Dataset Information

Etanercept (Enbrel^®) alternative storage at ambient temperature.

ABSTRACT:

Background

Biologic 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.

Methods

Test 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.

Results

Results 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.

Conclusion

Stability 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.

SUBMITTER: Shannon E

PROVIDER: S-EPMC5531722 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

Etanercept (Enbrel<sup>®</sup>) alternative storage at ambient temperature.

Shannon Edel E Daffy Joanne J Jones Heather H Paulson Andrea A Vicik Steven M SM

Clinical pharmacology : advances and applications 20170721

<h4>Background</h4>Biologic disease-modifying antirheumatic drugs, including tumor necrosis factor inhibitors such as etanercept (Enbrel<sup>®</sup>), 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 produ ...[more]

PMID: 28790869

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Project description:IntroductionEnbrel® (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.MethodsThe 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.ResultsA 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.ConclusionBased 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.FundingBiogen International GmBH.