent with BS-ETA. At the end of follow-up (median 4.4 years), 47 patients (13.7%) had retransitioned to OR-ETA. The median time until retransitioning was 0.55 years (interquartile range 0.2-1.3). Most patients (n = 34 [72.3%]) retransitioned because of a (perceived) loss of effect, followed by adverse events (23.4%). In total 3.8% of patients switched to another biological treatment or a Janus kinase inhibitor; 17.1% of patients discontinued BS-ETA without retransitioning or switching within the first year. Univariate determinants for retransitioning included initiating corticosteroids or intensifying immunomodulator treatment (odds ratio [OR] 2.37; 95% confidence interval [CI] 1.03-5.45) and the number of visits to the rheumatology department (OR 2.06; 95% CI 1.55-2.74). In the multivariate analysis, only the number of visits to the rheumatology department remained significantly associated with retransitioning (OR 2.19; 95% CI 1.60-3.01).ConclusionWhen introducing a biosimilar in clinical care, clinicians should anticipate that one in seven patients will retransition to the originator. A (perceived) loss of effect was the most frequently reported reason for retransitioning. Patients who visited the rheumatology department more frequently had an increased risk of retransitioning, which is likely to be related to patients reporting a loss of effect and to adverse events resulting in more visits to the rheumatology department.

Project description:ObjectivesEtanercept biosimilars show comparable efficacy to their originators among biologic-naïve patients with RA in randomized controlled trials. Nationwide guidelines have obligated prescribing of etanercept biosimilars from 2016, resulting in significant cost savings. This analysis aimed to compare the effectiveness of etanercept originator vs etanercept biosimilar amongst biologic-naïve RA patients treated in routine clinical practice in the UK.MethodsBiologic-naïve RA patients starting etanercept in the British Society for Rheumatology Biologics Register in Rhematoid Arthritis (BSRBR-RA) cohort study from 2010 were included. Data collected at start of therapy includes patient demographics and disease activity. Follow-up data includes changes in disease activity and anti-rheumatic therapy. Six- and 12-month primary outcomes include DAS for 28-joints (DAS28) remission, EULAR response and minimal clinically important difference in function. Etanercept drug survival was assessed using Kaplan-Meier and Cox regression, including reasons for treatment withdrawal. Multiple imputation accounted for missing data. Propensity-decile adjustment was used to account for confounding by indication.ResultsA total of 1806 biologic-naïve RA patients started etanercept: 1009 originator, 797 biosimilar. At 6 and 12 months, the proportion of patients achieving DAS28 remission and EULAR response were similar between treatments. During follow-up, 19% of originator patients switched onto etanercept biosimilar. Patients were censored at time of switch. Patients on originator were no more likely to stop therapy vs biosimilar; 71% of originator and 76% of biosimilar patients remained on therapy at 1 year.ConclusionsIn one of the largest analyses of patients with RA, biologic-naïve RA patients treated with etanercept originator showed similar outcomes vs biosimilar using real-world data. Drug survival, and disease activity after 6 and 12 months of therapy, was similar between cohorts.

Project description:BackgroundThere is little information about the functions and behavior change techniques (BCTs) needed to implement shared decision making (SDM) in clinical practice. To guide future implementation initiatives, we sought to develop a BCT taxonomy for SDM implementation interventions.MethodsThis study is a secondary analysis of a 2018 Cochrane review on interventions for increasing the use of shared decision making by healthcare professionals. We examined all 87 studies included in the review. We extracted relevant information on each study intervention into a spreadsheet. Coders had undergone a training workshop on intervention functions and online training on BCT Taxonomy version 1 (BCTTv1). We performed functions and BCTs coding trials, and identified coding rules. We used Michie's guide for designing behavior change interventions to code the functions and BCTs used in the interventions. Coders met to compare coding and discrepancies were discussed until consensus was reached. Data was analyzed using simple descriptive statistics.ResultsOverall, 7 functions, 24 combinations of functions and 32 BCTs were used in the 87 SDM implementation interventions. The mean of functions per intervention was 2.5 and the mean of BCTs per intervention was 3.7. The functions Coercion and Restriction were not found. The most common function was Education (73 studies). Three combinations of functions were most common (e.g: Education + Persuasion, used in 10 studies). The functions associated with more effective SDM implementation interventions were Modeling and Training. The most effective combination of functions was Education + Training + Modeling + Enablement. The most commonly used BCT was Instruction on how to perform the behavior (43 studies). BCTs associated with more effective SDM implementation interventions were: Instruction on how to perform the behavior, Demonstration of the behavior, Feedback on behavior, Pharmacological support, Material reward, and Biofeedback. Twenty-five BCTs were associated with less effective SDM implementation interventions. Four new BCTs were identified: General information to support the behavior, Tailoring, Exercises to conceptually prepare for the behavior, and Experience sharing and learning.ConclusionsWe established a BCT taxonomy specific to the field of SDM to guide future SDM implementation interventions. Four new BCTs should be added to BCTTv1.

