Auto-injector device effective for self-administration of certolizumab pegol
A new reusable auto-injector e-device allows for the safe and effective self-injection of certolizumab pegol (CZP), according to a new study.
“Patients, including those with impaired hand function, were able to use the e-device safely and effectively and rated their experience positively; most patients preferred the e-device over a CZP prefilled syringe (PFS),” researchers said. “The e-device may help enhance patient experience and increase CZP treatment adherence, potentially improving clinical outcomes”
The multicentre, open-label, phase III study compared the new device with CZP PFS in terms of efficacy and safety in 65 patients (mean age, 52.4±13.2 years; 68.7 percent female) diagnosed with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, plaque psoriasis or Crohn’s disease. Sixteen enrolees had impaired hand function, as measured by a score of at least 13.5 in the Cochin scale. [Expert Opin Drug Deliv 2020;doi:10.1080/17425247.2020.1747430]
All but one (98.5 percent) of the participants were able to safely and effectively deliver self-injections using the e-device by the second visit. This was defined as the ability to administer the complete dose of CZP without resulting in device-related adverse events preventing its continued use. Notably, all 16 patients with impaired hand function could use the device successfully.
These corresponded to improved scores on the Assessment of Self-Injection questionnaire. Self-confidence, for example, improved from visit 1 to visit 2 (5.4±3.1 to 6.2±2.5), as did satisfaction (7.1±1.3 to 7.3±1.1). Negative feelings about self-injection likewise improved, with scores decreasing from 2.2±2.2 at baseline, before injections, to 1.6±1.6 at visit 2.
As a result, 89.2 percent (n=58) of the participants reported that they preferred the new e-device to their current devices. This trend was stronger in patients with hand impairments (93.8 percent) than in those without (87.8 percent).
In terms of device safety, nine patients reported experiencing treatment-emergent adverse events (TEAEs) over the course of the experiment, yielding an incidence rate of 13.4 percent. All cases were regarded as mild, and no episodes were severe enough to prompt permanent withdrawal from CZP.
The most common TEAEs were conditions at the injection site and infections and infestations. There was one case of injection site haemorrhage and was designated as an unsuccessful injection.
“These results suggest that using the e-device may help address some of the challenges associated with self-injection and increase patient satisfaction,” the researchers said, pointing out that patients with impairments in hand function tend to suffer from poorer dexterity, making self-injection difficult for them.
Aside from better functionality, the device also displays on-screen instructions, controls and progress tracker which may help improve the patients’ feelings of self-confidence, which, in turn, may contribute to a successful self-administration.
“Although the sample size was small and so should be interpreted with caution, these design features may explain why patients with hand function impairments were more likely to prefer the e-device over their previous device,” the researchers added.