Study: Patients and Providers Prefer Biosimilar Etanercept's Auto-Injector

A recently published study found that the auto-injector device used to deliver a biosimilar etanercept was preferable to the auto-injector device used to deliver reference etanercept (Enbrel) among patients with rheumatoid arthritis (RA) and healthcare providers who treat patients with RA.

The study, funded by Merck, sponsor of the biosimilar etanercept product (Brenzys, which is also marketed as Benepali) compared the biosimilar’s auto-injector—which has no push button requiring use of the patient’s thumb, which allows 1-handed delivery, and which allows for visual and auditory confirmation of dose delivery—with the auto-injector of the reference etanercept. The study, conducted in Canada and Australia, was a counterbalanced crossover trial in which patients with RA (n = 191) and healthcare professionals (HCPs), comprising nurses and rheumatologists (n = 90), injected both devices into pads representing skin and reported on the ease of use.

All participants were blinded to the study sponsor. The researchers presented each participant with both devices in a counterbalanced order among participants. After receiving a demonstration, participants used both devices, then completed a forced-choice questionnaire.

The survey results for patients, of whom 157 (82.2%) were naïve to auto-injector experience for RA, were as follows:

• 74.3% preferred the biosimilar’s auto-injector device
• 79.1% found the biosimilar’s auto-injector easier to use than the reference product’s
• 63.3% said that the biosimilar’s auto-injector was better at indicating that a full dose had been administered
• 60.0% said that the biosimilar device’s cap was easier to remove
• 78.5% reported that the biosimilar’s auto-injector was easier to use to administer the dose
• 73.8% said they would recommend the biosimilar’s auto-injector to others
• 94.1% who had previously used the reference product’s auto-injectors (n = 17) reported that, given the choice, they would continue their treatment using the biosimilar’s auto-injector
• Overall, 83.3% of patients in Australia and 66.3% of patients in Canada preferred the biosimilar’s auto-injector overall
• Subgroup analyses of patients by age, gender, dexterity, and previous auto-injector experience demonstrated that each subgroup was independently more likely to prefer the biosimilar’s auto-injector to the originator’s, on all survey criteria

Results for the HCPs were as follows:

• 80% preferred the biosimilar’s auto-injector device
• 85.6% found the biosimilar’s auto-injector easier to use than the reference product’s
• 77.0% said that the biosimilar’s auto-injector was better at indicating that a full dose had been administered
• 55.2% said that the biosimilar device’s cap was easier to remove
• 84.4% reported that the biosimilar’s auto-injector was easier to use to administer the dose
• 83.1% said they would recommend the biosimilar’s auto-injector to patients
• 87.8% said that the biosimilar’s auto-injector would be easier to teach patients how to use
• Overall, 85.0% of HCPs in Australia and 76.5% of HCPs in Canada preferred the biosimilar’s auto-injector overall

The study’s authors note that their trial was limited by the fact that patients injected into a pad rather than into themselves, and also that participants used each auto-injector once rather than over the course of many doses of therapy, as preference patterns could vary with repeated use.

The researchers concluded that patients with RA and HCPs with experience in treating patients with RA indicated an overall preference for the biosimilar etanercept’s auto-injector device, and that the preference extended to various aspects of use. The researchers say that these findings can be used to understand the real-world experiences of patients who use such devices, and that healthcare stakeholders can use these results to make informed decisions when selecting an etanercept product for the management of RA.