The study, conducted in 80 patients with rheumatic diseases who elected to switch from treatment with originator etanercept to biosimilar etanercept, found that 80% were willing to switch, and switching did not affect treatment effectiveness during 1 year of follow up.
A Dutch study of 80 patients with rheumatic diseases who elected to switch from treatment with originator etanercept to biosimilar etanercept found that 80% were willing to switch, and switching did not affect treatment effectiveness during 1 year of follow up. The study by Wieland D. Muskens and colleagues, was presented at the annual European Congress of Rheumatology, held June 13-16, 2018, in Amsterdam. Because the study was a non-mandatory open-label transitioning study, the researchers were also able to investigate the effect of shared decision-making on 1-year retention rates and reason for withdrawal in daily clinical real-world practice.
Of the 69 patients who switched from originator to biosimilar etanercept, 75% were able to continue using biosimilar etanercept treatment. Patients enrolled in the study were diagnosed with either rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA). They had all used originator etanercept between June 1, 2016, and October 23, 2017, before being notified by mail of the possibility of switching over to biosimilar etanercept. The patients had an opportunity to consult with their rheumatologists about biosimilars and switching to a biosimilar at their next outpatient visit; they were assured that they could switch back to originator etanercept if they encountered difficulties with the biosimilar.
Following the switch, data were collected on disease activity (DA) [Disease Activity Score in 28 joints for RA and PsA and the Ankylosing Spondylitis Disease Activity Score for SpA] as well as medication use and adverse events from the time of the switch until October 23, 2017. Reasons for stopping biosimilars were verified using patients’ hospital health record systems. The researchers also assessed reasons for change in DA and discontinuation of biosimilar treatment.
A total of 69 patients taking originator etanercept elected to switch to the biosimilar after a median time of 5.1 years. By October 23, 2017 (median follow up of 307 days), the mean DA did not significantly differ from the DA at baseline: 3.1 (95% CI, 2.5-3.7) vs 2.8 (95% CI, 2.5-3.1). At the end of follow up, 25% of patients had discontinued their treatment and either switched back to originator etanercept (18%), switched to another biological medication (3%), or stopped treatment with biologicals.
Reasons cited for switching back to the originator were adverse events (58%), lack of effect (17%), and adverse event and lack of effect (25%). Among the patients who switched, only 1 serious adverse event was reported—a drug hypersensitivity reaction.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.