Dataset Information

Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali^®) Versus Etanercept (Enbrel^®) - Findings from a Nurse Survey in Europe.

ABSTRACT:

Introduction

Enbrel^® (etanercept: manufactured by Immunex Corporation, Newbury Park, Thousand Oaks, CA 91320, USA) was the first biological disease-modifying anti-rheumatic drug approved for the treatment of rheumatoid arthritis (RA) in Europe. More recently, an etanercept biosimilar (Benepali^®: manufactured by Biogen Inc, Cambridge, MA 02124, USA) was approved in the European Union. The perceptions and preferences of the Benepali autoinjector versus Enbrel MYCLIC autoinjector were evaluated by nurses from Europe.

Methods

The survey involved a 25-min face-to-face questionnaire-interview with nurses from France, Germany, Italy, Spain, and the UK, experienced in training patients on using the Enbrel MYCLIC autoinjector. Nurses viewed an instructional video and device-handling leaflet, received a live demonstration on the Benepali autoinjector and had access to both Benepali and Enbrel MYCLIC training autoinjectors. Nurses rated the importance of ten autoinjector attributes on a scale of 1-7 (1 = not important at all; 7 = extremely important) and provided their autoinjector preferences based on specific attributes. Nurses also gave their opinion on which autoinjector their patients with RA would prefer.

Results

A total of 149 nurses participated in this survey (France, n = 30; Germany, n = 40; Italy, n = 30; Spain, n = 19; UK, n = 30). 'Easy to operate the self-injection' was ranked as the most important attribute (mean score of 6.8), followed by 'easy to grip' (6.6) and 'intuitive/self-explaining usage' (6.6). Nurses preferred the Benepali autoinjector, with attributes of 'easier to operate' and 'more intuitive to use' being strong differentiators compared with the Enbrel MYCLIC autoinjector. Most nurses (86%) reported that their patients would prefer the Benepali autoinjector over the Enbrel MYCLIC autoinjector. 'Easy to operate the self-injection' and 'button-free autoinjector' were key drivers when selecting an autoinjector.

Conclusion

Based on these survey results, nurses in Europe reported a preference for the Benepali autoinjector compared with the Enbrel MYCLIC autoinjector for the majority of attributes assessed. In particular, attributes of 'easy to operate' and 'more intuitive/self-explaining to use' were highly rated for the Benepali autoinjector, which may allow easy handling of the autoinjector.

Funding

Biogen International GmBH.

SUBMITTER: Thakur K

PROVIDER: S-EPMC4999586 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundBiologic disease-modifying antirheumatic drugs, including tumor necrosis factor inhibitors such as etanercept (Enbrel®), have improved outcomes for patients with rheumatic and other inflammatory diseases, with sustained remission being the optimal goal for patients with rheumatoid arthritis. Flexible and convenient treatment options, compatible with modern lifestyle, are important in helping patients maintain treatment and manage their disease. Etanercept drug product (DP) is available in lyophilized powder (Lyo) for solution injection, prefilled syringe, and prefilled pen presentations and is typically stored under refrigerated conditions. We aimed to generate a comprehensive analytical data package from stability testing of key quality attributes, consistent with regulatory requirements, to determine whether the product profile of etanercept is maintained at ambient temperature.MethodsTest methods assessing key attributes of purity, quality, potency, and safety were performed over time, following storage of etanercept DP presentations under a range of conditions.ResultsResults and statistical analysis from stability testing (based on size exclusion high-performance liquid chromatography, hydrophobic interaction chromatography, and sodium dodecyl sulfate-polyacrylamide gel electrophoresis Coomassie) across all etanercept presentations (10 and 25 mg/vial Lyo DP; 25 and 50 mg prefilled syringe DP; 50 mg prefilled pen DP) showed key stability-indicating parameters were within acceptable limits through the alternative storage condition of 25°C±2°C for 1 month.ConclusionStability testing performed in line with regulatory requirements supports a single period of storage for etanercept DP at an alternative storage condition of 25°C±2°C for up to 1 month within the approved expiry of the product. This alternative storage condition represents further innovation in the etanercept product lifecycle, providing greater flexibility and enhanced overall convenience for patients.