Project description:BackgroundShared decision-making (SDM) is widely recommended and required by the Centers for Medicare and Medicaid for patients considering lung cancer screening (LCS).ObjectiveWe examined clinicians' communication practices and perceived barriers of SDM for LCS at three medical centers with established screening programs.DesignMulticenter qualitative study of clinicians participating in LCS.ApproachWe performed semi-structured interviews, which were transcribed and analyzed using directed content analysis, guided by a theoretical model of patient-clinician communication.ParticipantsWe interviewed 24 clinicians including LCS coordinators (2), pulmonologists (3), and primary care providers (17), 4 of whom worked for the LCS program, a thoracic surgeon, and a radiologist.ResultsAll clinicians agreed with the goal of SDM, to ensure the screening decision was congruent with the patient's values. The depth and type of information presented by each clinician role varied considerably. LCS coordinators presented detailed information including numeric estimates of benefit and harm. Most PCPs explained the process more generally, focusing on logistics and the high rate of nodule detection. No clinician explicitly elicited values or communication preferences. Many PCPs tailored the conversation based on their implicit understanding of patients' values and preferences, gained from past experiences. PCPs reported that time, lack of detailed personal knowledge of LCS, and patient preferences were barriers to SDM. Many clinicians perceived that a significant proportion of patients were not interested in specific percentages and preferred to receive a clinician recommendation.ConclusionsOur results suggest that clinicians support the goal of SDM for LCS decisions but PCPs may not perform some of its elements. The lack of completion of some elements, such as PCPs' lack of in-depth information exchange, may reflect perceived patient preferences for communication. As LCS is implemented, further research is needed to support a personalized, patient-centered approach to produce better outcomes.

Project description:Background. Accurate diagnosis of patients' preferences is central to shared decision making. Missing from clinical practice is an approach that links pretreatment preferences and patient-reported outcomes. Objective. We propose a Bayesian collaborative filtering (CF) algorithm that combines pretreatment preferences and patient-reported outcomes to provide treatment recommendations. Design. We present the methodological details of a Bayesian CF algorithm designed to accomplish 3 tasks: 1) eliciting patient preferences using conjoint analysis surveys, 2) clustering patients into preference phenotypes, and 3) making treatment recommendations based on the posttreatment satisfaction of like-minded patients. We conduct a series of simulation studies to test the algorithm and to compare it to a 2-stage approach. Results. The Bayesian CF algorithm and 2-stage approaches performed similarly when there was extensive overlap between preference phenotypes. When the treatment was moderately associated with satisfaction, both methods made accurate recommendations. The kappa estimates measuring agreement between the true and predicted recommendations were 0.70 (95% confidence interval = 0.052-0.88) and 0.73 (0.56-0.90) under the Bayesian CF and 2-stage approaches, respectively. The 2-stage approach failed to converge in settings in which clusters were well separated, whereas the Bayesian CF algorithm produced acceptable results, with kappas of 0.73 (0.56-0.90) and 0.83 (0.69-0.97) for scenarios with moderate and large treatment effects, respectively. Limitations. Our approach assumes that the patient population is composed of distinct preference phenotypes, there is association between treatment and outcomes, and treatment effects vary across phenotypes. Findings are also limited to simulated data. Conclusion. The Bayesian CF algorithm is feasible, provides accurate cluster treatment recommendations, and outperforms 2-stage estimation when clusters are well separated. As such, the approach serves as a roadmap for incorporating predictive analytics into shared decision making.

Dataset Information

One-year results after transitioning from etanercept originator to biosimilar in a setting promoting shared decision-making in rheumatology.

Publications

One-year results after transitioning from etanercept originator to biosimilar in a setting promoting shared decision-making in rheumatology.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets