A multicenter, open-label study to evaluate the safe and effective use of a new electromechanical auto-injection device for self-injection of certolizumab pegol

ABSTRACT

Background

ava® is a new reusable electromechanical auto-injector (e-Device) with disposable, single-use certolizumab pegol (CZP) dispensing cartridges.

Methods

RA0098 (NCT03357471) was a US, multicenter, open-label, phase 3 study designed to assess whether the e-Device can be used safely and effectively by self-injecting patients. CZP pre-filled syringe (PFS) self-injecting patients (≥18 years) diagnosed with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, and Crohn’s disease received training and self-injected CZP using the e-Device at 2 visits. The primary outcome was the proportion of patients able to self-inject safely and effectively at Visit 2, defined as: 1) complete dose delivery, and 2) no adverse events related to the e-Device precluding its continued use.

Results

65/67 patients (97.0%) completed the study, 64/65 (98.5%) performed safe and effective self-injection at Visit 2, and 67/67 (100%) performed safe and effective self-injection at Visit 1. Patient satisfaction and self-confidence increased over the two visits. Overall, patients reported a preference for the e-Device (58/65; 89.2%) compared to a PFS (4/65; 6.2%).

Conclusions

Patients were able to safely and effectively self-inject CZP using the e-Device and most preferred ava® over a PFS. No safety-related findings impacting the benefit-risk ratio of CZP were identified.

KEYWORDS:

• Self-injection
• certolizumab pegol
• e-Device
• patient preference

Acknowledgments

The authors thank the patients, the investigators and their teams who took part in this study. The authors also acknowledge Susanne Wiegratz, UCB Pharma, Monheim, Germany for publication coordination and Oliver Palmer, BSc (Hons), Emma Phillips, PhD, and Simon Foulcer, PhD, from Costello Medical, UK, for medical writing and editorial assistance based on the authors’ input and direction.

Authors contributions

Substantial contributions to study conception and design: D Tatla, I Mountian, B Schiff, B VanLunen, M Schiff; substantial contributions to analysis and interpretation of the data: D Tatla, I Mountian, B Szegvari, B VanLunen, M Schiff; drafting the article or revising it critically for important intellectual content: D Tatla, I Mountian, B Szegvari, B VanLunen, M Schiff; final approval of the version of the article to be published: D Tatla, I Mountian, B Szegvari, B VanLunen, M Schiff.

Declaration of interest

D Tatla, I Mountian, B Szegvari, and B VanLunen are employees of UCB Pharma. M Schiff research/grant support from UCB Pharma; consultancy fees form UCB Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Data sharing statement

Underlying data from this manuscript may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplemental material

Supplemental data for this article can be accessed here.

Additional information

Funding

This study was sponsored by UCB Pharma. Support for third-party writing assistance for this article, provided by Costello Medical, UK, was funded by UCB Pharma in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).