Project description:IntroductionBenepali® was the first etanercept (Enbrel®) biosimilar to be approved in the European Union. Both Benepali and Enbrel are available as autoinjector devices. In a recent survey, nurses from France, Germany, Italy, Spain, and the United Kingdom (UK) reported that their patients with rheumatoid arthritis (RA) would prefer the Benepali autoinjector compared to the Enbrel MYCLIC autoinjector. To determine whether patients' perceptions were similar to those of the nurses, this survey evaluated patients' perceptions and preferences of the Benepali autoinjector versus the Enbrel MYCLIC autoinjector in the same five European countries.MethodsPatients with RA using the Enbrel MYCLIC autoinjector participated in a 25-min, face-to-face questionnaire-interview. Patients were also shown an instructional video and device-handling leaflet, received a live demonstration on the Benepali autoinjector, and had access to both Benepali and Enbrel MYCLIC training autoinjectors. Patients rated the importance of ten autoinjector attributes on a seven-point scale (1 = not important at all; 7 = extremely important) and provided their autoinjector preferences based on specific attributes. Patients also gave their opinion on which autoinjector they would prefer to use for self-injection.ResultsOverall, 220 patients participated in the survey (France, n = 30; Germany, n = 65; Italy, n = 67; Spain, n = 12; UK, n = 46). 'Easy to operate the self-injection' was ranked as the most important attribute (mean score of 6.8), followed by 'easy to grip' (6.5), and 'intuitive/self-explaining usage' (6.3). Patients preferred the Benepali autoinjector, with the attribute of 'easier to operate' being a strong differentiator compared to the Enbrel MYCLIC autoinjector. Most patients (74%) reported that they would prefer to use the Benepali autoinjector over the Enbrel MYCLIC autoinjector. 'Easy to operate the self-injection' and 'button-free autoinjector' were key drivers when selecting an autoinjector.ConclusionsPatients in Europe reported a preference for the Benepali autoinjector compared to the Enbrel MYCLIC autoinjector. This finding is consistent with results from a recently reported nurse survey.FundingBiogen.

Project description:IntroductionImraldi™ is a biosimilar of the anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab and was recently approved in Europe for the treatment of various inflammatory conditions. Imraldi is administered via an autoinjector device that features distinct design attributes compared with other biologic TNF inhibitor autoinjectors, such as the Humira (adalimumab) Pen® and Enbrel® (etanercept) MyClic® Pen were developed by the relevant pharmaceutical companies. The aim of this study was to evaluate patients' and nurses' preferences for the Imraldi versus Humira or Enbrel MyClic autoinjectors in the UK and Germany.MethodsPatients with inflammatory joint or bowel disease and nurses with experience in educating patients with these conditions on self-injection participated in two survey studies, the first comparing the Imraldi and Humira autoinjectors and the second comparing the Imraldi and Enbrel MyClic autoinjectors.ResultsOverall, 101 nurses (UK, n = 50; Germany, n = 51) and 151 patients (UK, n = 90; Germany, n = 61) participated in both studies. In the first study, 85% of nurses and 78% of patients preferred the Imraldi autoinjector over the Humira autoinjector (P < 0.001); in the second study, 86% of nurses and 79% of patients preferred the Imraldi autoinjector over the Enbrel MyClic autoinjector (P < 0.001). Top reasons for preferring the Imraldi autoinjector included ease of use, ease of grip, and its button-free initiation mechanism. Most nurses indicated they would recommend the Imraldi autoinjector over the Humira and Enbrel MyClic autoinjectors, and most patients indicated they would choose the Imraldi autoinjector over the Humira and Enbrel MyClic autoinjectors to continue treatment.ConclusionNurses and patients in the UK and Germany preferred the Imraldi autoinjector over both the Humira and Enbrel MyClic autoinjectors, which may be a consideration, along with other factors, for treatment decisions in the management of patients with inflammatory joint or bowel disease.FundingBiogen International GmbH.

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:IntroductionIn 2016, SB4 (Benepali®) became the first etanercept (ETN) biosimilar to obtain marketing authorisation in Europe. Despite robust analytical and clinical comparisons, outstanding questions remain on SB4 use in routine practice.MethodsA systematic search for publications on real-world evidence of SB4 effectiveness, safety and drug survival was undertaken using search terms (SB4 OR Benepali OR biosimilar etanercept OR innovator etanercept) in the BIOSIS® Toxicology, BIOSIS Previews®, Embase® and MEDLINE® databases up to 17 January 2019.ResultsOf 959 articles identified, eight journal articles, two journal letters and 23 congress abstracts were selected on criteria of original real-world evidence with a clinical focus. As expected with real-world evidence, quality scoring showed that the evidence had high external validity but lower internal validity. A total of 13,552 patients were described across nine European countries and all approved SB4 indications: 2499 were ETN-naïve and 11,053 switched from reference ETN to SB4 (switchers). Switch acceptance rates (a combination of clinicians offering and patients accepting initiation on SB4) ranged between 51.6% and 99.0%; patient support programmes positively contributed to acceptance. Disease activity was generally similar pre- and post-switch (typically 3-month timeframe). Retention rates across studies were at least 75% (up to 12 months follow-up). No new safety signals were identified. Differences in discontinuation rates versus historic controls reported in some studies may have been influenced by differences in treatment practices, lack of clinician confidence and nocebo effects.ConclusionNearly 2500 ETN-naïve patients have been initiated on SB4 and outcomes are similar to those patients receiving reference ETN. Overall this systematic review of real-world evidence provides additional reassurance that SB4 is as effective and safe as reference ETN in both switched and naïve patients.FundingBiogen International GmbH.

Dataset Information

Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali^®) Versus Etanercept (Enbrel^®) - Findings from a Nurse Survey in Europe.

Introduction

Methods

Results

Conclusion

Funding

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali®) Versus Etanercept (Enbrel®) - Findings from a Nurse Survey in Europe.

Introduction

Methods

Results

Conclusion

Funding

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali^®) Versus Etanercept (Enbrel^®) - Findings from a Nurse Survey in Europe.