Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis

Advances in Therapy
Young Hee RhoTae Hyung Kim

Abstract

This study aimed to compare the usability of subcutaneous administration of SB4 (an etanercept biosimilar) via prefilled syringe (PFS) and autoinjector (AI) based on injection site pain, patient preference, and safety in patients with rheumatoid arthritis (RA). This was an open-label, single-arm, multicenter study to evaluate the usability and safety of the AI and PFS of SB4. Adult patients with RA received two injections of SB4 via the PFS, followed by six injections by the AI every week, up to 8 weeks. The primary endpoint was the change in injection site pain score immediately post-injection from week 1 (PFS) to week 3 (AI). Injection site pain after 15-30 min post-injection, overall impression, and preference for PFS and AI were also assessed. Safety was assessed up to 11 weeks after the first injection. A total of 54 patients were enrolled and 52 patients (96.3%) completed the 8-week treatment period. The mean difference in pain scores between PFS and AI was - 0.057 and the 95% CI of the difference was [- 0.63, 0.51], which was within the equivalence margin of ± 5. Overall impression of the device slightly favored the AI. Overall preference for the AI was more favorable when compared to the PFS in all categories. Adverse e...Continue Reading

References

Jun 28, 2011·Clinical Therapeutics·Jeffrey R Curtis, Jasvinder A Singh
Mar 8, 2013·Annals of the Rheumatic Diseases·Polina PutrikUNKNOWN Working Group ‘Equity in access to treatment of rheumatoid arthritis in Europe’
Nov 8, 2015·Arthritis & Rheumatology·Jasvinder A SinghTimothy McAlindon
Mar 15, 2016·British Journal of Clinical Pharmacology·Yoon Jung LeeRainard Fuhr

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Citations

Apr 5, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Evelien MoorkensIsabelle Huys

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