Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies
Authors Stauffer VL, Sides R, Lanteri-Minet M, Kielbasa W, Jin Y, Selzler KJ, Tepper SJ
Received 12 April 2018
Accepted for publication 17 July 2018
Published 17 September 2018 Volume 2018:12 Pages 1785—1795
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 4
Editor who approved publication: Dr Johnny Chen
Virginia L Stauffer,1 Ryan Sides,1 Michel Lanteri-Minet,2,3 William Kielbasa,1 Yan Jin,1 Katherine J Selzler,1 Stewart J Tepper4
1Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA; 2Pain Department, CHU Nice, Nice, France; 3Université Cote d’Azur, FHU InovPain, CHU de Nice, Nice, France; 4Geisel School of Medicine at Dartmouth, Hanover, NH, USA
Purpose: The aim of this study was to compare the usability and patient-rated experiences of an autoinjector with a prefilled syringe in patients with migraine, who self-administered galcanezumab, and to compare pharmacokinetic parameters between these devices.
Materials and methods: Patient-rated experiences with an investigational autoinjector and a prefilled syringe were compared in an open-label, 12-month study of once-monthly injections of galcanezumab 120 or 240 mg (NCT02614287). Patient-rated ease of usability was assessed with the Subcutaneous Administration Assessment Questionnaire (SQAAQ) and compared between devices. Positive responses on the SQAAQ were rated as “agree or strongly agree” to 12 statements. Tolerability was assessed by the frequency of injection-site-related adverse events (AEs) by device and injection location. In a separate study, galcanezumab pharmacokinetics in healthy subjects was compared between the devices (NCT02836613).
Results: In the open-label clinical trial, 179 patients used both the prefilled syringe and autoinjector at least once. The majority of patients (91%–97%) had positive responses on the SQAAQ to the use of autoinjector across the items assessed. There were 23 injection-site-related AEs with the first self-administered injection with the prefilled syringe (N=7) or autoinjector (N=16; P=0.061), with the most common AE for either device being injection-site pain. There were no significant between-device differences in injection-site-related AEs. For pharmacokinetics, the 90% CI for the ratio (autoinjector/prefilled syringe) of geometric least-square means for the galcanezumab area under the curve (AUC) concentration and maximum concentration (Cmax) was between 0.8 and 1.25, indicating no statistically significant difference in the galcanezumab concentrations regardless of the device used.
Conclusion: The ease of usability with either device was comparable, and there were no significant differences in tolerability between the prefilled syringe and autoinjector with the first self-administration; however, the analysis was not powered to detect a clinically significant difference. Galcanezumab pharmacokinetics were comparable between devices.
Keywords: galcanezumab, devices, self-administered injections, SQAAQ, pharmacokinetics
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