Many individuals—including myself—are needle phobic and fear injection-site pain. So the use of small needle auto-injectors can make drug administration easier for some patients. A study surveyed patients with rheumatoid arthritis (RA) after they switched from a prefilled syringe to an injection pen for self-administering a biosimilar to etanercept (Enbrel).1
You Might Also Like
Also By This Author
Etanercept and agents biosimilar to it are U.S. Food & Drug Administration (FDA) approved to treat RA, plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and plaque psoriasis.2 In November 1998, the FDA approved etanercept supplied in single use vials for reconstitution with syringes for self-administration to treat RA.3,4 In September 2017, the FDA approved etanercept in the form of a prefilled-cartridge for a reusable auto-injector (AutoTouch).5
In this study, Hibino et al. evaluated the usability of YLB113-002, which is biosimilar to etanercept, administered in an injection pen in patients with RA who switched from a prefilled syringe.1 Study participants were part of the YLB113-002 phase 3 clinical trial, which compared YLB113-002 to the reference product etanercept. The first 35 patients from the phase 3 trial who completed the consent form were enrolled in this observational study. A questionnaire was used to survey the patients who assessed their ability to operate the pen device and the potential convenience of this dosage form.
Patients self-administered 50 mg of subcutaneous YLB113-002 once weekly using the injection pen for eight weeks. The form and design of the injection pen were evaluated related to its appearance and grip ease, as well as the patients’ preferences for the syringe or pen. The study enrolled 10 men and 25 women, with a mean age of 53.8 years and a mean Disease Activity Score in 28 joints of 5.1, indicating moderate to high disease activity.
The results: Most patients (85%) rated the appearance and the design of the injection pen as easy or very easy to grasp. At the beginning of the study, all patients reported that they felt very scared or a little scared about injecting the medication with the syringe. At the end of this study, their fear of self-injection was reduced, with 28 patients (80%) reporting they felt no fear when using the injection pen.
When comparing the syringe to the injection pen with regard to qualitative operability and convenience, more than half of the patients reported that their anxiety decreased or very much decreased. The audible click at the start and end of the injection could be well to very well heard by 66% and 91% of patients, respectively. The differences between the syringe and pen injection were significant for all three of the following measures: 1) fear of the needle, 2) fear of self-injection and 3) feeling of injection site pain (P<0.001). The majority of the patients in this study judged the 50 mg of YLB113-002 injection pen to be easy to use, convenient and well tolerated.
The study’s limitations included the lack of a control group due to the nature of an observational study, but all patients had previously used the prefilled syringe. Also, the self-reporting of results can lead to recall bias. Additionally, the number of patients in this study was very small, so the results may not be generalizable to the overall RA population.
However, the fear of injection did decrease among these patients who had previously used prefilled syringes, suggesting this new injection pen for YLB113-002 may be preferred by patients.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Hibino T, Yoshido T, Sagawa A et al. Qualitative survey-based evaluation of operability and convenience for the etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid arthritis. GaBiJournal. 2020; 9(3):100–107.
- Merck. News release: Indications expanded for Merck’s etanercept biosimilar Brenzys. 2020 Sep 25.
- U.S. Food & Drug Administration. Etanercept (Enbrel) approval letter. 1998 Nov 2.
- U.S. Food & Drug Administration. Enbrel (etanercept) label. 1998 Nov 2.
- U.S. Food & Drug Administration. Enbrel (etanercept) supplement approval for auto-injector. 2017 Sep 14.